Categories
Antivaccine nonsense Bad science Medicine Skepticism/critical thinking

Antivaxxers and the “deadly” SARS-CoV-2 spike protein

Antivaxxers are citing three papers to support their claim that spike protein produced by COVID-19 vaccines is dangerous. Unsurprisingly and as usual, they’re misinterpreting the studies and misrepresenting their significance. COVID-19 vaccines are, in fact, very safe.

[This is an updated and greatly expanded version of previous posts about the SARS-CoV-2 spike protein and antivaccine misinformation being spread by antivaxxers about it. Consider it a one stop shop for deconstructing this disinformation.]

Specific narratives of antivaccine misinformation about any given vaccine generally consist of a combination of a subset (or all) of the following elements. First, of course, the narrative must, as all antivaccine narratives do, include a conspiracy theory, such as efforts by “them” (e.g., the government, big pharma) are trying to keep “The Truth” about vaccines from the public. Second, that “truth” about the vaccine, according to antivaccine narratives, is that it is dangerous—and preferably ineffective as well. Examples are numerous, and regular readers of this blog are familiar with the harms that antivaxxers falsely attribute to vaccines; e.g., autismautoimmune diseasescancer, and even death. To support the narrative of harm from vaccines, antivaxxers routinely portray vaccines as laden with toxins and made with “aborted fetal tissue” and “fetal cells“. It’s not enough, though, for antivaxxers to portray vaccines as dangerous to just the people receiving them. They have to portray vaccines as dangerous to others who have not received them as well. Before COVID-19, antivaxxers tried to claim that the recently vaccinated were dangerous because they “shed” virus from the vaccine (this does happen but is not dangerous and cases of disease from vaccine shedding are exceedingly rare). Unsurprisingly, in a case of everything old being new again, antivaxxers have co-opted many of tried-and-not-true narratives and deployed them in the service of spreading fear about COVID-19 vaccines, including the claim that they are made with “fetal cells“, portraying the lipid nanoparticles in them as horrifically toxic, and the mRNA in the Pfizer and Moderna vaccines as “experimental gene therapy” that “hacks the software of life“. They’ve even falsely claimed that COVID-19 vaccines cause cancer, Alzheimer’s disease, and death. But what about shedding? 

When COVID-19 vaccines based on mRNA technology were first introduced, I naively thought that antivaxxers would not be able to adapt the narrative of the vaccinated being a danger to the unvaccinated due to “shedding”, because the mRNA technology used by Moderna and Pfizer/BioNTech induces cells in the recipient only to make a single protein from SARS-CoV-2, the coronavirus that causes COVID-19. Similarly, COVID-19 vaccines based on adenovirus vectors, such as the AstraZeneca and Johnson & Johnson manufacture, simply use a different method to achieve the same goal: To produce the SARS-CoV-2 spike protein and thereby produce an immune response. None of the current COVID-19 vaccines produces a full intact coronavirus, not even a weakened one, as live-attenuated virus vaccines, such as the measles vaccine, use a weakened version of the measles virus. To summarize, current COVID-19 vaccines neither contain coronavirus, killed or live-attenuated, nor can they produce a full virus. None of this science stopped antivaxxers from adopting their narrative of “shedding” from vaccines as being a danger to those around the vaccinated. They happily started portraying the spike protein as deadly and falsely claimed that the vaccinated were “shedding” spike protein, leading to illness, menstrual disturbances, and even miscarriages in those exposed.

Over the last month, there have been three new papers that have been making the rounds among antivaxxers as “scientific proof” that not only is the coronavirus spike protein highly toxic to the vaccinated but that it is produced by the vaccinated in amounts that can cause those toxic effects. I thought I’d take some time to take a look at them. The first two papers are often presented as “slam dunk” evidence that the coronavirus spike protein is toxic and deadly (and, therefore, the COVID-19 vaccines are deadly), while the last paper is presented as evidence that mRNA vaccines produce enough spike protein to poison recipients. Spoiler alert: None of these papers show what antivaxxers represent them as showing, especially the third one.

Spike proteins and pulmonary hypertension

The first of these papers was one that I first noticed nearly a month ago on Twitter, although the study was older than that, dating back to January:

And here’s the study, from Georgetown and the Ukraine, “SARS-CoV-2 Spike Protein Elicits Cell Signaling in Human Host Cells: Implications for Possible Consequences of COVID-19 Vaccines“.

It turns out that this “study” isn’t even a study at all. Rather, it’s more like a “news and views” or opinion piece, a review article if you’re feeling particularly generous. Moreover, it was published in Vaccines (Basel), an open access journal in the MDPI group of journals. Unsurprisingly, MDPI journals are pretty dubious, with MDPI having been listed on Beale’s list of predatory journals in 2013. It ultimately successfully appealed and was removed from the list. However, from my perspective, I do not consider MDPI journals as being high quality and would never publish in one.

But what about the paper itself? Let’s just say that I was quite…underwhelmed…by it. Indeed, rarely in my many years of reading scientific papers have I seen so few experiments cited in a review article do such heavy lifting to provide such weak evidence for a conclusion like the claim that the spike protein can cause pulmonary hypertension. 

At its essence, pulmonary hypertension is high blood pressure in the lungs. The circulatory system is divided into two components, the pulmonary system, in which blood flows through the blood vessels in the lungs, picks up oxygen, and then flows to the systemic circulation (the rest of the body) to deliver that oxygen to the tissues. The pulmonary vascular system is a much lower pressure system than the systemic circulation, which is why the right ventricle, the chamber of the heart that pumps blood through the lungs, is less muscular than the left ventricle, which pumps blood through the rest of the body. In any event, pulmonary hypertension can be caused by a number of things, including some types of congenital heart disease, connective tissue disease, coronary artery disease, high blood pressure, liver disease (cirrhosis), blood clots to the lungs, and chronic lung diseases like emphysema. The sequelae of pulmonary hypertension can be severe, including right-sided heart failure, hemorrhage in the lung, clotting, pulmonary artery dissection, and more. Let’s just say that pulmonary hypertension can be very bad.

On what do these authors base their claim that spike protein can cause pulmonary hypertension? They cite the most tenuous of evidence, and not very much of it. For instance, The first study is nothing more than a cell culture study coupled with a postmortem study of lungs first published last August, in which the authors (who happened to be them—yes, they cited their own paper) combined observations to make the leap to speculation that spike protein alone can cause the problems seen in COVID-19. In the cell culture component, the authors treated the cells that line pulmonary arteries (pulmonary artery endothelial cells) and the smooth muscle that surrounds the endothelial cells with spike protein and found that spike protein can cause intracellular signaling in these cells of a sort associated with cell injury. They also examined postmortem lung tissues from patients who died of COVID-19 and found pulmonary vascular wall thickening, a hallmark of pulmonary arterial hypertension. That’s it. No, really, that’s it. To be fair, the authors did compare the lungs of patients who died of H1N1 influenza to those who died of COVID-19 and found that the pulmonary arteries were markedly thicker in the patients who died of COVID-19. It’s an interesting observation, but if there’s one thing that was observed early in the pandemic it’s that the ARDS (acute respiratory distress syndrome) caused by COVID-19 was like nothing critical care doctors had ever seen before.

There is no more, at least not from these authors. Sure, they do cite two other papers, one from 2005 showing that injecting mice with recombinant spike protein from SARS reduced the ACE2 expression and worsened acid-induced lung injury. The other paper is from December and reports that the full-length SARS-CoV-2 spike protein activated NF-κB (a signaling pathway I’m well familiar with) and AP-1 transcription factors as well as p38 and ERK mitogen-activated protein kinases. Again, you don’t need to know the details other than that these are survival and growth pathways, but also that this observation was not made in cells from the pulmonary vasculature, but rather from a cell line (A549) from the lungs and another (Huh7.5) from the liver. The relevance of this study to whether spike protein can cause pulmonary hypertension is questionable at best.

Now that’s it: One study by the authors, two observations, one involving spike protein and one involving actual viral infection, plus an old study of SARS spike protein. I say this because it needs to be emphasized that what the authors reported was in patients who died of infection with the whole virus, SARS-CoV-2. You have to separate the effects of full infection and the effect of spike protein alone, and the authors did not do this, other than as a prelude to speculation that spike protein alone might cause pulmonary hypertension. Even for “proof” commonly cited by antivaxxers, this was weak sauce.

The deadly spike protein, take two

About three weeks ago, antivaxxers started pointing to a study from the Salk Institute as yet more “proof” that the spike protein used in COVID-19 vaccines is toxic and deadly. For instance, behold Alex Berenson, the “pandemic’s wrongest man“, crowing about the study:

I was amused when I saw these Tweets to see Berenson use a term like “off-target effects” as if he actually knows what it means.

It turns out that this study on a preprint server has been published in Circulation Research. It also turns out—surprise! surprise!—to 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, and the Salk Institute press release even includes a disclaimer that the spike proteins made in cells by SARS-CoV-2 “behave very differently than those safely encoded by vaccines”.

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 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.

My concerns aside, let’s look at the experiments. 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.

To be honest, I’ve never been a fan of 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 detests the trend in scientific publications to dump all sorts of data into supplemental sections.

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 has been 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 the authors pointed out this very issue and took antivaxxers to task for misusing their study:

Since I first discovered this study, it’s just amused me how obvious it is that the antivaxxers citing this study have obviously not actually 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. This study by Uri Manor’s laboratory is interesting and potentially important because it begins to elucidate the role of the spike protein itself in the pathophysiology of SARS-CoV-2 infection and how the spike protein alone can cause damage, but it does not in any way suggest that spike protein made by a COVID-19 vaccine is in any way toxic at the concentrations it’s produced, much less that it’s in any way “shed” or that the “shed” spike protein can cause disease or miscarriages in the unvaccinated who encounter the vaccinated.

Which brings me to the last of the three studies, which was published late last week.

The deadly coronavirus spike protein produced by the Moderna COVID-19 vaccine?

On Friday, I started seeing a study popping up among antivaxxers. Unsurprisingly, the “pandemic’s wrongest man” was all over it on Friday. His ability to misinterpret studies and thereby spread prodigious amounts of COVID-19 disinformation is depressingly impressive:

The study itself was published on May 20 in Clinical Infectious Diseases, the official journal of the Infectious Diseases Society of America (IDSA) as a brief report by Ogata et al, entitled “Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients” and is the result of a collaboration between investigators at Harvard and the University of Montreal.

The study was very straightforward in design. In brief, investigators longitudinally studied blood samples from 13 participants who received two doses of mRNA-1273 (i.e., took samples at various time points after vaccination), Moderna’s mRNA-based COVID-19 vaccine. I can sum up the findings from the abstract, namely that investigators were able to detect spike protein in the plasma of 11 of 13 participants in the trial as early as one day after vaccination. To do so, they used a very sensitive technique known as single molecule array (SIMOA) to detect intact spike protein and its S1 fragment produced by RNA-1273.

A brief discussion of the spike protein itself is in order. The spike (S) glycoprotein of SARS-CoV-2 binds angiotensin-converting enzyme-2 (ACE2) on host cells. Spike itself is processed by proteases (protein-cleaving enzymes) into S1 and S2 subunits that remain associated with each other. Upon binding to ACE2 by the spike protein, the protein changes conformation that leads to S1 shedding and the cleavage of S2 by host proteases. You don’t really need to know the details for purposes of understanding this study, other than that spike protein has an S1 and S2 subunit, and these subunits associate with each other in the same conformation as they were before protease cleavage. This is a diagram of the structure.

SARS-CoV-2 spike protein structure.

But what does the authors’ finding of spike protein in the plasma mean, if anything? Haven’t we always been reassured that the spike protein from the mRNA vaccines doesn’t get into the bloodstream and remains in cells and on the surface of the cells that produce the protein after vaccination? Isn’t this study, as antivaxxers like Berenson claim, a reason to be afraid of the Moderna vaccine, at least? The short answer to that last question is no. The longer answer follows.

We at SBM like to repeat Paracelus’ famous dictum, dosis sola facit venenum, or “only the dose makes the poison”. It’s a general principle of pharmacology and toxicology, namely that the dose determines the effect of a drug, or, more specifically, the concentration of any substance in the bloodstream or organs that it affects (which is related, of course, to the dose) is what matters in terms of its effects. As I like to say, even water can be toxic if too much is ingested. That’s why I’ll refer back to a common antivaccine trope for which I long ago coined a term, “the toxins gambit“. Pre-pandemic, antivaxxers would point to every scary-sounding chemical they could find in vaccines and try to use it as evidence that vaccines were laden with “toxins”. My favorite example is, of course, formaldehyde, which is used in the preparation of some vaccines in order to inactivate the virus used as an antigen, leaving detectable traces behind in the vaccines. I first discovered the “formaldehyde gambit” (a form of the “toxins gambit”) when it was used years ago by Dr. Jay Gordon. The short version of the refutation of the “formaldehyde gambit” is to cite Paracelus and point out that the amount of formaldehyde in any given vaccine is exceedingly small, considerably smaller than what an infant produces due to their own normal metabolism. Indeed, peak body burden of formaldehyde has been estimated to be less than 1% of endogenous formaldehyde.

The same thing applies to this study cited by Berenson, as you will see. Before I describe how much spike protein the investigators found in the plasma of these 13 study participants, let’s look at the concentrations used, for example, in the cell culture experiments done by Uri Manor’s group as described in the second paper I discussed: 4 μg/ml.

Now, let’s look at the “money figure” from the paper, the first three panels of Figure 1. The reason that the authors also did the assay to detect the viral nucleocapsid protein was because the vaccine does not result in production of this protein. It was thus a negative control; unless the subject is infected with SARS-CoV-2, nucleocapsid protein should be undetectable.

Here’s the figure:

Spike protein after vaccination
Spike protein after vaccination with Moderna RNA-1273. Note the Y-axis units.

Now take a look at the Y-axis, in particular, the units on the Y-axis: “pg/ml,” or picograms per ml. That’s 10-12 grams/milliliter. What was the concentration used by Manor’s lab again? Oh, yes, 4 micrograms/milliliter. One microgram is 10-6 grams, or one million-fold more than one picogram! Or, as Uri Manor put it:

Or, as Ogata et al write:

S1 antigen was detected as early as day one post vaccination and peak levels were detected on average five days after the first injection (Figure 1A). The mean S1 peak levels was 68 pg/mL ±21 pg/mL. S1 in all participants declined and became undetectable by day 14. No antigen was detected at day zero for 12 of 13 participants, as expected. However, one individual presented detectable S1 on day zero, possibly due to assay cross reactivity with other human coronaviruses or asymptomatic infection at the time of vaccination. Spike protein was detectable in three of 13 participants an average of 15 days after the first injection. The mean spike peak level was 62 pg/mL ± 13 pg/mL. After the second vaccine dose, no S1 or spike was detectable, and both antigens remained undetectable through day 56. For one individual (Participant #8), spike was detected at day 29, one day after the second injection and was undetectable two days later.

Let’s be generous. Let’s look at panel B and examine the highest concentration of spike protein detected, which looks by the graph to have been around 90 pg/ml. Now, for ease of calculation, let’s just round up to 100 pg/ml as the highest average peak plasma concentration of spike protein after vaccination. That would still be a 40,000-fold lower concentration than 4 μg/ml. As an aside, the authors also detected IgG and IgA antibodies to spike protein and a correlation between clearance of detectable SARS-CoV-2 protein and the production of IgG and IgA.

But why did Ogata et al detect any spike protein at all? After all, we know that the spike protein is not secreted from the cells in which it is made because it lacks an amino acid sequence, a so called “signal peptide sequence” that would lead to its secretion. We know that the spike protein as made using the mRNA sequence template is membrane-bound, meaning that it’s embedded in the membrane of the cells that make it. The authors speculate in the Discussion:

In this study, 11 participants exhibit S1 antigen in plasma after the first injection, while nucleocapsid concentrations are insignificant in all participants, confirming that the detected S1 originates from vaccination and not natural infection. The presence of S1 is likely due to the nature of the encoded mRNA-1273 spike protein, which contains a cleavable S1-S2 site and enables release of S1 from the spike trimer2. We hypothesize that release of S1 protein could result from cleavage via mammalian cell proteases or circulating proteases. We observe an increase in S1 over an initial period of one to five days, suggesting that mRNA translation begins immediately after vaccine inoculation. Interestingly, spike protein appears in three of thirteen participants on average eight days after S1 is produced.

Translation: There are enzymes that can cleave proteins (proteases), and it is possible that these proteases clipped off the S1 subunit from the spike proteins in the membrane.

Another possibility:

The Simoa antigen assays for the full spike protein are designed to require antibody binding to both the S1 and S2 subunits for detection, resulting in a cleaved spike protein to be undetectable. Additionally, spike protein concentrations in plasma of vaccinated participants may be below our assay limit of detection. We hypothesize that the cellular immune responses triggered by T-cell activation, which would occur days after the vaccination, lead to direct killing of cells presenting spike protein and an additional release of spike into the blood stream. The mechanisms underlying release of free S1 and the subsequent detection of the intact spike protein remain unclear and require further studies.

In other words, another possibility is that the immune system killing the cells producing spike protein could result in the release of enough spike protein to be detectable by this very sensitive assay. Indeed, the authors note that the detection of spike protein “has not yet been described in any vaccine study, likely due to limitations in assay sensitivity and timing assessment”. In other words, the authors’ assay is so sensitive that it’s detecting incredibly minute amounts of spike protein from the vaccine in the blood that previous studies could not detect, simply because they used insufficiently sensitive assays.

As I was writing this, I was informed that an old friend Ed Nirenberg had done a similar analysis and had actually done me one better by comparing this study to another study of spike protein that reported that spike protein could damage the blood-brain barrier. That study used a 10 nM (nanomolar) concentration of spike protein, which, using the molecular weight of spike protein and S1 subunit and found:

A 10 nM solution of these [spike protein and S1 subunit] would equate to 14,610,000 pg/mL and 7,650,000 pg/mL respectively which are respectively 146100 times and 76500 times more spike protein than is found in plasma of vaccinated people.

Ed further notes:

Ah but I hear you protesting- the experts lied! They said no spike circulating- clearly there’s spike circulating. Not exactly. For one thing, the data available until this point didn’t show evidence of spike circulating, and we have a tendency in shorthand to say that that means there is no spike because we can’t prove a negative. All assays have limits of detection (in this case it’s labelled). A 10 nM concentration is very small- and yet this is still about 100,000 times more spike than what we find in plasma. This assay is pretty special to be able to find anything reliably at this concentration and I would be skeptical of its accuracy at this level if not for the time points that these things are appearing. Also note that this isn’t evidence of spike protein being secreted by the cells that receive the mRNA, which was the key consideration behind such claims and indeed based on the tiny quantities noted, that doesn’t appear to be happening. The appearance of intact spike in the plasma of this admittedly small sample is very rare and transient.

Exactly. The amount of spike protein that was detected by SIMOA in this study is low, basically not much above the current limit of detection for this protein, and, more importantly, very transient. There was nothing nefarious in previous statements that spike protein from vaccines does not circulate in the bloodstream, nor was it a lie. Again, to echo Ed, the key concern was that the cells that took up the lipid nanoparticles containing the mRNA should not secrete the spike protein product, which could, theoretically at least, actually produce a significant plasma concentration.

On Twitter, Alana Olgata notes that she’d like to repeat this study with other COVID-19 vaccines, which is not unreasonable:

No doubt antivaxxers will leap all over those papers when they are published.

The “deadly” spike protein and vaccine safety

As I stated near the beginning of this post, antivaxxers strive mightily, above all, to claim that vaccines are dangerous to those receiving them and those around the recipients, all with added conspiracy theories. It doesn’t matter how much they have to misinterpret or misrepresent scientific studies to do so. They’ll find a way to make their misrepresentations (or failure to put studies into proper context) sound like plausible evidence that vaccines are dangerous, and they’ve certainly been doing this with COVID-19 vaccines, starting with pointing to any study that finds a role for the spike protein alone in causing cell damage. Such studies are critical to the elucidation of the molecular mechanism by which SARS-CoV-2 infects cells, replicates itself, and causes so much damage to the lungs. It’s also important to note that target effects matter. Location matters. The main infection starts in the lungs, which is where the highest concentration of virus and therefore spike protein would be expected in the case of real infections. In the case of vaccination, the location is the muscle cells of the shoulder, and any spike protein that escapes is rapidly diluted in the bloodstream to the pg/ml range.

But what does Olgata’s finding for the Moderna mean regarding the safety of the vaccine? Basically nothing. The reason is simple. If there were a safety problem due to spike protein, after more than a quarter of a billion doses of vaccine administered in the US alone, there would have been safety signal by now, given the unprecedentedly intense vaccine safety surveillance effort that accompanied the rollout of these vaccines. Remember, this is a pharmacosurveillance effort that detected literally a one-in-a-million serious adverse event associated with vaccination with the Johnson & Johnson vaccine within a month and a half of its being distributed under an emergency use authorization. It beggars the imagination to suggest that, even if the transient appearance of spike protein after vaccination at a concentration of (at most) tens of picograms/ml were toxic, there would be no safety signal after so many doses. It’s even more ridiculous to propose that such a minuscule concentration of spike protein can be “shed” in quantities that could affect other people, given the incredibly low and transient concentration produced after vaccination.

Antivaxxers either don’t know or understand that themselves, or they know that the vast majority of people don’t know or understand that. All they need is a finding that any spike protein floats free in the bloodstream after vaccination, and they can use that finding to start an effective fear mongering campaign. That’s exactly what they are doing now.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

78 replies on “Antivaxxers and the “deadly” SARS-CoV-2 spike protein”

It boils down to these questions:

Is the vaccine safe? This is misleading. It is not one vaccine. It is a multitude of different vaccines dependent on manufacturer, differing with PEG carrier, formation of the spike protein, or use of attenuated/dead virus. The same issue applies to all of the following statements.

For the majority absolutely. For a small minority no, due to an abnormal response to the spike protein fragment or adverse reaction to the PEG carrier. This is a question of risk reward. Is the risk of getting the virus and getting very sick/hospitalized greater than getting an adverse reaction to the vaccine. Clearly the younger the patient, the greater the risk of the vaccine as the likelihood of severe disease/death is inversely related to age. Does the risk of getting very sick/death from the virus exceed the risk of death for a particular age group. The question is often rests on whether there is adequate treatment for children who become very sick for the virus. The answer is that there is adequate treatment for majority and death is almost unknown.

Is it effective? This boils down to the definition of effective. Does effective mean “prevention of infection/re-infection” or decrease in severity of disease? It appears to be effective in decreasing the severity of the disease (as measured in terms of hospitalization/death). As patients younger than 50 rarely get severe disease, the question is whether it prevents infection. This is not so easily answered as the number of cases was markedly decreasing prior to and coincident with immunization. The PCR test, as currently utilized, is over sensitive to detection of viral fragments. So the jury is still out. Some vaccines, such as the Sinopharm, do not appear to be particularly effective.

Is it necessary? This ties in to both the concept of safety and effectiveness. COVID-19 is no worse than other viruses, such as the flu, Coxsackie viruses, and other viruses that cause conditions such acute flaccid myelitis and that are endemic in the population. It also ties in with natural immunity. As the population changed from immunologically naive to immunologically mature, the number of cases began to drop precipitously (as is expected in any pandemic response in which a population successfully adapts).

What is the goal of vaccination? If the goal of vaccination is elimination of the virus, the odds are that this will never happen. We have been vaccinating against the flu for generations and the flu is still with us. Coronaviruses as a class and COVID-19 virus in particular mutate approximately 10,000X faster than the immune system can adapt. Fortunately most mutations are neutral or detrimental to the virus, a few increase infectivity without increasing severity and rare mutations increase infectivity and severity.

So if we conclude vaccination is necessary, is it necessary for everyone? for those at increased risk with comorbid conditions? As the severity of disease is inversely proportional to the age of the patient, the younger the patient the less compelling the argument for vaccination.

Amount of spike protein was picograms, and that only days. For shedding, spike protein must go out of the body. How do you think this would happen ?
Why do you think that symptoms of disease and disease are different ? If disease goes away, it symptoms will go too.
No vaccine is 100% effective. But I am certain that every reasonable consider 95 % better than 0%. It is enough to build herd immunity,, surely.
Goal of SARS CoV 2 vaccination is not elimination of virus. This cannot be done, because it has animal reservoir (smallpox did not).

@ Pathcoin

You write: “Is the vaccine safe? This is misleading. It is not one vaccine. It is a multitude of different vaccines dependent on manufacturer, differing with PEG carrier, formation of the spike protein, or use of attenuated/dead virus.”

Yet each and every vaccine was required to go through the same approval process and each and every vaccine is being followed by a variety of post-marketing surveillance systems, VAERS not the prime one in the U.S., check out CDC website: Vaccine Safety, specifically Vaccine Safety Datalink, and similar approval processes and post-marketing surveillance programs in many other nations.

You write: “Clearly the younger the patient, the greater the risk of the vaccine as the likelihood of severe disease/death is inversely related to age.”

According to the website Statista:

Number of coronavirus disease 2019 (COVID-19) deaths in the U.S. as of May 12, 2021, by age
0-17 287
18-29 2,163
30-39 6,299
40-49 16,987
50-64 87,915
65-74 125,939
75-84 156,777
85&older 171, 686

So, about a third younger than 65 and life expectancy is around 75, so about half died before.

In addition, you ignore the suffering, hospitalizations, and long Covid that many are still suffering from, plus while ill economic problems. There are studies finding vascular damage in young people, even children who were asymptomatic. Whether this will lead to long term consequences is currently not known.

You write: “Is it effective? This boils down to the definition of effective. Does effective mean “prevention of infection/re-infection” or decrease in severity of disease? It appears to be effective in decreasing the severity of the disease (as measured in terms of hospitalization/death). As patients younger than 50 rarely get severe disease, the question is whether it prevents infection.”

Given the severity of the disease, even in younger people (see above), the vaccine is quite good. And studies have found if re-infected (rare), severity significantly reduced, i.e., no need for hospitalization. In fact, the few cases re-infected so far asymptomatic.

You write: “What is the goal of vaccination? If the goal of vaccination is elimination of the virus, the odds are that this will never happen. We have been vaccinating against the flu for generations and the flu is still with us. Coronaviruses as a class and COVID-19 virus in particular mutate approximately 10,000X faster than the immune system can adapt. Fortunately most mutations are neutral or detrimental to the virus, a few increase infectivity without increasing severity and rare mutations increase infectivity and severity.”

A vaccine can only totally eliminate a virus if the sole reservoir for the virus is humans, e.g., smallpox, polio, measles. However, numerous well-done studies have found that the various flu vaccines over the past decades have been approximately 50% effective in preventing hospitalizations and deaths, some less so; but all better than nothing. I remind you that seatbelts only reduce death and serious injury by about 50%.

Yep, the coronavirus is mutating. So far the current vaccines work against variants; but if at some time in the future they don’t, mRNA vaccines can be designed and produced at super fast speeds, so, may not completely prevent a short term spike in hospitalizations and deaths; but reduce significantly the total. So, getting a booster vaccine not any different than getting flu vaccine every year.

You conclude with: “So if we conclude vaccination is necessary, is it necessary for everyone? for those at increased risk with comorbid conditions? As the severity of disease is inversely proportional to the age of the patient, the younger the patient the less compelling the argument for vaccination.”

Besides you being wrong about severity of disease being “inversely proportional”, yep, much younger lower deaths; but risk of long covid, vascular damage, etc. And, while some of the vaccines may not completely eliminate viral shedding, the significantly reduce it, thus protecting others who may not be able to be vaccinated, the vaccine did not work effectively, etc. A report in my home town found that 60% of adults had one or more comorbidities that put them at risk.

And as the current post and others on Respectful Insolence have shown over and over again, the vaccine(s) are extremely safe. Perfectly safe. No; but I live in the real world where benefits to cost based on probabilities, not black and white dichotomies.

Big chunks of the post above are repeated, as if by hitting “paste’ twice in a large copy-and-paste. I hope Orac spots it, and cleans it up.

I would indeed like to see “take 2,” the text of which appears to have been a casualty.

@ Pathcoin

One more important point:

A recent report by the University of Washington found underreporting of COVID deaths, estimating the actual number of deaths in U.S. at approximately 905,000, 50% higher than current official numbers. Yep, many had comorbidities; but even with mild congestive heart failure, Type 1 diabetes, etc. people not infected with COVID may have lived many more years. You can find the report and methodology at: University of Washington Institute for Health Metrics and Evaluation. They are considered a top flight respected institute.

If further study confirms the above, then the benefit to cost ratio of the vaccines will be considerably better than they already are, which are excellent.

Do you have a link or citation? 50% seems awfully high for underreporting deaths. From your vast experience as an epidemiologist, is that plausible?

I would really like to read the report (generally, too).

Of course Orac explains why anti-vaxxers’ vaccine fright porn is laughably unrealistic. Not that any of them would – or could- follow his de-construction.

I’ve noticed that initially anti-vaxxers were predicting immediate adverse effects from the vaccine including death thus leading to their focus on VAERS.
Interestingly, Mikey has recently added a new worry: death will proceed in 1-3 years. YEARS! So if we point out that the early studies and current widespread vaccination do not bear out their dire warnings, he can say, “Just WAIT!*

I’m looking forward to his “false flag” event.

Might he be genuinely concerned that one of his followers plans to commit serious antivax mayhem and cite him as inspiration?

It used to just be Kooksville over there, but it is now Bizzaroworld.

I can’t help thinking those calls might have just been the voices in Mikey’s head.

I think we have seen with the January 6th insurrection that there is every need to invoke “false flag” events early and often. For the loony-tunes Qanon followers there is no nonsense that is too stupid to believe.

There have been instant adverse reactions to the vaccination. Tens of thousands of deaths and adverse reactions in the millions. It’s only been a few months. Of course unlike covid death within 28 days of a positive PCR test, these reactions are all pure coincidence……..

It has been over 1 month since the CDC changed its guidance on mask wearing. At that time only 32% of the population of the US had been vaccinated. Since the changing of the guidance only 41% of the US population has been vaccinated.
It has been over 8 weeks since Texas and Florida ended the mask mandate (their cases have dropped).
So I asked the question back on the 27 of April what new peer reviewed new science or new science convinced the CDC to change their minds?

To date no one here has or can point to a single peer reviewed, published science that caused the CDC to change their minds.

CDC did not “end the mask mandate”. Firstly, it just give recommendations, and secondly it says masks are not needed if you are fully vaccinated. Peer reviewed science is any number of papers showing efficacy of vaccines.

@ Kay West

You point to Texas and Florida, so this is from Texas: “A mix of vaccinations, continued mask wearing, people already having immunity and the weather warming up has slowed down the spread, said Diana Cervantes, a professor of biostatistics and epidemiology at UNT Health Science Center.” (Lopez, 2021).

So, as you and others who don’t understand science continue to miss is that one can’t look at just one variable; but in the case of Texas, first, as vaccinations have gone up so has the number of people already exposed, then as the weather has warmed up, people spend more time outdoors where the risk is lower, and FINALLY MANY ARE STILL WEARING MASKS.

Thompson: “Abbott’s decision didn’t matter because nobody changed their behavior. According to the aforementioned Texas paper, Abbot’s decision had no effect on employment, movement throughout the state, or foot traffic to retailers. It had no effect in either liberal or conservative counties, nor in urban or exurban areas. The promaskers kept their masks on their faces. The anti-maskers kept their masks in the garbage. And many essential workers, who never felt like they had a choice to begin with, continued their pre-announcement habits.The governor might as well have shouted into a void. (Thompson, 2021).

As for peer-reviewed studies of the effectiveness of vaccines, I have dozens and even more articles on masks. Though not thorough, a recent NPR article discusses the CDC decision (Simmons-Duffin, 2021).

The question is why the sudden change. I already explained this several times in other exchanges; but briefly, not sudden; but based on cumulative evidence. However, I disagree with decision. First, rather than abrupt announcement CDC should have prepared nation by explaining the research, perhaps, taking a couple of weeks. However, I still disagree with the decision. In areas where many either vaccinated or already exposed, fine; but there are areas of U.S. where lower numbers either vaccinated and/or exposed and the new variants, some more transmissible and potentially virulent, though current vaccines protect against, could lead to a surge in hospitalizations, long Covid, and deaths, though fewer deaths than in beginning of pandemic because effective treatments now available; but more long covid cases.

Given your current post and previous ones, however CDC acts you will find fault. After all, you are far more an expert on pandemics, COVID-19, and vaccines than those at CDC. Right??? Why not contact your representative in Congress and suggest you replace the current CDC director???

Ah, Kay, just one more ill-informed person posting comments based on what??? Certainly not an understanding of the science of viruses, pandemics, and vaccines. Dunning-Kruger rears its ugly head.

References:

Lopez (2021 Apr 20). How Texas avoided COVID surge after Gov. Abbott opened state. Fort Worth Star-Telegram

Simmons-Duffin (2021 May 14). FAQ/ Yes, The CDC’s New Mask Guidance Was Based On Science / Shots – Health News / NPR.

Thompson (2021 May 21). The Texas Mask-Mandate Mystery . The Atlanticf

Though not thorough, a recent NPR article discusses the CDC decision

You might find <a href=”https://www.wired.com/story/the-teeny-tiny-scientific-screwup-that-helped-covid-kill/>this item from Wired interesting, Joel.

Are you opposing Orac because somebody pays you ? Try to argue with him, instead.

The NIH is calling for people who get paid to do research about vaccine hesitancy not write about it.
You have no idea how many readers Orac has – you probably assume the number of commenters equals number of readers- there are other metrics, believe me. Even if he had ten readers or followers totally, his work would still be important and none of your business– it’s his hobby.
He is frequently interviewed by other media because of his expertise combatting pseudo-science and anti-vax: does anyone interview you?

“The NIH is calling for people who get paid to do research about vaccine hesitancy not write about it.”

Why would they not want them to write about it? What would be their motivation to discourage them from sharing that information?

Apply for research funding to use scientific methods to address vaccine hesitancy, uptake, and implementation among groups experiencing health disparities through Notice of Special Interest (NOSI): Research To Address Vaccine Hesitancy, Uptake, and Implementation Among Populations That Experience Health Disparities.

Applicants should propose studies that emphasize collaborative partnerships with key community stakeholders to enhance vaccine access, uptake, and acceptance.

Projects must center on one or more NIH-designated populations experiencing health disparities, including racial and ethnic minority groups, less privileged socioeconomic status, sexual and gender minorities, and underserved rural populations. Focus on adults 18 years and older, with the exception of HPV-related topics, which may include minors 9 years and older.

So how does writing a blog meet those criteria?

@ Scientism Dave

I agree with Aarno, doesn’t matter whether Orac paid or not, though I believe not. You are avoiding your inability to actually address what he writes by using an ad hominem attack. Just shows that “scientism” as you use it translates to unscientific.

Small minds are constantly sent reeling over the fact that some people have an avocation they enjoy and which does not require remuneration.

Hey Dave, are you familiar with the concept of a hobby? Something you do for fun and not for money? That’s what this blog is, a hobby.

Maybe you should get a hobby. Bird watching is a lot of fun.

“No it isn”t. Sometimes it is like with oil spills and stuff.” — Throatwobblermangrove

Lots of scientists get money from the NIH. Funding research is one of the main purposes of the NIH. As it happens, the author of this blog is a cancer researcher so is more likely to apply to the NCI than the NIAID. But, so what? I can’t think why being NIH funded would be a problem. The NIH is certainly not paying for this blog.

Just for a laugh… I think?

Sacramento Bee, Monday.
A cafe in Mendocino charges $5 extra if you wear a mask! The owner of Fiddleheads, Chris Castleman, had been previously in trouble for allowing workers to go without masks.

Seriously. This town is quite photogenic, near several state parks and extremely hard to reach ( three pathways accessing it include long twisty roads through redwoods, narrow twisty roads over mountains and long twisty roads through a primeval forest with logging trucks- take your pick, all miles away from the main road which isn’t much). People go there for weekends/ weddings/ etc. It is quite expensive. Being in that county, I suspect it’s rather liberal but you never know.

The owner of that cafe also collected a large fine last summer for repeatedly refusing to comply with county mask mandates, and then closed down for the same reason. He also had a “trash your mask” 50% discount and briefly offered fake vaccination cards. In other words, he’s yet another asshole boss/business owner.

Apologies for the OT post.

A ‘rising star’ in the anti-vaccine movement could lose his medical license

https://www.rawstory.com/pediatrician-paul-thomas/

Oregon pediatrician Paul Thomas has had his medical license suspended due to his “gross negligence” for “promotion of an inadequate vaccine schedule, which did not meet the standard of care,” Willamette Week reports.
While the suspension of his license is temporary, the Oregon Medical Board is seeking a permanent revocation of his license and fines of up to $10,000 for each violation.

Includes a quote from a writer on Orac’s not-so-secret other blog.

In the photo of Thomas accompanying that story, he looks almost as big-eyed as Virginia does in the pic on her NWO Reporter “About” page.

Hmmm…

Kevin Vicklund

I had posted that same CDC research about 25 days ago, when I first posed the question “What peer reviewed science caused the CDC to change their position on masks?” . The research is on the efficacy of the vaccines (and vaccines in general). It is/was a restatement (with additional research) of the clinical trials. I never questioned the vaccine or its effectiveness (or even vaccines in general).

My question was a simple straight forward question what changed in the minds of the head of the CDC and the President, when she claimed a few weeks before the change in mask mandate/guidance/recommendation when she claimed were were “doomed” if we changed the mandate/guidance/recommendation or President Biden claiming that people who wanted to eliminate the masks were “Neanderthals”. Nothing in the research paper you or I cited said anything about mask.

Other posters have cited newspapers, magazines etc. but not peer reviewed science

The CDC was following public opinion, the politicians and the media who saw that lifting the mask mandate in several state without a marked increase in cases, they realized that they were on the loosing side of the argument

@ Kay West

You write: “Other posters have cited newspapers, magazines etc. but not peer reviewed science”

I did refer to NPR report because it cited studies. I could give a list of studies on masks; but you wouldn’t read them.

You write: “The CDC was following public opinion, the politicians and the media who saw that lifting the mask mandate in several state without a marked increase in cases, they realized that they were on the loosing side of the argument.”

And typical you ignore what I wrote that explains why there were no marked increase in cases, namely a combination of variables:

not just an increase in vaccines but an increase in those who were exposed. Even if asymptomatic they would have antibodies, so total number with antibodies larger than just those vaccinated. Do you understand this??? I doubt it.
warmer weather, so more out-of-doors where risk of transmission much less
regardless of mandate or not, many continued to wear masks.

And I don’t disagree that there was political pressure and as I already stated, I think they should have taken a couple of weeks to prepare people for the change by explaining the latest studies on vaccine effectiveness, mask effectiveness, number of exposed, warmer weather, etc. You ignore all this. For you, you want one definitive study. Why? Does it matter? Or are you incapable of dealing with more than one variable at a time? Yep!

And I would be willing to bet that the CDC researchers would have handled it differently; but CDC is subject to political pressures, much worse under Trump; but still political pressure.

And you might be interested in a recent report from WHO that we will in the future be experiencing more and more pandemics, coming at ever shorter intervals. Given that we are NOT a nation; but a polarized group of people, that we are 50 states, many more counties, even more cities, etc. we won’t prepare properly for the coming wave of pandemics. Americans, not all, but many are really stupid, out-of-sight out-of-mind. Public health, when it works, people take it for granted. And many Americans like you think in dichotomous black and white terms, thus incapable of dealing with reality.

In any case, so nice how you ignore anything that doesn’t fit into your all or none approach, in this case, mask mandate or not.

Here is the UN report, easily found on the web; but I doubt you will read it; but others following this blog may: IPBES (2020). Workshop on Biodiversity and Pandemics Report.
IPBES stands for Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services.

Personally, I think the CDC, FDA, etc. were so traumatized during Trump’s four years that it will take time for them to function effectively; but again, not black and white, they are still all that we have between a nightmarish world of disease and keeping it in check.

Today’s Washington Post has an article about how Trump’s minions are now claiming that he did great and Fauci is the one responsible for everything that went wrong. Sad, but not unexpected. The lies continue apace.

The research is on the efficacy of the vaccines (and vaccines in general). It is/was a restatement (with additional research) of the clinical trials.

This. Right here. The additional research, including studies not part of the Phase 3 trials, showed that the vaccines were efficacious at preventing spread. The original research wasn’t able to show that (because of the design of the trial, not anything to do with the vaccine itself). The reason we wear masks? To prevent the spread of Covid. If the vaccines are able to prevent the spread of Covid, then there is no need for the vaccinated to wear masks. And that’s exactly what the additional research showed.

Quite a bit of research came in during April showing that the vaccines were preventing the spread of Covid. That’s what drove the decision about masks for the vaccinated.

@ Kay West

Below is the articles I have and have read on masks. I have a much much larger reference list on the vaccines, especially international statistics and also estimates of how many infected, etc. And I would bet that the COVID group at CDC has a much larger MASK reference list.

MASKS Reference List

Centers for Disease Control:

Associated Press (2021 May 17), CDC head – mask ruling based on science – San Diego Union-Tribune.

Cook S et al. (2021 Apr 28). CDC unveils new mask guidelines for Americans who have had COVID-19 vaccine. CBS News.

Florko N (2021 May 11). CDC’s slow, cautious Covid-19 messaging seems out of step with moment. STAT

Karan A (2021 May 27). The CDC’s latest blunder is really about trust, not masks. STAT

Leonhardt D (2021 May 11). A Misleading C.D.C. Number. The New York Times.

Molteni M (2021 May 16). Mask mandates might be going away, but don’t ditch yours just yet. STAT.

Simmons-Duffin S (2021 May 14). FAQ: Yes, The CDC’s New Mask Guidance Was Based On Science / Shots. Health News: NPR.

Thompson D (2021 May 14). The CDC’s Big Mask Surprise Came Out of Nowhere – The agency’s communication strategy has lagged so consistently behind the research that it’s brought new meaning to the concept of “following the science.” The Atlantic.

Tufeksi Z (2021 Apr 28). The CDC Is Still Repeating Its Mistakes – The agency’s new guidelines are too timid and too complicated. The Atlantic.

Wosen J & Mapp LJ (2021 May 15). County, state mum on change to mask mandate. San Diego Union-Tribune.

Other:

Axelsen PH & Poland GA (2021 Feb 22). Vaccines, masks, distancing and credibility: An urgent warning for pandemic management . Vaccine; 39(8):1173-1174.

Bulfone TC et al. (2021 Feb 15). Outdoor Transmission of SARS-CoV-2 and Other Respiratory Viruses: A Systematic Review. The Journal of Infectious Diseases; 223(4): 550-561.

Epperly DE et al. (2020 Dec 10 medRxiv). COVID-19 Aerosolized Viral Loads, Environment, Ventilation, Masks, Exposure Time, Severity, And Immune Response: A Pragmatic Guide Of Estimates.

Fouda B et al. (2021 Apr). Identifying SARS-CoV2 transmission cluster category: An analysis of country government database. Journal of Infection and Public Health: 14(4): 461-467.

Gandhi M & Marr LC (2021 Jan 15). Uniting Infectious Disease and Physical Science Principles on the Importance of Face Masks for COVID-19. Med (New York, N.Y.); 2(1): 29-32.

Gorski D (2021 May 17). How anti maskers weaponize techniques of scientific analysis to attack mask mandates. Science-Based Medicine.

Leclerc QJ (2020 Jun 5). What settings have been linked to SARS-CoV-2 transmission clusters? Wellcome Open Research; 5: 83.

Lee C et al. (2021 May). Viral Visualizations: How Coronavirus Skeptics Use Orthodox Data Practices to Promote Unorthodox Science Online. CHI ’21: Proceedings of the 2021 CHI Conference on Human Factors in Computing Systems; Article No. 607: Pages 1-18.

Liang M et al. (2020 Jul). Efficacy of face mask in preventing respiratory virus transmission: A systematic review and meta-analysis. Travel Medicine and Infectious Disease; 36.

McGreevy R (2021 Apr 5). Outdoor transmission accounts for 0.1% of State’s Covid-19 cases. The Irish Times.

Parker-Pope T (2021 May 6). Do We Still Need to Keep Wearing Masks Outdoors? The New York Times.

Qian H (2021). Indoor transmission of SARS-CoV-2. Indoor Air; 31(3): 639-645.

Thompson D (2021 May 21). The Texas Mask-Mandate Mystery. The Atlantic

‘Quite a bit of research came in during April showing that the vaccines were preventing the spread of Covid. That’s what drove the decision about masks for the vaccinated.’
Kevin
Your statement is a belief or faith in the CDC, please cite this research that was used in the decision.

Joel These are not published peer reviewed nor are they science they are opinion mixed with facts some even counter dict one another or ther are written after the decision was made
San Diego Union-Tribune.
CBS News.
STAT
STAT
The New York Times.
Health News: NPR.
The Atlantic
The Atlantic
San Diego Union-Tribune.
The Irish Times
The New York Times.
The Atlantic

@ Kay West

You write: “Joel These are not published peer reviewed nor are they science they are opinion mixed with facts some even counter dict one another or ther are written after the decision was made”

Just how dishonest are you? Yep, I included some newspapers and magazines; but some of them gave good reviews. And I found some of the actual research from reading them. However, I also included the following in my comment from “published peer-reviewed journals”.

So, now beyond any doubt you have proven your are a dishonest ASSHOLE!

Axelsen PH & Poland GA (2021 Feb 22). Vaccines, masks, distancing and credibility: An urgent warning for pandemic management . Vaccine; 39(8):1173-1174.

Bulfone TC et al. (2021 Feb 15). Outdoor Transmission of SARS-CoV-2 and Other Respiratory Viruses: A Systematic Review. The Journal of Infectious Diseases; 223(4): 550-561.

Epperly DE et al. (2020 Dec 10 medRxiv). COVID-19 Aerosolized Viral Loads, Environment, Ventilation, Masks, Exposure Time, Severity, And Immune Response: A Pragmatic Guide Of Estimates.

Fouda B et al. (2021 Apr). Identifying SARS-CoV2 transmission cluster category: An analysis of country government database. Journal of Infection and Public Health: 14(4): 461-467.

Gandhi M & Marr LC (2021 Jan 15). Uniting Infectious Disease and Physical Science Principles on the Importance of Face Masks for COVID-19. Med (New York, N.Y.); 2(1): 29-32.

Leclerc QJ (2020 Jun 5). What settings have been linked to SARS-CoV-2 transmission clusters? Wellcome Open Research; 5: 83.

Lee C et al. (2021 May). Viral Visualizations: How Coronavirus Skeptics Use Orthodox Data Practices to Promote Unorthodox Science Online. CHI ’21: Proceedings of the 2021 CHI Conference on Human Factors in Computing Systems; Article No. 607: Pages 1-18.

Liang M et al. (2020 Jul). Efficacy of face mask in preventing respiratory virus transmission: A systematic review and meta-analysis. Travel Medicine and Infectious Disease; 36.

Qian H (2021). Indoor transmission of SARS-CoV-2. Indoor Air; 31(3): 639-645.

@ Kay West

And you failed to address my explanation that rates of an airborne infectious disease such as COVID depend on many factors. In Florida and Texas the total of people either vaccinated or having been infected (total with antibodies), the warmer weather (more time spent out-of-doors where risk of infection significantly lower, AND many still wear masks, either by personal choice and/or businesses, etc. still require them.

And nope, no peer-reviewed studies on the above; but interviews with scientists, public health officials and plain old common sense, something you lack given that you can only focus on one obsession at a time.

Come Sept/Oct when flu season arrives, I will get the vaccine and probably wear a mask when shopping. In 1969 I bought my first car, a used 1966 model. It had lap seatbelts. I immediately used them and required anyone riding with me to do so. A minor inconvenience; but even at a young age I weighed risk of flying through windshield if in an accident vs minor inconvenience of putting on and off a seatbelt. Same with masks. A minor inconvenience; but even if research found only reduced risk by, say, 20%, still better than nothing. And now that seatbelts are mandatory, do you believe an intrusion in your personal space???

Just one more example of what a dishonest ASSHOLE your are.

Well, here’s the Interim Guidance Document that recommended that fully vaccinea

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html#anchor_1619526549276

The first paragraph of the Overview section reads thusly:

Currently authorized vaccines in the United States are highly effective at protecting vaccinated people against symptomatic and severe COVID-19. Additionally, a growing body of evidence suggests that fully vaccinated people are less likely to have asymptomatic infection or transmit SARS-CoV-2 to others. How long vaccine protection lasts and how much vaccines protect against emerging SARS-CoV-2 variants are still under investigation.

Contained in that is a link to the growing body of evidence:

https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fmore%2Ffully-vaccinated-people.html

Note that while these were updated last week with additional research, a large portion of the 142 sources were used in determining the interim guidance. Have fun reading! (No, I’m not going to copy all the sources – I do note that a large number of the sources are published, peer-reviewed articles, while many others were pre-prints at the time of the decision)

(For some reason my first sentence got chopped a bit, maybe when I tried to fix a typo I noted before posting)

By my count (which may not be exact), 68 of those 142 sources are published, peer-reviewed articles. Roughly half.

From the Boston Globe:

“The Triple A Worcester Red Sox are offering free COVID-19 vaccines at Polar Park through Sunday in partnership with the Edward M. Kennedy Community Health Center.”

“Fans 18 or older who receive a Johnson & Johnson vaccine will be given a complimentary general admission ticket to that day’s game, along with a team cap.”

Since the team is commonly known as the WooSox, I would’ve expected them to offer freebies to fans who took elderberry extract and colloidal silver instead. But this is gratifying news.

Good and bad news from Florida, land of the DeSantis insanity: In spite of DimInsanity lifting the mask mandate or failing to respect its rationale from the very beginning (because $$$$, of course), I’m still seeing people of all ages masked in public places–probably about half of the randoms I see. My vet yesterday was very careless and came in unmasked although we were both double-masked (he’s fully vaccinated, I’m not). Medical practices are becoming more lax than grocery stores about this (!).

Rebekah Jones, the data scientist who was fired and then raided at gunpoint for refusing to massage (and lie about) Florida’s official COVID-19 statistics, has now been granted whistleblower status. That affords her federal and state statutory protections. She continues to get death threats. At least one Republican official resigned after the raid on her home to confiscate her computers. Her toddler had the inspiring experience of having a SWAT or some similar type of raiding team get a gun in the face. Welcome to the Sunshine State…..

Rebekah Jones, the data scientist who was fired and then raided at gunpoint for refusing to massage (and lie about) Florida’s official COVID-19 statistics, has now been granted whistleblower status.

That’s something. Now, if only the state would grant me a vaccination…. (I’m not a resident, just minding my late father’s house for a while. Like about half a year so far.)

Kewl, although it did sound begrudging. All I need now is a site and a ride.

Don’t know where you’re at, but I know that in Texas all they care is that you’re a US citizen, not what state you call home. (My aunt who lives in Guatemala flew up to Houston to get a first vaccination because she can’t get one in Guatemala.)

My vaccines don’t contain any vitamine E acetate. What’s wrong with those?

It’s trying to get you to get the J&J so you, you prime of youth fertile man-like entity, will get a blood clot and die. Avert! Look Away! Are RAIDs really worth it in the eara of kumbatchu levels of storage? Or can some of it just break and not hurt anything?

fuck you guys, I’m going home.

Maybe secretly even you have doubts but you write you want it and it is available in FL…plenty.

You know? I, um, do stuff, er, did stuff, and as you’ve gotten older, and myself, much, much older/younger because of that jew Einstien and his weird fuckall, I find your propasal up for debate.

Intelligent monostomes. You found them. You sick fuck.

[…] poses a danger to people may be based—incorrectly as we will see—on recently published studies, as documented here by David Gorski, a professor of surgery at Wayne State University and an editor at Science-Based […]

[…] poses a danger to people may be based—incorrectly as we will see—on recently published studies, as documented here by David Gorski, a professor of surgery at Wayne State University and an editor at Science-Based […]

For starters, read the disclaimers you have to click on to submit a data search in CDC WONDER.

IPAK’s journal is not noted for its high impact factor. I’m not familiar with the author, but the second paper’s authors (a computer scientist and a naturopath) are no more qualified to opine on virology and epidemiology than I am.

However, anyone can poke around in VAERS and play with the results.

But you have to keep in mind that the incidents are not vetted (we don’t know if they really happened as described). For instance my latest search shows deaths in 2001, 2010 and 2014 from the Covid-19 vaccines which didn’t even enter Phase 1 testing until 2020!

And there are about 10% more reports than incidents. i.e., some are duplicates.

We don’t know if they are statistically representative. Were there really that many more people 65+ who died 2-4 weeks after receiving their Covid-19 shots than died in the same period after getting their flu shots a few months before?

And, of course, causality is not determined.

But I did find one curious thing about those VAERS reports.

My search turned up 4765 reports for 4389 events.

Month …… Events
Jan ……….. 716
Feb ………. 1037
Mar ………. 1203
Apr ………. 1022
May …….. 521
Jun ………. 57

And there are 157 events with no date.

Since the peak of Covid-19 deaths runs about 2 weeks later than the peak of events, I compared the number of events for each month (which include some duplicates) with the number of vaccinations for the month ending the 14th of that month.

February and March are at least consistent, with events running at .00363 and .00382 % of vaccinations. But what happened in April and May?

The percentage went down to .00189 and .00166%

And June so far is only .0003%

Did the vaccines suddenly become safer?

Or were the deaths reported just a portion of the usual background deaths in the age group vaccinated. That declined as most people over 65 got vaccinated and we moved on to vaccinating people in their 20’s – 50’s. (My wife was vaccinated in January. I got both my doses in March. Our children were vaccinated in April and May.)

Of course I accept the disclaimers and this is just playing with numbers for my amusement.

But if you think those numbers represent a real effect, you need to come up with an explanation for how the vaccines suddenly got safer.

Thanks for your response. I think the big point of Dr. Rose’s paper is the uneven distribution of adverse events in the days following vaccination. To be sure, the longer after vaccination a health problem occurs the less likely it is that the person affected will suspect it is related to the vaccine and report to VAERS, but the incredibly steep drop her graphs show from just after vaccination to several days after is extremely suspicious, imo.

Have you seen this interview with Dr. Robert W. Malone – RWMaloneMD.com – about the vaccines and ivermectin? He’s a difficult person to dismiss.
https://www.bitchute.com/video/TH2HAmTp40xq/

With regard to the recent drop in reported events that may be related to the CDC being back-logged in reviewing, investigating and entering into the database, no?

He’s a difficult person to dismiss.

For you, perhaps. Maybe you should ask him to drop by rather than clutching your own pearls.

I saw the pulmonary hypertension article circulating on twitter a few weeks ago. It definitely fooled me at first– I’m so sensitive to news about heart disease. My family has a history of pulmonary hypertension (https://www.premiermedicalhv.com/divisions/services/pulmonary-hypertension/) and I was super nervous to read that vaccines could prompt it. Thanks for this info. I always need to do more research & sites like this help to dispel my fears.

[…] I’ve written about all these false claims. Spike protein does not have demonstrable reproductive toxicity, and the study to which antivaxxers point to claim that it accumulates in the ovaries is a rodent study that doesn’t show that much accumulation at all and doesn’t show that the spike protein floats free in the bloodstream at quantities sufficient to cause problems. Indeed, the evidence we have shows that the spike protein from the mRNA COVID-19 vaccines is only transiently detectable in the bloodstream at infinitesimal concentrations. […]

Want to respond to Orac? Here's your chance. Leave a reply! Just make sure that you've read the Comment Policy (link located in the main menu in the upper right hand corner of the page) first if you're new here!

This site uses Akismet to reduce spam. Learn how your comment data is processed.