Those of us who routinely counter antivaccine disinformation on social media have noticed a new antivax trope popping up again and again and again. It’s the claim that the spike protein produced by the mRNA in the Pfizer/BioNTech and Moderna COVID-19 vaccines (and now the adenovirus-based AztraZeneca and Johnson & Johnson vaccines) is highly toxic in and of itself outside of its association with the coronavirus infection itself. The intent is obvious: To portray COVID-19 vaccines as more dangerous than the infection. This new narrative by antivaxxers has led to their pointing to cherry picked studies with exaggerated findings, such as a study purporting to show that spike protein might cause pulmonary hypertension in the future or fantastical claim based on no science that those vaccinated with these vaccines “shed” spike protein, which then, miasma-like, poisons surrounding people to make them sick and, if they are women, screw up their menstrual cycles and even cause miscarriages.
They’re still at it.
Most recently, antivaxxers have been pointing to a study from the Salk Institute, UC-San Diego and Xi’an Jiaotong University in China. Behold Alex Berenson, the “pandemic’s wrongest man,” crowing about the study:
A few of my readers have asked me about this study, and I keep coming across antivaxxers crowing about it on Twitter. Misunderstanding a study like this, a study that the vast majority of them obviously haven’t read, much less understood, to spread antivaccine disinformation does get on my nerves after a while. So I responded.
Before I go on, the most obvious refutation to the claim that spike protein from COVID-19 vaccines is dangerous remains simple. Over 240 million doses of these vaccines have been administered thus far in the US alone, many more worldwide. If, as Berenson claimed, spike protein were so very, very toxic by themselves outside of the context of viral infection and at the concentrations produced in the body by the vaccines, we would have expected to see way more evidence of a safety signal related to vascular and clotting problems than we have. Right now, for instance, the J&J vaccine has been associated with a rare kind of clot at a frequency of roughly one or two-in-a-million. That’s not good evidence of horrific vascular toxicity due to COVID-19 vaccine spike protein. Of course, this leaves the question of whether, even theoretically, spike protein itself might be toxic, but as a practical matter, at least in the case of the level of spike protein made by the vaccines, the question has been answered with a resounding no.
But back to Alex Berenson’s claim.
It turns out that this study on a preprint server has been published in Circulation Research. It also turns out—surprise! surprise!—not definitely not to be “smoking gun” evidence for Berenson’s claims. Unlike the case of many papers cherry picked by antivaxxers to support their claims, it’s not that the paper is horrible, either. It’s not. It’s pretty decent, actually, at least as a preliminary, primarily observational study. Even more amusing, in it the authors expressly describe how their work actually demonstrates why vaccines that use spike protein as the antigen are so effective. One of them has also appeared on Twitter to take antivaxxers to task for misusing their study. (I’ll save these tidbits for near the end of the post.) It just amuses me that the antivaxxers citing this study have obviously not read the study itself, nor have they considered the background science and knowledge behind the study. They’ve just read the press release. What do you expect, though? They’re antivaxxers.
Since it’s the Salk Institute press release that’s doing most of the damage providing fodder for antivaxxers, let’s look at it first, and then I’ll look at the study:
Scientists have known for a while that SARS-CoV-2’s distinctive “spike” proteins help the virus infect its host by latching on to healthy cells. Now, a major new study shows that they also play a key role in the disease itself.
The paper, published on April 30, 2021, in Circulation Research, also shows conclusively that COVID-19 is a vascular disease, demonstrating exactly how the SARS-CoV-2 virus damages and attacks the vascular system on a cellular level. The findings help explain COVID-19’s wide variety of seemingly unconnected complications, and could open the door for new research into more effective therapies.
As the press release itself acknowledges, the concept that COVID-19 is primarily a vascular disease is not new. The observation that COVID-19 patients suffered from clotting problems led to this sort of speculation early in the pandemic.
Then:
While the findings themselves aren’t entirely a surprise, the paper provides clear confirmation and a detailed explanation of the mechanism through which the protein damages vascular cells for the first time. There’s been a growing consensus that SARS-CoV-2 affects the vascular system, but exactly how it did so was not understood. Similarly, scientists studying other coronaviruses have long suspected that the spike protein contributed to damaging vascular endothelial cells, but this is the first time the process has been documented.
Maybe, but let’s look at the paper itself. The first thing that those of you with access to the paper will notice is how short it is: Three pages, one figure. That’s because it’s not a full research paper, but rather a research letter. As a result, there’s no detailed Methods section, and the results are very briefly described (much too briefly, for my liking). To be honest, for some of the experiments, due to the brevity of the paper, I had a bit of a hard time making heads or tails of what, exactly, the investigators did. I’ll do my best trying to explain, however.
In brief, the the researchers used a “pseudovirus” that was surrounded by a “crown” of spike protein, like the coronavirus, but did not contain actual virus, dubbed Pseu-Spike by the authors. What is a pseudovirus? A reasonable question. In brief, a pseudovirus is a construct that has the external proteins of the virus of interest. There are a variety of pseudoviruses now, as described in this article in The Scientist:
Among these, researchers turned to models of the pathogen such as pseudoviruses and chimeric viruses that can be studied safely in labs with lower biosafety level (BSL) clearance than required for studying the wildtype version, in an effort to expand the study of the novel coronavirus. Pseudoviruses don’t replicate, rendering them harmless, but by replacing their surface envelope proteins with those of SARS-CoV-2, researchers can glean insights into the ways the pathogen infects cells.
And:
Pseudoviruses were first developed in the 1960s, after scientists began studying a vesicular stomatitis virus (VSV) isolated from cattle. In addition to replicating well in culture, they later learned that its surface protein, VSV-G, facilitates entry into all eukaryotic cells, making the virus a useful vector not only as a pseudovirus but as a ferry to deliver DNA into cells for therapeutic purposes. The first Ebola vaccine was developed using a VSV platform, and more recently, the virus has been engineered to seek out and destroy cancer cells.
HIV-based platforms, which came about in the 1980s, have since replaced VSV as the most common model for developing both pseudo- and chimeric viruses. Unlike VSV’s negative-strand RNA genome that must be transcribed once inside the cell, HIV’s positive-strand RNA genome can instantly begin translation, making pseudoviruses based on HIV faster to produce. HIV-based model viruses have now been used in many of the same applications as VSV, with scientists applying them to the study of diseases such as AIDS, SARS, MERS, and influenza.
Also, compared with natural virus, a pseudovirus can only infect cells in a single round, has broad host range, high titer, and is not easily inactivated by serum complement.
Unfortunately, it is not clear from the paper which of these platforms was used to produce the pseudovirus in the experiments or how that pseudovirus was developed and produced. This is the sort of information that a full-length research paper would describe in the Methods section and it’s important information for determining whether the pseudovirus used was likely to be a good model. In another issue with this paper, the authors also do not describe the “mock virus” that they used as a control or how it was constructed. As a result, I find it very difficult to interpret their results. In fairness, some of this confusion might be because I am not highly knowledgeable about this particular system and don’t have the background knowledge about methodology that the authors clearly assume that the reader possesses. On the other hand, in a paper this in a journal like Circulation Research, which is not a virology journal, and particularly given that this is a paper that was likely to make the news and be misused by antivaxxers after its release, explanatory details that allow scientists from other fields with knowledge of molecular biology (but who are not experts in this field) to understand what was done are critical. A Research Letter does not accomplish this.
What are their results, though?
Basically, the authors took pseudovirus or mock virus and instilled it into the tracheas of Syrian hamsters, three animals per experimental group. Another aspect of this study caught my eye, namely the amount of virus used, 5 x 108 pfu. For those of you not knowing what “pfu” stands for, it stands for “plaque-forming units.” Basically it’s a measure of the number of viable virus particles, virus particles that can infect cells and cause a plaque on a confluent layer of cells. That’s half a billion particles, far, far more of a viral challenge than the amount of virus launching any “natural” infection by SARs-CoV-2.
Using what is a highly artificial system, the authors compared the levels of a whole slate of protein markers related to cell signaling and oxidative stress in the mock- and Pseu-Spike-treated hamsters, as well as the histology of the lungs. I won’t go into detail about all of the markers examined, but rather will step back to take a longer view because it is not important for a lay person to understand all the phosphorylation of this protein or ubiquitination of that protein measured. (It’s also easy to get lost in the weeds of a study like this.) As stated, the authors found signs of inflammation in the alveoli (air sacs) of the Pseu-Spike-treated lungs, including thickened walls and inflammatory cells. They measured the levels of various proteins they deemed relevant:
AMPK (AMP-activated protein kinase) phosphorylates ACE2 Ser-680, MDM2 (murine double minute 2) ubiquitinates ACE2 Lys-788, and crosstalk between AMPK and MDM2 determines the ACE2 level.4 In the damaged lungs, levels of pAMPK (phospho-AMPK), pACE2 (phospho-ACE2), and ACE2 decreased but those of MDM2 increased (Figure [B], i). Furthermore, complementary increased and decreased phosphorylation of eNOS (endothelial NO synthase) Thr-494 and Ser-1176 indicated impaired eNOS activity. These changes of pACE2, ACE2, MDM2 expression, and AMPK activity in endothelium were recapitulated by in vitro experiments using pulmonary arterial ECs infected with Pseu-Spike which was rescued by treatment with N-acetyl-L-cysteine, a reactive oxygen species inhibitor (Figure [B], ii).
Translation: Compared to mock virus, Pseu-Spike altered signaling due to the ACE2 receptor, which is not surprising given that it’s been known for a year now that spike protein latches onto the ACE2 receptor in order to get SARS-CoV-2 into the cell. As a result, there was a lower level of ACE2 in the hamster lung tissue treated with Pseu-Spike, although looking at the Western blots in Figure 1B I am not particularly impressed by the magnitude of the decrease in protein level.
Also observed in the Pseu-Spike-treated hamster lung was decreased activity of eNOS, an enzyme that generates nitric oxide, as well as damage to the mitochondria, the “power plants” of the cell. The authors also did the same experiments in cell culture alone using pulmonary vascular endothelial cells (the cells the line the inside of the arteries in the lung), reporting that they recapitulated their findings, although they used spike protein at a rather high concentration (4 μg/ml). They also tested whether similar changes occurred in vascular endothelial cells genetically engineered to make a more stable and less stable version of ACE2. They did, although this is only suggestive, not slam dunk evidence, that it is the spike protein-induced degradation of ACE2 that results in these intracellular changes. The authors also reported that in pulmonary arteries isolated from the hamsters vasodilation induced by a drug called nitroprusside was not affected by Pseu-Spike, but the vasodilation caused by acetylcholine was impaired. Nitroprusside works by breaking down in the presence of oxyhemoglobin to produce, among other things, nitric oxide, while acetylcholine binds to specific protein receptors on the cell surface.
Indeed, I hate papers this short (e.g., some Nature or Science papers, which can be even shorter than this) because I can never quite figure out what the authors did; this is one of the rare cases of a paper that to me screams out for an online Supplemental Data and Supplemental Figures section, and I say this as someone who generally despises the trend to dump all sorts of data into supplemental sections.
My annoyances aside, let’s, for the sake of argument, take the results at face value and assume that this study shows what the authors say it shows, namely that spike protein damages endothelium, “manifested by impaired mitochondrial function and eNOS activity.” and can cause oxidative stress that destabilizes the ACE2 receptor, leading to lower levels of the receptor. The authors themselves note that by decreasing the level of ACE2, spike protein could actually decrease the infectivity of SARs-CoV-2, given that the coronavirus needs to bind to ACE2 to get into cells, while speculating that the dysfunction of endothelial cells could result in endotheliitis, or inflammation of the endothelium that more than makes up for the decreased infectivity.
But here’s the kicker, taken right from the final paragraph of the paper:
Collectively, our results suggest that the S protein-exerted EC damage overrides the decreased virus infectivity. This conclusion suggests that vaccination-generated antibody and/or exogenous antibody against S protein not only protects the host from SARS-CoV-2 infectivity but also inhibits S protein imposed endothelial injury.
In other words, the vaccine could be protective not just against infection by SARS-CoV-2 but also against endothelial injury from the spike protein.
I just want to reiterate again that this is a contrived system. It’s far from a worthless system, as pseudovirus systems have value in studying the role of spike protein in the pathogenesis of COVID-19. However, given the crapton of pseudovirus used in this hamster model, I really question any relevance of this system to vaccine safety issues with respect to mRNA- or adenovirus-based vaccines that produce the spike protein as an antigen. Why? The mRNA or adenovirus from the vaccines does not distribute extensively given that it’s an intramuscular injection, and the spike protein is highly unlikely to attain concentrations in the circulation anywhere near the high levels produced by the model used in these experiments. Moreover, the spike protein from the vaccine is not attached in a crown-like array on a virus particle (or pseudovirus particle), but rather exists as naked single protein molecules, and, as I described before, it’s unclear that in this form spike protein, compared to the “crown of spikes” that gives coronaviruses their name, is anywhere near as effective at causing these downstream effects in cells. Add to that the fact that mRNA, even the modified mRNA in the vaccine, doesn’t hang around very long and therefore doesn’t generate spike protein for very long. (Doubters should consider this: Why do the mRNA vaccines both require a second dose 3-4 weeks after the first dose if, as many antivaxxers claim, the vaccines crank out spike protein indefinitely?)
Indeed, one of authors points this very issue on Twitter:
I’ll conclude, as I have so often, by complaining about the press offices of universities hawking studies like this. The study itself, as I said, is interesting, but not evidence that existing vaccines that use spike protein as the antigen are unsafe or damage the vasculature. Add to that, again, the fact that >240 million doses of these vaccines have been administered in the US alone, all without a signal suggesting that they cause any sort of spike protein-induced blood vessel damage of the sort reported in this model. Unfortunately, the Salk Institute press release appears to have been written without any consideration as to how to avoid making it easy fodder for antivaxxers to use as propaganda. In the past, this sort of lapse was forgivable. In the middle of a pandemic, it is not, particularly given that on social media very few read the actual study while most read the no more than the press release or even much beyond the headline.
In fact, I have an idea for authors and university press officials from here on out. Any study of the spike protein’s role in the pathogenesis of COVID-19 should include in the study itself and in any press releases a strong disclaimer emphasizing how the results of the study do not say anything about the safety of COVID-19 vaccines, for the sorts of reasons I have listed above. Consider it a useful “pre-bunking” of the disinformation antivaxxers use basically any study about spike protein to produce these days.
365 replies on “About that Salk Institute paper on the “deadly” COVID-19 spike protein”
If you are so sure the COVID-19 vaccines are safe…I am still trying to figure out why there has been a MASSIVE increase in deaths reported to VAERS from the COVID-19 shots. Not a modest increase–a huge and unprecedented increase. Over 40% of all deaths ever reported to VAERS in its 30+year history have been reported in the last 4 months, from the COVID-19 vaccines.
I stopped by here last week to get some ideas on possible answers to this question, which I did get. I looked into them to the extent I could, and found none held water. None of our public health authorities have written any kind of analysis of this issue, and studies about COVID-19 vaccine safety avoid it.
http://www.virginiastoner.com/writing/2021/5/4/the-deadly-covid-19-vaccine-coverup
You really are poking the bear, aren’t you??
Yeah…I have a “thing” for informed consent.
Not “informed consent.” More like misinformed refusal, as I’ve written about many times before, for example, as part of this post. https://www.respectfulinsolence.com/2020/09/28/fisher-using-covid-19-to-spread-fear-about-all-vaccines/
Is this person suggesting that at a time we are engaged in an unusually large vaccination campaign, compared to the past, coupled with strong official efforts to increase reporting to VAERs (and some, though probably trivial numerically, intentional reporting to vaers by antivaccine activist), seeing an increase in VAERS report is surprising?
(And yes, I know the person tried to say vaccines numbers has not gone up. But since she doesn’t actually have access to the number of vaccines administered outside Covid-19 in this year, she’s basically making that up, especially given that we are before flu season, the only vaccine recommended for the general population),
I’ve never heard anyone suggest that Ginny was particularly bright.
Misinformation of the type you posted undermines informed consent.
Trying to point to raw VAERS reports numbers, ignoring the fact that they’re investigated and analyzed and examined and have shown no signals is an effort to misinform, even if it’s the result of lack of knowledge and understanding.
Dorit Reiss, your theories are interesting and all, but where is your evidence? Why are there no articles or research studies about the massive increase in deaths reported to VAERS? Except mine, of course…
Dorit Reiss said:
“Misinformation of the type you posted undermines informed consent.
“Trying to point to raw VAERS reports numbers, ignoring the fact that they’re investigated and analyzed and examined and have shown no signals is an effort to misinform, even if it’s the result of lack of knowledge and understanding.”
In other words, HIDING the massive increase in VAERS death reports from vaccine customers is actually NECESSARY for informed consent. That’s a hoot. I guess you gotta hope so, because I’ll bet 99% of them were totally unaware of it when they consented to the COVID-19 shot.
Naturally, I would have expected a few of the many pro-vax experts in the COVID-19 market (like you) to have written articles (like mine) about why the massive increase in deaths reported to VAERS is nothing at all to worry about. If it were possible, that is. But, NADA.
We could have avoided so much drama and controversy if the manufacturers had just created a traditional vaccine composed of the virus itself, as is done with influenza. Especially with a vax campaign this large (most if not all of the planet) tried-and-true would have been a safer bet.
You’re either very naive or disingenuous. (I can’t decide which.) No, no we couldn’t have “avoided so much drama and controversy.” Had existing COVID-19 vaccines been made the “old-fashioned way,” antivaxxers would have demonized them just as badly using most of the same tropes. The only misinformation they wouldn’t be able to use would be the “gene therapy” distortion.
Did it ever occur to you that there’s a reason why the first two successful vaccines were based on mRNA/lipid nanoparticle technology. Making coronavirus vaccines the “old-fashioned way” has been tried without much success. Moreover, mRNA has the huge advantage of being far more easily scalable to make huge quantities of vaccine and flexible so that the mRNA can be rapidly changed without having to go through the entire approval process again to cover variants. Indeed, I’d be willing to bet that flu vaccines will soon be based on mRNA technology given the success of COVID-19 vaccines. The technology used to make flu vaccines is primitive, dating back to the 1950s. Seriously, they still grow the virus that is killed to make the vaccine in millions of eggs! Also, before the pandemic, antivaxxers demonized the flu vaccine every year, in particular 11 years ago during the H1N1 pandemic.
@ NWO Reporter
New World Order, paranoid conspiracy theorists? Nothing will change your mind; but I’ll repeat:
Rise of antivaccinationists. Numerous blogs, social media
Lack of understanding how vaccine approved and how quickly made it to market. First, both phase 2 and 3 trials were run simultaneously for some. But the phase 3 studies included 30,000 or more participants, did follow-ups and continue them, and they did, despite lies, clearly include both minor and serious adverse events, including deaths. And they produced vaccines while clinical trials were being conducted. So ready if approved; but if not approved, government promised to reimburse. Earlier, once vaccine approved could take many months to produce. And though first mRNA vaccine approved, lots of research before on them. I was volunteer; but only after I reviewed my textbooks in molecular biology, genetics, and found every study done on mRNA vaccines. All of the above allowed antivaccinationists to play on people uneducated unscientific fears.
VAERS: anyone can submit. Nothing blocked. Post Hoc Ergo Prompter Hoc. Rooster crows, sun comes up. Does rooster crow cause sun to rise? Given all the antivaccinationist publicity, if someone dies after vaccine, people remember vaccine and, thus report. However, CDC has dedicated teams who investigate each and every report, including obtaining medical records. For instance, approximately 2,500 Americans die every day from cardiovascular disease, so if someone received COVID vaccine and died, say 10 days later, 25,000 American would have died before COVID or COVID vaccine existed. CDC looks at medical records closely. During criminal investigations, sometimes police may bring in numerous suspects; but doesn’t mean even one will be found to be the culprit. People like you and other antivaccinationists would probably just want to throw all in prison directly, save money on further investigation and trial, etc.
Again, nothing I say will change the mind of a paranoid conspiracy theorist, so why don’t you just crawl back under your rock.
Dr. Harrison, your theories are interesting and all, but where is your evidence? You may be willing to assume a “benign” reason for the massive increase in vaccine deaths reported to VAERS based on your prior knowledge, but we are dealing here with an entirely unprecedented situation–an increase so enormous that calling it “massive” is conservative. Why has no one made an organized attempt to analyze the situation? Why don’t you? You’ve already gotten your paper half-written in these comments–now all you need is the data and analyses to go with it.
You know oddly enough I had someone else give me the “anyone can submit to VAERS” excuse as to why I should discount what I read there. Many are noticing there’s far more deaths for Covid vaccines then there are for ‘regular” ones. The person who gave me this rhetoric had gotten nasty side effects from a Covid vaccine that very day with tingling and numbness in their legs, and still believed in the vaccines. What’s scary is I answered back well if VAERS can’t be trusted then who is keeping the numbers to keep up with the side effects and patterns then? You seriously expect someone who gets a blood clot or other disabling illness to get “help” from the CDC. That’s laughable, first of all most very ill people don’t have the time or energy and from what I have seen those facing side effects are being censored in endless public venues. There’s no where really to turn for them.
You know what’s funny is I believed the narrative until I noticed the extreme hand of censorship and then it woke me up. Something didn’t add up here. I believe 20 years ago, there’s no way these poor quality “vaccines” would have passed muster, their inability to provide true immunity or limit transmission fully being part of that picture. I sometimes think America has grown too corrupt and science too corporate owned and profit influenced to really create the level of scientific success we had before. Vaccines used to even have the expectation of actually working and being safe. This “gene therapy” they call “vaccines”, that don’t even have lasting power, are abysmal.
Some points:
There is increasing evidence that the vaccines do effectively reduce transmission.
The vaccines are not gene therapy.
https://www.respectfulinsolence.com/2021/02/16/latest-antivaccine-lie-about-covid-19-vaccines-theyre-gene-therapy/
https://www.respectfulinsolence.com/2021/02/19/mercola-falsely-claims-legally-moderna-pfizer-covid-19-vaccines-are-not-vaccines/
https://www.respectfulinsolence.com/2021/02/08/antivaxxers-misuse-vaers-database-to-spread-fear-of-covid-19-vaccines/
https://www.respectfulinsolence.com/2021/02/17/misuse-of-the-vaers-database-by-antivaxxers-continues-cardiac-edition/
https://www.respectfulinsolence.com/2020/12/31/bells-palsy-and-fake-covid-19-vaccine-aes/
500poundpeep
Did you ask your friend if they were going to report their problem with the pins-n-needles legs side-effects to VAERS?
If no one reports these effects the pattern can not be discerned.
It’s a death vaccine & you know it. Quit lying.
MANY TV doctors & other LIARS will suffer in the end for promoting this –
DEATH VAXXXXX.
The possibility that the spike protein produced by the mRNA can cause side effects could explain some of the infrequent but unusual symptoms. Many develop local pain at the injection site. In some patients the vaccine nano particles may not stay localized but travel elsewhere in the body where the inflammation could result in more damage, such as the CNS. Perhaps a safer way to vaccinate would be to inject into the biceps muscle with a tourniquet applied. The nano particles would be more likely to stay at the injection site. The spike proteins would be produced in the muscle itself. I don’t think it is safe to conclude that the side effects experienced by some people in the days following vaccination are a product of their imaginations.
Who says that the side effects are a product of imagination? Don’t forget, its only a side effect if it’s LINKED to the vaccination rather than occurring in close temporal proximity.
A sore arm would be normal, given you’ve just had a needle and some fluid stabbed into it. Also, the immune reaction itself would cause varying levels of pain and feeling a bit rubbish. I had a mildly sore arm and 24 hours of feeling a little crap. My partner had loads of muscle pain and felt terrible.
As for all the mega-deaths and spontaneously giving birth to two headed calfs etc. I’d take it more seriously if I though the people doing the shouting were competent.
1) Vaccines aren’t given in the bicep, they’re given in the deltoid.
2) Vaccines aren’t given into the bloodstream, so I don’t know what value a tourniquet would be? Where would you apply the tourniquet? At the elbow or shoulder? How long would you leave it on, knowing that a full tourniquet is very damaging?
I would leave it on until the head fell off. Just to be sure.
@NWO Reporter
“Over 40% of all deaths ever reported to VAERS in its 30+year history have been reported in the last 4 months, from the COVID-19 vaccines.”
Um, you are aware that this particular mass vaccination campaign involved first and foremost elderly and frail people? You know, people who have a rather limited life expectancy due to natural causes?
So yes, it is to be expected that many thousands of these people die every week — and that includes many people who have been recently vaccinated. Same thing happened in Norway: reports of lots of (very) elderly people dying withing one or two weeks after being vaccinated. No connection with the vaccinations could be established, and most causes of death were consistent with pre-existing conditions. Old people die, that’s how things go.
Anyway, I have a new homework assignment for you that might cheer you up: figure out the number of Covid-19 deaths vs. vaccination rates by age group, including trends, over the past 4 months.
Richard Rasker do you often critique articles without reading them? Or did you make a special exception for me?
“You know, people who have a rather limited life expectancy due to natural causes?”
Toldja.
@NWO Reporter
“Richard Rasker do you often critique articles without reading them? Or did you make a special exception for me?”
Do you often blindly pursue your own line of ‘reasoning’, completely ignoring what the other person says? Or did you make a special exception for me? (These questions of course are purely rhetorical, as this thread already shows the answers to be a resounding “yes” and “no”, respectively.)
Anyway, I didn’t critique anything. I merely provided the simplest explanation for your claim that relatively many people who received a Covid-19 vaccine were reported to have died.
The special exception I made for you is that I actually responded to you, even with all the red flags signalling that you are a conspiracy believer, an antivaccine crank, and possibly a troll. You most certainly are not looking for answers.
Richard Rasker, let me clarify: Your explanation about giving the C19 vaccine to frail elderly people is directly and specifically addressed (and refuted) in my paper. That’s why I chided you for not reading it.
Could i get like a ceiling cat oil on paint paper? I really dig your stuff.
CDC does study VAERS reports:
Shimabukuro T. Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine – United States, December 21, 2020-January 10, 2021. Am J Transplant. 2021;21(3):1326-1331. doi:10.1111/ajt.16517
Orac- you’re a huge dangerous LIAR.
And you are a moron. Some concrete criticism.
a doctor middle aged heart specialist in Florida fell over dead 15 mins after taking the jab. Listed as a heart attack death.
You need a job, check the local funeral parlors. Ever since the vaccine has come out they have been making money.
India stats show that the un vaxxed are not dying. Since they are the most un vaxxed nation but have the less deaths.
Sheepl, you are our annoying nieghbors, believe me we don’t want you dead.
Thank you.
Does any of you with experience in publishing in science journals have a sense for why and how authors choose the short research letter format, compared to a full article?
I do appreciate the authors speaking up, too.
That’s an interesting question. If you look at the single figure, it’s what I like to call a “mega-figure.” I mean, it’s got eight panels, some of which have four images. There’s enough material there for at least three figures, if not four. Four good figures can make up a respectable short paper in another format, and if they needed to pad it out they could have added a couple of figures verifying expression of their pseudovirus or something like that. So I’m not sure why they chose such a brief format, particularly given that there are so many authors.
As a shareholder in Moderna, Inc I would recommend you to stop deceiving your readers here and you should understand that defrauding the public during a clinical trial may put you at risk. You can comment and misrepresent in defining what you think is the mRNA platform here, but one place you can not is the UNITED STATES
SECURITIES AND EXCHANGE COMMISSION where you can learn what MODERNA‘S filing quarterly reports defines their mRNA-1273 aka Covid-19 vaccine as experimental gene therapy.
You can participate in wordplay all you want on the internet, in the media, or on Jimmy Kimmel- but as any investor understands, that a public company must use clear and true statements in their filings. I certainly hope you have good lawyers when people start pointing to this blog as interfering and misleading their informed consent; MODERNA and their shareholders believe in this technology but also understand its risks.
What is has become a great concern to me is that investors have more knowledge and proper disclosures to make decisions on investments than the public who are making decisions regarding their biological bodies. I have never seen so much gaslighting around technology or pharma in my life. I certainly feel it is important to keep the standards of informed consent and that is why I encourage you to spend a little time learning about mRNA.
I included some excerpts directly from Moderna’s SEC filings, so your readers can understand that they be called vaccine’s in the market but they are new Gene Therapy technologies.
Moderna, Inc.
Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict.
No mRNA drug has been approved in this new potential class of medicines, and may never be approved as a result of efforts by others or us. mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines.
•differences in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials to later clinical trials;
•preclinical and clinical data are often susceptible to varying interpretations and analyses, and many investigational medicines believed to have performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval;
•our investigational medicines may have undesirable side effects, such as the immunogenicity of the LNPs or their components, the immunogenicity of the protein made by the mRNA, or degradation products, any of which could lead to serious adverse events, or other effects. One or more of such effects or events could cause regulators to impose a clinical hold on the applicable trial, or cause us or our IRBs or ethics committees to suspend or terminate the trial of that investigational medicine or any other of our investigational medicines for which a clinical trial may be ongoing;
As a potential new class of medicines, no mRNA medicines have been approved to date by the FDA or other regulatory agency. Successful discovery and development of mRNA medicines by either us or our strategic collaborators is highly uncertain and depends on numerous factors, many of which are beyond our or their control. We have made and will continue to make a series of business decisions and take calculated risks to advance our development efforts and pipeline, including those related to mRNA technology, delivery technology, and manufacturing processes, which may be shown to be incorrect based on further work by us, our strategic collaborators, or others. Prior to the Phase 3 trial for mRNA-1273 and that of one other company, there had never been a Phase 3 trial in which mRNA is the primary active ingredient, and there has never been and there may never be a commercialized product in which mRNA is the primary active ingredient. Our mRNA investigational medicines that appear promising in the early phases of development may fail to advance, experience delays in the clinic, experience clinical holds, or fail to reach the market for many reasons, including:
•discovery efforts at identifying potential mRNA medicines may not be successful;
•nonclinical or preclinical study results may show potential mRNA medicines to be less effective than desired or to have harmful or problematic side effects;
•clinical trial results may show potential mRNA medicines to be less effective than expected (e.g., a clinical trial could fail to meet one or more endpoint(s)) or to have unacceptable side effects or toxicities;
•adverse effects in any one of our clinical programs or adverse effects relating to our mRNA, or our lipid nanoparticles, or LNPs, may lead to delays in or termination of one or more of our programs;
•the insufficient ability of our translational models to reduce risk or predict outcomes in humans, particularly given that each component of our investigational medicines and development candidates may have a dependent or independent effect on safety, tolerability, and efficacy, which may, among other things, be species-dependent;
*The positive interim data from the ongoing Phase 1 study of mRNA-1273, our vaccine candidate for the treatment of SARS-CoV-2, may not be predictive of the results of later-stage clinical trials, which is one of a number of factors that may delay or prevent us from receiving regulatory approval of our vaccine candidate.
The positive interim data we have announced from the ongoing Phase 1 study of mRNA-1273 are based on only the limited number of subjects enrolled in the first phase of the Phase 1 clinical study. Further results from the ongoing Phase 1 study or any interim results of our Phase 2 or Phase 3 studies for mRNA-1273 could show diminished efficacy as compared to the interim Phase 1 study results or that the neutralizing antibodies are not sufficiently durable without repeated boosting. We also may observe new, more frequent or more severe adverse events in subjects participating in these clinical studies. In addition, the interpretation of the data from our clinical trials of mRNA-1273 by FDA and other regulatory agencies may differ from our interpretation of such data and the FDA or other regulatory agencies may require that we conduct additional studies or analyses. Further, the assays being used to measure and analyze the effectiveness of vaccines being developed to treat SARS-CoV-2 have only recently been developed and are continuing to evolve. The validity and standardization of these assays has not yet been established, and the results obtained in clinical studies of mRNA-1273 with subsequent versions of these assays may be less positive than the results we have obtained to date. Moreover, the samples of convalescent sera, or blood samples from people who have recovered from COVID-19, used to benchmark the level of antibodies produced by subjects receiving mRNA-1273 in clinical studies, have been taken from a small number of people and may not be representative of the antibody levels in a broader population of people who have recovered from COVID-19. The future results in clinical studies of mRNA-1273 may not be as positive when compared to the antibody levels in other samples of convalescent sera. Various preclinical animal studies of mRNA-1273 are ongoing, including preclinical studies in non-human primates. If safety data observed in these preclinical studies are inconsistent with safety data from clinical studies, we may be required to conduct additional studies of mRNA-1273. Any of these factors could delay or prevent us from receiving regulatory approval of mRNA-1273 and there can be no assurance that mRNA-1273 will be approved in a timely manner, if at all.
SARS-CoV-2 vaccine (mRNA-1273) is being developed in collaboration with NIAID. BARDA has agreed to fund the advancement of mRNA-1273 to FDA licensure. Contracts and grants funded by the U.S. government and its agencies, including our agreements funded by BARDA and DARPA and our collaboration with NIAID
So Pfizer generated 3.5 BILLION dollars in revenue (a quarter of Pfizers total revenue) with a profit of 900 MILLION off of the Covid vaccine.
That was just in the first 3 months of this year. Somebody posted here that drug companies don’t make much profit off of the vaccines.
https://www.nytimes.com/2021/05/04/business/pfizer-covid-vaccine-profits.html?action=click&module=Top%20Stories&pgtype=Homepage
Vaccines can certainly be profitable.
Now imagine how Big Pharma would be cleaning up if there were NO Covid-19 vaccines. Drugs to treat Covid-19 are big business.
“in a report focused on antiviral drugs, Morningstar forecast more than $10 billion in sales potential for authorized treatments led by Eli Lilly’s bamlanivimab and Regeneron’s two-antibody combination or “cocktail” REGEN-COV (casirivimab and imdevimab).”
http://genengnews.com/a-lists/top-7-best-selling-covid-19-vaccines-and-drugs-of-2020/
That’s just two treatments. Add in all the others plus what’s coming down the pipeline, in addition to the vast amounts spent on drugs and other treatments for supportive care, and you’ll get a sense of the revenue that drug makers are foregoing in order to produce vaccines.
“Imagine how Big Pharma would be cleaning up if there were NO Covid-19 vaccines.”
This ‘skeptic trope’ is NOT a good argument against accusations of the “they’re just pushing vaccines for profit” ilk. Because, of course, for most intents and purposes, there is no monolithic Big Pharma, but rather a range of pharmaceutical firms that compete against one another. Pfizer isn’t foregoing profits in the treatment and supportive care market by producing a vaccine, because there’s no guarantee they’d get that business vs. it going to Lily, Regeneron and others.
Even just employing it as a heuristic, repeating the monolithic Big Pharma concept reinforces it, and is unwise as such.
Dr. Joel’s arguments about where vaccines sit in various firm’s business models, relative profitability, etc. are ultimately more persuasive, as they are based in reality, however less pithy they may make for Tweet level comments.
While we’re on the subject of Big Pharma(s), I shall point out again that the pharma sector contributes heavily to Republican politicians, including those who have coddled pediatric anti-vax in the past, and those who are doing various forms of COVID denial, anti-vax, anti-mask yadda yadda now. But then, these Republicans are pro-business, anti-regulation, and not inclined to do anything to rein in piratical profiteering wherever the pharmas do try to engage in it.
Lest anyone doubt that Pfizer has a significant greedhead scumbag quotient, as a former resident of New London, CT, I can assure you that they do.
@ Dangerous Bacon
Yep, right on, the companies would make far more for treatments. Hospitalization would cost, doctors bills, and for those still working, loss of income, etc. So, the overall cost to us and the economy would be exponentially more than for the vaccines.
However, funeral directors would have a thriving business.
Bacon
Seeing as the vaccines do not totally prevent infection, the pharm companies are still making money on various treatments. They are nor forgoing any money, they are collecting on both vaccines and treatments right at this moment.
Do you really believe J&J has stopped producing their other products to just make vaccines?
@ Aelxa Vaccines did prevent smallpox and polio. Pharma do not sell antiviral therapies targeting them.
Aarno
You just come out of left field with this comment……
“@ Aelxa Vaccines did prevent smallpox and polio. Pharma do not sell antiviral therapies targeting them.”
We are talking about the COVID-19 “vaccine” injections and various medications being used to treat COVID-19 making the Pharma companies lots of money.
Your comment has nothing to do with COVID-19, merely a sign of your need to say SOMETHING anytime I write a comment.
It certainly would be better if no one did.
@Aelxa OK, let us speak about COVID vaccines. They work in Israel:
https://www.worldometers.info/coronavirus/country/israel/
Market for remdesevir is shrinking fast, you notice.
Narad
?????????!!!!!!!
Me to Aarno…
“Your comment has nothing to do with COVID-19, merely a sign of your need to say SOMETHING anytime I write a comment.”
Narad…
“It certainly would be better if no one did.”
I guess your name is No One now, Narad.
You just could not resist…..mmmmm ?.
Aarno
Remdesevir is an antiviral.
Do you really think SARS-CoV-2 is the only virus on Earth plaguing humans?
There are alot of other viruses out there available to use Remdesevir against.
And Israel is only one very tiny country, the rest of the World is still fighting like hell. Did you see India lately.
Oh, and another fully vaccinated US doctor who had gotten the two doses of the Pfizer “vaccine”, an infectious disease specialist in fact, just died after catching COVID-19 in India when he went there to help family.
It is interesting to note that two people in the US MidWest have been found infected with the India variant already, which has I believe about 17 gene changes on the protein spike. These are two people who never went to India.
I love how the US is not allowing travel to the US from India…. except for US citizens and Permanent Residents.
Doesn’t that remind us of the “No travel from China” travel ban back in February 2020???Except for US citizens and Permanent Residents of course. Who brought the virus home, of course.
The government appears not to have learned the lesson yet, NoTravel No Matter Who You Are!!!!!!! Or else complete strictly monitored two week quarantine in a virtual prison when you come home, and if you break quarantine you will pay!!!
Do not count out Remdesivir yet, you may need it soon even with your vaccination.
@Aelxa I though we speak about COVID. Remdesivir is FDA approved for COVID.
Antivirals are very virus specific, I am afraid that most of them have are use against COVID
Did you miss the fact that mRNA vaccines are 95% effective ? It is not 100%. I am sure that you would prefer 95% possibility win to 0%. I certainly do.
I was talking about you, not to you. Mind your place.
I was talking about you, not to you, F*ckwit. Mind your place.
^ Whoops. I thought the first one (from the iPad) didn’t go through last night. Sorry about the dup.
Wanna guess how much more they would make if they sold a cure instead?
@ Kay West
Compared to profits and total revenue, the profits from vaccines are a small part. The current pandemic aside, on average world-wide sales of vaccines account for about 2 – 3% of total pharmaceutical revenues and vaccines are much more expensive to produce.However, drug companies make much more profit on statins, insulin, etc. because people have to use on daily basis and the profit margins are much higher.
And if COVID dies down, a basically short-term profit, some continued; but not at current high levels.
However, it really doesn’t matter that they made a profit. Do you expect any company/corporation to produce something for nothing or at cost? If you are against profit and have some family member or friend with diabetes, I suggest you recommend them NOT use it since the company makes a profit, actual obscene profits.
One extreme example is epi-pens, developed in 1950s by monies from U.S. military, cost about $10 to manufacture and currently sell two for $400. However, in UK and other nations sell two for $50 and companies still make money.
The bottom line is that overwhelming evidence shows that the COVID vaccines save lives, save hospitalizations, save people from long COVID, etc. I would rather a company make a profit on something that saves lives than much of the stuff that Americans waste money on.
However, the FDA has the power, but doesn’t implemented, to limit profits on approved drugs, etc. And the New York Times article clearly indicates their profit margin was way to high; so, FDA should act; but doesn’t change just how incredibly effective the vaccine is. But the profit margin just another example of how our government more in pockets of corporations rather than protecting interests of citizens.
Well I guess I should be happy that Joel didn’t call me “DEARY”
You really need to read up on the EPIPEN. The reason the cost of the EPIPEN went up was that Richard Durbin in 2013 sponsored a law which made it almost mandatory that all school should have EPIPENs (not the generic kind but the brand name drug, EPIPEN had spent over 4 Million dollars to get this law passed) in every school. At the same time the FDA had a back log of over 4,000 generic drugs waiting for approval four of these were generic EPIPENs .
But to my point on Pfizer making 900 Million dollars in 3 months from vaccines was to point out that everyone will need boosters and will ensure a continuing cash flow.
As you always talk of your minority friends and the fact that you are Jewish etc. etc. You claim to read mountains of books, articles, research guess you missed these little tidbits
“Why Every Racist Mentions Their Black Friend”
“Feeling threatened leads people to overestimate the importance of past actions.”
https://www.psychologytoday.com/us/blog/the-inertia-trap/201405/why-every-racist-mentions-their-black-friend
“Making Mountains of Morality From Molehills of Virtue: Threat Causes People to Overestimate Their Moral Credentials”
https://journals.sagepub.com/doi/abs/10.1177/0146167214533131
So not only are you a sexist but a racist/bigot.
Nope.
^ There was a subsequent hearing, but my back is killing me and I just want to make it to the end of the Cubs game, so I’m not going through it.
@Kay West Merck and Pfizer top drugs before COVID are there:
https://www.fiercepharma.com/pharma/top-10-drugs-from-new-merck-new-pfizer
You notice that Gardasil just makes into list. Treatment of chronic diseases, and conditions is more profitable than few times vaccine shot, no surprise here.
@ Kay West
“Why Every Racist Mentions Their Black Friend”
I’d really to meet the genius who declared that having a black friend is a proof of racism.
(For the record: I have no friend and do not want any.)
According to the CDC, the “United States Government” has purchased ALL COVID-19 vaccines–owns them until they are injected into someone. I have no idea what the purchase price was… https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html
No wonder India is as bad as Alabama. You should be ashamed.
As an aside, I’ve really taken a liking to these d8 carts. Too much so for my comfort.
Anyways, I was picking up another one today and the guy got chatty. He asked me If I had my shots, he clarified that, indeed, the second one will put you on your ass for a couple days. He “had to be honest” and state that he is not getting it because he has all these “questions”. I told him his stuff was sketch and to “have a nice day.”
900 million off 3.5 billion is only 25% profit. That’s not a lot at all percentage-wise. That’s about what Walmart has to clear on sales to stay profitable.
Christopher
The Pfizer company made 3.5 Billion in total revenue from all products made and sold, and 900 Million of those total revenues was profit from the sale of the “vaccine”.
That means 25% of all their profits came directly from “vaccine” sales.
Pfizer’s other drugs are highly profitable, the one I have to take every day has a retail price of $10,000 a month.
Compare that to a “vaccine” that only costs about $6 an injection. Of course there are alot more people getting Pfizer’s “vaccine” injected than people who need to take my daily injection every day..
Read more carefully.
If Walmart made 25% of their profits from a single product being sold, they would be ecstatic.
Considering the damage of the virus and the flailing reaction to it have caused to the world, maybe Pfizer did not get enough profit from the vaccine. We should want everyone to be motivated to have the next vaccine ready even before a pandemic happens.
That requires a huge possible payoff, Because most of those efforts will never be rewarded. 10 or 100 years from now we may have another Spanish flu, such a unexpected bolt of lightning event is the one where we’ll need a vaccine yesterday.
The most expensive ( mrna) covid vaccines are reportedly about $20 apiece, with the other types being far cheaper ($2?) Even for an individual who shrugs off the virus as many do, $20 is far less than the economic and health damage of their possibly being a vector to pass the virus along. The vaccine also means that they can go back to normal work and everyone else can receive the products of that work.
So the pharma business model means that they sometimes push out expensive stuff that is of less than advertised benefit, in this case there’s a case that they are being underpaid.
That strikes me as a lowball. I mean, the CDC price for a dose of, e.g., Twinrix (in a 10-dose pack) is $6.20.
far cheaper ($2?)
No, going from memory probably ~&10 though the Indian Gov’t has been pressuring the Serum Institute to produce one at $3 which probably means they are below cost. This may be one reason among many that the Institute is moving a lot of production capacity to the UK.
Today the VAERS death reports, which are acknowledged to be less than 10% of the actual cases tell their own story. The under-count has always been there so the comparison stands anyway. With more than 12,000 deaths associated with the COVID “vaccines” alone, this is about 4 times the total from all vaccines combined since 1901!
The slimy “Fact Checkers” all over this since it was merely equal, have NO legitimate answer so shift the goal posts or create straw-men. The first response has been the old “There is no proof the vaccines were the cause of death” but this ignores the fact that and all criticism of the system is equal for all VAERS reporting. What they do not point out is that “Proof” isn’t a thing in science. A theory gets support from evidence but it can be disproved with other evidence so proof is a red-herring. They ignore the fact that any false reporting on VAERS faces 25 years in prison and it is not mandatory, most doctors do not even know it exists and the doctor must be convinced the vaccine was the cause and state as much.
The only way to make it less likely for anyone to take the time and responsibility to fill in a report, would be to put it behind a locked door with a Minotaur guarding it.
Believe what you like. Facts are available for your due diligence and they will catch up to you this time whether or not you care to pay heed to them. This is for the suitably informed not entirely without it’s entertainment aspect. It does seem like a giant cognitive test with the elements of both classical Darwinist theory and it’s modern tongue in cheek variant.
There are almost daily hilarious famous last words live sketches playing out globally if one keeps an eye out. It comes however with very real risks to the healthy in body and mind. Both directly from the true unclean, which are those who have become walking prion factories randomly infecting un-vaxxed around them with the actual problem at the heart of it all. The virus was only relevant as a carrier for these little devils. The more efficient method being to jam them into your bloodstream, (proved now, not just local as ‘assumed’) and even to make people into mega factories on a microscopic scale of the gain of functioned wee beasties. That be the genius of the mRNA version of these abominations.
The other concern we the free and unbranded humans of this planet have is of course the zombies, that intuition first but increasingly science and psychology is pointing the way towards. Get jabbed sure, I’m not stopping you, but try and force me and you won’t live long enough to die from yours or develop a taste for brains. The blindness to the sheer fascism of the demands being made by the maskhole cult which has nothing to do with science unless we refer to the kind which existed before Francis Bacon’s time, is astounding. Every damned thing being “demanded” by the frightened sheep flies directly in the face of the core of human rights since WWII.
It is as if the oaths and ethics training with which modern medical training and daily supervision have evaporated overnight in the face of something nobody would for the most part know was going on if they weren’t plugged into the media trumpeting the “War of the World’s” level of destruction ongoing just outside their curtains or the next hill if your curtains happen to be open. Better shut them anyway, the COVID may see you and naturally you know it can penetrate walls and glass if it wants to. NUREMBERG CODE my babies. Look it up if you’ve never heard of it or think it is some Novel you say you’ve read meaning you’ve heard the “Title” before. Read it and think about every thing being ordered to us all by our dictators. It isn’t a case of “The code is more what you’d call ‘guidelines’ than actual rules.” as Hector Barbossa said either.
This claim was addressed on a related blog…
https://sciencebasedmedicine.org/vegan-cardiologist-dr-joel-kahn-is-amplifying-misinformation-and-conspiracy-theories-about-covid-19-vaccines-and-vaers/
Looks like a lost cause.
This is my kind of vaccination incentive:
https://www.foxnews.com/us/new-jersey-offering-free-beer-for-covid-19-vaccine-recepiants
Wow. This article says basically nothing about the entire point of the study itself, instead opting to spin the paper for something else entirely. The paper found evidence for and concluded that the spike protein causes vascular damage even without any viral matter whatsoever(!), and in turn, COVID-19 is largely a vascular disease. Almost nothing in this ‘analysis’ even addresses this. Perhaps it would be best to stick to breast cancer surgery instead of getting lost in the vaxx/antivaxx wilderness without a compass because of the obvious Dunning-Kruger effect at play here.
Silly troll. The entire blog post addresses EXACTLY what the paper shows in terms of the effects of spike protein on vascular endothelium, the weaknesses of the model used, and why this study is NOT evidence that spike protein made by COVID-19 vaccines causes vascular damage. Seriously, you’re the one suffering from Dunning-Kruger.???♂️
Wrong again. You provide no scientific basis to refute the findings of this study. Blathering on about vaccines and avoiding the very point of the study itself, in which it is clear that the spike protein — even without viral RNA — damages the vascular system. They have provided evidence that COVID-19 is as much a vascular disease as it is a respiratory disease.
I suggest you keep your surgical mask on, because when you take it off your Dunning-Kruger is exposed for all to see.
If you read the post, it is not challenging the possibility that COVID-19 can cause vascular damage – in fact, it supports it – or the possibility that the spike protein is involved, though it points out the limits of this study as evidence.
What it’s correcting is the use anti-vaccine activists are trying to make of this possibility to attack COVID-19 vaccines. The post explains why that’s without basis.
@Dorit: This new generation of drive-by trolls is, if it were even possible, impressing me even less than previous generations of drive-by trolls. I think our drive-by trolls are getting more ignorant and obtuse in their attacks.
“76er” is pretty clearly a repeat visitor under different names, given the “wrong again” bit.
Here’s an excellent description of a change they’ve made to the spike protein in the vaccines that almost certainly changes how the vaccine spike protein bonds with the ACE2 receptor (even if it was possible that the vaccine spike protein was freely circulating). Essentially, the viral spike protein injects part of itself into the ACE2 receptor via spring action, making for a much tighter bond than you would normally get from protein-protein interaction. The vaccine spike protein has been modified to prevent this spring action. There’s also some discussion as to why this modification prevents the ADE adverse reaction that a number of failed vaccines have produced.
https://cen.acs.org/pharmaceuticals/vaccines/tiny-tweak-behind-COVID-19/98/i38
If what the article describes is at all accurate, vaccine spike protein simply won’t bond very well at all. And the variants of concern are believed to be more infectious because they bond much better with ACE2 than the original.
“Narad” is clearly a repeat visitor under the same name. Given the whole “Narad” bit.
It is anoying.
For goodness sakes they removed one vaccine from the market for “blood clots”.
Ok tell us why and how the “spike proteins” from the vaccines won’t do the same damage in the body?
Still didn’t read the entire posting, did you 76er?
You know, this recent influx of antivax trolls is even more ignorant than the last batch.
@ 500 pound peep: because there are so very many fewer spike proteins generated from vaccination than from infection.
That’s why.
Thought that this might be interesting blog fodder for you.
https://www.bbc.com/news/blogs-trending-56845610
The damage being done by this sort of thing–and all the rest–is that public health experts are now resigned that we will NOT reach herd imminity and that instead of eradicating the virus we will move to managing it with minimal hopitalizations and deaths–something like flu.
https://www.nytimes.com/2021/05/03/health/covid-herd-immunity-vaccine.html?searchResultPosition=7
Even with 100% of a region/country vaccinated herd immunity is likely temporary. Variants continue to breed in many parts of the world and they will show up sooner or later. Herd immunity will have to be global, and that won’t happen soon.
Mike Adams ( Natural News, Monday):
the spike protein is a bioweapon that will spread from person to person resulting in massive death. Extermination! There is no need to vaccinate more people because it will SPREAD by itself..
He is obviously confabulating based on an article that says vaccines of the future may function in this manner.
In other news..
we may not ever reach herd immunity
Thanks, anti-vaxxers, your efforts have beedn successful
BEEN
@ Denice Walter
“Thanks, anti-vaxxers, your efforts have beedn successful”
There also is a shortage of materials for vaccine manufacturing, I’ve heard. And patent issues seem to be problematic in the current context. Logically, patents should not be an impediment to vaccine manufacturing and hence delivery, but a catalyst. I may be uninformed, but I do not believe antivaxxers have a huge audience nowadays in, say, India. Vaccine hoarding also was counter-productive. Something is wrong in that policy architecture or lack thereof…
@ F68.10:
“.. I do not believe antivaxxers have a huge following nowadays, in, say, India.”
Heartrending, unforgettable images of Indians trying in vain to get medical assistance/ oxygen for family members, makeshift clinics set up outside of Sikh temples, funeral pyres everywhere..
Doctors of Indian origin around here and internationally are trying to help as are many governments.
Sceptics who follow anti-vax lore for years have speculated that a return of VPDs because of low vaccination rates might serve to counter anti-vax talking points because many anti-vaxxers are too young to remember massive outbreaks of measles etc in the past. Their leaders now try to convince them that Covid doesn’t affect them or is not real to keep them from making the connection which we’ll all see as vaccine rates increase ( such as in Israel, California, NY area, New England, UK). I imagine some anti-vaxxers will blame it on poverty in India or something being wrong with the population that makes the more vulnerable.
I thought our local (NZ) antivaxxers couldn’t sink any lower until I found one last night who was claiming that no-one’s dying of covid-19 in India – all those deaths (according to her) were due to starvation.
Absolutely repulsive individual.
Because of course that’s what Mikey’s claiming…?
Even better ( or worse):
Tenpenny has a video 8 Ways mRNA Covid Vaccines Can Kill You
and it’s just as atrocious as you imagine. Circulating around Brghteon, Bitchute, PRN, other highly suspect BS sites
I won’t repeat her mchanisms of action
Mikey is now ranting about what Dr Hotez wrote in Nature in his usual unreality-based fashion AND he lists the doctor’s phone numbers, twitter and ways to contact his employers. Orac is familiar with Mikey’s work.
“The authors took mock virus and instilled it into the tracheas of Syrian hamsters.”
Are you sure this was published in Circulation Research, not The Onion?
I see the three page paper has 21 (count ’em… twenty-one) co-authors. Did each of them write one-seventh of page? At that rate, how many 1/21ths of a publication does it take to get tenure or promotion.
I’m sure it’s no consolation, but college and university press offices are just as bad or worse in the way they generate PR out of the humanities as with the sciences. But then, they don’t answer to the academic side of the institution, but to the development (i.e. fund-raising) department, which is higher up the pecking order. Anyway, I definitely do feel your pain there.
Eh, that’s not a totally absurd number of authors, in the grand scheme of things. The people who actually did the work, plus everyone’s PI gets to be a lot of people really quickly.
Have you ever seen the author sections on a physics paper? That can be a whole page of names, if it’s done at some place like CERN.
This was always a PITA in the ApJ Letters.
@ NWO Reporter:
You write: “Dr. Harrison, your theories are interesting and all, but where is your evidence? You may be willing to assume a “benign” reason for the massive increase in vaccine deaths reported to VAERS based on your prior knowledge, but we are dealing here with an entirely unprecedented situation–an increase so enormous that calling it “massive” is conservative. Why has no one made an organized attempt to analyze the situation? Why don’t you? You’ve already gotten your paper half-written in these comments–now all you need is the data and analyses to go with it.”
The bottom line is that the CDC has teams that investigate thoroughly each and every VAERS report of a serious adverse event, which, of course, death is serious. They access medical records, etc. So, whether you accept my reasons for the increase in reports or not, they have been investigated and were NOT found to be caused by the vaccine. As for my assuming a “benign” reason, whatever the reason is, it wasn’t the vaccine and I don’t assume that antivaccinationist websites and social media are benign; but that is a different story.
As I wrote, police may in some crimes have only a few suspects and in some crimes have many; but if they do there job, doesn’t matter why they had few or many. Maybe not a perfect analogy; but it makes the point.
And, as I’ve written several times, no matter how well I document my reasoning, you will find either a reason to reject it or come up with something else. That is what people who subscribe to paranoid conspiracy theories do.
Tell me, have you ever read a single book on immunology, epidemiology, microbiology, etc.? If not, then you don’t understand the basics of how and why vaccines work. However, an analogy I’ve given before is military war-games. Simply, military put through simulations of real combat without live ammunition. Vaccines introduce microbes in some form that they don’t represent live ammunition; but everything else, so, just as with military, our immune systems are trained and ready.
Why don’t you give up? The vast majority of people following this blog just find you, at best, amusing, at worse, an example of many of the problems we have in this nation.
Ginny is just attention-whoring. She seems to have abandoned her old blog (with all the gems of wisdom from Rappoport) and now is dropping links to her personal site. Those are the real payload; the hit-and-run word blobs are just frosting.
Listen to the language this shill uses, the first thing he does is label anyone who doesn’t trust this particular vaccine an “anti-vaxer” repeats the word and gives his psychoanalysis of hypothetical people he doesn’t even know, what a clown
“psychoanalysis of hypothetical people”
Hamlet? Smeagol? To which hypothetical people do you refer?
Orac’s article evidently opened a portal to a woo dimension.
Only those with hypothetical intelligence can traverse it.
I find that deeply concerning how the
word “anti-vaxxer is being abused.
I took all the other vaccines that were necessary, including TB ones when I was in education when I was young.
Those vaccines didn’t have the risks of these Covid ones.
One thing I notice is when questions are not answered and ad hominens or trying to discredit your debaters comes first as a technique, it shows a problem there.
Where did you grow up? BCG has never been a routine vaccine is the US.
One notes that you have not pointed out a single error in fact, science, or interpretation of this study. Instead, you distract by perseveration on a single word that offends you. It’s a obvious dodge so that you don’t have to address the substance of the post. You could prove me wrong with substantive refutations, but I highly doubt that you will.?
“I took all the other vaccines that were necessary”
Which vaccines currently recommended for adults and children do you endorse as safe and effective?
No, those older vaccines didn’t have the risks of the COVID ones.
They had more.
The smallpox vaccine is dangerous, and has serious side effects. Think about why you don’t have to take that one any more.
It’s just ignorance and most likely people paid my pharma. Some are just pro animal torture and lack empathy. Rise above. I stand with the indigenous, natives, aborigines….the original antivaxxers not the limited view that Western Medicine is the only way and holy grail. It’s a brainwashing and lacks zero ethical compass.
Some questions for you.
Why is there open and active censorship of regular people discussing their side effects from the Covid vaccines being censored on social media? I belong to two Covid vaccine side effect groups on Facebook, two with memberships in the thousands were removed, one while I was reading it. Why is all this censorship happening? You can crow about conspiracy theorists but when regular people are being silenced that’s a problem.
If the spike proteins harm people with Covid19 and give them blood clots, why wouldn’t spike proteins from Covid “vaccines” do the same? Isn’t the fact many of these vaccines have given people vascular related problems like blood clots and heart inflammation a wake up call? I would like to know when the manufacture of spike proteins in the body of the vaccinated turn off.
Why are people being labeled “anti-vaxxers” to silent them when many who question the Covid “vaccines” and the safety of new mrna technology received all other vaccines. I got a tetanus shot just last year because it was due. I know that one is safe and effective. Don’t you see the manipulation in tossing terms like that around to silence critics or those who question the safety of these vaccines?
Why do they want to give experimental vaccines to children who have little to no risk from Covid where the long term effects of these vaccines is far worse?
Have you read any of the cases on VAERS like about the 15 year old who had a heart attack. It doesn’t take that much time to do a basic internet search to find the endless tragic outcomes from these vaccines.
Do you know the way to San Jose?
Will you still love me tomorrow?
What’s the freqency, Kenneth?
It’s ultra ultra wide band. The tuning is temporal, no one frequency bucket has any detectable power.
It’s so loud yet completely hidden in the herd.
“If the spike proteins harm people with Covid19 and give them blood clots, why wouldn’t spike proteins from Covid “vaccines” do the same?”
This was pretty well explained in the article, but to cover it again, the vaccines (all of them) make way, way, way less spike protein than an infection.
It’s like the difference between a handfull of sand and a landslide. One of those will destroy your house. The other will not.
Also, since you brought up your tetanus shot (probably a Tdap, depending on what country you live in), what kind of vaccine is that? Do you know that technology? Are you interested in learning?
It looks like in some people it’s enough spike proteins to do harm to them if one looks at the long lists of adverse affects. The blood clots and myocarditis etc in some patients as a case in point.
One odd thing is how becoming ill, [for most a few days] has become normalized with this vaccine when they tell people your immune system is being primed to fight Covid. While side effects happen with other vaccines, there was not this idea that one was to have to take to their bed and puke for a few days because the “vaccine was supposedly working”.
I don’t mind finding out how tetanus shots work. All I know is I got it, and life was fine. I had no ill effects and I can trust it to work, and happy to have gotten it.
I wasn’t like 10 plus people I knew who got the Covid vaccines getting sick for a few days. [I know of one that had seizures and two who had tingling and numbness in their legs. It was weird as a chronically ill person to watch healthy active people marching off, and taking a vaccine that made them sick. One lady was in bed for two weeks, and I believe had to visit a hospital. One of my elderly friends had to call 911 she got so sick. There’s a reason that they have posted articles about people getting the first shots and not returning for the second. I know the posters here do not agree with my opinion that the Covid vaccines are poor quality but that is one factor that plays into my opinion.
I know you all assume that everyone who is rejecting Covid vaccines are all hopeless and ignorant antivaxxers but if I took other vaccines, doesn’t that prove that does not apply to me? There’s many others like me as well. That’s why I think it’s disappointing that your main arguments here seem to be saying “you’re a bunch of crazy anti-vaxxers!” I don’t even trust alternative/holistic medicine and have told people much of it doesn’t work–don’t get me started on homeopathy, so some here need to open their eyes.
Most traditional vaccines work from a small piece of an inactivated virus or bacteria etc. I am a layperson so not explaining this exactly but that’s how they worked and they are proven safe. mRNA is something totally different. I in fact have interest in finding out if a more traditional vaccine is available for Covid besides mRNA vaccines, I would look at it’s safety of course.
Some people may choose to be late adopters, or are taking a wait and see approach.
Not everyone is the type of personality that wants to get a new medical technology before they work the kinks out. I’ve had enough medical suffering and already have am almost deaf. I don’t need to add more. I would think a more friendly approach would work for this blog rather then the stance, of anyone who questions mRNA vaccines, is a “crazy anti-vaxxer” because it’s simply not true.
fivehundredpoundpeep:
Hi, friendly neighborhood immunologist here.
A couple of things.
First, there are other vaccines that have a reputation (and data to back it up) of making people feel pretty cruddy after getting immunized. When I got my smallpox immunization I had a running sore for about a month and the lymph nodes in my armpit on that side swelled up for a couple of days. I personally have not had a yellow fever vaccination, but friends have told me it can really wipe you out.
Second, because COVID is still circulating heavily in the population some people are getting COVID after their first shot (less likely but not improbable) and some might think that their COVID symptoms are actually from the vaccine.
Third, you would probably find the history of the development of vaccines very interesting and useful, but in general the progression over time is to include less and less of the pathogen of interest to make the vaccine safer (either from reversion to wild type or side effects). So going from attenuated virus to killed virus to protein subunit to mRNA is introducing only the minimum material needed for the immune system to mount a response without the risk of disease.
I don’t assume the vaccine hesitant are “crazy anti-vaxxers” – I hold that designation for the people who deliberately spread lies about vaccines that I then have to spend time debunking for my friends who don’t have the knowledge base to debunk for themselves.
I saw her today at the reception….
Here we go…
“one while I was reading it.”
Wow. Yep, that’s the government or possibly thier Kindle tool.
Oh look at mr. mediocre on tv here complaining about how he can’t say fuck on tv.
Well you don’t have to believe me, but I was on Facebook reading it, when it went poof! and this censorship is happening. People even just questioning the vaccines can be banned from a myriad of discussion boards.
You know free speech used to be something that was important to Americans. I guess I am an old lady I remember when there were actual investigative journalists. This has nothing to do with being a jerk cussing on TV but people talking about personal side effects from vaccines.
That doesn’t mean the local paper is duty-bound to give you an op-ed.
@ fivehundredpoundpeep
You write: “If the spike proteins harm people with Covid19 and give them blood clots, why wouldn’t spike proteins from Covid “vaccines” do the same? Isn’t the fact many of these vaccines have given people vascular related problems like blood clots and heart inflammation a wake up call? I would like to know when the manufacture of spike proteins in the body of the vaccinated turn off.”
Imagine a finger cut off and used for fingerprints. Cut off, it can’t do anything. Same with S-spike protein. It isn’t attached to the virus, can’t do anything but be recognized by immune system, just as cut off finger can be fingerprinted. The mRNA that is responsible for the production of S-Spike protein disintegrates in a few hours, so, once disintegrated, no more S-Spike protein manufactured.
The S-Spike Protein from the virus isn’t the cause of blood clots. It is antibodies reacting to different aspects of the covid virus that also react to endothelial cells in blood vessels. Called autoimmunity. Every person has a different assortment of antibodies. Sometimes these antibodies recognize both an aspect of the invader and, while not exact, some aspect of a cell, so they attack both the invader and the cell. This is also the main explanation for several autoimmune diseases, e.g., diabetes. However, the S-spike protein is so specific and different from blood vessel endothelial cells that basically zero chance that antibodies that target it would also target blood vessel endothelial cells.
You write: “Why do they want to give experimental vaccines to children who have little to no risk from Covid where the long term effects of these vaccines is far worse?”
First, they are NOT experimental vaccines. They have gone through the same Phase 1, Phase 2, and Phase 3 clinical trials as any other vaccine. While children do have little to no risk, some have been found to have endothelial damage; but more importantly, since they interact with many others, even though they shed fewer viruses, they put at risk many others, e.g., those who can’t be vaccinated because of certain autoimmune diseases, those undergoing chemotherapy for cancer, etc. And any of those at risk could be, for example, exposed while out shopping, in parks, etc. Plus, recent research has found that some of the newer variants of COVID are in fact infecting kids. While few die, more and more are developing variants of long Covid.
You write: “Have you read any of the cases on VAERS like about the 15 year old who had a heart attack. It doesn’t take that much time to do a basic internet search to find the endless tragic outcomes from these vaccines.”
According to American Heart Association: “Each year, approximately 6,300 children younger than 18 years of age experience out-of-hospital cardiac arrest ”
That is approximately 17 every day. So, since I’ve not seen the exact VAERS report, let’s say the heart attack occurred three days after the shot. Without the shot, 51 kids would have a heart attack. A parent might think the vaccine was involved and report it to VAERS; but the CDC has active teams that thoroughly investigate each and every serious adverse event, including accessing medical records. Just because something happens after a vaccine doesn’t mean vaccine responsible. Roosters crow, the sun rises, doesn’t mean the sun rises in response to roosters crowing. This is a logical fallacy called Post Hoc Ergo Prompter Hoc. Quite possibly the kid had an underlying birth defect, perhaps not noticed until first heart attack, etc.
Reference:
American Heart Association. Youth & Cardiovascular Disease. Statistical Fact Sheet 2015 Update. Available at: https://www.heart.org/idc/groups/heart-public/@wcm/@sop/@smd/documents/downloadable/ucm_472920.pdf
Thanks for explaining the S-Spike Protein, that helps, and I just asked question again but had not read your response yet, so thank you.
I still believe we need more study for long term effects of these vaccines but thanks for at least admitting that some people medically should not be vaccinated. I have multiple autoimmune diseases some that are very serious, one has even deafened me [nearly deaf at severe and profound level] Also many people including me have had anaphylaxis and my history of this is severe. It does seem you would have a more reasonable approach then one size fits all and would be at least open to some people not being viable medical candidates for the vaccines. I had no choice but to keep my health care going, aka going to medical places even during the worse of the lock downs.
I did admit to someone yes there will be some statistical deaths, Grandpa Joe would have died on the Tuesday he got the vaccine just by chance, but having read so many bad side effects, I don’t think we can brush off all the side effects as being under the statistics umbrella. Just read CovidVaccinated on the reddit board. Yes I know it’s reddit. I am not a doctor with access to medical records but for SO MANY to be given such horrific outcomes, that place is a wake up call. As a chronically ill person I hang out on medical boards and beyond the individuals I know who got sick, seeing people complain about horrible things in reference to Covid vaccines has not been pleasant either.
I am not a Republican or anti-vaxxer that thinks Covid is not real. I wear the masks etc.
@fivehundredpoundpeep (out of nesting here): I also have an autoimmune disease, and my doctor made a point of getting me vaccinated early because of that autoimmune disease: both because of the effects of the disease, and because the treatment for that disease is an immunosuppressant drug. That wasn’t just her: the state’s list of people to be prioritized when they were still saying “over 70 or certain specified medical conditions” included people receiving immunosuppressant therapies.
More generally, it sounds like you may be one of the (relatively few) people who shouldn’t be vaccinated for medical reasons. If you look at any of the sensible FAQs about the vaccine, they include things like “I have an autoimmune disease, should I get this vaccine?” and the answer is “talk to your doctor about your specific health risks, this is more complicated than we can cover in a FAQ.”
Vicki
I hope you are aware that since you are on an immunosuppressant drug, that the vaccine most likely did not activate your immune system to make antibodies.
Just this last week there was a report of a man on a immunosuppressant drug who got a COVID-19 vaccine, waited two weeks and went out to dinner with friends. He promptly got COVID-19 and died.
Testing showed that he had made Zero antibodies to COVID-19.
So if you think you are protected, you are most likely not. You should ask your doctor to run an antibody test to see if you made any antibodies at all in response to your “vaccine” injection.
Until you have positive proof of adequate antibody protection, you should be wearing a mask and taking all precautions to protect yourself from infection with COVID-19.
And how long the “vaccine” will work for you if you did make antibodies….that is an unknown. In non-immunosuppressed people they expect it to protect from six months to a maximum of about a year.
@Vicki Here is rheumatology advice:
https://www.rheumatologyadvisor.com/home/general-rheumatology/acr-covid19-vaccine-clinical-guidance-for-patients-rheumatic-musculoskeletal-diseases/
You perhaps do not know that Aelxa is always lying. If your body produce zero antibodies, you must life in a bubble.
“Why is there open and active censorship of regular people discussing their side effects from the Covid vaccines being censored on social media? ”
Good thing you’re here on Orac’s blog where you can make dozens of posts, without any of them being deleted.
Some questions for you.
Why is Orac responsible for your inability to find the same Facebook comment twice?
Why are you pushing the only Covid vaccine with actual dangerous side effects (the old-fashioned J&J blood clot vaccine made the way that you like with no new technology. Have you read about the VAERS report about the vaccine that caused a child to turn into the Incredible Hulk? It doesn’t take any time at all to see the tragic results of non-vaccine use – real people die, but since there’s no vaccine to blame, those deaths don’t matter.
Yes and their excuse “ removed for spreading medical misinformation” unashamed hypocrisy!
Yesterday, Tucker Carlson railed against colleges that will require their students to be vaccinated for COVID before they return to class.
At which point he invoked (surpise, surprise) the Association of American Physicians and Surgeons opposition to college vax requirements and endorsed parents complaining to the deans, and other unspecified acts of ‘resistance”.
His rant included advancing the idea that the vaccine affects women who are pregnant or breastfeeding, and speculating that it could negatively impact fertility. He didn’t mention the ‘the spike protein is toxic by itself!’ line yesterday, but give him time. I’m sure he’ll get to it, as he continues to represent himself to the Fox audience as the voice of the ‘real science’.
Carlson’s program draws the highest ratings in cable news, and many pundits believe he would win the GOP nomination for POTUS in 2024 if he chooses to run.
University vaccines mandates aren’t new. Here is a 1925 case about them. https://casetext.com/case/wallace-v-regents-etc
(I know that’s not your point, but it might be helpful to readers).
TV and video demand tension and controversy, or the audience clicks to another tab. A presenter has to find or create that tension, or the mass audience will run away and their show will be canceled. Maybe he believes there is a danger to the vaccinations. maybe he doesn’t and he’s just trying to hold onto audience share, Maybe he’s really a science nerd without the science background, and is thus misled.
So, write him a calm and reasoned letter laying out the evidence, or enlist a well-known biologist to do so. TV never was and never will be a reliable source of impartial information.
“So, write him a calm and reasoned letter laying out the evidence, or enlist a well-known biologist to do so. ”
I shall assume this bit of comedy is unintentional.
Either that, or it’s disingenuous.
“Carlson’s program draws the highest ratings in cable news”
Funny, I have never seen him listed on the standard pirate site top dalies.
This is a what I see has been missed from the reference by Kay West to the NYT article. In the notes of the financial statements is ” Adjusted Income(2) Before Tax (IBT) Margin for BNT162b2, – High-20s as a Percentage of Revenues” or the description is ” The BNT162b2 revenue projection incorporated within Pfizer’s 2021 financial guidance includes 1.6 billion doses that are expected to be delivered in 2021 under contracts that have been signed through mid-April 2021. This guidance may be adjusted in the future as additional contracts are executed.
Adjusted(2) IBT margin guidance for BNT162b2 incorporates the current expectation for revenues for the product, less anticipated Adjusted(2) costs to manufacture, market and distribute BNT162b2, including applicable royalty expenses and a 50% gross margin split with BioNTech, as well as shared R&D expenses related to BNT162b2 and costs associated with other assets currently in development for the prevention and treatment of COVID-19. It also includes R&D expenses related to other mRNA-based development programs which are excluded from the collaboration with BioNTech. It does not include an allocation of corporate or other overhead costs.” Note the 50% gross margin split, which means their pricing is twice the margin they are reporting as I read it, which I do not have a problem with, nor is this really a discussion about money because their pricing is in line.
The exciting news from the Earnings Conference Call readout “we are continuing our efforts to evaluate the Pfizer-BioNTech COVID-19 vaccine in additional populations. •We expect to hear back shortly from the FDA on our application for expanded Emergency Use Authorization for our COVID-19 vaccine to include individuals 12 to 15 years of age.•The Pfizer-BioNTech pediatric study evaluating the safety and efficacy of our COVID-19 vaccine in children six months to 11 years of age is ongoing. We expect to have definitive readouts and submit for an EUA for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children six months to two years old are expected in the fourth quarter.•We also expect to have Phase 2 safety data from our ongoing study in pregnant women by late July/early August.
“we are making progress with improving the stability of our COVID-19 vaccine.•On Friday, we submitted new stability data to the FDA, and we believe we could soon receive an update to the EUA Prescribing Information allowing the vaccine to be stored at standard refrigerator temperatures (2°C to 8°C) for up to four weeks. •We also are working on a ready-to-use formulation that, subject to generating supportive stability data and obtaining regulatory approval, could potentially be stored at standard refrigerator temperatures for up to 10 weeks, and up to six months at -50°C to -70°C. If successful, we expect to have the data to support this formulation in August.Fifth, as we move closer to a potential approval for our investigational 20-valent pneumococcal conjugate vaccine for adults – which, if approved, may be launched during an ongoing pandemic – we plan to begin this month a study of co-administration of the Pfizer-BioNTech COVID-19 vaccine with the 20-valent pneumococcal conjugate vaccine ”
” we are evaluating the safety and immunogenicity of a third dose of the existing formulation of our COVID-19 vaccine to understand the effect of a booster on immunity against the SARS-CoV-2 variants in circulation. Additionally, we have started an evaluation of an updated, prototype variant version of our vaccine that encodes the spike protein of the lineage B.1.351 SARS-CoV-2 variant, which includes the mutation E484K, first identified in South Africa. This study is designed to establish a regulatory pathway to update the current vaccine to address any future variant of potential concern in approximately 100 days, if needed. We expect to have immunogenicity data for both studies in early July”
“Pfizer has emerged as a leader in mRNA development, and we are exploring a wide range of opportunities for the technology.We are making rapid progress with our potential flu mRNA program, and we aim to maintain mRNA leadership with two potential game-changing mRNA approaches to a flu vaccine expected to enter the clinic in the third quarter of 2021.We will test multiple constructs in Phase 1/2 to facilitate swift selection of an optimal tetravalent flu product dose regimen. We aim to develop initially a tetravalent flu vaccine using the modified mRNA platform. Pending the generation of favorable immune and tolerability Phase 1/2 data, a potential rapid progression to Phase 3 is possible, given our large-scale pharmaceutical science and manufacturing capabilities.We also are exploring the potential to address other infectious diseases that we plan to discuss in the near future.In addition to prophylactic vaccines for infectious diseases, we believe mRNA has the potential to address a wide range of therapeutic areas, including cancer and genetic disease. As you have seen, today we have increased our 2021 R&D guidance to reflect our plans to increase our mRNA capabilities, build momentum in our targeted areas of interest, and deliver on mRNA’s breakthrough potential for the benefit of people worldwide. You can expect to hear more about our plans and potential applications in the coming weeks.”
https://investors.pfizer.com/investors-overview/default.aspx
I’m updating and I’m not completely comfortable with doing this out in public — seems a me time kind of thing.
Serious question here guys.
My daughters both living in London were both vaccinated due to the UK governments continual threat of the truncating of basic liberties to the non vaccinated particularly not being able to travel to see me as I reside in another country (so you might understand my nauseating sense of guilt should they now experience side effects, in fact I’m now contemplating vaccination Incase there is any possibility of death).
Does anyone know of any proven methods to prevent or reverse any of the harmful byproducts of Covid vaccinations? I’m looking at medicinal fungi studies now.
God Bless
?
There is no proof given in this article that demonstrates that the amount of spike protein produced in the humastudyody is less than that of the virus itself. Which peer reviewed studies is this from? It’s not in the Pfizer or Moderna applications.
There is basically nothing in this piece that addresses the demonstration of how spike protein alone is a dangerous mechanism. The stimulated antibodies take weeks to formulate, in which time the spike proteins have replicated constantly — remember a thing called cellular division??
In December the CDC declared that spike proteins were a “harmless” part of the virus, now this study contradicts that with evidence.
More lyrics and a melody, and you’ve got a winner.
Read it again.
The author of the Salk Institute scientific article, went himself to Twitter and addressed the overuse of his “demonstration”, notably when extrapolating it as evidence of harm from the spike protein in vaccine.
His tweets are quoted by Orac.
Remember a thing called RNAse? The mRNA is short-lived and won’t be around for the cell division.
And anyway, a cell division won’t multiply the present mRNA. It’s not that a mitosis does. And the mRNA are not part of the cell genome..
The spike proteins produced by the cells aren’t floating around anyway. Mostly. They end up either anchored in the cells’ membranes or cut into bits by the cell itself and presented at its surface as targets for the immune system.
The spike protein is a transmembrane protein. It’s that it does. Getting stuck in the producing cell’s membrane. That’s how the newly-formed virions can collect them and add them to their surface, when they exit the cell – they snag a bubble of cell membrane on their way out of the cell.
The mRNA injections are delivered in liposomes — which means they are not available to RNAse that are just floating about — otherwise they would be shredded/destroyed too rapidly. Instead we have lipid nanoparticles that we are given no documentation on how they travel and what tissue they are likely to be embedded in. I understand the mRNA is not subject to cellular division, but are the spike proteins? Where is the evidence this is or is not the case?
Those who are reporting heart attacks/clots/etc from the vaccines: is it perhaps because some liposomes get embedded and then the immune system does it’s job: cytotoxic attacks on cells that appear infected with viruses? Or maybe it’s spikes that escape cells and latch onto others that then cause endothelial growth and clotting? Or why not both?
I am not ‘tolling’ to ask seriously for at least one peer reviewed study that demonstrates a quantitative analysis of how much spike protein is actually created in the human body — measured directly — and not just via indirect observation measuring IgG or whatever antibodies.
Thanks.
“Embedded”? What would that accomplish?
The LNPs are taken up by antigen-presenting cells and then head off to the lymph circulation. Have a review.
@76er MRNA will go into cell, and there RNA would be destroyed by RNAase
I consider the vaccines poor quality because of the need for constant boosters, the short term even expected [more mild illness]–those who don’t have severe effects but flu like illness, and the fact they do not give full immunity like traditional vaccines. Of course this is differing opinions I understand. With the transmission, yes you are right they are studying more on that but I have seen contradicting articles and studies. Pfizer is more the one in the 90s, isn’t J&J lower in effectiveness?
Thanks for your other articles and links, I will read those and will comment later on them on their comment list. I am short on time now so that will later on. I am interested in what you have to say on the gene therapy matter. I believe when examining issues in looking at both sides. I am still not pro-mrna vaccines but will see what you say on the matter.
What about that gene therapy matter?
The mRNA vaccines are not gene therapy.
Stop listening to people who are dishonest in their definitions.
You can define gene therapy as “using nucleic acids in a medical treatment” – i.e.; as the mean used in the treatment.
But then, you don’t get to pivot and use the other possible definition, i.e. the one using the target of the treatment. The usual definition of gene therapy is a treatment which will modify the genome, or modify the way the genome is being run by the cells.
To be honest, up until recently, most actual gene therapies approaches fitting the latter definition, would also have fit the former definition.
But again, one is precise or one is not.
Now, if you have in mind other applications of mRNA technologies, some of them could be gene therapies, you will have to be more specific.
Athanic
Only in the USA.
An article in Pharmaceutics published in February 2020 called “Opportunities and Challenges in the Delivery of mRNA based Vaccines”
“mRNA vaccines are only targeted for cytoplasmic delivery, circumventing the risk of genomic integration [4]. The relatively short half-life results in transient and more controlled expression of the encoded antigen. Moreover, mRNA can be produced in a cell-free environment by in vitro transcription (IVT), thereby eschewing the use of microbes or cultured cells for production, and avoiding the associated quality and safety issues in the production. This permits simple downstream purification and rapid and cost-effective manufacturing [5]. However, mRNA is often promulgated on the grounds of the popular opinion that when using mRNA, unlike DNA, the stringent gene-therapy regulations are bypassed because mRNA does not integrate into the host genome.
However, in reality, this only holds true in the US since in Europe, any active pharmaceutical ingredient, which contains or consists of a recombinant nucleic acid, used in or administered to human beings, falls under the scope of the regulation for advanced therapy medicinal products [6]. Therefore, mRNA-based therapeutics are categorized as gene therapy.”
These so-called mRNA “vaccines” are not gene therapy, in the US ONLY.
In Europe where they invented the use of mRNA they are classified as GENE THERAPY.
You know, the change in the name makes perfect sense since no one in America will willingly and easily take a treatment that is Gene Therapy. Call it a “vaccine” instead and most people are programmed from childhood to take vaccines will allow it to be injected into their bodies.
So you all can call it a “vaccine”, but I will call it what it is called where it was invented….. Gene Therapy.
And if you think I am against Gene Therapy, I take an injection of recombinant Human Growth Hormone made by Pfizer every evening but I know exactly what gene therapy is and this medicine saves my life every day, and it is my choice to take it. And I know what the risks are for this specific treatment I take.
@Aelxa Gene therapy is fixing a lethal gene. Ethical problems are caused by this fact.it woiuld be permanent altering the genome. MRNA vaccines are transient, and should not cause worries. Europe has accepted mRNA vaccines, gene therapy would cause much more discussion. It is strange, too, that something can be gene therapy in one country and not in another. We are speaking about a regulatory pigeonhole there.
Aarno
If you read my other posting on the topic, these mRNA “vaccines” are also considered Gene Therapy by the US government per the Vice President of a company which has to jump through those legal hoops to get their mRNA and recombinant products approved for use in the US.
Legally Gene Therapy is using genes to prevent or treat disease.
The mRNA in these “vaccines” carry genes into the cytoplasm, genes that the cytoplasm uses to make more of those genes…..which genes are the spike protein.
Hence legally these mRNA “vaccines” ARE Gene Therapy.
Tough tooties, dude. Like I told someone else you can dislike it, but you will lose in court if you say they are not Gene Therapy.
@Aelxa However, FDA thinks that they are vaccines:
https://www.fda.gov/media/142749/download
“The SARS-CoV-2 pandemic presents an extraordinary challenge to global health. There are currently no FDA-licensed vaccines to prevent COVID-19. Commercial vaccine manufacturers and other entities are developing COVID-19 vaccine candidates using different technologies including RNA, DNA, protein, and viral vectored vaccines. ”
Notice RNA vectored vaccines. FDA has bigger boots here, I would say
As a shareholder in Moderna, Inc I would recommend you to stop deceiving your readers here and you should understand that defrauding the public during a clinical trial may put you at risk. You can comment and misrepresent in defining what you think is the mRNA platform here, but one place you can not is the UNITED STATES
SECURITIES AND EXCHANGE COMMISSION where you can learn what MODERNA‘S filing quarterly reports defines their mRNA-1273 aka Covid-19 vaccine as experimental gene therapy.
You can participate in wordplay all you want on the internet, in the media, or on Jimmy Kimmel- but as any investor understands, that a public company must use clear and true statements in their filings. I certainly hope you have good lawyers when people start pointing to this blog as interfering and misleading their informed consent; MODERNA and their shareholders believe in this technology but also understand its risks.
What is has become a great concern to me is that investors have more knowledge and proper disclosures to make decisions on investments than the public who are making decisions regarding their biological bodies. I have never seen so much gaslighting around technology or pharma in my life. I certainly feel it is important to keep the standards of informed consent and that is why I encourage you to spend a little time learning about mRNA.
I included some excerpts directly from Moderna’s SEC filings, so your readers can understand that they be called vaccine’s in the market but they are new Gene Therapy technologies.
Moderna, Inc.
Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict.
No mRNA drug has been approved in this new potential class of medicines, and may never be approved as a result of efforts by others or us. mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines.
•differences in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials to later clinical trials;
•preclinical and clinical data are often susceptible to varying interpretations and analyses, and many investigational medicines believed to have performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval;
•our investigational medicines may have undesirable side effects, such as the immunogenicity of the LNPs or their components, the immunogenicity of the protein made by the mRNA, or degradation products, any of which could lead to serious adverse events, or other effects. One or more of such effects or events could cause regulators to impose a clinical hold on the applicable trial, or cause us or our IRBs or ethics committees to suspend or terminate the trial of that investigational medicine or any other of our investigational medicines for which a clinical trial may be ongoing;
As a potential new class of medicines, no mRNA medicines have been approved to date by the FDA or other regulatory agency. Successful discovery and development of mRNA medicines by either us or our strategic collaborators is highly uncertain and depends on numerous factors, many of which are beyond our or their control. We have made and will continue to make a series of business decisions and take calculated risks to advance our development efforts and pipeline, including those related to mRNA technology, delivery technology, and manufacturing processes, which may be shown to be incorrect based on further work by us, our strategic collaborators, or others. Prior to the Phase 3 trial for mRNA-1273 and that of one other company, there had never been a Phase 3 trial in which mRNA is the primary active ingredient, and there has never been and there may never be a commercialized product in which mRNA is the primary active ingredient. Our mRNA investigational medicines that appear promising in the early phases of development may fail to advance, experience delays in the clinic, experience clinical holds, or fail to reach the market for many reasons, including:
•discovery efforts at identifying potential mRNA medicines may not be successful;
•nonclinical or preclinical study results may show potential mRNA medicines to be less effective than desired or to have harmful or problematic side effects;
•clinical trial results may show potential mRNA medicines to be less effective than expected (e.g., a clinical trial could fail to meet one or more endpoint(s)) or to have unacceptable side effects or toxicities;
•adverse effects in any one of our clinical programs or adverse effects relating to our mRNA, or our lipid nanoparticles, or LNPs, may lead to delays in or termination of one or more of our programs;
•the insufficient ability of our translational models to reduce risk or predict outcomes in humans, particularly given that each component of our investigational medicines and development candidates may have a dependent or independent effect on safety, tolerability, and efficacy, which may, among other things, be species-dependent;
In addition, since the path to licensure of any vaccine against COVID-19 is unclear. Unexpected safety issues, including any that we have not yet observed in our Phase 1 or 2 clinical trials for mRNA-1273, could lead to significant reputational damage for Moderna and our technology platform going forward and other issues, including delays in our other programs, the need for re-design of our clinical trials and the need for significant additional financial resources.
Risks related to our reliance on third parties
*We have in the past entered into, and in the future may enter into, strategic alliances with third parties for the development and commercialization of our development candidates and investigational medicines. If these strategic alliances are not successful, our business could be adversely affected.
Manufacturing our vaccine candidates involves a complicated process with which we have limited experience. We are dependent on third-party organizations to conduct a portion of our vaccine manufacturing activities.
*The positive interim data from the ongoing Phase 1 study of mRNA-1273, our vaccine candidate for the treatment of SARS-CoV-2, may not be predictive of the results of later-stage clinical trials, which is one of a number of factors that may delay or prevent us from receiving regulatory approval of our vaccine candidate.
The positive interim data we have announced from the ongoing Phase 1 study of mRNA-1273 are based on only the limited number of subjects enrolled in the first phase of the Phase 1 clinical study. Further results from the ongoing Phase 1 study or any interim results of our Phase 2 or Phase 3 studies for mRNA-1273 could show diminished efficacy as compared to the interim Phase 1 study results or that the neutralizing antibodies are not sufficiently durable without repeated boosting. We also may observe new, more frequent or more severe adverse events in subjects participating in these clinical studies. In addition, the interpretation of the data from our clinical trials of mRNA-1273 by FDA and other regulatory agencies may differ from our interpretation of such data and the FDA or other regulatory agencies may require that we conduct additional studies or analyses. Further, the assays being used to measure and analyze the effectiveness of vaccines being developed to treat SARS-CoV-2 have only recently been developed and are continuing to evolve. The validity and standardization of these assays has not yet been established, and the results obtained in clinical studies of mRNA-1273 with subsequent versions of these assays may be less positive than the results we have obtained to date. Moreover, the samples of convalescent sera, or blood samples from people who have recovered from COVID-19, used to benchmark the level of antibodies produced by subjects receiving mRNA-1273 in clinical studies, have been taken from a small number of people and may not be representative of the antibody levels in a broader population of people who have recovered from COVID-19. The future results in clinical studies of mRNA-1273 may not be as positive when compared to the antibody levels in other samples of convalescent sera. Various preclinical animal studies of mRNA-1273 are ongoing, including preclinical studies in non-human primates. If safety data observed in these preclinical studies are inconsistent with safety data from clinical studies, we may be required to conduct additional studies of mRNA-1273. Any of these factors could delay or prevent us from receiving regulatory approval of mRNA-1273 and there can be no assurance that mRNA-1273 will be approved in a timely manner, if at all.
Our reliance on government funding and collaboration from government and quasi-governmental entities for certain of our programs adds uncertainty to our research and development efforts with respect to those programs and may impose requirements that increase the costs of development, commercialization and production of any programs developed under those government-funded programs.
SARS-CoV-2 vaccine (mRNA-1273) is being developed in collaboration with NIAID. BARDA has agreed to fund the advancement of mRNA-1273 to FDA licensure. Contracts and grants funded by the U.S. government and its agencies, including our agreements funded by BARDA and DARPA and our collaboration with NIAID
????♂️
@Mark As a Moderna shareholder you should read FDA documents:’
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19
It is about how to get EUA for vaccines. So first, you can get it, and secondly, they are vaccines.
Can you please explain what you mean by “the need for constant boosters”?
Are you talking about the COVID vaccines that use the prime-boost immunization strategy? That’s extremely standard in immunology and is used for many, many different vaccines.
Are you talking about vaccines like the influenza vaccine, which is re-formulated every year for the dominate strain? That’s not a failure of the vaccine, that’s addressing the mutations of the virus.
Or are you talking about vaccines for diseases like tetanus and pertussis? Those require boosters because humans don’t build long-lasting immunity to those pathogens (specifically the toxins they produce). That’s not a failure of vaccine design, that’s the immune system not working how we would like. (Humans don’t build long-lasting immunity after catching whooping cough either, so it’s not just the vaccine.)
JustATech
You know very well that the CDC and the companies making these “vaccines” are saying we may need regular “boosters” to deal with the coming variants sooner rather than later.
So why ask 500poundpeep about what she means regarding boosters?
@Aelxa. If virus changes enough, a new vaccine is needed. Booster is used, when the virus has not been changed.
Aarno
It is obvious you are not keeping up…….
“In the trial, Moderna is testing a 50-microgram dose of its vaccine in previously vaccinated individuals. It found the booster dose increased neutralizing antibody responses against the original virus as well as B.1.351 and P.1, two variants that have since spread to other countries, including the U.S.
The company also said a booster shot of its other vaccine, which it is calling mRNA-1273.351, generated an even better immune response over its current vaccine against the B.1.351 variant from South Africa. The new vaccine is a variant-specific booster shot intended to target B.1.351.”
Why don’t you tell Moderna that? That they should not call their other shots, that are not the present version being given to people, “booster” shots.
It should be amusing to listen in and hear your conversation with them.
@Aelxa If you actually read what wrote, Moderna is speaking about new virus variants. They say that booster dose as such helps.
But it is obvious that if virus mutates enough, a vaccine is needed. There is no vaccine against all kind of viruses.
No vaccine provides 100% immunity, and immunity wanes with time. The reason that you need an annual flu shot is because of different variants of influenza, and it’s hardly surprising that COVID will likely require annual shots as well. It’s hard to see how COVID doesn’t become endemic in the population at this point. Other vaccines require boosters – I think that current recommendation is to get TDaP every 10 years now.
Aelxa, your comment makes clear that Europe defining mRNA vaccines as “gene therapy” is a legal, not scientific, definition.
Julian
And as you well know if a thing is legally true, you can fight all day in court and lose.
But it is legally true for the simple reason that the mRNA carries DNA SEQUENCES made up of GENES that the cytoplasm then replicates (those genes are the spike protein everyone is talking about).
Those genes are then what the immune system reacts to and makes antibodies against since the genes are so foreign to the body and are recognized as such.
“Through a process known as transcription, an RNA copy of a DNA sequence for creating a given protein is made.
This copy – mRNA – travels from the nucleus of the cell to the part of the cell known as the cytoplasm, which houses ribosomes. Ribosomes are complex machinery in the cells that are responsible for making proteins.
Then, through another process known as translation, ribosomes ‘read’ the mRNA, and follow the instructions, creating the protein step by step.
The cell then expresses the protein and it, in turn, carries out its designated function in the cell or the body.” —from Moderna website
So legally it does not matter if the DNA sequences in the mRNA came from our own DNA in the our cell’s own nucleus, or if the mRNA was not made inside our own cells nucleus and was made in a lab instead.
These mRNA injections are legally Gene Therapy.
You can call it Mommy Moderna’s Miracle COVID Vaccine if you want to….but legally it is STILL Gene Therapy.
@Aelxa MRNA vaccines does not carry genes. Genes will pass to daughter cells during cell division. This is why gene therapy is controversial
Careful, Aarno, the pretend lawyer might sue you.
@ fivehundredpoundpeep
You write: “I still believe we need more study for long term effects of these vaccines but thanks for at least admitting that some people medically should not be vaccinated. I have multiple autoimmune diseases some that are very serious, one has even deafened me [nearly deaf at severe and profound level] Also many people including me have had anaphylaxis and my history of this is severe. . . Covid is not real. I wear the masks etc.”
I am a volunteer in the Moderna Covid vaccine trial. I started September 2020. We signed up for 25 months, so we go in every so often for blood tests, fill in questionnaire weekly, and have monthly phone calls. However, given everything we know about how the mRNA vaccines work, the likelihood of long-term effects is about zero.
Since you admit covid is real, wearing a mask, practicing physical distancing smart; but these reduce significantly your chances of being infected. Don’t eliminate them. So, you should want as many people who can be vaccinated to be vaccinated to both protect them and yourself.
You write: “I did admit to someone yes there will be some statistical deaths, Grandpa Joe would have died on the Tuesday he got the vaccine just by chance, but having read so many bad side effects, I don’t think we can brush off all the side effects as being under the statistics umbrella.”
As I’ve written numerous times, the CDC thoroughly investigates every case report to VAERS of a serious adverse reaction. People can write whatever they want on social media; but then they should get some sort of confirmation, e.g., labs tests, etc.
You write: “I consider the vaccines poor quality because of the need for constant boosters, the short term even expected [more mild illness]–those who don’t have severe effects but flu like illness, and the fact they do not give full immunity like traditional vaccines. Of course this is differing opinions I understand. With the transmission, yes you are right they are studying more on that but I have seen contradicting articles and studies. Pfizer is more the one in the 90s, isn’t J&J lower in effectiveness?”
Poor quality? First, studies have now found high antibodies more than six months after getting the vaccine. Second, even if antibodies diminish, the memory B cells that produce them remain. It takes about 10 days for our immune systems to recognize and respond to an invader; but once recognized, even if antibodies low, the memory B-cells can churn out super fast and super high amounts, so we are still protected. And B-cells (produce antibodies) only one arm of adaptive immune system. T-cells also are both circulating and there are memory T-cells. As for poor quality? I go in every year for a physical, blood tests, prodding, etc. And I get the flu shot every year, even though it only about 50% effective; but this means 50% reduced risk of serious illness, 50% reduced risk of hospitalizations, and 50% reduced risk of death. Seatbelts only reduce death and serious injury by 50% and I have been using them long before public health messages to use and later laws requiring. The COVID vaccines, Moderna and Pfizer, are 95% effective and if I need to get a booster every year, I prefer a sore arm and, perhaps, mild fever, to what COVID could do to me.
If you want to read something that will help you understand how vaccines work, I highly recommend a short book on immunology: Lauren Sompayrac. How the Immune System Works (6th Edition). While I have several 800 page undergraduate texts, his 150 page book is both accurate and a good read. amazon.com has it and perhaps your public library.
I don’t have time to just keep supplying you with info. If you want to understand mRNA, get a book on molecular biology or genetics. I’m sure your public library has some.
And Athaic is ABSOLUTELY RIGHT, mRNA vaccines are NOT gene therapy! ! !
Joel
Try reading this article published November 2020 at Endpoint News titled “Promising RNA tech comes with regulatory, CMC headaches…
“November 4, 2020 07:11 AM EST
Cell/Gene TxFDA+
Promising mRNA tech comes with regulatory, CMC headaches
Kari Oakes
As the buzz builds around messenger RNA (mRNA) technology’s use for two leading Covid-19 candidates, manufacturers and regulatory professionals are facing facts: This is not simple technology.
Complex manufacturing processes, delivery vehicles that must be treated more as drug substances than excipients, and potential immunogenicity headaches are among the challenges industry faces as this promising technology is harnessed to address an increasing number of health conditions.
At October’s virtual Euro Convergence conference, Tracy Meffen, VP for quality and regulatory affairs at Genevent Sciences Corporation, walked attendees through the basics of the technology, placing focus on chemistry, manufacturing and control (CMC) considerations from a regulatory affairs perspective.
Two types of RNA therapeutics work in different ways to create opposing effects, explained Meffen. By carrying genetic information in single-stranded RNA that enables protein synthesis, mRNA therapeutics up-regulate proteins that are faulty or missing. In contrast, the double-stranded RNA strands of siRNA therapeutics degrade mRNA after transcription, thereby preventing translation and eliminating excessive proteins that cause disease because they are faulty or overabundant.
Messenger RNA is considered by both the FDA and the EMA to be gene therapy “even though RNA does not interact with the genome,” said Meffen in giving a regulatory overview of the two types of RNA therapies. However, mRNA, which is regulated by the FDA’s Center for Biologics Evaluation and Research (CBER) is not yet classified as a regenerative medicine advanced therapy (RMAT). EMA considers mRNA to be an advanced therapy medicinal product (ATMP).”
Wow, a company that deals with mRNA clearly states that the FDA considers mRNA to be GENE THERAPY.
This is a vice-president of Quality and Regulatory Affairs that has to deal with the FDA, saying that the FDA considers mRNA a gene therapy.
I believe this means mRNA is a Gene Therapy.
Joel & Athanic
Even Boston Children’s hospital calls the COVID-19 mRNA injections ” a form of Gene Therapy”……
“Other new approaches blur the line between gene therapy and drug treatment. For example, antisense oligonucleotides (ASOs) are drugs made up of short, synthetic pieces of DNA or RNA that target the messenger RNA made by the faulty gene. They prevent the gene from being translated into a “bad” protein or, in some cases, trick the cell’s machinery into making a “good” protein. Researchers can even customize ASOs to single patients. Tim Yu, MD, PhD, in the Division of Genetics and Genomics at Boston Children’s, has developed this approach to treat several very rare genetic conditions.
Another approach, RNA interference, uses small RNAs to “silence” a targeted gene by neutralizing the gene’s mRNA. (The lentivirus described above uses RNA interference to silence the BCL11A gene.)
Even the messenger RNAs used for some COVID-19 vaccines represent a form of gene therapy. The mRNAs introduce genetic code that cells then use to make the coronavirus spike protein, encouraging people to develop antibodies to the virus.”
So while you all here keep saying these mRNA injections are not gene therapy, Boston Children’s says it is Gene Therapy.
I guess Orac can call them and try his best to convince a hospital that does Gene Therapy treatments, that they are incorrect.
What FDA actually says about matter is this:
https://www.fda.gov/media/142749/download
“The SARS-CoV-2 pandemic presents an extraordinary challenge to global health. There are currently no FDA-licensed vaccines to prevent COVID-19. Commercial vaccine manufacturers and other entities are developing COVID-19 vaccine candidates using different technologies including RNA, DNA, protein, and viral vectored vaccines. ”
So they are actually, according to FDA, RNA vectored vaccines. Why do you just
check FDA ?
Aarno
I choose to believe a Vice President of a company that makes mRNA peoducts saying that these are Gene Therapy and that the FDA regulates them as Gene Therapy just as the EU regulates them as Gene Therapy…..over an FDA MEDIA announcement.
It is actually industry guidance, not a media release. FDA tells industry what it can do. Check the date. It is June 2020
fivehundredpoundpeep: “I know you all assume that everyone who is rejecting Covid vaccines are all hopeless and ignorant antivaxxers but if I took other vaccines, doesn’t that prove that does not apply to me? There’s many others like me as well. That’s why I think it’s disappointing that your main arguments here seem to be saying “you’re a bunch of crazy anti-vaxxers!…I am not a Republican or anti-vaxxer”
Given that Orac’s article and multiple posters have taken pains to explain why the spike protein paper does not demonstrate vaccine dangers and to go over what mRNA vaccines do, I find your claims of Covid-19 vaccine doubters summarily dismissed here as antivaxers to be a strawman argument.
It’s nice that you say you got a tetanus shot. As I asked you earlier without getting a response, what vaccines on the pediatric and adult schedules do you endorse and recommend that people get?
Full-blown antivaxers characteristically dodge that question.
I think that what this paper shows is that the only people who should worry about vaccine side effects are the ones whose mother’s are hamsters.
King Arthur and his knights are in trouble. https://youtu.be/cAy4zULKFDU
And the fathers get the blame as well. Don’t forget them. Especially when they come in smelling of incindiberries. Y’all ‘member when a man could cheat and maybe come in smelling of nothing more incriminating than afrosheen and spermicide? PepperRidge Farms ‘members. Now it’s like, “symtec? what have you done? don’t give me that ‘my job’ shit; what have you done ?” And why do you smell of Elon and ozone? Are you working for ULA? You know they’ve busted their purity of essensce when they disconnect their brain and pin this Tucker Carlson I’m listening so intently incredulous face on when confronted with this line of questioning. They can all blow spike-fingers out of the millions of pours covering their retched, replicating, emmiting, bleating bodies. I got no use for them any more. Dirty men. Dirty, tricksy, false.
To follow up on what I wrote to Monsieur F earlier:
it seems that the anti-vaxxers/ woo-meisters I survey are increasingly ramping up fear about how deadly Covid vaccines are, that they are untested, how they damage immunity/ fertility,
cause blood clots/ strokes, etc.
Could it be that perhaps they have maintained some slight ability to discern reality and that they comprehend that vaccines are slowing the pandemic so they want to slow down acceptance of vaccines enough to stop the progress we have already made?
I remarked to someone else that maybe we would continue to have pockets of resistance and thus, higher levels of infection in er… certain places and SURE ENOUGH, the nightly news reported these areas exactly where you might expect them
@ 76er
You write: “The stimulated antibodies take weeks to formulate, in which time the spike proteins have replicated constantly — remember a thing called cellular division??” AND “I understand the mRNA is not subject to cellular division, but are the spike proteins? Where is the evidence this is or is not the case?
When a cell divides it duplicates the proteins in its DNA. The Spike proteins are NOT in its DNA, they are in the cytoplasm outside the cell nucleus and they are foreign proteins, not remotely related to anything the cell’s DNA would produce. The evidence is in the science of molecular biology.
And as I’ve written before, imagine cutting off a finger, taking it to a lab, then using it to get a fingerprint. The cut off finger can’t do anything. Can’t pull a trigger. Can’t poke a hole in your eye. Can’t even ring a doorbell. Same with Spike protein when NOT attached to the virus it only serves as a fingerprint to antibodies to recognize.
When attached to the virus, of course they aren’t harmless, just as when finger attached to a person it may not be harmless.
Don’t be too sure about the harmlessness of detached body parts.
I found this interesting paper, this is only a small section of what was written on Medscape regarding the paper……
“While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within two days. Whereas in the US cases of CVST after vaccination, headache symptoms began at least six days after vaccination and persisted for at least a week for most.
“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was seven days in the US CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they state.
The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.
In their accompanying editorial, Karron et al point out that in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18 to 59 years (median age, 37 years).
The editorialists report that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18 to 50 years. This is compared with a background rate of approximately 0.05 to 0.13 per million per month.”
Notice Orac said it was only 1 to 2 persons in a million who got blood clots from the adenovirus vaccines. And here it is 5 in one million. That seems like not too many right?
And what was the usual amount reported?
“This is compared with a background rate of approximately 0.05 to 0.13 per million per month.”
Wow, that is a HUGE increase over normal numbers.
But notice their view of VAERS….
“The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.”
The authors feel that the blood clotting problem is under-reported.
As I had read and asked someone before how the CDC could expect Zero strokes reported, and get 19 cases…. and still those 19 cases did not ring any bells at the CDC. And there was a full list of such clotting conditions that were being ignored, with cases being far beyond the numbers expected..
Hey, I have heard the excuses that this is a very rare side-effect but for those 5 in a million people…. I believe those who won that 5 in a million lottery are not pleased, especially those who died.
But for people getting the vaccine, I hope you are now aware that if you develop a severe headache 6 days after your injection…. to then get your butt to the Neurologist and be tested before you throw a clot that kills you.
You could cite that 0/19 stroke thing again. I remember is was an issue about time period: 19 total, 0 in the time period in question. No problem there.
In addition try to find the original paper. Journos are not always reliable
Aarno
Why don’t you try reading the comment again. There were ZERO expects cases. And instead they had 19 cases. Try to read more carefully.
And I posted a comment with the link to the paper.
I said original scientific paper, as published
And now we have a new paper from Denmark saying the incidence is not 3 to 4 in a million, but they experienced a 1 in 40,000 incidence…..m
“A new study that systematically monitored rates of vascular and thromboembolic events in people receiving the AstraZeneca COVID-19 vaccine has found it to be associated with a rate of cerebral venous sinus thrombosis (CVST) of 1 in 40,000.
Using national health records, the researchers identified rates of arterial and venous events in a cohort of 282,572 people aged 18-65 years within 28 days of receiving a first dose of the AstraZeneca vaccine in Denmark and Norway from February 2021 through to March 11, 2021 and compared these with expected rates in the general population of the same age and sex.
Results showed seven cases of CVST in the vaccinated cohort.
“If we monitored this number of people in this age range over 28 days, we would expect to see 0.3 cases of CVST. We found a rate 20 times higher than that, which translates to 1 excess case in every 40,000 people vaccinated,” lead author Anton Pottegård, PhD, told Medscape Medical News.
“When we first saw this figure, it was much higher than the estimates being reported from spontaneous reporting systems with the vaccine,” Pottegård, who is professor of pharmacoepidemiology and clinical pharmacy at the University of Southern Denmark, Odense, commented.
“But now actually the most recent rates of this adverse effect from spontaneous reports are not so out of line with our figures. The official European Medicines Agency (EMA) rates are now about 1 in 50,000 for individuals aged 20 to 49,” he added.
Pottegård explained that spontaneous reporting systems are useful to find a signal of an adverse event, but they are not reliable for an accurate risk quantification as the adverse events are often underreported and there are usually delays in events being reported. “Our estimate will be more reliable as we are systematically collecting data on this,” he said.
“Early on, we thought CVST was a very rare occurrence — with figures of 3 or 4 in a million being reported, but now it looks like our estimate of 1 in 40,000 is more realistic,” he added.
Just another paper showing reporting systems vastly unreport adverse events.
@Aelxa Why do you not never give a proper citation ? This time, not even a link.
Because all she does is copy and paste from Medscape. The paper is here.
@Narad Actual paper was of course different:
“The absolute risks of venous thromboembolic events were, however, small, and the findings should be interpreted in the light of the proven beneficial effects of the vaccine, the context of the given country, and the limitations to the generalisability of the study findings.”
One problem is that in Denmark, as usual risk groups were vaccinated first.
Sorry Alexa, I can’t hear your 5 per million over the 10,000 or more per million that die after getting Covid.
Oh, and I just looooved the Salk paper that said that COVID-19 was a vascular disease.
Do any of you remember me saying that almost a year ago? That COVID-19 was clearly a vascular disease and not a respiratory disease….. and you all jumped down my throat saying I was nuts, etc (just place the usual insults you guys dish out to me).
Oh, I am soooooo vindicated by Salk. I am laughing my ass off over this one.
I ‘member, I told you to have a cookie a few days later after someone linked to a paper where a computer came up will all kinds of vascular treatments for this particular disease. And the scientists where all like this computer is broken and not primarily fuckused on pulmonary stuff. One lady scientist, who was in the Moderna trial, had a train to catch thus didn’t contribute anything at all (she seemed in a hurry like she forgot to give birth, or something) to weasle wording out of their miscommunication.
One of them, iirc, was a drug to tone down production of hyaluronic acid which is great for minimizing interaction with that pesky Lady Cassandra-Karen O’Brien.Δ17 but not so great in your lungs as it attracts bunches of it’s weight in moisture and turns to jellow.
https://youtu.be/q75igh4TXw8?t=1
Nicholas Wade just came out with long piece on covid virus origins in the lab in Wuhan…do you have any articles in the archive that deal with this? Wanting to debate with a Trump idiot on the internet and I need ammo lol
A Trump idiot is claiming that Covid was a deliberate release from Wuhan? Doesn’t that make Trump look even worse – right now, everything thinks he’s just a fellow who failed because of a natural disaster that he wasn’t up to dealing with. If Covid was deliberate, Trump is someone who failed to respond to an enemy attack, and surrendered instead – as if Roosevelt had responded to the Pearl Harbor attack by shutting down military bases.
@ Kay West
You write: “Well I guess I should be happy that Joel didn’t call me “DEARY.”
I have NEVER used “deary”. Are you delusional???
And obviously you didn’t understand the point I was making, namely, that the profit margin on medical drugs and devices are often far greater than on vaccines, for instance, statins, insulin, drugs used daily. Or, very expensive therapies, e.g., monoclonal antibody treatments. As I wrote, our government sides too often with the corporations which is what you describe for the epi-pen. Is that too complicated for you???
And as I have made clear several times, I get the flu vaccine every year, a vaccine that is only at best 50% effective, reducing risk of severe disease, reducing risk of hospitalization, and reducing risk of death. Even if not covered by my health plan, I would pay out of pocket $20 or $30 per year for it. I pay much more yearly to get my teeth cleaned and checked. I have NO insurance for this, so pay it all. So, paying for a COVID booster shot to reduce (and COVID vaccines, at least Moderna and Pfizer 95% effective) serious illness, hospitalization, long COVID, and death well worth it. And, yep, they will continue to make a profit; but fewer will get the booster as the pandemic wanes; but the total amount going for boosters is nothing compared to the medical costs (including profit), economic costs to those who become sick, etc.
And I would be happy to support a government that controlled the costs of medicines, etc., that allowed reasonable; but not exorbitant profits by the pharmaceutical industry. Many other nations do that. And I will say it one more time, namely, the profit on anything doesn’t say whether it is valuable, neutral, or harmful. Focusing on profit is just a way many can attack vaccines, ignoring the overwhelming evidence of the suffering, disabilities, and deaths they prevent. On the other hand, if someone were to discuss how our government allows obscene profits in general, that would be a reasonable position.
So, how did you go from discussing the profits on vaccines to attacking me for mentioned being Jewish and calling me a sexist, racist/bigot??? Can’t you stay on topic?
Yep, I went off topic when someone else made bogus claims about the Holocaust. I explained how being Jewish I became aware of Holocaust at an early age because friends of my parents had numbers tattooed on their forearms. Once aware I began a lifetime of reading, attending seminars, and I have been close friends with several families where one member was a Holocaust survivors. Then I was attacked as a misogynist and racist. Totally foolish as I exchanged comments with both men and women. I had a number of unpleasant exchanges with Scott Allen. Sounds like the name of a man. And I haven’t had one black friend; but many, just mentioned the one. I participated in protests against both Vietnam War and Segregation way back in 1960s and would have joined the Freedom Riders except for being a coward and also probably too young. And how is it proof I am a racist if I mention one particular friend? One of my roommates in college was Catholic, does that make me an anti-Catholic by mentioning it? In fact, he and his wife will be visiting California from their home in Florida in June. We have remained friends for over 55 years. I was even best man at his wedding.
Basically you are a very sick individual who twists what others say. Calling me a sexist, racist/bigot is just despicable; but then again, your comments on this blog indicate your lack of intelligence, not because you are a woman; but just a despicable excuse for a human being.
NYT:
we’re “turning the corner” with Covid.
@Joel A. – Come on, pony up, this imaginary use of the word deary was really a typo for dreary.
@ Ross Miles
You could be right; but I get the impression that Kay West lacks imagination. ?
@ evodevo
Below is a list of some of the articles I have. Note that several are before 2019, finding corona virus antibodies in Chinese, finding mutants in bats that attach to ACE2 receptors and one that found covid antibodies in Americans before December 2019. Also, I have a number of articles on American labs experimenting with gain of function on various viruses and on serious lab breaches in U.S. I wonder what would have happened if outbreak started here. Even if from naturally occurring mutants, world knowing about our lab experiments and breaches . . . The flu pandemic of 1918-19 has strong evidence originated in U.S. Note I will read Wade’s paper later today. Note. since pandemic, papers on COVID have been free for download, so you should be able to access the following by typing in title.
Origins COVID-19 Virus:
Anderson KG et al. (2020 Apr). The proximal origin of SARS-CoV-2. Nature Medicine; 26(4); 450-452.
Basavaraju SV Serologic testing of U.S. blood donations to identify SARS-CoV-2-reactive antibodies: December 2019-January 2020. Clinical Infectious Diseases.
Chen YN et al (2019 Nov 22). Entry of Scotophilus Bat Coronavirus-512 and Severe Acute Respiratory Syndrome Coronavirus in Human and Multiple Animal Cells. Pathogens; 8(4): 259.
Chen S (2020 Nov 16). Coronavirus hunters pick up another piece of the trail in Italy. South China Morning Post.
Cheng VCC (2007 Oct). Severe Acute Respiratory Syndrome Coronavirus as an Agent of Emerging and Reemerging Infection. Clinical Microbiology Reviews; 20(4); 660-694.
Ge XY (2013 Nov 28). Isolation and characterization of a bat SARS-like coronavirus that uses the ACE2 receptor. Nature; 503 (7477): 535-8.
Guo YR et al. (2020 Mar 13). The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak – an update on the status. Military Medical Research; 7(1): 11.
Hu D et al. (2018 Sep). Genomic characterization and infectivity of a novel SARS-like coronavirus in Chinese bats. Emerging Microbes & Infections; 7(1): 154.
Liu SL (2020 Feb 26). No credible evidence supporting claims of the laboratory engineering of SARS-CoV-2. Emerging Microbes & Infections; 9(1): 505-507.
Menachery VD (2015 Dec). A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence. Nature Medicine; 21(12): 1508-13.
Morens DM & Breman JG (2020 Sep 9). Coming to terms with the real bioterrorist behind Covid-19: nature. STAT.
Qiu J (2020 Mar 11). How China’s “Bat Woman” Hunted Down Viruses from SARS to the New Coronavirus. Scientific American.
Seyran et al. (2021 Mar). Questions concerning the proximal origin of SARS‐CoV‐2. Journal of Medical Virology; 93(3): 1204-1206.
Wang N et al (2018). Serological Evidence of Bat SARS-Related Coronavirus Infection in Humans, China. Virologica Sinica; 33: 104-107.
Woodward A (2020 May 2). A US researcher who worked with a Wuhan virology lab gives 4 reasons why a coronavirus leak would be extremely unlikely. Business Insider.
As I’ve scanned the nyms of commenters, when my eyes hit “fivehundredpoundpeep” my brain instead gestalted it to “fivehundredpoundpoop”.
I’m not into scatology, so I’ll reject a Freudian interpretation. So is it something like clairvoyance, or just presbyopia?
; – )
Given her contributions to this blog’s comments, I favor your interpretation.
You are not the only one, I just was affraid to post it.
Sadmar & Orac & Renate
I think the comments you all just made regarding 500poundpeep’s name are disgusting.
That really shows how degraded your mindset gets, to descend into feces territory.
I think you guys owe 500poundpeep an apology. But I highly doubt any of you will do so.
Also NYT:
Rich countries come back to life as Covid ravages poorer countries
@ Joel A. Harrison, PhD, MPH – THX
@Orac “Indeed, I’d be willing to bet that flu vaccines will soon be based on mRNA technology given the success of COVID-19 vaccines.”
An almost sure bet. Pfizer claims progress with a potential flu mRNA program, with potential mRNA approaches to a flu vaccine with their expectation to enter the clinic in the third quarter of 2021. Pfizer is testing multiple constructs in Phase 1/2 to facilitate selection of an optimal tetravalent flu product dose regimen. Given their capabilities, I would expect a rapid progression to Phase 3 is possible. Pfizer is also trying to incorporate a booster in the same dose, to inoculate against emerging Covid variants. I would guess that Moderna is also on it, but have no knowledge of what they are doing.
So, last night Tucker Carlson continued blasting out all the COVID antivax takes to the Fox News faithful. This time it was ‘the vaccine will KILL you’, based mainly on the VAERS numbers referenced in this thread, plus some side-effect reports from Alex Berenson and “researchers at Oxford and UCLA”. fivehundredpoundpeep will be happy to learn Tucker railed against Facebook for banning LifeSiteNews, in his telling “a nonprofit news organization” which had just “reported government numbers from the VAERS database”. In contrast, Tucker praised Senator Ron Collins for grilling NIH director Francis Collins about “why so many Americans seem to be dying after the shot.”
CNN reported today that while some Fox contributors Tweeted criticisms of Carlson’s take, there’s been no such dissent on-air. The network is backing its biggest star 100%.
I report this stuff here because it’s a sign that anti-vax in now an entirely different thing in socio-political terms than it was just a few years ago — the familiar here terrain of TMI, AoA, RFKJ, Vaxxed etc. That was, in the larger scheme of things, a fringe movement with very little power. Now, as Peter Hotez has noted ,”Being against vaccines [is] seen now as a badge of loyalty to the Republican Party… antiscience is a major platform of the Republican Party, and that’s very scary for the country … antivaccine attitudes.[are] now mainstream in the Republican Party where they have money, clout, and a lot of power.” What we need to add to that is that the Republican Party is in the thrall of Trumpism, which is in turn driven by the right-wing media bubble, in which Fox News sits at the top of the heap, and within Fox Tucker is King. As Nicole Wallace used to say about the relationship between Fox and the Trump administration, maybe it’s not so much a case of State-run-media as a case of media-run-State.
So why are Trumpists like Carlson and Johnson so anti-vaccine, given that Trump himself brags about creating the vaccines (Operation Warp Speed only happened because of him, donchaknow)? Well, first, the base had already absorbed the COVID denialism that Trump and his surrogates like Peter Navarro and Larry Kudlow spewed out for the better part of a year. But now, they’re against vaccination first and foremost because Biden is for it. There are two parts to this. The first is ideological. They want their base to hate and fear Biden and the Dems, which they try to feed via culture wars, portraying the Dems as gray mind-controlling ‘socialists’ (by which they mean Stalinists) out to extinguish all freedom and ready to send all dissenters off to some gulag of cancel culture. Antivax is a neat fit to that narrative. Second, and this is where it gets really sick, they want Biden’s programs to fail. Period. If the administration’s vaccination campaign succeeds and we get out of the pandemic, Biden will get the credit which will boost his chances for re-election. So they want the pandemic to continue, for people to continue to get sick and die, for the economy to remain restrained, for schools to need to remain closed, etc. etc. so they can blame Biden for all that., so they can own “open up and return to normal”. Like I said, sick, but what do you expect?
One thing I expect: the big pharma firms will still make large campaign donations to many of these people because the GOP supports lowering corporate taxes, opposes regulation, and will fight Biden’s proposal to suspend IP rights on the vaccines in order to help fight the pandemic in poor countries. You want a cynical take on the pharmas? How about this: If the pandemic continues to rage unrestrained in other parts of the world, many new variants may evolve that will not be affected by current vaccines, creating new markets for new vaccines in the wealthy countries that can and will pay whatever Pfizer and Moderna chooses to charge. Of course, the pharmas could disabuse anyone of that by cooperating with Biden on the IP issues. I’m not holding my breath, though.
Cut and paste error: the Senator who grilled NIH director Collins was, of course, Ron Johnson, (GQP – WI).
Russia and China both have programs to distribute their vaccine to the “poor countries”. China has a mass of positive trade balance and can afford to send out billions of doses of the vaccine at no charge if they so desire.
Many of those countries have very wealthy elites and highly lucrative industries such as oil production; it is only their governments which keep the bulk of the people poor.
If governments and NGOs wished to have vaccines free of patents, they could easily have hired researchers and conducted the work themselves. They chose not to.
“China has a mass of positive trade balance and can afford to send out billions of doses of the vaccine at no charge if they so desire.”
They’ll be delivered in a few days on a Long March 5B rocket. Ivory Coast got the previous shipment.
@ Spectator
Actually the U.S. government did subsidize some of the vaccine research, e.g., Moderna, which is why Moderna agreed to treat their vaccine as a non-profit. Doesn’t mean they sold it at a loss; but . . . And government researchers did cooperate with them. However, Pfizer refused any U.S. government monies.
And having a patent, which gives a company a monopoly, doesn’t mean they can price-gouge. There are actually articles in law reviews that make clear that the U.S. government can cap profits if they so wish. Unfortunately, they don’t.
I hope it doesn’t hit anybody. Around here, if it comes in at a low enough angle the tornado will deflect it into the tornado magnet {trailor park that lines and protects the city}. There may or may not be tears. It depends on the local news cycle and the trial of that cop.
@ Spectator
What you fail to understand about patents is that they are in the Constitution, not to benefit individuals or companies; but to encourage individuals and companies to do research, develop technologies, etc. to “promote the general welfare.” However, if a patent is given to a company and it charges exorbitant prices, e.g., some gene therapies, etc. then the government can legally step in; but doesn’t.
Also, about 90 – 95% of all basic research is funded through various government entities, e.g., grants, etc and carried out in government run facilities. Also, 50% of applied research is either funded by various government entities or carried out in government run facilities. So, much of what private companies claim cost them, not true. In addition, there have been several well-done evaluations that disprove the high amount pharmaceutical companies claim developing a drug or medical device cost.
Spectator, absolutely–that sort of thing has been happening since the dawn of civilization. But if you look deep enough…meaning, at least a dozen hours or so of research focusing only on sources that are not promoting vaccination–you will find the vaccine paradigm is flawed from its foundations. Its purpose is not to improve public health, it is to control the public.
??♂️
NWO, if you science deniers were able to think logically and unselfishly then you wouldn’t have to be micro-managed. It’s like watching Homer Simpson in a field of rakes.
How does that work, Ginny? In detail. Here.
OMG, It is headed right for me. I can make it hit atlanta and tunica with my one-shot rail-gun. And that would save me. Would you miss them??
It’s a personal choice. It’s an EXPERIMENTAL Medical Treatment using GENE THERAPY. It ( Pfizer) treatment does NOT prevent getting or spreading the virus. Thousands are being KILLED by the “vaccine” and hundreds of thousands are being hospitalized or permanently disabled by this “vaccine” so if I CHOOSE not to take it, excuse me. The survival rate for WILD “covid” is OVER 99% so EXCUSE ME if I am hesitant to inject this crap in my body. LOL
I must admit I kind of like this comment: large number of tropes packed into a small number of words. Not only is it quick to read and dismiss, but with a further small increment in trope density I have every expectation that the trolls will collapse beyond the CT event horizon.
It is not gene therapy,it is not experimental and its is 95% effective. THOUSANDS have died, but tens of millions have been vaccinated. Some of them die after vaccination in any case.
Citation needed for everything in your comment.
@ rs
“I must admit I kind of like this comment: large number of tropes packed into a small number of words.”
It’s a tactical comment.
Full of tact.
Full contact.
I’ve been following two developments in parallel recently:
— select areas ( UK, Israel, parts of the US/ EU) report both increases in vaccinations and drops in infection rates, serious illness and deaths leading to planned re-openings, loosening of restrictions and gains in economic activity
— alt med advocates are increasingly ramping up fear of Covid vaccines, efforts at mitigation and governmental interference
Sounds like desperation to me. Twitter ( What’s Happening today) reports suspicious adverse events/ deaths on VAERS and “Yellow Card” systems.
Mike Adams attacks Dr Hotez as Mengele and is giving out his/ his employers contact information. See Orac’s latest post about woo in private schools.
The usual suspects direct their rage at Dr Fauci, governmental agencies, pharma companies, Mr Gates and sceptics even more vehemently than is their habit. ( AoA, CHD, PRN, GMI etc)
Could it be that they see that the course of the pandemic is changing, for the better, due to vaccination ?. And Covid is ravaging places like India with little vaccination?
As cities re-open, schools allow greater numbers of students in-person attendance, businesses allow more people in their shops/ restaurants, sports venues have vaccinated/ unvaccinated sections and more universities require vaccination, we can expect their fury to grow and hear more haranguing by trolls at RI..
( personally, I’ve been watching airline prices since February and they’re up, maybe 40% for July and August so I bought some)
.
“sports venues have vaccinated/ unvaccinated sections”
I’m not always a “The needs of the many outweigh the needs of the few. Or the one. But not this one.” kind of guy; not being “fully” vaccinated yet I wouldn’t want to be surrounded by that other either. And they don’t wan’t gnarly nano spike-fingers wafting into their ears so I guess the feeling might be mutual but for different reasons.
But, If I can detatch from the miftedness of masks unmandated before I could get mine aside, It is the replication that must be minimized. If the finicky thing is just going to keep doing this: https://youtu.be/yiBHj8Xs4sg?t=112 it might manage to morph into being somebody some day.
So, letting the unvaxed hide in the heard seems like it should minimize that. So the same, clumping them together would seem like it shouldn’t.
Maybe the unvaxed are fuel rods and there is some critical mass that starts spitting daughters out like crazy — the vaxxed are the graphite**.
**This analogy does not work. It’s backwards, It’s best to keep the rods pulled out and away from each other.
Bad analogies 101: This thing can be turned on me and it will get out of control.
OK. But with the rods (~Chads/legitimate bidness factory owners..economy…slave owners…,$40 a rim job Rod.) pulled out then the town can’t get ‘power’ to make all them widgets.”
Good point, fellow bud, err, dial tender. Just jab them ‘Chads’ one at a time and cram them right back in there as fast as possible. Deep, and hard. Be an Influencer.
@ NWO Reporter
You write: “if you look deep enough…meaning, at least a dozen hours or so of research focusing only on sources that are not promoting vaccination–you will find the vaccine paradigm is flawed from its foundations. Its purpose is not to improve public health, it is to control the public.”
Well, I have spent thousands of hours, not just focusing on sources promoting vaccines; but the history of infectious diseases, epidemiology, immunology, etc. Anyone, except paranoid conspiracy theorist like yourself, who looks at the aforementioned will understand how vaccines are one of the main reasons that human life-expectancy, especially among developed nations, has increased. Take just smallpox, for example. Follow World Health Organization’s program for eliminating. As vaccinations progressed from one Third World Nation to the next, smallpox completely, I repeat, completely, disappeared. Nothing else changed, not safer water, better hygiene, better nutrition, etc. In fact, disabilities and deaths from other microbes continued at the same rates. I could go on and on. And go back to smallpox outbreaks in U.S. prior to vaccine. Then follow as smallpox ended in U.S. while still raging in other parts of world, etc.
People like you are great for “COMIC RELIEF”. Stupid on STEROIDS! ! !
If you are so sure of yourself, why not brag by using your real name???
Would I be more booguie if I ate insects, like Bezos, or meat glue bits like us cis-booguies.
Joel, Ginny Stoner is a well-known attention-whoring crank.
Thought yu might like this: https://arstechnica.com/science/2021/05/what-cats-love-of-boxes-and-squares-can-tell-us-about-their-visual-perception/
The only thing Augie likes about boxes is gnawing on them. The carpet is covered with shreds of cardboard.
“The only thing Augie likes about boxes is gnawing on them.”
Is “Augiie” {Tim approved} perhaps handi-capable? Or blind?
— Oppie/avie, what are you doing, Oppie?
[…] and Heather 78th DarkHorse Podcast Livestream: The Good People Game (at Salk Spike discussion) About that Salk Institute paper on the “deadly” COVID-19 spike protein David H. Gorski does not think […]
Well they could have called it the more apt (as per the graphic) wiffle-bat protein or the pestle-penis protein but ohh no they did not because the immune system might have started laughing with it and not at it and, by Jenner, that shall not stand! So this paper exists. — r/showerthoughts
And it doesn’t really address the worrisome shedding. Has anyone ever seen that movie Maximum Overdrive with those wonky trucks? I’m tellin’ ya’, it’s that nanotech. The engines are fixing themselves and putting me out of a job {I put sawdust in used cars so that they last more than three days without smoking too much after being driven off the lot — it packs the rod journals, valve guides, and oil control ring. And other stuff to. I mean, I do other stuff to. I have a fallback position}.
The spikes are nanobots, everybody sais it, stop lying.
.
`
And I like the stock.
I had a great research assistant position after college at Large Famous Northeastern Ivy Research University, Inc in the late 80s/early 90s when science press offices were first becoming a thing. My PI was shocked to discover that he had absolutely no control or input into how his research was presented by the PR people. After several other professors were similarly burned we had a meeting with the press office, and only one of them had taken Biology after High School. It was stunning.
@ Aelxa
You write: “Even Boston Children’s hospital calls the COVID-19 mRNA injections ” a form of Gene Therapy”……”
Yep, they wrote: “Even the messenger RNAs used for some COVID-19 vaccines represent a form of gene therapy. The mRNAs introduce genetic code that cells then use to make the coronavirus spike protein, encouraging people to develop antibodies to the virus.”
But whoever wrote it got it wrong. Nancy Fliesler is a senior editor. I couldn’t find any info what her education was. Messenger RNA is NOT the same as genetic code. DNA and sometimes RNA are genetic code. Believe what you want, just additional example of how stupid you are. Pick up any intro to molecular biology book.
You write: “And now we have a new paper from Denmark saying the incidence is not 3 to 4 in a million, but they experienced a 1 in 40,000 incidence…..m . . . lead author Anton Pottegård, PhD, told Medscape Medical News.
So what does the paper actually say: “Conclusions: Among recipients of ChAdOx1-S, increased rates of venous thromboembolic events, including cerebral venous thrombosis, were observed. For the remaining safety outcomes, results were largely reassuring, with slightly higher rates of thrombocytopenia/coagulation disorders and bleeding, which could be influenced by increased surveillance of vaccine recipients. The absolute risks of venous thromboembolic events were, however, small, and the findings should be interpreted in the light of the proven beneficial effects of the vaccine, the context of the given country, and the limitations to the generalisability of the study findings.”
So, the risks were “small” and “could be influenced by increased surveillance of vaccine recipients.”
You just jump on anything that confirms your rigid unscientific antivax position. Check it out yourself:
Pottegård A et al. (2021 May 5). Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population based cohort study. BMJ.
Oh, in another Danish paper with Pottegård as one of the authors, the conclusion was: “Risks of venous thrombolism and major bleeding were low to moderate in hospitalized and community-managed COVID-19 patients. These risks were comparable with patients suspected of but testing negative for SARS-CoV-2 and with influenza patients.” Dalager-Pedersen et al. (2021 Jan 5). Venous thromboembolism and major bleeding in patients with COVID-19: A nationwide population-based cohort study . Journal of Infectious Diseases.
What you don’t understand is that science looks at probabilities. When one evaluates the rates of a disease in any group, one looks at confidence intervals, that is, a range of rates that would fall within a normal range. Why? For several reasons: 1) using a sample means it may not be exactly the same as entire population; 2) even if one uses entire population, could miss cases and/or even populations don’t not maintain absolute stable rates, they fluctuate. So both studies used confidence intervals. Just one more example of your ignorance of science or, perhaps, you just jumped at an interview rather than looking at the actual paper.
Aelxa apparently failed to note that Nancy Fliesler is a “[s]trategic communicator and storyteller with experience in science, medicine and healthcare, including blogging, digital content, PR, video/television, publications development and social media,” rather than being any sort of official spokesperson for BCH.
^ I.e., “science” by press release.
@ Narad
EXCELLENT! ! !
You do know how to find info. I always download any article that you give a URL to.
I wonder if I’m gonna get flamed just for writing this, but here goes anyway:
1) This article observes that the study needed a “crapton” of pseudoviruses to obtain its results, whereas the vaccines allegedly produce only a modest quantity of spike protein. Besides the obvious and legitimate question for proof of the latter claim, I would like to point to this study: https://www.sciencedirect.com/science/article/pii/S2589004221001383 , whereby even minimal levels of isolated spike protein were found to be highly fusiogenic. My reasoning is that, IF even minor quantities of spike protein make it into the bloodstream and come into contact with platelets, they are totally capable of forming a thrombus. Unfortunately, you don’t need a lot of thrombi for things to get dangerous. Even just a single one can do a lot of damage if it ends up in a bad place.
2) Contrary to the assertion that the vaccine reaction is localized to the muscle and the proximal lymph node, I am aware of several studies that have found dissemination of vaccine material in distal tissues. See for example https://www.sciencedirect.com/science/article/pii/S1525001617301569 , Table 1 and section “Biodistribution Studies”; or https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf , page 47, last paragraph. It seems, therefore, perfectly reasonable to expect to find spike protein from the vaccine in the blood. If you want to make the claim that this is not possible, then the burden of proof is on you.
3) Can we at least agree that we wouldn’t be arguing and calling each other names right now over any of this, if they had bothered doing animal studies to find out about this stuff beforehand? Or is asking for new medications to be tested on animals first before rolling them out on humans anti-scientific and conspiratorial too now?
4) I love freedom of choice. Especially when it comes to medicine. I want everyone who decide that they want this vaccine to have access to it. All I’m asking for is that others respect my own decision for my own body that no amount of spike protein belongs into my blood.
And I feel that betting the farm only on vaccines was a myopic decision. Therapeutics need to be emphasized a lot more. I am very aware that some diseases like smallpox and polio were eradicated thanks to vaccines. But a vaccine is a tool, not a goal in and of itself. If I need to put a nail into a wall, I’m not anti-screwdriver if I think that a hammer would be better suited for the task at hand. We’re not going to eradicate the flu with vaccines anytime soon, and Covid seems much more similar to flu than to smallpox to me.
I guess that takes care of that. <a href=”https://www.reuters.com/article/factcheck-covid-vaccines/corrected-fact-check-covid-19-vaccines-are-not-experimental-and-they-have-not-skipped-trial-stages-idUSL1N2M70MW:>Bye.
Thank you for your reply. As the article you cited yourself clearly states, the animal tests have been running in parallel with the human distribution. What I said is that the animal tests ought to be started AND concluded and their results evaluated BEFORE you start giving stuff out to people (“beforehand”).
Pity to see you go so soon. I was looking forward to discussing the rest of my points with you. Any takers?
please don’t feed the Sea Lions!
The “fusing” described in the paper is formation of syncytia. Do platelets have binding sites for SARS-CoV-2 spike? Do platelets form syncytia?
Platelets don’t “fuse” when forming clots, they change form physically which fosters aggregation which is something very different from fusing.
Thank you for your insight. I admit my ignorance on the details of this process and will research it to the best of my ability. Again, thank you.
While researching to find an answer to this question, I’ve come across this paper which I think is highly relevant. I’m leaving it here for other people and my own reference.
S. Zhang et al: “SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19”
https://jhoonline.biomedcentral.com/articles/10.1186/s13045-020-00954-7
Don’t forget to follow down the papers that cite it.
Third time I try to post a comment here. Let’s see if my Google account is banned too. Probably yes. Funny how Silicon Valley these days decides what is science and who is allowed to speak as a scientist, just like the Pope and the Inquisition did at the time of Galileo.
1) This article observes that the study needed a “crapton” of pseudoviruses to obtain its results, whereas the vaccines allegedly produce only a modest quantity of spike protein. Besides the obvious and legitimate question for proof of the latter claim, I would like to point to this study: https://www.sciencedirect.com/science/article/pii/S2589004221001383 , whereby even minimal levels of isolated spike protein were found to be highly fusiogenic. My reasoning is that, IF even minor quantities of spike protein make it into the bloodstream and come into contact with platelets, they are totally capable of forming a thrombus. Unfortunately, you don’t need a lot of thrombi for things to get dangerous. Even just a single one can do a lot of damage if it ends up in a bad place.
2) Contrary to the assertion that the vaccine reaction is localized to the muscle and the proximal lymph node, I am aware of several studies that have found dissemination of vaccine material in distal tissues. See for example https://www.sciencedirect.com/science/article/pii/S1525001617301569 , Table 1 and section “Biodistribution Studies”; or https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf , page 47, last paragraph. It seems, therefore, perfectly reasonable to expect to find spike protein from the vaccine in the blood. If you want to make the claim that this is not possible, then the burden of proof is on you.
3) Can we at least agree that we wouldn’t be arguing and calling each other names right now over any of this, if they had bothered doing animal studies to find out about this stuff beforehand? Or is asking for new medications to be tested on animals first before rolling them out on humans anti-scientific and conspiratorial too now?
4) I love freedom of choice. Especially when it comes to medicine. I want everyone who decide that they want this vaccine to have access to it. All I’m asking for is that others respect my own decision for my own body that no amount of spike protein belongs into my blood.
And I feel that betting the farm only on vaccines was a myopic decision. Therapeutics need to be emphasized a lot more. I am very aware that some diseases like smallpox and polio were eradicated thanks to vaccines. But a vaccine is a tool, not a goal in and of itself. If I need to put a nail into a wall, I’m not anti-screwdriver if I think that a hammer would be better suited for the task at hand. We’re not going to eradicate the flu with vaccines anytime soon, and Covid seems much more similar to flu than to smallpox to me.
@mod, please delete this post. It is redundant since the first one got through after all. Thank you.
More than two links, and the comment automatically goes into the moderation queue.
“And I feel that betting the farm only on vaccines was a myopic decision. Therapeutics need to be emphasized a lot more.”
Personally, I feel that constructing strawmen is a futile endeavor. There’s been an enormous amount of attention to researching and testing drugs that could treat Covid-19.* Health care professionals do have somewhat of a bias toward preventing disease rather than trying to eradicate it once it occurs, which explains what you feel is a disproportionate emphasis on vaccination.
*as well as a great deal of time spent (and often wasted) debunking HCQ and other drugs ballyhooed as being Covid-19 cures, but which are anything but.
**antivaxers like a certain self-described “objective, pro-vaccine rational scientist” continually tout new proposed Covid-19 treatments and denounce physicians for not embracing them immediately despite a lack of good evidence for their use, while simultaneously denouncing vaccines which _have_ established effectiveness and safety.
I have tried to stay informed to the best of my ability about treatments, but of course I’m sure there’s much I’m missing. If you can fill me in I would be most grateful.
In my country (not the US, so ymmv), the only drugs that I know are being used in any meaningful capacity are monoclonal antibodies and corticosteroids, both with good results actually. Plus antipiretics, pretty much like candy, which I’m not sure is such a good idea honestly.
I know that remdesivir was heavily promoted worldwide last year but, afaik, with lackluster outcomes.
Favipiravir is not available here at all. The off-label use of hcq+zinc, or ivermectin (despite the fact that at least for the latter I have read many studies showing promise) is prohibited even if the patient requests it, and prescribing them anyway likely means losing your license. I’m even seeing vitamin D being badmouthed in the media (!).
The feeling I get is that the common approach here seems to be to tell people to take paracetamol and wait at home until their saturation level is borderline life-threatening or they feel they can’t breathe anymore, at which point they’re rushed to hospital. Which is crazy to me considering that early treatment is so important with virtually every other (treatable) disease.
Perhaps there may be more going on behind the scenes, but what I’m seeing with my own eyes is that almost all of the hope and focus is being put on the vaccines. Meanwhile, from a therapeutic point of view, I know there must be a better way than what I’m seeing. At the very least they might as well open up an ivermectin trial, considering that quite a number of people are buying the veterinary variety and OD’ing on it because they are being denied the one for humans.
Personally, I have found the weekly TWiV interviews with Dr Daniel Griffin to be an excellent source to keep track of the evolving guidance on treating Covid-19.
https://www.microbe.tv/twiv/twiv-752/
Clincaltrials.gov identifies 66 studies involving ivermectin and Covid-19 with 33 of them listed as recruiting. So, there is lots of research going on. But since ivermectin is tightly bound to proteins in the blood, getting a therapeutic dose available will be difficult.
I voted with my arm and got two doses of the Pfizer vaccine. But if I did get a breakthrough infection, I might ask to get molnupiravir or perhaps sign up for this trial.
https://www.merck.com/news/merck-and-ridgeback-biotherapeutics-provide-update-on-progress-of-clinical-development-program-for-molnupiravir-an-investigational-oral-therapeutic-for-the-treatment-of-mild-to-moderate-covid-19/
It was identified almost a year ago as one of several already approved antivirals that showed significant effect against SARS-CoV-2 in human cells, not just vero cells. But it took way too long to get animal and Phase 1 trials launched and the Phase 2/3 trial won’t have final results until about September. But perhaps early results will be good enough to justify an EUA.
@ stufidiesserevittime
The article you refer to deals with the S-Spike Protein ATTACHED to the virus. In addition, the S-Spike Protein used in the vaccine is NOT the complete S-Spike Protein. In either case, as I’ve explained in several comments, if you cut a finger off and then fingerprint it, it can do NO damage; however, a finger connected to a hand can poke you in the eye, pull a trigger, etc.
As for the flu vaccine, it found few serious adverse events and NO deaths; yet, the flu does kill.
You write: “And I feel that betting the farm only on vaccines was a myopic decision. Therapeutics need to be emphasized a lot more.”
Lots of research is being conducted on treatments for COVID-19; but without the vaccine healthcare systems would be overwhelmed and people literally would die because they couldn’t get medical help. Actually this has already occurred.
You write: “We’re not going to eradicate the flu with vaccines anytime soon, and Covid seems much more similar to flu than to smallpox to me.”
First, even high flu season only kills around 50,000. COVID killed 500,000 and many survivors suffer long-Covid. Those who survive flu, even those hospitalized, almost all return to norman life after short period of recuperation.
No, flu vaccine will not eradicate flu. Vaccines did eradicate smallpox and polio because neither smallpox nor polio viruses mutated and both only have human reservoirs. Flu and Coronaviruses have animal reservoirs and mutate. However, the more people vaccinated, the fewer will get sick and die. Seatbelts reduce deaths and serious injury by about 50%, the current Moderna and Pfizer vaccines reduce deaths and serious conditions by about 95%. I should mention they are working on a flu vaccine that will use conserved parts of the virus so that mutations will not get around the vaccine.
You write: “Can we at least agree that we wouldn’t be arguing and calling each other names right now over any of this, if they had bothered doing animal studies to find out about this stuff beforehand? Or is asking for new medications to be tested on animals first before rolling them out on humans anti-scientific and conspiratorial too now?”
If you understood research, you would know that testing on animals NO guarantee of anything. A prime example was thalidomide that caused horrific birth defects (phocomelia). It was tested on animals and didn’t cause birth defects. I can think of other drugs that didn’t work on animals; but saved human lives, etc. And since the Phase 1, Phase 2, and Phase 3 clinical trials of the COVID vaccines were all fully informed volunteers, what is your problem? I am 74 and was a volunteer in the Moderna COVID vaccine trial. We received an almost 20 page informed consent form we needed to read and sign. Then we had to watch a webinar that went detail by detail through it. I have been a whole blood donor; but am now donating convalescent plasma every four weeks. They use it for hospitalized COVID patients. My titers for the COVID antibody are HIGH.
You really don’t know what you are talking about.
Reference:
Bahl K (2017 Jun). Preclinical and clinical demonstration of immunogenicity by mRNA vaccines against H10N8 and H7N9 influenza virus. Molecular Therapy: 25(6)l
Theuerkauf SA (2021 Mar 19). Quantitative assays reveal cell fusion at minimal levels of SARS-CoV-2 spike protein and fusion from without. iScience
Thank you very much for your extensive reply.
It may be true that perhaps I don’t know what I’m talking about as you say (after all, like Socrates put it, I know that I don’t know) but at least I’m trying my best to understand. Just by simple logic I can see that what I’m being told in the media cannot be the full story, and I refuse to simply shut up and do as I’m told. I am always open to changing my mind if the information at hand warrants it, and if people take the time to explain things to me that helps a lot, but I will always question everything that doesn’t make sense to me until I do understand.
I am fully aware that human beings and mice are not identical. I know about thalidomide, although I’m not sure if it had also been tested on pregnant animals. Regardless, you can’t tell me that animal studies have no value at all. If there is a concern about the biological and specifically pathological activity of the spike protein in and of itself, an animal study done beforehand would have likely provided much insight into it either way.
I have re-read the Theuerkauf article. Please do correct me if I’m wrong but my understanding is that they used capsids of lentiviruses, with a spike protein on them (i.e. unable to infect and replicate like a wild sars-cov2 specimen, the lentivirus being merely a vector), and the fusion activity was caused by the spike protein itself. Using your analogy, it was a cut-off finger mounted on a rollerskate. Somehow they found it still be able to pull a trigger and gouge your eyes out.
I’m just saying that this is concerning, because potentially I could see the same risk with the mRNA-manufactured spike protein (or, for that matter, with Novavax’s and Sinovac’s spike protein pin-cushion vaccines). If you want to claim that the vaccines are safe because it is impossible for their spike proteins to have the same effect, I think the burden of proof is on you.
I am much younger than you, also a blood donor. I am very happy for you that you got the vaccine that you obviously think is very favorable to you. I really am. My uncle is over 80, with a laundry list of comorbidities. He got his vaccine in February. I find it perfectly rational that he would conclude that in his situation the benefits would outweigh the risks. And I’m happy that he has had no ill effects that I know of, just like you.
So, we agree, covid shares more similarities with the flu than with polio. I agree that it seems to be several times worse than the flu, about an order of magnitude seems fair, at least for certain age groups. But (thankfully) it is not like a transmissible H5N1 or an airborne rabies. I sure wouldn’t be worrying about possible blood clots of the vaccine if that was the case, I would be scrambling to get as many doses as I have loved ones. But since it is comparable to the flu, the fact remains that some people may have worse odds with the vaccine than with an infection. Case in point, the children that in many countries (including my own) many want to force or coerce into being vaccinated as well. I have a daughter, and as a parent my duty is to make the decisions that are best for her, and her alone. Not for some stranger that she might infect unless she takes a medication that may man her more risk than benefit.
Summing up, I’m not in the business of curtailing other people’s freedoms. I want everybody else to be as free as I insist on being myself. Thank you for your post, I would love talking to you some more if you have the time.
And… The Payload of the Day is “begging the question.”
“Somehow they found it still be able to pull a trigger and gouge your eyes out.”
That better have been with a RONCO Eyeout Easy Popeilzy gouger, Mr. “Now best you straighten up and fly right or I’m going to lower your boom.” — Dark Nark, GHS
Fantastic post! Thank you so so much for the information, the links, and your personal testimony.
@Narad: Well, I never saw the need to have my four-year-old vaccinated against the flu. I had her vaccinated against things like meningococci, pneumococci, Japanese encephalitis, diphtheria, pertussis and polio. I think it was a good decision and I would do it again. The MMR vaccination is a long story.
Anyway, my point stands. Not sure what question you see being begged here.
The phrase refers to making a claim that assumes the claim in the first place. Joel wrote,
And from this you get “[COVID-19] is comparable to the flu”? Because polio? Spare me.
No, I get that Covid is comparable to the flu by an order of magnitude from this quote: “First, even high flu season only kills around 50,000. COVID killed 500,000”. And I know that Covid deaths are highly stratified by age, so for small children the two diseases are even more similar, i.e. both largely harmless to them.
I am not aware of any significant issues of long Covid in young children either.
Meanwhile, I am aware of individual but confirned cases of cerebral thrombosis in adolescents after they were vaccinated.
I know that post hoc does not equal propter hoc. But this condition is so exceedingly rare in this demographic that these stories are definitely suspicious, even more so considering that the vaccinations have started for them only very recently.
FYI: a measles infection will destroy existing immune memory, so if you child gets the measles (and I really, really, really hope that they do not) they will probably need to re-do their vaccines.
She did get the MMR shot. She had a heavy reaction to it, high fever and lethargy for a few days. She recovered but was left with very noticeable regressions on her milestones, which she was already behind with.
In hindsight, I think that the vaccine schedule may have been too harsh on her system. If I could go back in time I would have a long conversation with the pediatrician if it wouldn’t be a better option to spread out the vaccinations over a longer time frame, to give her more time to recuperate. I’d say that’s one of the biggest regrets in my life.
Anyway, what’s done is done and happily she seems to be catching up pretty well now. Thank you for your concern.
@ stufidiesserevittime
You write: “I am fully aware that human beings and mice are not identical. I know about thalidomide, although I’m not sure if it had also been tested on pregnant animals. Regardless, you can’t tell me that animal studies have no value at all. If there is a concern about the biological and specifically pathological activity of the spike protein in and of itself, an animal study done beforehand would have likely provided much insight into it either way.”
First, animal studies were conducted: “Due to the urgent need for a vaccine in a surging pandemic, Pfizer and Moderna were given approval to simultaneously test their vaccines on animals while they were conducting Phase 1 trials on humans. The vaccines were tested on mice and macaques.” I was tired when I wrote my first comment. I have several articles that clearly state they did animal studies. However, I repeat that they were NOT necessary as the volunteer trials of both Modern and Pfizer vaccines each included over 30,000 and, as one of them, we were closely followed, including regular lab visits for blood tests, weekly questionnaires, and monthly phone calls. So, how would an animal study have given any additional insight. Yep, if an animal study found problems, probably would NOT have led to human trials; but we had the human trials and NO PROBLEMS.
You write: “I have re-read the Theuerkauf article. Please do correct me if I’m wrong but my understanding is that they used capsids of lentiviruses, with a spike protein on them (i.e. unable to infect and replicate like a wild sars-cov2 specimen, the lentivirus being merely a vector), and the fusion activity was caused by the spike protein itself. Using your analogy, it was a cut-off finger mounted on a rollerskate.”
First, so how would a cut-off finger on a roller-skate do damage? Maybe bump into someone, cause, at best, a bruise. The lentivirus capsid protected the S-Spike Protein from antibodies and if you read carefully, it was a complete S-Spike Protein. As I wrote, the mRNA vaccines only led to production of a recognizable part of the Spike; but not key elements that allow it to fuse with ACE2 Receptors and enter.
You write: “So, we agree, covid shares more similarities with the flu than with polio. I agree that it seems to be several times worse than the flu, about an order of magnitude seems fair, at least for certain age groups. But (thankfully) it is not like a transmissible H5N1 or an airborne rabies. I sure wouldn’t be worrying about possible blood clots of the vaccine if that was the case.”
No, we don’t agree. Yep, it mutates like the flu and has an animal vector like the flu; but differs SIGNIFICANTLY. Not just the 10 fold higher number of deaths; but survivors with Long-Covid and asymptomatic, including kids, found with damage to blood vessels. Only time will tell if this damage heals or leads to other problems. And the new variants of COVID-19 are causing higher percentage of cases in younger people. Though not dying, Long-Covid and asymptomatic blood vessel damage being found. And, the current vaccines, while not as effective against some of the variants, may get one of them, still prevent serious problems and deaths.
As for not like a transmissible H5N1 of an airborne rabies? Actually H5N1 was only caught by people in intimate contact with infected animals and usually for a prolonged time. COVID-19 is much more transmissible. As for “airborne rabies” only lab workers.
You write: “I have a daughter, and as a parent my duty is to make the decisions that are best for her, and her alone. Not for some stranger that she might infect.”
And some stranger may infect her or you. We live in communities, including those who can’t be vaccinated, e.g., certain autoimmune diseases, too young, undergoing cancer treatment. How do we protect them? Confine them to their homes? In communities we have both rights and responsibilities. People like you turn my stomach. If you or someone you love does get infected by someone like you, I wonder what your reaction would be? Perhaps, you would vote to outlaw quarantining people coming from infected areas or, for instance, even with active TB?
You write: “I would love talking to you some more if you have the time.
I’ve already wasted enough time on you, given your lack of a sense of community.
References:
Beatrice Dupuy (2020 Nov 25). Pfizer and Moderna did not skip animal trials. AP. Available at: https://apnews.com/article/fact-checking-afs:Content:9792931264
@ stufidiesserevittime
Children do die from the flu. Some years more than 200 in U.S. And between 7,000 and 26,000 hospitalized annually. Besides miss school and suffer. In addition, while incubating can pass on to other vulnerable people. But, of course, you could care less if while shopping your child infected someone who couldn’t be vaccinated. Their fault, right? They should just lock themselves in their homes and never venture out, never grocery shop, never go to parks, etc.
Well, according to the CDC, 238 children (defined as under 18) died from Covid, so that’s even more proof that Covid and the flu are absolutely comparable for this age group.
Children also sometimes die from drowning in swimming pools, having trees or fences falling on them, or being struck by lightning. And let’s not even start about bicycles. That’s all very tragic but not a reason to roll every child up in bubble wrap.
I used to get the flu 2-3 times a year when I was a kid. Yes, I missed school. My tonsils hurt, I was miserable. Guess what, I’m still here to talk about it today. Please let’s not act like the common flu is a civilization-ending plague now.
And to answer your question, yes, a sick person has my sympathy. I will accept to wear a mask around them (assuming it even does any good at all), wash my hands, socially distance, get tested before I enter a room with them and whatnot. But nobody can convince, pressure, gaslight, guilt-trip or force me to take a chance with my child’s health and give them a medication with short and long term side effects that are still unknown, unquantified and actively debated, and probably not in my child’s favor. Heck, I’ll sooner rip someone’s throat out with my bare teeth if I have to before I’d let my loved one getting harmed.
Are you being intentionally obtuse? Out of how many cases?
We will have to agree to disagree then. I’m all for helping out random strangers, but my daughter and my family come first.
I have nothing personal against you, in fact you seem very knowledgeable and I much respect that (which is more than I can say about your, frankly, pretentious and judgemental tone), but yes, if it comes down to it I would rather see you and the whole world burn to the ground than putting life and limb of somebody I love in jeopardy. And I’m proud of it, too. Deal with it.
Thank you for the explanation about the Theuerkauf article, I will re-re-read it in that light. When you say that the spike protein of the vaccines is incomplete, I assume you are referring to this that was posted in this comment section earlier somewhere: https://cen.acs.org/pharmaceuticals/vaccines/tiny-tweak-behind-COVID-19/98/i38 . It is very interesting, I was unaware of it. It says that AstraZeneca didn’t use this tweak, it made me wonder if that might be one of the reasons why it has such a bad rep. I will look into this and think about it, I may possibly change my mind about this issue to an extent.
I am aware that Covid can be very ugly. It is interesting that you mention vascular damage, as it is my understanding that more often than not, people do poorly when it goes blood-borne and causes diffuse intravascular thrombosis (as the autopsies found last year, like https://pubmed.ncbi.nlm.nih.gov/32422061/ ; and which explains perfectly the ground-glass opacities). That is precisely why I’m feeling so squeamish about the idea of spike proteins from a vaccine ending up in the blood. But again, I’m always open to re-evaluate and reconsider.
I understand that long covid is a (still largely unknown and not quantifiable) problem but so are the long term effects of (repeated) vaccinations. Especially if this going to become a recurring thing. It seems to be common knowledge that the second shot packs a much worse punch than the first one in terms of side effects. What if the third turns out to be even worse, for example? And then so on. At what point do you stop. And what happens when you do stop? With so many unknowns, for sure at this stage I just can’t feel as confident (either way) as you seem to be.
@ stufidiesserevittime
You write: “yes, if it comes down to it I would rather see you and the whole world burn to the ground than putting life and limb of somebody I love in jeopardy. And I’m proud of it, too. Deal with it.” However, you also write: “My uncle is over 80, with a laundry list of comorbidities. He got his vaccine in February. I find it perfectly rational that he would conclude that in his situation the benefits would outweigh the risks.”
You do understand that the vaccine doesn’t guarantee absolute protection and as people age, e.g., over 80, the level of protection, though worth getting the vaccine, may be less than the overall 95%. Quite simply, you or your child could be asymptomatic and infect your uncle or some complete stranger. And if the whole world burned to the ground, you and your loved ones would be alive in a world that is a living hell, short of food, clean water, and vulnerable to the few survivors who may be really nasty desperate people. Despite what you choose to believe, the risks from the vaccine are far far far less than from the actual disease. And, you might find me unpleasant; but I was raised to believe in community, to take some responsibility for my fellow beings. And I have over 40 years of education and experience understanding vaccines, reading histories of vaccine-preventable diseases, studying immunology, etc.
If you consider yourself even minimally open-minded, get hold of Lauren Sompayrac’s “How the Immune System Works (6th Ed). amazon.com has it and probably your public library. I could recommend some 850 page Intro to Immunology; but it is about 150 pages and a great read, including well-illustrated. Then you might, just might, understand how vaccines actually work.
Thank you for your recommendation. I’ve just ordered the book (I only found Fifth Edition that will ship to my place, I suppose that will have to do). I love learning new things.
Yes, I understand that vaccines (and everything else for that matter) aren’t 100%. Even if A and B are both protected at 95%, the overall protection would still not be 100% (it would be 99.75% if my math is good).
So, if my uncle was, say, 80% and my child 95%, then the result I get is 99%. That means that for my uncle, whether the child is protected or not makes an absolute difference of 19% (from 80% to 99%).
That has to be compounded with the chance of my child actually being infected and asymptomatic, her actually spreading asymptomatically (which I understand doesn’t happen nearly as often as some people make it out to, in fact might even be a rare event), my uncle getting infected, and him having a bad outcome. If I have my child take a quick home test before letting her see him, the chance further drops by a factor equal to the test’s rate of false negatives.
So the final probability can be kept quite low just with non-medical interventions as long as we behave responsibly. Knowing, again, that nothing we ever do can be 100%.
On the other hand, that (hopefully) low probability has to be weighed against the chance that the child could be harmed by the vaccine. This probability cannot be fully quantified as of yet. It may well turn out be very small. But it cannot be zero either, and as a parent I must err on the side of caution when exposing my child to risks (especially if these risks don’t even result in a net personal benefit to her).
Anecdotal, I know, but the other day I saw a news report that broke my heart of a mother in Utah who had her athletic 17-year-old son take the vaccine, then a few days later out of the blue he came down with multiple strokes and is fighting for his life right now. Post hoc ergo propter hoc, I know, but still, how likely is it for this kind of thing to be happening to teenagers and twenty-somethings. There are quite a number of such stories that I have seen documented. Some of these thrombosis cases may well be coincidences but they can’t all be, not in all these young people anyway.
Sure, I would prefer the world to be a happy place where everybody is healthy and safe. But given the choice, I would still prefer to live with my family in a world that’s a pile of ashes, than go through what that mother must be going through right now.
Peace 🙂
@ stufidiesserevittime
You write: “I understand that long covid is a (still largely unknown and not quantifiable) problem but so are the long term effects of (repeated) vaccinations. Especially if this going to become a recurring thing. It seems to be common knowledge that the second shot packs a much worse punch than the first one in terms of side effects. What if the third turns out to be even worse, for example?”
Yep, the second shot did cause me some discomfort; but compared to what? Actual infection with COVID? And having studied the literature for over 40 years, I have found NO evidence of “long term effects of (repeated) vaccinations.” One can always find the odd article, so what? Individual articles can even be written by honest sincere professionals; but individual studies are subject to random effects, which is why I rely on numerous studies, etc. Some evidence that getting flu vaccine several years in a row lessens effectiveness, called original antigenic sin; but still confers more protection that without vaccine. Take one rare condition, Guillain-Barre, yep, about 1 per million shots; but GB much higher from actual flu.
You write: “With so many unknowns, for sure at this stage I just can’t feel as confident (either way) as you seem to be.”
Maybe unknowns in your mind; but not in the minds of those who have devoted lifetimes to studying vaccines. And, as opposed to other pharmaceutical products, the requirements for approval of vaccines are much much more stringent, including sampling of lots, visiting production facilities, and post-market surveillance, not just VAERS; but Vaccine Safety Datalink, and several others. Go to: CDC Vaccine Safety Available at: https://www.cdc.gov/vaccinesafety/index.html
In addition, almost all developed nations do their own evaluation of vaccines and have their own post-marketing surveillance systems and WHO has its own and links to others. Developed nations with different cultures, histories, economic, political, educational systems. Do you really believe that so many different nations have public health researchers that could care less about their respective children?
I get the flu vaccine every year, try to be first in line.
Before I volunteered for the Moderna COVID vaccine trial I got out my textbooks on molecular biology, reviewed carefully chapters on mRNA, then did thorough search of PubMed and Google Scholar for any papers on mRNA and vaccines, then went to FDA website and downloaded everything I could find. While anything is possible, I was reasonably confident that mRNA vaccine was both safe and effective and the clinical trials and subsequent published articles confirm this.
@ Aelxa
You write: “However, mRNA is often promulgated on the grounds of the popular opinion that when using mRNA, unlike DNA, the stringent gene-therapy regulations are bypassed because mRNA does not integrate into the host genome. However, in reality, this only holds true in the US since in Europe, any active pharmaceutical ingredient, which contains or consists of a recombinant nucleic acid, used in or administered to human beings, falls under the scope of the regulation for advanced therapy medicinal products [6]. Therefore, mRNA-based therapeutics are categorized as gene therapy. . . In Europe where they invented the use of mRNA they are classified as GENE THERAPY.”
And: “If you read my other posting on the topic, these mRNA “vaccines” are also considered Gene Therapy by the US government per the Vice President [Tracy Meffen] of a company which has to jump through those legal hoops to get their mRNA and recombinant products approved for use in the US.”
And: “So legally it does not matter if the DNA sequences in the mRNA came from our own DNA in the our cell’s own nucleus, or if the mRNA was not made inside our own cells nucleus and was made in a lab instead. These mRNA injections are legally Gene Therapy.”
From FDA (2018 Jul 25). “What is Gene Therapy: Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms: Replacing a disease-causing gene with a healthy copy of the gene; Inactivating a disease-causing gene that is not functioning properly Introducing a new or modified gene into the body to help treat a disease.
And from Wikipedia. Gene Therapy: “The concept of gene therapy is to fix a genetic problem at its source.”
From FDA: Moderna COVID-19 Vaccine
From Clinical Trials.gov: Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19)
First, we live in the United States, not in Europe. Secondly, what someone, Tracy Meffen, in an interview for a news article says, is just that, one person’s opinion in an interview. I have been following the mRNA Covid vaccines since first became aware of back in Summer 2020 and downloaded everything on clinical trials from FDA website, all referred to them as VACCINES.
As for the EU including them as Gene Therapy, please give a detailed reference, doesn’t really matter. I can include Leukemia under cancers or under Blood Diseases, doesn’t change what it is. And I went to the European Medicines Agency website and found both Moderna and Pfizer vaccines. NO MENTION/USE OF GENE THERAPY in either, simply explained as vaccines.
And you continue to ignore that there is a BIG difference between mRNA created by DNA and mRNA infected into the cytoplasm. One is based on the cell’s DNA and may be produced over and over again. The other disintegrates rapidly and CANNOT enter the nucleus. So call it what you want. You are WRONG. Again, we live in the United States, so I rely on FDA, not on you.
You write: “Oh, and I just looooved the Salk paper that said that COVID-19 was a vascular disease. Do any of you remember me saying that almost a year ago? That COVID-19 was clearly a vascular disease and not a respiratory disease….. and you all jumped down my throat saying I was nuts, etc (just place the usual insults you guys dish out to me). Oh, I am soooooo vindicated by Salk. I am laughing my ass off over this one.”
Yikes!. I have articles going back to early outbreak of pandemic that found vascular damage; but it is also a respiratory disease. As usual in your infinite stupidity, you find one paper that says what you want to believe. Yep, its major damage is to vascular system; but it also, in many cases, invokes acute respiratory distress syndrome among other things, note “respiratory” and lung cells have ACE2 receptors, so the first damage it does is often to the lungs. The world isn’t black and white as you in your infinite stupidity would like to believe.
By the way, no admission you were wrong about the Danish studies???
“By the way, no admission you were wrong about the Danish studies???”
I painted his (his mother was Danish) yohoo gold and he failed to obtain superpowers sufficient to defeat me. He also died because the gold paint was latex-based and he was not painted in his own state. Who knew? Damn HIPPA.
@orac
a shareholder in Moderna, Inc I would recommend you to stop deceiving your readers here and you should understand that defrauding the public during a clinical trial may put you at risk. You can comment and misrepresent in defining what you think is the mRNA platform here, but one place you can not is the UNITED STATES
SECURITIES AND EXCHANGE COMMISSION where you can learn what MODERNA‘S filing quarterly reports defines their mRNA-1273 aka Covid-19 vaccine as experimental gene therapy.
You can participate in wordplay all you want on the internet, in the media, or on Jimmy Kimmel- but as any investor understands, that a public company must use clear and true statements in their filings. I certainly hope you have good lawyers when people start pointing to this blog as interfering and misleading their informed consent; MODERNA and their shareholders believe in this technology but also understand its risks.
What is has become a great concern to me is that investors have more knowledge and proper disclosures to make decisions on investments than the public who are making decisions regarding their biological bodies. I have never seen so much gaslighting around technology or pharma in my life. I certainly feel it is important to keep the standards of informed consent and that is why I encourage you to spend a little time learning about mRNA.
I included some excerpts directly from Moderna’s SEC filings, so your readers can understand that they be called vaccine’s in the market but they are new Gene Therapy technologies.
Moderna, Inc.
Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict.
No mRNA drug has been approved in this new potential class of medicines, and may never be approved as a result of efforts by others or us. mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines.
•differences in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials to later clinical trials;
•preclinical and clinical data are often susceptible to varying interpretations and analyses, and many investigational medicines believed to have performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval;
•our investigational medicines may have undesirable side effects, such as the immunogenicity of the LNPs or their components, the immunogenicity of the protein made by the mRNA, or degradation products, any of which could lead to serious adverse events, or other effects. One or more of such effects or events could cause regulators to impose a clinical hold on the applicable trial, or cause us or our IRBs or ethics committees to suspend or terminate the trial of that investigational medicine or any other of our investigational medicines for which a clinical trial may be ongoing;
As a potential new class of medicines, no mRNA medicines have been approved to date by the FDA or other regulatory agency. Successful discovery and development of mRNA medicines by either us or our strategic collaborators is highly uncertain and depends on numerous factors, many of which are beyond our or their control. We have made and will continue to make a series of business decisions and take calculated risks to advance our development efforts and pipeline, including those related to mRNA technology, delivery technology, and manufacturing processes, which may be shown to be incorrect based on further work by us, our strategic collaborators, or others. Prior to the Phase 3 trial for mRNA-1273 and that of one other company, there had never been a Phase 3 trial in which mRNA is the primary active ingredient, and there has never been and there may never be a commercialized product in which mRNA is the primary active ingredient. Our mRNA investigational medicines that appear promising in the early phases of development may fail to advance, experience delays in the clinic, experience clinical holds, or fail to reach the market for many reasons, including:
•discovery efforts at identifying potential mRNA medicines may not be successful;
•nonclinical or preclinical study results may show potential mRNA medicines to be less effective than desired or to have harmful or problematic side effects;
•clinical trial results may show potential mRNA medicines to be less effective than expected (e.g., a clinical trial could fail to meet one or more endpoint(s)) or to have unacceptable side effects or toxicities;
•adverse effects in any one of our clinical programs or adverse effects relating to our mRNA, or our lipid nanoparticles, or LNPs, may lead to delays in or termination of one or more of our programs;
•the insufficient ability of our translational models to reduce risk or predict outcomes in humans, particularly given that each component of our investigational medicines and development candidates may have a dependent or independent effect on safety, tolerability, and efficacy, which may, among other things, be species-dependent;
In addition, since the path to licensure of any vaccine against COVID-19 is unclear. Unexpected safety issues, including any that we have not yet observed in our Phase 1 or 2 clinical trials for mRNA-1273, could lead to significant reputational damage for Moderna and our technology platform going forward and other issues, including delays in our other programs, the need for re-design of our clinical trials and the need for significant additional financial resources.
Risks related to our reliance on third parties
*We have in the past entered into, and in the future may enter into, strategic alliances with third parties for the development and commercialization of our development candidates and investigational medicines. If these strategic alliances are not successful, our business could be adversely affected.
Manufacturing our vaccine candidates involves a complicated process with which we have limited experience. We are dependent on third-party organizations to conduct a portion of our vaccine manufacturing activities.
*The positive interim data from the ongoing Phase 1 study of mRNA-1273, our vaccine candidate for the treatment of SARS-CoV-2, may not be predictive of the results of later-stage clinical trials, which is one of a number of factors that may delay or prevent us from receiving regulatory approval of our vaccine candidate.
The positive interim data we have announced from the ongoing Phase 1 study of mRNA-1273 are based on only the limited number of subjects enrolled in the first phase of the Phase 1 clinical study. Further results from the ongoing Phase 1 study or any interim results of our Phase 2 or Phase 3 studies for mRNA-1273 could show diminished efficacy as compared to the interim Phase 1 study results or that the neutralizing antibodies are not sufficiently durable without repeated boosting. We also may observe new, more frequent or more severe adverse events in subjects participating in these clinical studies. In addition, the interpretation of the data from our clinical trials of mRNA-1273 by FDA and other regulatory agencies may differ from our interpretation of such data and the FDA or other regulatory agencies may require that we conduct additional studies or analyses. Further, the assays being used to measure and analyze the effectiveness of vaccines being developed to treat SARS-CoV-2 have only recently been developed and are continuing to evolve. The validity and standardization of these assays has not yet been established, and the results obtained in clinical studies of mRNA-1273 with subsequent versions of these assays may be less positive than the results we have obtained to date. Moreover, the samples of convalescent sera, or blood samples from people who have recovered from COVID-19, used to benchmark the level of antibodies produced by subjects receiving mRNA-1273 in clinical studies, have been taken from a small number of people and may not be representative of the antibody levels in a broader population of people who have recovered from COVID-19. The future results in clinical studies of mRNA-1273 may not be as positive when compared to the antibody levels in other samples of convalescent sera. Various preclinical animal studies of mRNA-1273 are ongoing, including preclinical studies in non-human primates. If safety data observed in these preclinical studies are inconsistent with safety data from clinical studies, we may be required to conduct additional studies of mRNA-1273. Any of these factors could delay or prevent us from receiving regulatory approval of mRNA-1273 and there can be no assurance that mRNA-1273 will be approved in a timely manner, if at all.
Our reliance on government funding and collaboration from government and quasi-governmental entities for certain of our programs adds uncertainty to our research and development efforts with respect to those programs and may impose requirements that increase the costs of development, commercialization and production of any programs developed under those government-funded programs.
SARS-CoV-2 vaccine (mRNA-1273) is being developed in collaboration with NIAID. BARDA has agreed to fund the advancement of mRNA-1273 to FDA licensure. Contracts and grants funded by the U.S. government and its agencies, including our agreements funded by BARDA and DARPA and our collaboration with NIAID
Now do the same for Pfizer’s mRNA-based vaccine.?
You should read FDA documents, actually:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19
It is FDA that gives EUA.
@ stufidiesserevittimesays:
You write: “Well, according to the CDC, 238 children (defined as under 18) died from Covid, so that’s even more proof that Covid and the flu are absolutely comparable for this age group. Children also sometimes die from drowning in swimming pools, having trees or fences falling on them, or being struck by lightning. And let’s not even start about bicycles. That’s all very tragic but not a reason to roll every child up in bubble wrap.”
Nope, not absolutely comparable for age group. First, you look at only deaths; but we are finding vascular damage in young people, including kids; but more importantly they can be asymptomatic or just in incubation stage and give it to others, e.g., supermarkets, playgrounds, parks, etc. And though studies indicate kids less responsible for infecting others, its not all or none and as i wrote, the new variants are infecting kids/young people and though not killing “many” are causing long-Covid and vascular damage. And they do infect easily others with flu.
As for your other causes of kids deaths. Yikes! What an absolutely absurd comparison. So, if we can’t prevent some cancers, why bother with others or if we can’t prevent car accidents, why bother keeping our water supply safe? Nope, we can’t prevent all deaths, not just kids but adults; but we can eliminate, thus reducing, some of the causes and, again, besides the new variants putting kids at greater risk than earlier, kids can infect others, both with flu and COVID. But, you could care less, that is, unless someone infects your or your kids with covid or flu, and this time your reaction or theirs isn’t just an unpleasant week. Yep, no man is an island, except in your mind!
And by the way, I lived in Gothenburg, Sweden for almost 10 years, didn’t own a car, and bicycled year round except when ice on roads. They had excellent separate well-maintained bike paths and I ALWAYS wore a helmet and a bright reflective vest, and at night, front and tail lights.
“Out of how many cases?”
Who knows how many children have had an asymptomatic Covid infection. Could be many, could be few, could be almost all of them. But thinking about it, why would that even matter to the question whether a child should be vaccinated?
What I’m comparing here is the risk of dying of Covid vs. the risk of dying from the vaccine (setting aside for a moment the separate issue of long-term effects for both).
Assuming that there are about 9 million children in the US, then if you are a child in the US you have ~ 200/9M = 0.0022% annual chance of death from the flu, and a ~238/9M = 0.0026% annual chance of death from Covid.
Whether that’s because Covid is a highly prevalent but very non-lethal disease in children (more like flu), or more lethal but then less prevalent (extreme example: H5N1, ebola, or rabies) is immaterial. We only vaccinate children against diseases that are actually dangerous to them. For different reasons, both the common flu and rabies are not dangerous enough to children to warrant vaccinating all children against either of them. At least according to conventional wisdom.
@ stufidiesserevittime
You write: “Who knows how many children have had an asymptomatic Covid infection. Could be many, could be few, could be almost all of them. But thinking about it, why would that even matter to the question whether a child should be vaccinated?”
So, you totally ignore what I wrote about studies now finding vascular damage in children. If one follows your thought process, only deaths count, then it was a waste of time to vaccinate children against polio. Fewer died of polio in the early 1950s than died from the flu.
You write: “Whether that’s because Covid is a highly prevalent but very non-lethal disease in children (more like flu), or more lethal but then less prevalent (extreme example: H5N1, ebola, or rabies) is immaterial. We only vaccinate children against diseases that are actually dangerous to them. For different reasons, both the common flu and rabies are not dangerous enough to children to warrant vaccinating all children against either of them. At least according to conventional wisdom.”
Less prevalent than H5N1, ebola, or rabies? Also less prevalent than being struck by a meterorite. Only rabies has actually occurred in U.S., not counting once a couple of cases of ebola that is only contagious when symptomatic and when symptomatic, they are too sick to even get up. According to CDC: “From 1960 to 2018, 127 human rabies cases were reported in the United States.” That is about two cases per year and almost none died because of the vaccine. Compare this to 238 children dying from Covid in just one year. And, as I wrote, maybe the flu isn’t so dangerous to children, that is, if you don’t mind 7,000 – 26,000 hospitalized. See CDC Flu & Young Children. As for comparing flu with rabies, are you totally NUTS? Up to 26,000 hospitalized and 238 deaths and, maybe, one case of rabies per year, assuming that one of the two cases was a child.
“Conventional wisdom”, only if you mean by conventional wisdom your unscientific illogic. And you continue to ignore that some of the new Covid variants are infecting and causing greater damage in children. And despite what you choose to believe, the risk to children from flu vaccine is far far less than from flu, basically approaching zero, and you continue to think that focusing ONLY on you and yours is a sane approach. Well, if more and more were to think like you we would see deaths and hospitalization skyrocket from flu and other vaccine-preventable diseases. And that includes you and yours being at ever increasing risk. What is your education? What is your profession? I suggest you Google Dunning-Kruger Effect, basically the less one knows the more certain one is.
You probably won’t read them; but here are two papers, one of lab tests of damage to children from COVID and one comparing seriousness of COVID and flu (I’ve got more articles):
Ratchford S (2021 May 6). Healthy Young Adults Who Had COVID-19 May Experience Long-Term Impact on Blood Vessels and Heart Health. Cath Lab Digest.
St. Peter E (2020 May 28). Distinctive Features: Study shows striking differences in lung injury between deceased COVID-19 and flu patients. Harvard Medical School News.
By the way, studies have found that some nations where people feel a sense of community are the same nations with the lowest Covid deaths.
No, I am not ignoring what you said about vascular damage. I was replying to Narad who asked me why I was comparing the flu with Covid in my previous post, and I explained that I was comparing the annual death count in children from Covid vs flu. I explicitly acknowledged long term effects, saying that they are separate issue. We can talk about them too if you like, but the question was about my previous post where long covid was not mentioned.
No, I am not saying that flu and rabies are the same thing. Precisely, what I was saying is that they showcase OPPOSITE scenarios. One is highly prevalent but rarely fatal in children. The other is (without a vaccine) virtually 100% fatal, but not prevalent.
Since Narad had asked about case fatality ratios, my point was simply that case fatality ratio is not the appropriate variable to consider when asking the question if a population-scale vaccination program makes sense or not. We don’t vaccinate ALL children against H5N1 despite it being lethal. Or against ebola, Or the bubonic plague. Or against a host of other deadly but rare diseases. It just doesn’t make sense, in terms of absolute risk reduction, or NNT if you will.
The one who is making absolute claims with no admission of uncertainty is you, professor, not me, so it’s kind of ironic that you would cite Dunning Kruger (not calling you ignorant here like you did me, just condescending). FYI, I am grateful for every link I have been given in this discussion, I have said thanks and I have read them all so far. Unlike you, I have repeatedly had the humility to admit that there are things I don’t know. I also don’t understand what you’re trying to accomplish by being so abrasive to me all the time despite me always being polite and respectful to you. Do you think you can somehow demean people into agreeing with you? Whatever, I’m not interested in ad hominems so I’ll move on. The only thing I am interested about is understanding the science and finding out the truth.
By “conventional wisdom” I mean that so far I am aware of no country in the world that mandates flu vaccinations or preventative rabies vaccinations for all children. I am old enough to remember a time when flu vaccines did not even exist at all, and that even back then the flu was not considered a terrifying and lethal disease, in children and in adults. The only exception being the very old and very frail who were approaching the end of their lives anyway. If a healthy adult had said that they were scared of the normal flu back then we would have laughed at them. We saw it as an annoyance and a part of life. And I still do.
Not sure what my academic qualifications add to the discussion. I think even people with no education at all have the right to ask questions and try to understand what is happening. Even if I was a plumber I wouldn’t just “shut up and take it already, just trust us (signed, the same people who gave you the opioid crisis and knowingly had asbestos in their baby powder)”.
But if it matters to you, I am an engineer working in telecommunications security. I also used to volunteer as a first responder. Point being, I understand basic math and I am capable of reading a scientific paper. Obviously I don’t have even close to your expertise in molecular biology, but I am willing to put in the effort to learn and better myself. I also have no hidden agenda. I am not on some sort of crusade against vaccines or something. I get flak from vaccine sceptics all the time when I call them out on what I think they get wrong. But to their credit I will say, I appreciate that they are asking questions. Whom I really don’t understand are the people who say, just inject me with whatever, I don’t care what it is, as long as I’ll be allowed go on trips again.
You say, “Studies have found that some nations where people feel a sense of community are the same nations with the lowest Covid deaths”. I had to LOL. Are you saying that in Italy we have no sense of community?
What about India? Or Ecuador? Or Brazil?
Yeah, right. Meanwhile your hyper-individualistic American society that you’re trying to export everywhere in the world is a blessing to humanity, second only to gain of function research.
So much for your feeble impersonation of a concerned member of the general public. Your freak flag is now in full view.
FTFY.
Obviously, if asymptomatic COVID cases are very common,herd immnitu wouyld have been achieved long since. How many asymptomatic cases Brazil have ?
Children are not vaccinated against COVID, have you noticed ? So another problem with your comparison.
So, I have read the two publications that you cited. Thank you. I mean it. I truly appreciate the information.
The second one doesn’t surprise me at all. It fits perfectly with the many other autopsy reports that I read from last year where they found diffuse pulmonary embolisms in Covid fatalities. And with the ground-glass opacities. I totally agree with you that Covid can be terrifying, especially (it would seem to me) when not only the respiratory tract is infected but the pathogen gets into the bloodstream in significant quantities.
I admit my initial understanding of the causal relationship between the spike protein and the thrombosis was very crude and did not take the cytological details into account. I will do my best to study and understand this in more depth.
You are right, the first article (and the references it cites) is indeed very scary. Especially since I take it that the data seems to indicate that there may not necessarily be a direct relationship between the severity of the primary infection and the long term effects. This is definitely something to take into account in a risk vs benefit analysis, indeed. I am happy I learned something new today. Even if you seem to hate my guts for some reason, thank you.
Joel, that cite should be to Experimental Physiology. The paper is open access.
@ Narad
Thanks for the reference; however, I cited the lab’s press release on the article; but, of course, the actual article is much better.
Maybe I should hire you to do my internet searches? ?
Huh? What’s your problem?
I have been told, “a first pass evaluation would tend to indicate alot.”
@ Narad:
Geez, what a profound argument. Very convincing, I am so impressed.
So, what metric do you propose we should use when deciding if we should give kids medication of any kind, if not risk vs benefit assessment? Profit to the pharma industry?
Maybe it’s a cultural thing. In my part of the world we don’t just pump kids full of drugs unless there’s very good reason.
You don’t have a f*cking denominator, genius. It’s not my fault that this elementary concept seemingly cannot penetrate your skull.
@ stufidiesserevittime
You write: “So, what metric do you propose we should use when deciding if we should give kids medication of any kind, if not risk vs benefit assessment? Profit to the pharma industry?”
First, despite what you believe, overall the pharmaceutical industry makes far more money treating diseases than on vaccines. In fact, on average, the total sales of vaccines worldwide comprises between 2 and 3% of pharmaceutical revenues. A couple of pharmaceutical companies do make a significantly larger percentage of their revenues from vaccines. On the whole, they make far more just selling statins. Second, of course they make a profit. Do you expect any business to sell something for nothing? Everything sells for profit; but profit doesn’t say whether beneficial, neutral, or harmful. A foolish argument to bring up profit. In fact, vaccines are far more costly to manufacture than most other pharmaceuticals, partly because they are biologics, and partly because FDA regulations are much much more stringent.
As for benefit vs risk assessment, yep; but the risk needs to include hospitalizations, possible asymptomatic long term damages, and risk to others, not just strangers; but loved ones. Your focus on yourself and immediate family, if everyone thought as you, especially based on false beliefs in serious adverse events risk, then few would get vaccine and everyone, including you and family would be at seriously increased risk. It is selfish, and short-sighted to rely on others and not feel an obligation to community.
The denominator is the 9M children in the population. See that “9M” after the “/”?
As in, if you’re one of the ~9 million children living in the US, what’s your chance of dying from one disease vs the other. Do you even read the posts you comment on?
It’s not about the change of dieing in the whole population, but the chance of dieing in relation to the number of infected people. And with covid this number might be lower, because of the things we do to stop the spread, like social distancing, masks and lockdowns.
@Renate: Thank you for your comment.
You say that the important metric is the chance of dying in relation to the number of infected people.
I respectfully disagree, for the reasons stated above. Based on the case fatality ratio, we should be vaccinating like crazy for diseases like rabies, H5N1, ebola, bubonic plague. These are all extremely lethal to those who catch them.
The reason why there are no mass vaccination campaigns for any of these is that they are not a threat to public health, despite being so deadly to the infected, because the chance of catching them (at least where you and I live) is very low.
I’m saying this specifically for the purpose of calculating individual risk vs benefit ratios.
And yes, long term effects must be plugged into the equation as well.
@ stufidiesserevittime
Once more, dying is just one measure. Severe potentially long term damages are also IMPORTANT. Polio killed very few; but left many crippled to various degrees and many who, often after a year of painful retraining, regained most of their mobility, later succumbed to post-polio syndrome 30 – 40 years later. I actually personally knew two who when I first met them seemed just like everyone else, then several years later began walking with a cane, then in a wheelchair, then bedridden.
The vascular damage from COVID could potentially be the beginning of a deteriorating condition or just open someone up to other infections that without the vascular damage they would have withstood. I tend to err on the side of caution and despite what you choose to believe, the COVID vaccines are extremely safe, especially compared to the actual disease, and the safety includes kids. And even at the outset of the pandemic I didn’t wear a mask when I walk my dog twice daily a mile each time, 5 am and 8 pm. If I saw anyone, just either walked up someone’s driveway or crossed the street; but if standing in line at Costco, even maintaining 6 feet physical distance, I always wear a mask. It is one thing to briefly pass someone on the street; but if standing in line for several minutes the odds, though still not great, of being infected increase. Since wearing a mask is not big deal, except fogs up my glasses, I will continue to wear. I can see without my glasses, so shop without them, then put on if need to read label on something.
And I contacted the clinical trial center where I was a volunteer in the Moderna Covid vaccine trials and told them as soon as they have it I want the booster designed for the variants.
@Joel A. Harrison, PhD, MPH
You are absolutely right. I agree. Death is not the only metric. The only point I’m trying to make (in a sub-thread started by Narad specifically on this subject) is that I think it’s a conceptual mistake to use case fatality ratio as opposed to absolute risk specifically for the purpose of a risk vs benefit analysis of a vaccine with respect to fatal outcomes.
I totally get that long covid is an issue. Again, especially the finding that there was no significant outcome difference found in the mild-to-moderate vs severe/critical cohorts in the Riou et al study.
Of course, this is one study, and limited to hospitalized patients, but yes, absolutely, I find it alarming too. Together with the findings of the other studies you cited, I absolutely see the potential for life-long (and life-shortening) sequelae of a mild (or perhaps even asymptomatic?) infection. The polio comparison is very apt indeed. I thank you again for the links, I appreciate it very much and I will try to follow this area of research closely.
By the way, Amazon tells me that I can expect the Sompayrac text within two weeks. Can’t wait for it. Thanks again.
For the record, I’ve never had a problem with wearing a mask. Last year I used to sew them up out of microfiber towels and hand them out for free in the neighborhood and to friends. I had gotten pretty good at it actually if I may say so myself. Triple layer, iron wire for the nose bridge, folds on the side to fit the cheeks, no central stitch and everything. I used to love being able to just stick them in a water boiler after each use. Now the politicians in the area have mandated FFP2 standard. Don’t know if any of it helps though, especially considering the way I see most people use them. The impact on the environment is awful. I keep seeing discarded ones lying around everywhere.
Yea, seeing walking chin diapers navigate to get into my face makes me hurl — {there is a sodium bicarbonate shortage (long story)} (the ribbed turnback tube into the bag witholds much of that). I bought 28 Orek bags early last year, burned through about 5 making prototypes and duplicate for family member. I’m on the one final bag in the last iteration still (14 months). The window seal needs replacing, it inexplicably gets crunchy.
Yea, I see them everywhere also. That is not a mask problem, that is a people problem.
When I was a kid, there was this commercial with this crying Indian {Native American, for the Red Sox fans) because all this trash was on the interstate. I got into trouble in class interpereting that he was not crying because of the Snickers wrappers but because the White Man burned down his home, took his land, raped his wife, and killed his children.
Then again, I’ve never run on the ‘popularity’ plank. Then again, I might. Gen-z is looking toward the aging pothead willing to try new things.
Number of certified COVID cases is quite high, too. Perhaps this should be taken account, too ?
@ stufidiesserevittime
You write: “By “conventional wisdom” I mean that so far I am aware of no country in the world that mandates flu vaccinations or preventative rabies vaccinations for all children. I am old enough to remember a time when flu vaccines did not even exist at all, and that even back then the flu was not considered a terrifying and lethal disease, in children and in adults. The only exception being the very old and very frail who were approaching the end of their lives anyway. If a healthy adult had said that they were scared of the normal flu back then we would have laughed at them. We saw it as an annoyance and a part of life. And I still do.”
First, rabies vaccine does have serious side-effects, since only a couple of cases a year, the benefits to risk ratio would be highly against vaccinating, not the same with flu, regardless of whether mandated or not. I used seatbelts long before required by law or even public health messages encouraging. As for flu, read up on 1918-1919 pandemic that not only killed up to 750,000 Americans when our population was 1/3 what it is; but killed young people more than old. However, given World War I, etc. American public forgot. Then we had flu pandemics in 1957 and 1968. Not as lethal as 1918s; but 1957 in U.S. estimated between 70,000 and 116,000 deaths in a population half today’s and 1968 deaths about 100,000, again in a much smaller population. I won’t bother to give hospitalization statistics. As for “the very old and very frail who were approaching the end of their lives anyway,” exactly why I have nothing but CONTEMPT for people like you. When my grandparents and parents died I would have done about anything to have them around even for just one more year. Without flu many of the aforementioned might have live for several more years, even quality years.
You write: “I also don’t understand what you’re trying to accomplish by being so abrasive to me all the time despite me always being polite and respectful to you. Do you think you can somehow demean people into agreeing with you?”
Besides coming up with why bother worry about flu since kids could die by lightening, bicycle accidents, drowning, I wonder if seatbelts weren’t mandatory if you would use them and insist your kid do so as well? After all, only prevent deaths and serious injury by about 50%. And bringing up rabies, ebola, etc. Yep, if one looks at history some people have died from meteor showers; but I don’t stay awake at night worrying about it. And your absolute contempt for the lives of older people, well, that is grounds for being abrasive, etc.! ! !
You write: “Obviously I don’t have even close to your expertise in molecular biology, but I am willing to put in the effort to learn and better myself. I also have no hidden agenda.”
So, I suggested you get a copy of Lauren Sompayrac’s book “How the Immune System Works (6th Edition). Read it, then post again and I might be willing to suggest further readings.
You write: “I am an engineer working in telecommunications security. I also used to volunteer as a first responder. Point being, I understand basic math and I am capable of reading a scientific paper.”
Yep, engineers are good at math; but not the type of statistics and research designs used for infectious diseases, so, nope, a degree in engineering doesn’t automatically ensure what you claim. I have a PhD, four Masters degrees, a 3-year prestigious NIH post-doctoral fellowship; but if someone were to give me several plans for building a bridge over a river, I couldn’t choose because I have NEVER taken a course in structural engineering, though if the math were perhaps Calculus I could follow it.
You write: “You say, “Studies have found that some nations where people feel a sense of community are the same nations with the lowest Covid deaths”. I had to LOL. Are you saying that in Italy we have no sense of community? What about India? Or Ecuador? Or Brazil? Yeah, right.”
Research has found that Italy had asymptomatic cases in December, was hit hard before they could even react; but South Korea, Taiwan, and New Zealand acted early in January to warnings from China. New Zealand, of course, had the advantage of being an island; but not the others. And again, India, Ecuador, Brazil, three nations with clear caste systems, and Brazil’s leader, Bolsanaro as Trump, has refused to admit Covid’s danger. More example of your inability to draw logical analogies.
And finally you write: “Meanwhile your hyper-individualistic American society that you’re trying to export everywhere in the world is a blessing to humanity, second only to gain of function research.”
A “blessing to humanity.” Really? We have 4% of world’s population; yet 25% of incarcerated with an estimate that 100,000 are TOTALLY innocent; yet we have a CRIMINAL criminal justice system that bends over backwards to NOT overturn convictions. I have been following the innocence projects since preteen years and it takes so much effort and time to just get one case overturned that they can only take on a few every year. We have the highest per capita murder rate, including mass murders, among OECD nations. And we are responsible for killing over 20 million people in the Third World, crippling many more, and overturning democracies, not defender of the free world. Below is a reference list, if you dare. Our lying government tells people we are intervening to prevent Communism and the Domino Theory. Lie. We use our military to further interests of corporations, e.g., oil, etc., arms industry, or as George HW Bush, when polls were down, went to war against Iraq, polls up briefly; but he still lost election. Watch movie: Wag the Dog. And we are NOT a democracy: Electoral College, Gerrymandering, Voter Suppression, and huge amounts of money spent to influence people who don’t take the time to really investigate issues. I often leave half of ballot blank because I don’t have time to investigate all the propositions and offices.
There is also an excellent book on why both our criminal and civil justice systems often fall far short of justice compared to several other legal systems: Robert Kagan. “Adversarial Legalism”
By the way, I have lived in five other nations and done quite a bit of traveling, so I saw how the Swedish and Canadian health care systems actually work and I have kept up by looking at studies, including international comparisons. Did you know that in some areas of the United States the infant mortality is much higher than many Third World nations???
U.S. Military – Our Government Lies Used for Defense when, in reality, used to further Corporate Interests
William Blum (2003). Killing Hope: US Military & CIA Interventions since World War II. Available at: https://www.cia.gov/library/abbottabad-compound/13/130AEF1531746AAD6AC03… [also for purchase on amazon.com
Major General Smedley Butler War Is A Racket. Available at: https://ratical.org/ratville/CAH/warisaracket.pdf [Butler is the most decorated marine in American history]
Mason Gaffney (March 2018). Corporate Power and Expansive U.S. Military Policy. American Journal of Economics and Sociology, Vol. 77, No. 2. Pages 331 – 417. Available at: https://www.globalresearch.ca/corporate-power-and-expansive-u-s-military…
Stephen Kinzer (2017). The True Flag: Theodore Roosevelt, Mark Twain, and the Birth of American Empire. Henry Holt. Available amazon.com. Also available San Diego Public Library
Stephen C. Schlesinger (1983). Bitter Fruit: The Untold Story of the American Coup in Guatemala. Inexpensive copies available on Amazon.com Also available San Diego Public Library
The Cook County judicial ballot is an absolute nightmare to evaluate. At least one only has to choose three out of nine for the Metropolitan Water Reclamation District. The judges are an entire separate ballot sheet.
The Italian judiciary is a whole ‘nother kettle of fish.
[…] About that Salk Institute paper on the “deadly” COVID-19 spike protein May 4, 2021 […]
@ stufidiesserevittime
You write: “Based on the case fatality ratio, we should be vaccinating like crazy for diseases like rabies, H5N1, ebola, bubonic plague. These are all extremely lethal to those who catch them. The reason why there are no mass vaccination campaigns for any of these is that they are not a threat to public health, despite being so deadly to the infected, because the chance of catching them (at least where you and I live) is very low.”
You just keep up with the false analogies. They aren’t a threat! Period! Being struck by lightening can be lethal, so what? What are the odds? Despite what you continue to believe, flu is not benign, not only kills 200 or more kids; but hospitalizes 7 – 23,000 yearly and, as opposed to covid, kids can easily asymptomatically or while incubating pass on to others, including family and friends and since flu vaccine only reduces risk by about 50%, could kill their grandparents, etc. And kids can develop from covid long term vascular damage!
Joel A. Harrison, PhD, MPH
See? We agree. You literally used the same wording as me.
Meteor showers aren’t a threat. So, the example of meteor showers shows that case fatality ratio is not the right metric to use when deciding on preventative measures. That is literally ALL I’m saying in this thread. Which, again, ad nauseam, was started by Narad who called me out on why I was using absolute risk and not case fatality rate.
For the specific purpose of risk vs benefit assessment for fatalities. Again, at nauseam, long term sequelae are very important but OFF TOPIC for the purposes of this very specific question.
“Which, again, ad nauseam, was started by Narad who called me out on why I was using absolute risk and not case fatality rate.”
You weren’t “using absolute risk,” dipshit, you pulled a single number out of your ass and apparently decided that it allowed for a comparison with something you didn’t quantify, demonstrating over and over that it’s something you’re not able to do in the first place.
It’s like a f*cking monument to the First Rule of Holes.
It’s somewhat curious that you showed up right after fivehundredpoundpeep vanished, though.
@Joel A. Harrison, PhD, MPH
I absolutely expect, in fact demand, that regulations should be much more stringent for vaccines than for therapeutic medications. After all, vaccines are given to healthy people; while therapeutics are reserved those who are already sick and have much higher acceptable risk.
In fact, that is exactly my whole point here. In a risk vs benefit assessment for therapeutic medication it makes sense to use case fatality ratio because medication is intended to people with an unconditional risk; whereas absolute risk should be used for vaccines because their recipients only have a conditional risk.
And again, yes, how many times do I have to tell you that I agree that death is not the only metric. Two other people called me out on the specific way I was proposing to calculate risk assessment for the specific outcome related to deaths. Of course I’m gonna talk about that in my reply to them.
And yes, I agree, any business is entitled to a fair share of profits in return for their products. That doesn’t mean, however, that we should ignore the checkered past of some of these companies when it comes to putting profits over human lives.
@ stufidiesserevittime
You write: “That doesn’t mean, however, that we should ignore the checkered past of some of these companies when it comes to putting profits over human lives.”
And as I’ve explained; but you ignore, not only are the FDA requirements for approval of a vaccine far more stringent than for any other pharmaceutical product or medical device or food, for that matter; but the post-marketing surveillance involves numerous programs. And, as I explained almost all developed nations have similar programs and WHO collates many of them. Again, your infinite foolishness, different nations, different cultures, histories, political systems, economic systems, educational systems, so, do you really think that all their researchers are either incompetent, in pocket of Big Pharma and/or callous towards the welfare of their nation’s children?
You just keep grasping at straws. Please don’t get the vaccine, don’t wear a seatbelt, etc. after all you could be struck by lightening or infected with Ebola, or maybe attacked by a bat with rabies.
And while I’m sure you got excellent training in engineering, it is an applied science, focusing on how to, not training in research, research type statistics, and even if some, the methods for testing, for instance, steel alloys, differ immensely from studying people and diseases. As I wrote, I am highly educated; but would NEVER give an opinion on a bridge because I have NEVER studied structural engineering, etc.
Give it a rest!
You write: “In a risk vs benefit assessment for therapeutic medication it makes sense to use case fatality ratio because medication is intended to people with an unconditional risk; whereas absolute risk should be used for vaccines because their recipients only have a conditional risk.”
So, we have well-done studies that have NOT found deaths from Flu or Covid vaccines; but if they did find one death per, say, 5 million vaccinated, compared to the number of deaths from flu, hospitalizations and suffering, number of deaths from Covid and long covid, including kids with vascular changes, it’s a no brainer, at least for people with a brain that they use. And, as I’ve mentioned several times, polio killed very few, almost none, in the 1950s, so case fatality ratio would NOT be the appropriate measure. And if one of the COVID variants causes a huge upsurge in long COVID and kids with vascular damage, but few deaths, case fatality again would NOT be an appropriate measure.
You, as many, see the world in dichotomies, black and white and that isn’t how public health works.
Get a sandwich board.
After posting a link to my paper in the first comment of this story and waiting patiently, I am still waiting for an answer to two questions: 1) why has there been a massive increase in deaths reported to VAERS from the COVID-19 shots; and 2) why has that massive increase not been detected as a potential safety problem by the VAERS system?
The increase is NOT due to a more aged population of vaccine customers, because all age groups, 0-17, 18-64 & 65+ showed a similar increase.
The increase is NOT due to more vaccines being given this year than in other years, as of end of 1st quarter.
Dorit Reiss suggested an answer: That VAERS death reports are “investigated and analyzed and examined and have shown no signals.” But it’s just too vague to go on. How do these “investigations” and “analyses” and “examinations” interact with the VAERS statistical analyses? What criteria are they examining? And, etc.
@ NWO Reporter
No one gives a shit what you think; but below is a reference list where you can find out just how the CDC does evaluate vaccine safety, not VAERS; but the Vaccine Safety Datalink, a real-time link with HMOs totaling over 12 million members. Every vaccine, lot number, date given, person’s demographics, including comorbidities, etc. included and as I’ve written before and you just don’t care, the CDC also has teams that any single VAERS report of a serious adverse event is thoroughly investigated, including obtaining medical records. And I explained; but you ignore, that given the rise of the antivaccinationist movement, including blogs, social media, etc. the misunderstanding that the Covid vaccines weren’t approved based on standard requirements, including animals studies, over 30,000 volunteers, etc. and voila, we have way more reports. And you are just too stupid to understand Post Hoc Ergo Prompter Hoc. Once primed, if a husband dies from heart disease 10 days after receiving flu vaccine, spouse may suspect the vaccine and report it to VAERS; but we know that without any vaccines that, on average, 2,300 Americans die daily from heart disease, so 23,000 will die during the 10 days following the vaccination. So CDC goes to medical record and guess what they find?
So, keep making a fool of yourself, supporter of paranoid conspiracy theories.
Rapid Cycle Analysis with Vaccine Safety Datalink, etc
Reference List
CDC (2020 Aug 24). Vaccine Safety Datalink (VSD): Vaccine Safety Monitoring – VSD. Available at: https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html
CDC (2021 Apr 26). Emergency Preparedness and Vaccine Safety. Available at: https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/emergencypreparedness/index.html
CDC (2021 Mar 3). Rapid Cycle Analysis (RCA) to monitor the safety of COVID-19 vaccines in near real-time within the Vaccine Safety Datalink (VSD Project #1342. Version 1.1).
CDC (2021 Feb 24). Rapid Cycle Analysis (RCA) to monitor the safety of COVID-19 vaccines in near real-time within the Vaccine Safety Datalink: PROTOCOL SUMMARY.
CDC (2021 Jan 28). V-safe active surveillance for COVID-19 vaccine safety. Version 2.
Kulldorff M et al. (2011 Jan 19). A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance. Sequential Analysis; 30(1): 58-78.
Lieu TA (2007 Oct). Real-Time Vaccine Safety Surveillance for the Early Detection of Adverse Events. Medical Care; 45(10 Suppl. 2): S89-S95.
McNeil MM et al. (2014 Sep 22). The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety. Vaccine; 32: 5390-5398.
Nelson JC et al. (2012). Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data. Pharmacoepidemiology and Drug Safety; 21(S1): 62-71.
Nelson JC et al. (2013). Adapting Group Sequential Methods to Observational Postlicensure Vaccine Safety Surveillance: Results of a Pentavalent Combination DTaP-IPV-Hib Vaccine Safety Study. American Journal of Epidemiology; 177(2): 131-141.
Shimabukuro T (2021 Mar 1). COVID-19 vaccine safety update. Advisory Committee on Immunization Practices (ACIP). CDC.
World Health Organization (accessed 2021 May 8). Design of Vaccine Efficacy Trials to Be Used During Public Health Emergencies—Points of Considerations and Key Principles.
Yih WK (2011 May). Active Surveillance for Adverse Events: The Experience of the Vaccine Safety Datalink Project. Pediatrics; 127(Suppl. 1): S55-S64.
Dr. Harrison, not one of your many references even remotely address the questions I presented here, which are specific to VAERS data gathered in the last 4 months. (Except the Shimabukuro reference, which had relevant material that I discussed in my paper, which I suspect you never read.) Do you think no one will notice if you just spew enough citations and insults?
Since people keep bringing up those VAERS death numbers for the Covid-19 vaccines, i decided to do a little digging and number crunching.
So what about all those VAERS reported deaths after the Covid-19 vaccines?
I did a VAERS inquiry for all death reports for the Covid-19 vaccines. These numbers are as of May 7, 2021 for the period December 2020 through April 2021. VAERS lists 3540 Events Reported, which represent 3326 total events. For the purpose of this analysis, I assumed that each event reported represented a separate death, which may be a slight over count.
Out of that 3540 events/deaths, 2779 were for people age 65 and up. 66 were for unknown ages, so I included them in my totals.
I also looked up CDC records for Covid-19 deaths, All Cause deaths, and just FWIW, Influenza deaths. The CDC breaks out the deaths in 10 year age groups including 65-74, 75-84 and 85+.
The 3000+ deaths after vaccinations sounds like a lot. But 45,926,146 people 65 and older received at least one Covid-19 vaccination. So, those deaths represent only 0.0062% of that age group and only 0.3719% of the 765,256 people in that age range who died in the first four months of this year.
The benefits of the Covid-19 vaccinations are clear. In January 29.89% of all deaths were Covid-19 related. By March when I received both doses of my vaccination, that had dropped to only 8.59% and in April it was only 7.02%.
If that rate had stayed the same, we would have lost another 16,000 senior citizens in April alone!
And, of course, the same people who bemoan those deaths reported to VAERS and claim the CDC did not correctly investigate them, are happy to accept the validity of the 8 cases of CVST reported in people receiving the Johnson & Johnson vaccine so they can gripe about that.
“1) why has there been a massive increase in deaths reported to VAERS from the COVID-19 shots”
Mommy blogs.
2) why has that massive increase not been detected as a potential safety problem by the VAERS system?
It filters out mommy blog input.
Cancelled. Awkward.
Tim–If more VAERS death reports are due to “Mommy blogs” (more awareness), then why is the rate of deaths reported normal for non-COVID-19 vaccines, and off-the-chart only for COVID-19 vaccines?
Because if one didn’t get the vaccine then they wouldn’t report an adverse event to VAERS?
I’m just spitballing here, you just might.
I can’t answer your question for legal reasons and my sworn duty to protect the BGP. It is filtering out mass “call to action” event reporting. You know, spam.
“then why is the rate of deaths reported normal for non-COVID-19 vaccines, and off-the-chart only for COVID-19 vaccines?”
Mommy blogs.
Which number did I pull out of my Narad?
The 238 Covid fatalities aged less than 18 in a year? That’s CDC data.
The 9 million children living in the US? That’s US census data. Closer to 8.9 million if you want to be fastidious about it.
What didn’t I quantify? The ~200 kids who die of flu every year? That figure was cited by prof. Harrison.
I don’t even know what to answer to someone saying that I didn’t quantify the number 200.
You know? For a community of scientists who ostensibly want to save humanity, you are remarkably unkind to people.
You write: “you are remarkably unkind to people.”
I patiently responded to your first few comments; but when it became clear that you would continue to either focus on one or two things or just come up with something else, especially analogy of H5N1, Ebola, Lightening, Rabies, etc. nothing will change your mind. And, yep, I don’t have much respect for people that do this.
Yep, I mentioned about 200 deaths of kids from flu; but 7 – 23,000 hospitalizations and that asymptomatic or in incubation stage they could infect grandparents, kids with autoimmune diseases, kids and adults undergoing cancer treatment, etc. and you’ve made it absolutely clear in your immense stupidity that your family comes first, ignoring that if more thought as you, then stats on deaths from flu, Covid, etc. would skyrocket and you and family would not be exempt. So basically, whether conscious or unconscious, your lack of community is based on others having a sense of community; but even with higher vaccine rates, sometimes people still exposed. The last cases in U.S. from smallpox were from people visiting from abroad who weren’t vaccinated, came through Canadian border. Fortunately it was variola minor, a type of smallpox with lower death rates; but still extremely unpleasant week or so.
Professor Harrison,
it’s getting tiresome trying to keep up a polite conversation with you.
I am not ignoring what you are saying. It is you who are deliberately ignoring and misrepresenting what I am saying. It seems you are willfully looking for excuses just to insult me.
I have already told you several times that my point was about a specific technicality about a specific part of a calculation, and which one of the following two, asbolute risk of death or case fatality ratio, is the more appropriate variable to use for that specific part of the calculation. I have already acknowledged at least four times that I fully agree that sequelae are important and need to be evaluated too. I won’t repeat myself again. If you still haven’t seen me acknowledging this, it’s time you go get a new pair of glasses.
I am also sick and tired of you passing moral judgement on me. You know jack about who I am and what I’ve done in life. Just because my loved ones come first doesn’t mean I don’t care for others as well, once I’ve made sure my loved ones are as safe as they can be.
I have already conceded points in this discussion so your accusation that I’ll never change my mind is moot. What you can’t do is change my mind with insults. Where you were able to do so, was when you gave me data and sound reasoning. Which I am still happy and grateful for despite your insufferable demeanor.
I don’t buy for a second that you care about others. Your constant acrimony tells me that you’re not motivated by compassion. My theory is that you just love the sound of your own voice when you virtue signal from your high horse of self-proclaimed moral superiority.
I keep seeing documented reports of people going into convulsions, getting blood clots, or dying unexpectedly after the vaccinations. I understand that some of these may well be coincidences but it’s getting more and more untenable by the day that they all are. I can tell immunology is your area of expertise. Still, no matter how much you are confident that you know your stuff and got it right, if you were truly compassionate, all these cases would at least give you pause and make you wonder if you aren’t missing something after all. Maybe it’s a small detail, but even so, future versions of the vaccines could be made even safer, for example, so that even these people don’t have to suffer needlessly. The fact that you can compartmentalize and ignore this side of human suffering just so you can persist in your unshakable certainty looks like narcissism to me.
I am asking questions, you have all your answers cast in stone.
And if you see a bridge and your functioning brain tells you that there’s likely a problem with it, you are a fool if you just trust whoever built it and cross it anyway. I demand to understand what I am being asked to put into my child’s body and into mine. I demand to be told the honest truth about all the known risks, all the known benefits, and all the unknowns, so that I can make a truly meaningful, informed decision. I can tell the media aren’t doing this, not even the slightest bit of honesty from them, so whatever my academic titles and my training may be, I see that I need to find out the information for myself. Even if it is a lot of work, and a lot of zealots on both sides make it even more difficult than it already is.
And yes, at the end of all this, the final word on what goes into my body will be mine and mine alone, rightfully so. Better people than myself gave their lives for me to have this right. The alternative is a nightmare we don’t want to have to live through ever again.
As people have tried to say to you any number of times, it depends how many children have flu or COVID. If there few deaths with high fatality rate, ring vaccination would be one possibility.
Again, how many asymptomatic cases does Brazil have ? Evidently not many, because COVID is raging. This even though COVID has spread quite freely
@ NWO Reporter
You write: “Tim–If more VAERS death reports are due to “Mommy blogs” (more awareness), then why is the rate of deaths reported normal for non-COVID-19 vaccines, and off-the-chart only for COVID-19 vaccines?”
Simple, the other vaccines have been around for a long time, so to suddenly think things have changed would be difficult; but, as I explained to your stupid self, people believe that the COVID vaccine was based on something they completely didn’t understand, mRNA, and believed wrongly that it did NOT go through the complete FDA requirements for approval. Historically, only after a vaccine was approved did a company begin to produce it; but the U.S. government, due to the pandemic, agreed to pay for the vaccines, even if ended with them being dumped, so they were produced and ready to go. You are really a closed minded stupid paranoid conspiracy theorist. And I explained and also gave a list of references that you could read to learn how the CDC evaluates vaccine safety; but I doubt you will even try to go through the list, in fact, I doubt you are intelligent enough to even understand it; but the bottom line is, doesn’t matter how many people report on VAERS if a thorough evaluation finds no vaccine associated. As I explained, about 2,300 American die every day from cardiovascular disease. So, in the past, if this happens after a vaccine, most people, knowing, given many years of the use of the vaccine, won’t think it caused cardiovascular death; but with a new, different type vaccine, then the same number of deaths will lead to more reports. I realize that a rigid idiot like you will never accept anything that doesn’t fit into your paranoid delusions, so be it.
So basically, Dr. Harrison, you are saying people are too stupid to discern when a VAERS report is appropriate; and that the COVID-19 vaccines have actually increased the level of stupidity. Present company and you excepted, of course. Your hypothesis does not surprise me. Do you have any actual evidence to back that up, or does it just make you feel good?
@ NWO Reporter
You write: “Dr. Harrison, not one of your many references even remotely address the questions I presented here, which are specific to VAERS data gathered in the last 4 months.”
Moron, they explain the policy and thorough procedures used to evaluate vaccine safety, procedures that were used in the Shimabukuro paper, which if you actually looked at the reference articles would allow you to understand just how thorough and valid it is.
You write: “Do you think no one will notice if you just spew enough citations and insults?”
I think the vast majority of those following this blog think my insults are understated and, yep, that is what science does, it explains things and gives references. Not once have you actually tried to explain, using valid methodology, why you don’t accept Shimabukuro’s paper.
@squirrelelite
You seem polite and factual in addition to being knowledgeable, so may I ask you a question please? Not a criticism, not an objection, just an honest question.
You said “The benefits of the Covid-19 vaccinations are clear. In January 29.89% of all deaths were Covid-19 related. By March when I received both doses of my vaccination, that had dropped to only 8.59% and in April it was only 7.02%.
If that rate had stayed the same, we would have lost another 16,000 senior citizens in April alone!”
I’ve read several epidemiological papers (for example, https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/982499/S1208_CO-CIN_report_on_impact_of_vaccination_Apr_21.pdf ; or https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00947-8/fulltext) that show the same result. High infection and death rates in January that drop over the following months, in parallel with vaccine uptake.
The unanimous conclusion is that this is due to the vaccines, which are protecting people. However, we also know from last year that the spring and summer months were characterized by dropping numbers despite no vaccines being available yet. That suggests to me that Covid has a seasonal behavior, which is all but uncommon for respiratory infections.
So, it would seem to me that both the vaccines and the natural, seasonal progression of the winter 2020-2021 covid wave are contributors to the drop in numbers. The question is, how do we quantify each of the two contributions. Was it mostly because of the vaccines, was it mostly seasonal, or about an equal split?
What I see quantified in the papers I’ve seen is: A) the vast majority of TOTAL infections over the whole period was in the non-vaccinated. This is not surprising, because the peak of the infections was at a time when hardly anyone in the population was vaccinated. If, say, 1% of the population is vaccinated, it is expected that at least 99% of the infected will be unvaccinated regardless of the vaccine’s efficacy. It is also indisputable that B) infections have decreased as vaccine uptake increased. However, seasonality may be a confounder.
What I would be interested to see would be a comparison, OVER TIME, of the ratio between breakthrough infections and naive infections, with the vaccination quota in the population. That should be an empirical measure of the vaccine’s effectiveness.
What I mean is, if I split the population into two groups of different sizes according to a random criterion, I would expect the ratio of infections between the two groups to be equal to the ratio of the two sizes.
If, instead, one group has a lower chance of infections than the other (because it is protected by the vaccine), I would expect the ratio of infections between the two groups to be equal to the size ratio multiplied by the risk reduction factor.
Seeing a graph like that would give me a definitive answer and put my mind to rest. I was very surprised that no study I’ve seen so far did this despite having access to the required data.
So my question to you is, are you aware of any study who looked at this?
As an aside, I saw on the CDC’s website that, starting May 14 (i.e. tomorrow), breakthrough cases will no longer be reported unless they are severe enough to result in hospitalization or death. Meanwhile, I assume that, in the non-vaccinated population, a positive PCR test will continue to be fully counted even if the person is asymptomatic, paucisymptomatic, or resolves in outpatient setting. I think this is a scandal. Do you worry as well that this might distort the statistics in the future and make it more difficult to properly compare the figures?
Thank you very much well in advance, looking forward to a productive exchange with you. 🙂
those are fairly reasonable questions. I recommend you look up the numbers at one of the main aggregation sites like the NY Times, JHU, or just Wikipedia and analyze them yourself. Excel or Google Sheets can let you do all sorts of comparisons and graphs.
But, I went to Wikipedia to get the daily death totals.
Month …….. Senior Deaths …….Total Covid-19 Deaths …. % Senior
Jan …………..80,909 …………………….91,276 ……………………88.6
Feb ………… 35,794 …………………… 68,081 …………………… 52.6
Mar ………… 15,742 …………………….. 35,164 ………………….. 44.0
Apr …………. 7,836 …………………….. 23,114 ………………….. 33.9
I’m confident the CDC will continue to study cases according to vaccination status. It just may not merit a specific call-out in a particular report. This is done routinely for all sorts of disease outbreaks from measles to influenza. it’s how we evaluate the effectiveness of the vaccines.
And the actual Phase 2 and 3 studies will be monitoring their participants for another year and a half until those studies officially close out.
Personally I’m looking forward to the results from the college transmission studies that recently kicked off and the national serology survey that I am participating in. That will give us a better handle on how many people might have some protection from infection.
But check out the 3 studies listed here.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness.html?s_cid=10464:covid%20vaccine%20effective:sem.ga:p:RG:GM:gen:PTN:FY21#Research1
@squirrelelite:
Thank you so very much for your reply. Everything you’ve said makes sense to me. I’ve bookmarked the page you linked to and will proceed to read the studies. I just wanted to say thank you to you before I do 🙂
@Aarno Syvänen
Thank you very much for your comments. The point I’m trying to make is precisely that the case fatality rate (Number of fatalities divided by the number of cases) would not be the right metric for what I’m trying to calculate. Perhaps I can give you an example to better explain what I’m thinking.
But before I do that, I need to make yet again the disclaimer that yes, deaths are only one part of the picture. Also, I’m going to use an imaginary example with numbers that I won’t choose to be realistic or represent any one particular real-world case. I will choose the numbers to be easy to visualize so that they can more easily illustrate what I’m trying to say.
Let’s consider an IMAGINARY disease that is 100% deadly. (Case fatality rate = 100%).
Let’s also imagine that each person living in a certain country has a 1% chance to be infected over a given time span, say one year.
Let’s imagine you develop a vaccine against the disease. The vaccine gives 100% immunity over the same time span, but has side effects that result in a 3% mortality from the vaccine. Again, I know this is far from realistic, I’m just using numbers that are easy to visualize.
If you compare the case fatality rate of the disease (100%) against the death risk from the vaccine (3%), it is clear that the disease is A LOT more deadly.
However, if based on this analysis you decided to vaccinate all people in the country, you wouldn’t benefit them. You would actually harm them, because your intervention would raise their death risk from 1% (from their absolute risk of death from the disease) to 3% (from your intervention).
I hope this makes it clear why I am saying that it would be a conceptual mistake to use case fatality rate to evaluate the risk vs benefit, limited to deaths only, of a vaccine.
Conversely, let’s imagine that you also had a medication to treat the disease. With the drug, 90% of patients recover and 10% die. Superficially, you could say that the performance of the drug (10% deaths) is worse than the vaccine’s (3%). However, you would actually benefit people with the drug, because you only give the drug to sick people, so you are saving 9 out of 10 who would have died without impacting those who would have been fine anyway.
The crux of the matter is that vaccines are given to healthy people before they are exposed, not to sick ones. So you have to consider their absolute (i.e. unconditional) risk, not their conditional risk.
I hope this explains my point that, from the perspective of determining whether it makes sense to deploy a massive vaccination campaign for children, and only looking at deaths (which, again, I know is reductive) the flu and covid are comparable because the total deaths, over the same population and over the same time span, are comparable (238 vs. about 200).
And why I disagree that case fatality rate, even assuming we can estimate it (the only way would be antibody tests on a significant portion of the population and I’m not aware this is being done, please do correct me if I’m misinformed in this respect), would be a good indicator for this very specific, narrow and partial purpose.
Again, for the sequelae, which I agree may well turn out to be more important than just mortality, we need a different approach, as obviously the flu does not have the type of long-lasting consequences that Covid may turn out to have. So that may change everything. But just looking at the mortality aspect alone, I think the figures show that vaccinating children against covid would give them about the same benefit as vaccinating them against the flu.
About the issue of herd immunity, good question. It still remains to be conclusively determined, I think, how long natural immunity lasts, and how it holds up with the mutation of new variants.
You’re not trying to calculate, you’re trying to passive-aggressively assert that influenza and COVID-19 are “comparable,” and hence there’s no reason for the aggressive response to the latter. This is not just “reductive,” it’s feeble minded.
CDC recommends Ebola vaccination:
https://www.cdc.gov/mmwr/volumes/70/rr/rr7001a1.htm
And rabies too:
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5902a1.htm
You will notice that risk groups are vaccinated.
Question is,what is COVID risk group ? How many COVID cases there are ? P
Risk group is everybody
@Aarno Syvänen
Thank you very much for the links, and for your insight.
The second study you cited recommends vaccination against rabies post-exposure, so it’s not comparable to a mass vaccination against Covid to be done preemptively on healthy (uninfected) people.
The first one recommends that only lab workers and medical personnel, who are specifically working or expected to be working with the ebola virus or ebola patients, should be vaccinated. It does not recommend that the general population be vaccinated against ebola.
I see this as corroborating my thesis that (prophylactic) vaccination needs to take absolute risk and not case fatality rate into account. Case fatality rate for ebola is the same (50-90%) from the perspective of a lab worker or first responder of a dedicated ebola unit, as it is for Joe Sixpack. If any of these people were infected, they would have the same expectancy of outcome.
However, the vaccination is recommended for one group but not the other, because the absolute risk of death from ebola is much higher for healthcare workers (high chance of bad outcome, high chance of exposure) than for the general public (exact same high chance of bad outcome, negligible chance of exposure).
So, unless you think that covid has a comparable chance of bad outcome as ebola (which I firmly disagree on), I believe the second study does not support the conclusion that we should be vaccinating all children against covid for the reason that we reasonably decided that dedicated healthcare providers and lab workers should be vaccinated against ebola.
You missed other part: Risk group should be vaccinated, but which are COVID risk groups ? Nearly everybody, because everybody can get ot.
Exactly. Pre-exposure prophylaxis is recommended for at-risk groups. Age-stratified PrEP data for India could be interesting, but I’m not in the mood to go hunting for it.
@squirrelelite
So, I’ve looked at the three studies that are linked in the page you provided. The one by Thompson et al states that they adjusted their estimates using “Cox proportional hazards model accounting for time-varying immunization status”, which is exactly what I was looking for. Pity they just say it and don’t show it but I will trust that they did their job honestly and properly, so I think this answers my question.
The one by Tenforde et al also says that their vaccine effectiveness estimates were adjusted by, inter alia, calendar month, which is more vague of a statement but probably also goes somewhat in the direction of what I was saying.
Based on the data I’ve seen so far, I think I can be satisfied for now that the vaccines seem indeed to be ~95% effective at protecting from hospitalization and from infection, with seasonality not being a significant confounder.
Thank you once again for your help.
Cox proportional hazard model is explained here:
http://www.sthda.com/english/wiki/cox-proportional-hazards-model
You could find standard statistics from web
@ stufidiesserevittime
Why fewer cases during the summer? Is COVID seasonal? Not exactly. During the summer people spend more time out-of-doors. While one can still be exposed and infected, the risk is much less. In addition, during summer people often open windows, so doesn’t “hang” in the air. And nope the studies don’t show that if 1% vaccinated, then only 1% of cases; but I won’t bother any further.
As for squirrelelite being much more pleasant than me, a couple of possible reasons: 1. he is just far more tolerant of people who claim to agree; but only come up with one more reason to question; 2. he hasn’t been in a long exchange with you; perhaps didn’t notice some of the really nutty analogies you used (see below). I’ve been dealing for many years with people like you and it gets tiresome.
Yep, sometimes you seem quite reasonable and others not even close. While rare, when I studied psychology there were cases of split personalities. Wonder if you are one? It was NOT even close to reasonable to compare deaths, suffering, hospitalizations, long Covid, and vascular damage to Ebola, H5N1, rabies, lightening, etc. And no comment about my response to your claiming U.S. moral leader of the world??? Did you even bother to check out some of the articles I listed, most available for free download?
What a quack. Diagnoses me over the internet with split personalities now. The only thing this shows me is that you know even less about psychology (not to mention, medical deontology) than you know about the statics of bridges. What was it you said again about the Dunning-Kruger effect? Clown.
You evidently have reading comprehension issues. I never claimed that the studies show that 1% vaccination rates correspond to 1% breakthrough rates. I said that if 1% is vaccinated, then AT LEAST 99% of infections are EXPECTED to be in the non-vaccination group REGARDLESS of the vaccine’s efficacy. Just because of the size disparity of the two populations. I clearly said that the vaccine efficacy would be measurable by the further reduction in breakthrough rate beyond this expected ratio due to relative population size.
Now, I am not a native English speaker so I understand that I may not always express myself in a way that sounds natural to you. Yet somehow others (like squirrelelite) do seem to understand what I’m trying to say.
Maybe the reason is that you, professor Harris, read my posts with a mind willing to misunderstand so that you can attack me.
I cited rabies, ebola, H5N1, lightning strikes and meteor showers (the latter being something you brought up first) as COUNTEREXAMPLES to show the inappropriateness of using the case fatality rate for the specific comparison that I was making. Those counterexamples were of diseases with high fatality rate but low prevalence, precisely intended to show, ad absurdum, that case fatality rate was not the correct metric to use.
It should have been obvious that I was being highly sarcastic when I said that the “hyper-individualistic American society” was the best thing ever for the world. I didn’t want to embarrass you by remarking that you missed the point so grossly, but since you are asking, yep, absolutely, I’ve seen the progressive americanization of many societies and it was never to the good of anyone except a handful of profiteers. I think we agree on that part. By the way, you talk complete nonsense when you try to argue that Brazilians have no sense of community just because of one of their politicians, all in an attempt to defend your laughable and insulting thesis that Covid deaths inversely correlate with sense of community. Brazilians and Latin Americans are among the warmest people I’ve ever known, in addition to my own Italian countrymen. Definitely more so than the Swedes you cited. Who are good, polite, hard-working people for sure, but much less group-oriented. It is clear that the toll of the pandemic depends on other factors and the “sense of community” angle is utter woowoo, and odious vitcim-blaming to boot.
Oh, and by the way, Taiwan is an island too.
The only part of your post that is of any value is the first, when you say that the virus isn’t seasonal per se, and the seasonal behavior of the disease depends on how people behave. Yes, good point, I fully agree.
Without supplementation, vitamin D levels are naturally higher in the warmer months too. I would think that is also a significant factor.
P.S.
You speak, in a denigrating tone, of “people who claim to agree; but only come up with one more reason to question”.
Imagine that. The gall of still having follow-up questions after professor Harris spoke his Word of Divine Gospel. If I agree with something, I say it and I mean it. If I don’t, I say that as well. Politely, normally, unless someone really works hard at pissing me off. And if I get second thoughts or still have a question, I will ask it too. It’s called being curious and intellectually honest. I know of historical settings where it was even considered a moral obligation for a student to ask questions to their teachers if they hadn’t understood something.
Keep it clean, Socrates.
I am calculating the rate of yearly deaths over total population <18, and finding that they are comparable for flu and covid. This is math.
I am also asserting that this, as opposed to CFR, is the better metric to use for the assessment of mass vaccinations for children, for which I provided extensive reasoning.
And yes, from the perspective of the mortality figures alone, I would conclude that vaccinating all children would make about the same sense for flu and covid.
Again. I agree that there is the whole other issue of long term issues, which needs separate consideration. If that part of the equation is large enough, it may swing the balance the other way. It all depends on the numbers.
If you find a flaw in my example point it out. Or provide your own reasoning for your own (counter-)theses.
Your link points to a well-known finding that statistics for the flu have dropped almost to zero world-wide this year. This is interesting and the reasons can be investigated and discussed. So, what are you trying to tell me with this? Given that there’s hardly any flu around at the moment, I would say it didn’t make much sense to get vaccinated against the flu last fall, and if the figures keep being so low, next season as well.
You write: “Your link points to a well-known finding that statistics for the flu have dropped almost to zero world-wide this year. This is interesting and the reasons can be investigated and discussed. So, what are you trying to tell me with this? Given that there’s hardly any flu around at the moment, I would say it didn’t make much sense to get vaccinated against the flu last fall, and if the figures keep being so low, next season as well.”
Yep, given mask usage, physical distancing, etc. flu almost non-existent; but, given the incredible safety of the flu vaccine and that it was impossible to know when mask wearing and physical distancing, etc. would end, when enough were vaccinated with COVID vaccine and others already exposed with antibodies, I erred on the side of caution. A slight jab better than the risk. Given the history of flu, something you ignore, e.g. 1918 750,00 dead Americans with 1/3 population, 1957 and 1968 pandemics, and even during mild flu season, 30,000 or more die and many more hospitalized, a simple jab for me, given the extreme safety of the vaccine, and given flu could appear again, especially if we stop mitigating measures for COVID, at any time. Oh, I forgot your callousness that most deaths from flu were in seniors with only a few years to live.
Once more, an example how you look for an excuse not to vaccinate.
∗headdesk∗
@ stufidiesserevittime
You write: “By the way, you talk complete nonsense when you try to argue that Brazilians have no sense of community just because of one of their politicians, all in an attempt to defend your laughable and insulting thesis that Covid deaths inversely correlate with sense of community. Brazilians and Latin Americans are among the warmest people I’ve ever known, in addition to my own Italian countrymen.”
There are different senses of community. South Korea, Taiwan, and New Zealand have it as nations. Brazil has it within localities; but is a society with wide differences in SES and little to no indication that the wealthier care about the poor. What about the absolute brutal treatment of Amazon natives? And it isn’t just loggers, etc., it is Brazilians moving in. And Brazil has large pockets of extreme poverty and super wealthy. It is you who miss the point. And, yes, Taiwan is an island, as New Zealand; but New Zealand lies far away, Taiwan has several international airports, etc. I’ve actually been to Taiwan twice.
The point is, whether you wore or didn’t wear masks, is that many Americans considered requirement to wear a mask as an attack on their personal freedom. Yikes! What a horrid attack on personal freedom, wearing a little mask. We have laws mandating seatbelts, isn’t that an attack on personal freedom? And seatbelts don’t prevent harm to others, while masks do. Maybe this is something we can agree on. It is an example where extreme individualism with little to no sense of community ends up hurting everyone.
You write: “What a quack. Diagnoses me over the internet with split personalities now. The only thing this shows me is that you know even less about psychology (not to mention, medical deontology) than you know about the statics of bridges. What was it you said again about the Dunning-Kruger effect? Clown.”
Yep, you do have problems with English. I wrote: “While rare, when I studied psychology there were cases of split personalities. Wonder if you are one?”
Wonder? Not a diagnosis. And, maybe I was being sarcastic. I guess you are the only one allowed to do so???
You write: “I cited rabies, ebola, H5N1, lightning strikes and meteor showers (the latter being something you brought up first) as COUNTEREXAMPLES to show the inappropriateness of using the case fatality rate for the specific comparison that I was making. Those counterexamples were of diseases with high fatality rate but low prevalence, precisely intended to show, ad absurdum, that case fatality rate was not the correct metric to use.”
But you wrote: “Whether that’s because Covid is a highly prevalent but very non-lethal disease in children (more like flu), or more lethal but then less prevalent (extreme example: H5N1, ebola, or rabies) is immaterial. We only vaccinate children against diseases that are actually dangerous to them. For different reasons, both the common flu and rabies are not dangerous enough to children to warrant vaccinating all children against either of them. At least according to conventional wisdom.”
And as I pointed out, flu kills over 200, hospitalizes 7 – 23,000, rabies 1 or 2, so NOT a valid comparison. No mention of case fatality rates in that comment.
And you wrote: “So, we agree, covid shares more similarities with the flu than with polio. I agree that it seems to be several times worse than the flu, about an order of magnitude seems fair, at least for certain age groups. But (thankfully) it is not like a transmissible H5N1 or an airborne rabies.”
As I pointed out H5N1 was not highly transmissible, only people exposed directly to the animals, not people to people transmission, though there may have been one instance, a family that lived in close quarters; but . . . and only case of airborne rabies was in a small lab. So, not appropriate comparison.
You write: “And if you see a bridge and your functioning brain tells you that there’s likely a problem with it, you are a fool if you just trust whoever built it and cross it anyway.”
Wow! Really stupid. Of course if I see an already built bridge that looks dangerous I won’t use it; but I wrote if someone gave me several plans for building a bridge. Talk about who doesn’t pay attention to what others write! ! !
And I don’t mind, even welcome follow-up questions; but that isn’t how I read yours. Yours sounded like, yep, I agree; but but but, that is looking for some excuse not to get vaccinated and/or not to vaccinate your kid.
You write: “It should have been obvious that I was being highly sarcastic when I said that the “hyper-individualistic American society” was the best thing ever for the world.”
I went back and re-read what you wrote. YEP, mea culpa, I definitely misread it. One point for you. As I’ve written on many occasions, even a broken clock gets the time right twice daily. I guess I got locked into seeing everything that you wrote that indicated you were looking for an excuse to finally not agree, that I failed to notice when you were being sarcastic. Oh well, I’m only human.
But finally, your absolute position on protecting your family, let the whole world be damned, said it all.
You wrote: “but yes, if it comes down to it I would rather see you and the whole world burn to the ground than putting life and limb of somebody I love in jeopardy.”
Sounds like an absolute position to me.
And though you ignore it, the first few of my posts were polite and explanatory. I just got tired of your unending questions that I saw as looking for some way to justify not vaccinating, to practice me first and to hell with everyone else. You did say that getting vaccinated is an individual choice, no ifs ands or buts.
Now, I have suggested several times a book you should read and said that if you read it and I believe you did, then I would be willing to enter into a more pleasant dialogue. Why not read it? If you don’t understand the basics of immunology, then you can’t really understand how and why vaccines work! ! !
Once more: Lauren Sompayrac. “How the Immune System Works (6th Edition).
Read it and I will try to interact in a positive way, start afresh.
One last thing. I have known and been on friendly terms with people from almost all racial and ethnic groups. The YMCA I belonged to for almost 20 years, currently in lockdown, had people from everywhere, including Brazil, Ecuador (where despite your “community” suffered horrible murders from both military and rebel groups and terrible poverty with super rich and super poor), Palestine, Peoples Republic of China, etc. and enjoyed knowing them and often after working out would drink coffee, go to lunch, sometimes visit each others homes. I agree with what Martin Luther King said: Judge people by the content of their character. And I have been good friends with a Taiwanese since late 1980s, though haven’t been in touch lately. He lives near Houston.
As a Jew I have known since undergraduate days Moslems, some Arabs, one a Palestinian and found them extremely good people. In fact, though rare, still in touch by e-mail with Palestinian who lives in the Palestinian Authority and I cringe at how Israel treats them. And, though Jewish, I am anti-Zionist. Israel in my opinion and that of many other Jews is not a Jewish state; but a betrayal of Judaism. I would much rather have as next door neighbors some of the Palestinians I met during my six months in Israel that many of the Jews I met, though I also met many good people who were Jewish as well. And besides having read both the Old and New Testament, have read Koran, parts of Hadith, biographies of Mohammed, etc. Mohammed taught among other things that there shall be NO compulsion in religion and that Jews and Christians were NOT to be harmed, allowed to live their lives, so ISIS may call themselves Moslems; but if Mohammed came back today, they would behead him. If you are even interested, I suggest you read the following about what Judaism teaches how to treat non-Jews, something the State of Israel ignores. Doesn’t mean I agree with Hamas, who practice a religion that rejects much of what Mohammed taught:
Rabbi Reuven Hammar (2016 Apr 21). The Status of Non-Jews in Jewish Law and Lore Today. Available at: https://www.rabbinicalassembly.org/sites/default/files/public/halakhah/teshuvot/2011-2020/Hammer%20Teshuvah%20Final.pdf
stufidiesserevittime: “I absolutely expect, in fact demand, that regulations should be much more stringent for vaccines than for therapeutic medications. After all, vaccines are given to healthy people; while therapeutics are reserved those who are already sick and have much higher acceptable risk.”
It’s already been pointed out to you that vaccines are in fact studied more extensively than other therapeutic agents; there are multiple post-approval surveillance systems plus a large volume of (often repetitive) studies conducted to address specific concerns about vaccines supposedly causing chronic ailments.
You are mistaken in assuming that drugs and other treatments are reserved for sick people, as opposed to vaccines given to the healthy. It’s easy to find long lists of preventative meds given to healthy people to forestall disease (cholesterol and BP-lowering drugs for instance). These lists include vaccines, given to vulnerable folks who may be healthy or already have chronic conditions that could be greatly exacerbated by vaccine-preventable diseases.
I hope this post has not bruised any tender feelings, as I wouldn’t want to be busted by the Tone Police on behalf of a studiously polite poster, who nevertheless manages to accuse another of being a “quack”.
@ Dangerous Bacon
As a non-observant Jew, despite bacon not being Kosher, in my book you are more/better than Kosher.?
I took a day off this comment section to collect myself.
I admit that when I read the passage, “While rare, when I studied psychology there were cases of split personalities. Wonder if you are one?”, I did lose my temper and called professor Harrison names (“quack”, “clown”) that I shouldn’t have. I retract those remarks and offer my sincere and humble apologies to professor Harrison. I am absolutely at fault for letting myself go like that.
Not as an excuse (since that was indeed inexcusable) but only for context, I will mention that that came after I had been repeatedly insulted by other posters in this thread (“freak”, “dipshit”) as well as having had multiple attacks to my person. I would appreciate it if that could stop as well. I see no reason why a technical discussion between experts in the field and members of the general public should need to be so toxic. And I very much appreciate professor Harrison’s conciliatory words in his last message to me. Thank you.
Moving on. While I’m waiting for my Sompayrac textbook to arrive (Amazon tells me I can expect it by May 25), I have tried to take a closer look at the minutia of the various versions of the spike protein, in the wild virus as opposed to the various available vaccines.
Based on (https://cen.acs.org/pharmaceuticals/vaccines/tiny-tweak-behind-COVID-19/98/i38 and https://sciencebasedmedicine.org/spike-proteins-covid-19-and-vaccines/), if I understand correctly, it would seem that the Moderna vaccine uses a modified, stabilized version called HexaPro, and additionally only encodes for a fragment of it. I now completely understand professor Harrison’s analogy with the cut-off finger and I’m satisfied that the results of the paper by the Salk Institute most probably don’t apply to the Moderna vaccine.
Again if I understand correctly, the BioNTech product also uses HexaPro, but synthesizes the full protein. So, according to professor Harrison’s analogy, it would be like the whole hand, but tied up so that it can hardly move? (I take it that while those edits were done primarily to make the spike protein more resistant to temperature and other stressors, they also have a secondary effect on its affinity to the ACE2 receptor to an extent, correct?). So, I could see why the results of the Salk research would only partially apply to the Moderna vaccine, maybe even only minimally.
Meanwhile, AstraZeneca did not make use of HexaPro, nor have I found any source that they made any other modification. Is it correct to say, then, that the AstraZeneca vaccine encodes for the same spike protein as it is also expressed on the wild virus? So, the fully functional hand, figuratively speaking? That would explain why it has been strictly regulated or even banned in so many countries, and why it has such a horrible reputation by word of mouth.
I am happy to put this discussion on hold until after I’ve received the book and am done reading it carefully, and again I would like to thank everybody for the materials and explanations you have provided.
A few final remarks. I agree with professor Harrison about the masks. I was among the first to wear them in my area last year. I’ve never seen a problem with it (unless if one is engaged in strenuous aerobic exercise), and never really understood why some people make such a big fuss about it. I’m still not sure how much of a difference it makes in practice. I can see that it would reduce viral loads to an extent by blocking droplets, but there’s also the issue of air flow (like from the sides), so it’s hard for me to quantify the effect. I’ve read several studies with inconclusive / opposing results.
@ Bacon, yes, I am aware that there is also preventative medication. But that too is only given to people with a high risk profile. My mother takes aspirin every day, because she had a heart attack ten years ago. I don’t have to. I remember there had been a proposal in the US to add statins to the water supply. I can only say that I think sanity prevailed when that idea was scrapped.
See you all in several weeks, then. Stay healthy and take care.
P.S.
If I keep asking questions, I assure you, it’s only because I want to understand (and I am missing much information in order to be able to do so). I don’t need anybody’s blessing or absolution for a decision that’s mine and mine alone to make anyway. Even if I do eventually decide to take the vaccine and recommend it to others (and if so, which one), I still want to understand what I’m doing and what it is doing inside me.
I have realized that I wrote two incorrect things here that I’d like to rectify.
The stabilized spike protein that Moderna, Pfizer/BioNTech and J&J are using is called 2P. HexaPro is a further improvement with 6 mutations that will be used in future versions of the vaccines.
2P also doesn’t seem to reduce affinity to the ACE2 receptor. The reason why it is deemed less harmful than the wild spike protein is due to some other mechanism related to the prevention of state transition that, quite honestly, I don’t really understand yet.
Source:
“These structural and biochemical data show that the introduction of the 2P prefusion-stabilizing mutations does not interfere with receptor binding […]”
(R. Kirchdoerfer et al: “Stabilized coronavirus spikes are resistant to conformational changes induced by receptor recognition or proteolysis”, page 8, second paragraph; https://www.nature.com/articles/s41598-018-34171-7)
@stufidiesserevittime To cite
“We recently developed stabilizing mutations for coronavirus spikes that prevent the transition from the pre-fusion to post-fusion states. Here, we present cryo-EM analyses of a stabilized trimeric SARS-CoV S, as well as the trypsin-cleaved, stabilized S, and its interactions with ACE2.”
Authors study S protein by producing different versions of it.
@ stufidiesserevittime
OK apology accepted.
A long time ago in a graduate course at University of Texas School of Public Health a medical student proposed adding beta-blockers to water supply. He wasn’t joking and I was the first to call him out. As for statins, the current guidelines have been controversial as several on committee that promulgated them have strong ties to pharmaceutical industry. I have, as my usual obsessive-compulsive self, delved into the issue, helps also to have had cardiologist acquaintance. The benefits/cost ratio for statins is quite good if everything else held constant and total cholesterol over 200; but current guidelines much lower. And they look at just total cholesterol, not triglycerides, High Density Lipids, or the ratio. Great for pharmaceutical industry; but not for people who probably don’t need them. Besides labeling unnecessarily at risk, there are significant side-effects, including risk of peripheral neuropathy, memory, etc.
Maybe I was wrong reading into your continuous questions that you were looking for an excuse not to vaccinate; but maybe not completely as you continued to downplay seriousness of flu; but what really angered me was two things: 1. your consigning old people to possible premature deaths from flu, etc. As I wrote, they may have had years left. And even ones in poor health may want to survive to some event, e.g., grandchild’s graduation, child’s marriage, my own grandfather wanted to live to their 60th; but didn’t make it by a few months, and, of course the loss to loved ones. There is NEVER enough time, it goes by in a blink of an eye. My grandmother died just before her 91, not flu, etc; but over 25 years later and isn’t a day that goes by that I don’t wish she had lived another few years. And your absolutist you and family first. As i wrote, if everyone thought like that, then just with COVID the deaths and suffering would have been exponentially higher as each thought they wouldn’t take the minuscule risk of a vaccine, etc.
In any case, as promised, if you return after reading what I consider the absolute best book on immunology, and I’ve read several much larger texts, we can start afresh.
Professor Harrison,
I acknowledge that you may not be entirely wrong about that. I have thought about that too and, to an extent, I give you that I did sound callous. I absolutely agree that the life of an old and/or sick person has the same value as everybody else’s. I was taught a saying, “when an old person dies, it’s like a library burning to the ground” and I believe that is true.
My father missed his granddaughter’s birth by less than a month due to an aggressive cancer. It was his last wish to witness that, and he had agreed to undergo a very unpleasant chemotherapy for a better chance to see it happen. Even without the cancer, I am sure that he would have stood very little chance during the first covid wave of 2019 in Italy, especially considering that he was a (retired) physician and, knowing him, I have no doubt that he would have volunteered to help out during the crisis without a thought.
So, I really am all for protecting the elderly and the frail. It just shouldn’t come at the expense of the future of the younger generations. It goes both ways you know. I would never dream to ask my colleague to take any chances with her son’s health just to protect me. If it comes down to it, I would totally find it fairer for it to be me who has to bite the bullet rather than him.
I will admit that perhaps I am somewhat more paranoid than warranted, but I also blame the media for that. I would have felt less anxious if there had been an open debate between all views, and all information was out in the open. I do have a bias towards taking a contrarian stance when I think I see censorship and propaganda, although I realize that that is irrational too. I am seeing a sizeable number of reports from people who make a credible claim to have been hurt by the vaccines, and all I want is to make the best decision. And for that I need the data and the knowledge. I am thankful for anyone who can help me with that.
See you all in several weeks.
@ stufidiesserevittime
One last thing. I have NEVER had the rank of Professor. I was an Assistant Professor for several years in a Department of Preventive Medicine and Community health in a medical school. It was on grant money, not a regularly funded position, so it ended. Actually I have always been a much better student than careerist, having earned not only a PhD, but four Masters degrees, and an NIH Post-Doctoral Research Fellowship; but I lived in five nations, traveled a lot, and worked in between. Have NEVER married, though actually several women proposed to me, frightening? Groucho Marx once said he would never join a club that would have a member like him; well, I would NEVER marry a woman crazy enough to want to marry me?. I prefer curling up with a good book or research papers or attending seminars or watching documentaries and nature programs on my computer. Don’t own a TV. And since January 2020 have been closely following pandemic, including reviewing texts and papers on corona viruses in general and having downloaded and read over 1,000 papers on COVID.
However, despite not personally being married nor having children, I have more or less my entire life supported programs that benefit people in general and especially children, all children, developmentally challenged, etc.
And more crow that I have to eat. I sorely misjudged you, Dr. Harrison. You’re cool 🙂
@ stufidiesserevittime
Please don’t eat crow or any other bird or animal. As a vegetarian I avoid unnecessary harming of wildlife. ?
@ stufidiesserevittime
Yep, our mass media isn’t always reliable and blogs and social media are just plain dangerous.
However, my point was that sometimes it isn’t really a choice between ones family and others; but either everyone contributes or the risk to ALL of us increases. And at some point one has to act. Seems to me you just want more and more info, which translates to delaying taking any action. Given what you now know about the COVID vaccines, I should think you would go get one. I recommend the Moderna or Pfizer; but the Johnson & Johnson also good, just the first two high probability no infection. The Johnson & Johnson high probability no need for hospitalization, long COVID, or death; but possibility of mild flu-like symptoms; but if its the only available, go for it.
By the way, I found one more article that you might find of interest:
Yi-Ying CHen & Yibeltal Assefa (2021). The Heterogeneity of National Responses to the COVID-19 Pandemic: a mixed-method study. BMC Public Health; 21: 835.
From Abstract:
“Cross-national comparison suggests that there were nine indicators to explain epidemiological differences between the countries, and they were 1) leadership, governance and coordination of response, 2) communication, 3) community engagement, 4) multisectoral actions, 5) public health capacity, 6) universal health coverage, 7) medical services and hospital capacity, 8) demography and 9) burden of non-communicable diseases.”
Notice “community engagement” is one of the indicators. I try NEVER to assume that one variable will explain things. I think this is a good paper.
And, just as an extreme example, families in Holland, Poland, France, and Germany, even Berlin, hid Jews during the war, knowing that if caught they, their entire family, would probably be executed. Sometimes one has to risk their own, including even children, for others, even at extreme personal peril; but, of course, getting a flu vaccine or a Covid vaccine, given their minuscule risk, doesn’t come close in comparison. I’m sure some Italian families did the same!
Dear Dr. Gorski,
I understand you deal with a lot of misinformation from traditional anti-vaccinators. However, it seems that many of us who are pro-vaccine and have ensured that their children have been vaccinated against traditional childhood diseases are being lumped into the category of “anti-vax” because of our hesitancy to take a new type of vaccine tested at “Warp Speed.” I’ve read the affirmations that no corners have been cut on the way to testing these vaccines for EUA. As a scientist who works in testing, I don’t see how this is possible. As the adage goes, “Fast, cheap, good: pick any two.” The media and bureaucratic effort to steamroll people with concerns, particularly about vaccinating children, are unsettling.
My grandmother worked in a polio ward and I definitely understand the harms of failing to vaccinate against infectious disease. I would, however, advise a gentler approach for all parties concerning this new mRNA technology.
Thank you for this article. It was very good. I wish everyone would be slower with press releases nowadays, but we have to keep the marketing people busy.
“As a scientist who works in testing, I don’t see how this is possible.”
Really? Yet you do not know how to find and read science papers (which Orac has liberally referenced in many articles), wherein you will learn how the basic technology and the vaccines have been tested in RCT and monitored in the field over hundreds of millions of doses. I don’t believe you are what you claim to be.
“I don’t see how this is possible.”
Up front money:
https://www.politifact.com/article/2020/nov/19/pfizer-moderna-covid-19-vaccines-and-operation-war/
Building out facilities, manufacturing vaccine,…, clinical trials all going on concurrently while they awaited approval. That’s not how it has been done before where funding just trickles in until it looks like a viable product could be on the way. A ‘bet’? Perhaps less so with the government money cushioning potential losses of billions of dollars spent on new facilities and new machines and vials of vaccines should they have turned out to be crap what with the arms falling off and all.
Sounds like you’re arguing that we got “Fast and Good.” Pfizer has had numerous, costly ethical problems in the past so hopefully authorities took the approach of “trust, but verify.”
My read of that article is that the government paid for no Pfizer R&D but pledged to buy doses and help scale.
Moderna was given $1 billion for R&D. I didn’t see any promises to either company to financially-backstop any failed products. In Pizer’s case, R&D was given an internal blank check which would’ve cost them $1.5 billion if the product failed. I have no idea what that would do to their P&Ls.
Normally in tech there are races to be “first to market” to hit market windows and capture market share by establishing a beachhead with “innovators” and “early adopters.” Hitting market windows frequently involves minimizing features and testing. This is explained further in “Crossing the Chasm” but I’ve witnessed it firsthand.
@rs
You don’t sound like you know what I am or have any experience doing what I do. This blog is about insolence though and I applaud yours. Could you please point me to the comparison of all-cause mortality between vaccinated and unvaccinated groups for the mRNA vaccines? This should be dirt simple.
You said what you are yet you do not exhibit the relevant abilities. You can’t find the “one true trial” that you demand, and you avert your sight from the megatanker load of data from trials and real-time monitoring of vast numbers of doses that do exist?
No, you’re no scientist. Silly sock troll is silly. But do continue; you don’t seem to mind and I am somewhat amused.
“Hitting market windows frequently involves minimizing features and testing.”
O RLY?: https://pbs.twimg.com/media/DdGq_1JXkAEsAc1.jpg
Sigh. At least this one who doesn’t get it isn’t overtly complaining.
@rs,
Such as? What is it you said you did for a living?
They monitored deaths in the trial:
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
I’m asking for the follow-up data. This should be easy for you to produce.
Funny, you ask us to produce something, then reveal that you had the data you were requesting all along, and then move the goalposts to “where’s the follow-up to this specific study” when it’s not expected to be released until next month, because that’s how time works. But here’s something to tide you over until Pfizer-BioNTech finish their rolling submission for full approval.
https://www.medrxiv.org/content/10.1101/2021.03.01.21252652v1.full-text
Enjoy!
This is an annoyingly arrogant blog post. Self proclaimed smart people are the worst. It’s like you think no one is worthy of an opinion that’s not your own. Are only intelligent people allowed to make choices? Should people have autonomy? Since there is no long term testing you can’t claim you know the safety of these vaccines. You are trusting what you’ve read so far with no first hand knowledge. Have you done any studies personnel anything having to do with this virus or any vaccine? Since you don’t know the millions of people that aren’t planning to get this vaccine you can’t lump them all in as antivaxers. There are likely lots of different reasons. You seem like a follower who feigns deep thinking and insolence while sticking to the status quo and ridiculing those who don’t.
One notices that you haven’t refuted a single fact, piece of science, or assertion in my post.
I just want to congratulate the owner of this blog for not censoring dissenting opinions. Very rare these days. I would also encourage the author to reach out to Bret Weinstein and ask to go on his podcast, perhaps with Dr. Malone, to fully explore the topic.
A final word about the “anti-vaxxer” epithet. Many people, myself included, never have had any issues with prior vaccines. These novel vaccines, both mRNA and viral vector, have no long-term safety record because they’ve never had widespread use before. The VAERS adverse reports are off-the-charts, not just in the US but in the UK equivalent. Could that solely be due to the large number of people vaccinated in a short period of time? Perhaps, but I’ve seen no evidence of that. If someone could provide a denominator-total vaccines of all time given in a time period-there could be a meaningful comparison.
The VAERS death reports were up for 2 or 3 months as the vaccine campaign ramped up, but even so they were less than the expected normal death rate for seniors who were the primary group initially vaccinated. As vaccinations shifted to younger adults, the VAERS death reports also dropped off a lot in May and June.
Also, the CDC was encouraging doctors to report deaths after one of the Covid-19 shots even if there didn’t appear to be a causal connection so they give each case a closer inspection. AFAIK, the only death connected to the vaccines so far was one of anaphylaxis.
The biggest long term side effect of any vaccines so far is people dying of cancer 40 or 50 years later because they didn’t die of the disease much earlier. We have found several significant side effects of previous vaccines like GBS, diverticulitis, vaccine-derived polio, etc. But they all were detected in less than 2 months after the vaccine. Because the vaccine ingredients are metabolized in a few weeks, the only things remaining that might cause a problem are the immune components like antibodies and memory B- Cells.
And the VAERS reports are not even confirmed to be correct. 3 of the VAERS reported deaths occurred prior to 2019!
Hello, great article. I would add the vaccine spike protein seems locked in prefusion conformation (we should ask the manufacturers to be sure) so it may not interact with ACE2 receptors like the pseudovirus of the study did. So… not the same spikes…
@steveclaude5331
For what it’s worth, I’ve read that AstraZeneca didn’t use the 2P stabilized version of the spike protein (source: https://cen.acs.org/pharmaceuticals/vaccines/tiny-tweak-behind-COVID-19/98/i38 , second last paragraph)
More to the point, I’ve also found this article (R. Kirchdoerfer et al: “Stabilized coronavirus spikes are resistant to conformational changes induced by receptor recognition or proteolysis”). I admit it’s too complex for me to understand in detail, but I quote: “These structural and biochemical data show that the introduction of the 2P prefusion-stabilizing mutations does not interfere with receptor binding” (“Discussion” section, last paragraph). By contrast, I have searched but couldn’t find any research papers suggesting that the stabilized spike proteins are less toxic than the wild ones.
@ Dr Harrison: I just wanted to say that I’m about one third through the Sompayrac textbook (fifth edition was the most up to date I could get). Thank you for the recommendation, it’s very well written and extremely interesting and informative.
P.S. Sorry, I forgot the link to the Kirchdoerfer paper. Apologies, here you go: https://www.nature.com/articles/s41598-018-34171-7
I have a “naive” question (i.e., a question without an “agenda), but I really would appreciate a reasoned response from anyone who can give me one. My question is as follows: Has anyone pulled/isolated the COVID-19 virus out of its protein shell and used it to create a “traditional” vaccine. That is take the pathogen, perhaps weaken it, and created an injection with it such that it would kick-start/notify/teach the immune system? A friend of mine says they did, but it was “ineffective” and that’s why they created the mRNA inoculation.
The traditional method would have taken years.
Here’s a link from January discussing the various vaccine types and trials. SHort answer yes, but limited success. mRNA is much faster to develop, now that we have the past decade of research on SARS and MERS and others to draw on.
https://www.gavi.org/vaccineswork/there-are-four-types-covid-19-vaccines-heres-how-they-work