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Should we bypass phase 3 trials of a COVID-19 vaccine?

Steve Salzberg proposed, in essence, bypassing phase 3 trials for a COVID-19 vaccine. It was a very bad idea for a number of reasons. To his credit, Steve later admitted his mistake.

As the pandemic continues to rage out of control in the US, naturally attention has turned to the possibility of a vaccine against COVID-19. Indeed, even a couple of months ago, I expressed concern that “Operation Warp Speed,” the program promoted by the Trump Administration to speed the release of a coronavirus vaccine, might be moving too fast, to the point that safety might be compromised. The problem with the imperative to develop a vaccine as rapidly as possible in order to halt the pandemic and allow life to go back to more or less normal is so powerful that it can even affect people who should know better, people that I otherwise admire, even. I’m referring to this Tweet that I saw yesterday from Steve Salzberg:

You can see from the Tweet what an irresponsible position Steve Salzberg is advocating. My first reaction was shock, as it seemed that he was advocating bypassing phase 3 trials of a coronavirus vaccine. At least the Tweet certainly seemed to read that way, leading to strong pushback and his backpedaling:

It’s always bad form for a writer to blame his readers when they misconstrue what he says. My personal policy is always first to reread what I wrote and ask myself if the fault lies with me that led people to get the wrong message from something I wrote. It’s a difficult exercise that requires a degree of humility, but it’s necessary. Sometimes I do end up concluding that people are willfully misunderstanding or misrepresenting, but I try really hard not to conclude that until I’ve thoroughly read and reread what I’ve written and asked others if they came to the same conclusion about its meaning as those who seemed to be misinterpreting it.

In fairness, a Tweet is easy to screw up and end up saying what you didn’t mean, and I did read the blog post, We Should Consider Starting Covid-19 Vaccinations Now:

Development of new Covid-19 vaccines is proceeding at a furious pace, which is good news for the world. We already have two vaccines in phase 3 trials in the US and Europe; each of these trials which will vaccinate many thousands of people, and then wait to see how many get infected. If the vaccines work, then in a few months’ time we’ll be able to start large-scale production.

But we don’t have to wait. Both of these vaccines (from Moderna and Oxford University/Astra Zeneca) have already been shown, in phase 1 trials, to be safe and probably effective. That’s why the companies are moving ahead and giving each vaccine to 30,000 more people: they are fairly confident that the vaccines are safe. The NY Times reports that 3 other Covid-19 vaccines are also in phase 3 trials: one from BioNTech and Pfizer, and two from Chinese companies, Sinopharm and Sinova Biotech.

So why not start administering millions of doses right now? We should at least consider the possible benefits–and the costs.

There’s so much wrong here. First of all, phase 1 trials do not show efficacy. That’s not their purpose. They are designed to demonstrate safety, but that doesn’t really tell the whole picture. Basically, phase 1 studies are designed to make sure that there aren’t any gross toxicities, but, as I’ve discussed many times with respect to “right-to-try” laws, most phase 1 studies have few subjects in them. Again, the idea is to find severe, frequent toxicities that might show up in such a small sample. The second purpose of phase 1 trials is to find the best dose to test in a phase 2 clinical trial going forward; this is called dose-finding or dose-escalation. The idea is to give the drug (or vaccine) to a group of people until what are called “dose-limiting toxicities” are reached. In any event, it’s a huge misunderstanding to think that phase 1 trials, particularly of a vaccine, will demonstrate efficacy.

To be fair, Salzberg does seem to partially understand this. (I’ll get to that in a moment.) First, let’s see what his primary argument is:

So the current phase 3 plans for these vaccines work like this: identify a large number of people (30,000 in at least one of the trials) and give half of them the vaccine, and give the other half a placebo. Then wait for a few months and see how many people get Covid-19. If the vaccine is working, then we’ll see that significantly fewer people in the vaccinated group get sick.

Great. We should definitely do this, and we are.

But we’re in the midst of the worst pandemic since 1918. The careful, step-by-step vaccine approval regimen wasn’t designed for a global emergency, in which every day of delay means that thousands of people die.

At this point, it occurred to me that these are exactly the same sorts of arguments used by proponents of so-called “right-to-try” laws and that what Salzberg was proposing over the weekend was, in essence, “right-to-try” for vaccines. What do I mean? Regular readers know that I’ve written about the sham that is “right-to-try” for a long time. Basically, “right-to-try” laws purport to allow patients with terminal illnesses access to experimental therapeutics, as long as the drug or treatment had successfully passed at least one phase 1 trial. (I’ve discussed the fallacy of assuming that passing a phase 1 trial means that a drug is safe more times than I can remember.) Of course, the fallacies behind these laws are many. For one thing, there’s no guarantee that the drug will help, and, indeed, it’s more likely to harm than help in most cases. For another thing, right-to-try laws require the patient to pay. That’s not the case in Salzberg’s proposal, but, as you will see, everything else sounds a lot like right-to-try:

We already know that the vaccines in phase 3 trials are safe–otherwise it would be unethical to give the vaccine to 30,000 people, as these trials are doing. (Note: phase 3 trials sometimes uncover safety issues that affect only a small percentage of people–issues that might not appear in smaller phase 1/2 trials. So phase 3 also assesses safety, on a larger scale.) Weighing the risks versus the benefits, I think we should immediately ramp up production, using government funds rather than private money, and then offer these vaccines for free to anyone who wants them.

Even this argument betrays a misunderstanding of clinical trials, particularly clinical trials for vaccines. Here’s what I mean. The standards for vaccines are very different than those for drugs in terms of safety in that the standard for vaccines is much higher. It has to be, because, in contrast to drugs, which are administered to treat disease, vaccines are administered to huge numbers of people without disease in order to prevent disease. The tolerance for adverse reactions in a vaccine is therefore much lower than it is for drugs, particularly drugs for serious illnesses. What that means is that even a phase 3 clinical trial is only the beginning of safety monitoring. As I’ve described many times before, we have multiple postmarketing safety monitoring systems for vaccines, including one passive (Vaccine Adverse Events Reporting System, or VAERS) and three active surveillance systems, including the Vaccine Safety Datalink, the Post-licensure Rapid Immunization Safety Monitoring System (PRISM), and the Clinical Immunization Safety Assessment (CISA) Project.

Any vaccine developed to combat COVID-19 is likely to be administered to hundreds of millions, if not billions, of people, but lets just say that we administer an unproven vaccine to millions, as Salzberg proposed, while doing a phase 3 clinical trial with 30,000 or so subjects, and let’s imagine that we are doing this concurrently. Basically, this would involve administering millions of doses before we know even the frequency and severity of adverse events found in the phase 3 clinical trial. Does that make any sense? Any clinical trialist would tell you that it doesn’t. The same issue applies to efficacy. A plan like Salzberg’s would involve administering millions of doses of a vaccine to anyone who wanted it before we even knew for sure if the vaccine was effective in preventing COVID-19. Again, phase 1 trials will only find common adverse events. Even phase 2 trials, which involve a few hundred people would find only relatively common adverse events. Less common adverse events don’t show up until the phase 3 trials, and rare advere events might not be detected until postmarketing surveillance. (Accepting the possibility of rare adverse events after a vaccine passes phase 3 is a tradeoff that we accept because it is not practical to do randomized controlled trials of hundreds of thousands or millions of people.)

There’s another issue, though. Giving out millions of doses of a vaccine would render the completion of a concurrent phase 3 trial, for all practical intents and purposes, impossible. Why would anyone enroll and risk getting a placebo when they don’t have to? Why wouldn’t everyone conclude from a program like Salzberg’s that the vaccine must work? No matter how much you tell people that we don’t know if the vaccine works, actions speak far louder than words. If you’re giving away millions of doses of a vaccine to anyone who wants it, the message is that it works.

Here are some more excellent considerations, in particular the likelihood that a vaccine that’s made it through phase 1 and 2 trials will show sufficient efficacy and safety in a phase 3 trial to be approved and the issue of what happens if there are severe adverse reactions in the people not on the clinical trial who get the experimental vaccine:

As mentioned above, there’s also the likelihood of undermining trust in the system we have set up to administer vaccinations. The premature deployment of an unproven vaccine would have a not negligible probability of resulting in adverse reactions that could well seriously undermine trust in vaccines, with consequences that go far beyond just COVID-19.

There’s another wrinkle, as a vaccine researcher named Natalie Dean pointed out in a New York Times editorial:

It is possible that some Covid-19 vaccines may not prevent infection entirely, but they could still prepare a person’s immune system so that, if infected, they would experience milder symptoms, or even none at all. That’s similar to the flu vaccine: It’s not perfect, but we advise people to get it because it reduces intensive care admissions and deaths.

How many people need to be protected by a vaccine before it’s recommended for widespread use? Ideally, rates of disease will be 70 percent lower in vaccinated people than in unvaccinated people. The World Health Organization says a vaccine should be at minimum 50 percent effective, averaged across age groups. (We know from influenza that vaccines don’t always work as well on older adults whose immune systems have declined.)

This benchmark is crucial because a weak vaccine might be worse than no vaccine at all. We do not want people who are only slightly protected to behave as if they are invulnerable, which could exacerbate transmission. It is also costly to roll out a vaccine, diverting attention away from other efforts that we know work, like mask-wearing, and from testing better vaccines.

Also:

There are ways for vaccines to be approved without definitive efficacy data, based on animal or immune response data instead, but the bar is extremely high, and for good reason. A precondition is that efficacy trials are not possible, typically because the disease is so rare or sporadic that it would require hundreds of thousands of participants to be followed for many years to tell if the vaccine is effective (rabies, for example). That is not the situation here.

These examples are extreme exceptions, not the rule.

Basically, Salzberg, whose work I’ve long admired, allowed the need for a vaccine against COVID-19 to lead him to propose a solution that would be risky at best and actively harmful at worst. He essentially assumed the best case scenario, namely that the vaccines under testing will be effective and safe, based on phase 1 and 2 studies. Indeed, he explicitly said this while defending his post on Twitter:

As anyone who’s ever been involved in drug or vaccine development knows, that’s likely a bad bet, one you’re more likely to lose than win. Sure, we could do what Salzberg says and find out that we’ve guessed right. That would be fantastic—and fairly unlikely. More likely, such a plan would result in adverse reactions in the “right-to-try” group that result in the degradation of trust in vaccines, all while making it very difficult, if not impossible, to actually complete the phase 3 trial needed to properly assess efficacy and safety. It could even result in more, not less, deaths from COVID-19 and other infectious diseases.

Now here’s the part that warmed the cockles of my heart. Salzberg heard the criticism, and he changed his mind, admitting he was mistaken:

The admission:

In my previous post, I suggested that while we’re pursuing Phase 3 testing of several promising Covid-19 vaccines, we could simultaneously offer those same, unapproved vaccines to a wider community of volunteers, as long as those volunteers were fully informed. The benefits of moving quickly, I argued, would outweigh the risks.

I was wrong. After reading many of the responses to my article, some of them outlining the risks in greater detail, I have concluded that (1) the risks are greater than I presented them, and (2) the benefits are not as great as I had thought.

There are two things we can learn from this incident. First, our bias is to assume that best and that speed in developing a vaccine will necessarily save more lives. Second, and perhaps more important, we learned the value of humility, of quickly admitting error when we make one. Doing so is very, very difficult, and most of us have a hard time doing it.

Also, desperate times call for desperate measures:

That’s right, desperate times call for science-based medicine. And the humility to admit when we are wrong and move on.

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]

115 replies on “Should we bypass phase 3 trials of a COVID-19 vaccine?”

Dear Sir, I must humbly point out that you are mistaken about the history, mechanics, and scientific rationale of pre-market clinical use of investigational medicines. First, widespread clinical use of an investigational SARS-COV2 vaccine would not come via Right To Try (a poorly-informed initiative that recently sashayed into a domain that was already well served by Expanded Access and -in some cases- the Emergency Use Authorization). For an immediately life-threatening condition or risk factor, Expanded Access to an investigational therapeutic, diagnostic, or vaccine can generally begin prior to pivotal trial and has been permitted by FDA for more than 30 years. Second, Expanded Access programs (EAPs) have provided treatment options to over a quarter million people who could not take part in research trials of the particular products. Most importantly, and contrary to popular lore, no true Expanded Access program has EVER impeded the enrollment of the particular product’s research trials. Read that again: Not ONCE has it happened, despite the number of times you’ve heard the old narrative of early access competing with research trials for subjects. (Before citing the AZT program in AIDS, know that that treatment program began in 1986 -a year before before Expanded Access regulations were promulgated- and was not a true EAP.) The reasons are simple (A) FDA does not authorize EAPs that could compete with research trials for enrollment or other resources and (B) sponsors are generally not motivated to allow EAPs to compete with their research trials. Expanded Access programs are simply not for the patients who are candidates for research trials. This is managed through inclusion/exclusion criteria that differentiate the very few in the geographic and circumstantial catchment of an enrolling study from the very many who are outside the catchment of the study but are still medically suited for exploratory treatment. History has shown that well designed, large-scale Expanded Access programs can identify responder phenotypes, validate findings of small research trials with real world use, and generally help -not hinder- a new product’s clinical development while bringing treatment options to populations in need. Integrating large-scale access programs in the overall clinical development process is a smarter, more humane, and more efficient way for our clinical trial enterprise to engage our healthcare system. It’s a 33 year old solution, created by Tony Fauci and Frank Young whose recognition is long overdue. For a skeptical scientist, you exhibited quite a few wives tales in your post today. Just as you praised Mr. Salzberg for admitting he was wrong, I will look forward to seeing your self-correction in your next blog. -Jess Rabourn

What Salzberg was proposing was NOT Expanded Access (more colloquially called compassionate use), as you should well know given your description of the program. In addition, the examples of AIDS, cancer drugs, etc. are not comparable because, as you point out, there were criteria and there was regulation. Moreover, the number of patients who have accessed (and access) Expanded Access programs is minuscule compared to what Salzberg proposed in his post, which was nothing less than ramping up production of millions of doses of an unproven vaccine BEFORE the phase 3 clinical trials are completed and letting basically anyone who wants the vaccines to have them—for free. Seriously, these are rather obvious differences. Expanded Access programs are nothing like this. You tout that EAPs have provided treatments to a quarter of a million people. That’s great! It really is! But how long have they existed? Since the 1990s? That’s a quarter of a million people over almost three decades. What Salzberg is proposing is MILLIONS of people over months, all subsidized by the government.

I Googled you and notice that you are affiliated with a group that runs and advocates for pragmatic expanded access trials:

https://www.linkedin.com/in/jess-rabourn-cfa-3a5a3616/
https://widetrial.com

Nothing wrong with that, although it is relevant information that you didn’t mention. Moreover, there’s nothing on the site that I saw that is anything like what Salzberg proposed.

As for “right-to-try,” that was an analogy. Of course, Salzberg wasn’t actually literally proposing a”right-to-try” for a vaccine, but, when you look at what he’s proposing, it bears a lot of the hallmarks of right-to-try. The difference is that, unlike the case for actual right-to-try laws, his would not be for a specific indication, nor would it be for only patients with life-threatening or terminal diseases. I’ve been writing about right-to-try laws since they first reared their ugly head six years ago; so I’m quite familiar with what they are, the deceptions behind them, etc.:

https://respectfulinsolence.com/tag/right-to-try/

No, I don’t think there are any significant errors I need to correct.

There has to be a difference between an emergency use authorisation or other fast track use of a treatment for an existing disease to a vaccine administered to an otherwise healthy person.

If I was dying of some disease and there was an experimental treatment, I would jump at it (provided there was some decent data on efficacy). A vaccine for a disease that I have a maybe 99% chance of surviving (and have a decent chance of not getting at all if I am sensible) – No thanks, I will wait for the Phase 3 results. THEN, I will stand in line to get it ASAP.

There are multiple problems. The main one is that the author is clearly deficient in knowledge to propose such a solution in a public forum and influential magazine such as Forbes.
By passing stage 3 is an incredibly bad idea. Demonstrating clinical efficacy of a vaccine requires 4 conditions: safety, induces immunity, the immunity needs to be protective, and side effects are less severe than the disease.

An assumed but rarely stated requirement for widespread vaccination is that the entire population is at risk for severe disease or death. This is clearly not the case with COVID-19. The at risk groups are clearly defined. There are a few individuals who succumb to the virus and do not fit within the defined high risk groups (but this is true of all pathogens). The flu is an excellent model. Despite widespread vaccination, there are still fatalities to the flu. The difference between the flu and COVID-19 is that the entire population is at risk (albeit some risk is mediated by previous exposure to the flu and prior vaccinations). Like COVID-19, many who succumb to the flu are older (above the age of 65), have diabetes type 2, are obese and have hypertension.

These hurdles are high for COVID-19. Most people are asymptomatic or minimally or mildly symptomatic and are only detected due to testing, either voluntarily or when they seek medical care for an unrelated condition. Some people develop moderate symptoms and actively seek medical care. And a small percentage require hospitalization and intensive care. Widespread testing has proven this beyond a doubt.

Testing the efficacy of a vaccine wen about 80% of the population already has evidence of some degree of immunity due to cross reacting T cells is a hurdle unique to COVID-19.

The vaccines are not without side effects. About 1/3 of recipients develop transient flu like symptoms, fevers, arthralgias or myalgias. Some side effects may not be known for a long time. Vaccine producers are very concerned about this and are requesting legislative immunity against liability. The swine flu vaccine appeared to be safe but resulted in an epidemic of Guillain-Barre (low in absolute numbers but high in relative incidence). Wide spread use of polio vaccines had led to the emergence of a new strain (vaccine derived polio virus).

In order to bypass some problems with developing vaccines against COVID-19 (high incidence of possible autoimmunity and accessible target for immune attack) highly innovative techniques using adeno-virus vectors are employed. It’s not clear if there is any long-term danger to these methods, as the material is being inserted into the genome.

What is the best lesson? Write about what you know.

“The at risk groups are clearly defined.”
What world are you living in? Here’s the current statement for people with Alpha 1. This is current as of July 31, 2020.

We currently don’t know whether healthy Alphas are at greater risk of complication and long-term health issues if they have COVID-19. There is reason to believe that lung damage, if it occurs in an individual with Alpha-1 will likely be worse, but this has not been studied.

“What is the best lesson? Write about what you know.”

Clearly you don’t know anything about T cells, then. Goodness, I spent like three very long posts explaining to Tim how T-cells work and why we would expect that a lot of people would have at least a few naive T cells floating around that would respond to a COVID-19 antigen. That’s how T-cells work.

You have to already have a T-cell receptor that responds to an antigen before you get infected with the pathogen that makes that antigen in order to get a T cell response. After you get infected, then you make more T cells with that specific TCR, and if you survive the infection you probably (no guarantee) make memory T cells with that TCR.

So, no, it is not a hurdle at all to testing any COVID-19 vaccine. In case you haven’t noticed, researchers are looking for antibodies, not T-cells.

Look, I get that immunology is very, very complicated and hard to understand. That’s why immunologists tend to specialize in one specific part of the immune system. But just because it is complicated and difficult doesn’t give any of us an excuse to make things up.

What is the best lesson? Write about what you know.

I’m sure you could find some pathology blog somewhere to natter away.

An assumed but rarely stated requirement for widespread vaccination is that the entire population is at risk for severe disease or death.

Really? No that is complete bulldust. Otherwise we would never have bothered with a vaccine for rubella. Ribella after all is only a serious disease for unborn babies.

Chris is correct: assuming a requirement for widespread vaccination is “the entire population has to be at risk for severe disease or death” is bulldust.

Rubella, which causes congenital rubella syndrome (CRS), is an excellent example: the burden of severe illness is congenital birth defects (~20,000 cases/yr pre-vaccine), although the majority of the pre-vaccine incidence (~12 million cases/yr) was in young children and a generally mild illness. So entire birth cohorts of girls and boys are vaccinated: girls are protected from subsequent CRS when they mature because vaccine immunity is long-lasting, and boys are vaccinated to reduce transmission and achieve herd immunity. Unsurprisingly, when this policy of broad vaccination to protect a smaller high-risk group is adopted in different countries the results are predictable when herd immunity is achieved (https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5940a4.htm).

Conversely, there are no examples of just vaccinating or screening pregnant women, because it isn’t nearly as effective as vaccinating more broadly. Unfortunately, at least one high income country doesn’t get this concept as per Dr Vince (https://vaxopedia.org/2019/03/20/japans-rubella-outbreak-should-be-a-warning-about-what-could-happen-here/).

OK, how about the polio vaccine, then? In most people polio is just a GI disease and no big deal. Except when it becomes paralytic. Or fatal.
So even though most people will not die or be disabled by polio, we still vaccinate against it.

In adult women Rubella can cause Chronic Joint Pain. And Men can enjoy Severe Testicle Pain.

Up to 70% of Adult Women who get Rubella will develop Chronic Arthritis. In rare instances, there is Brain bleeding or inflammation, or Liver damage.

https://www.cdc.gov/rubella/about/complications.html

When I was a kid they did not prevent children from getting rubella from a playing with each other, it was much, much safer than getting it as an adult.

It is not a dangerous disease at all, if you are a child. Only pregnant women who never had Rubella and their fetuses are at risk.

In the 1964-1965 Rubella epidemic 12.5 million people were affected, with less than 50,000 fetuses affected, due to most women being immune from having had the virus as a child already. Rubella came in regular 6 to 9 year cycles, making it easy to expose cchildrenand eliminate the danger of birth defects in fetuses and Chronic Arthritis in adult women.

https://rarediseases.org/rare-diseases/rubella/

It is not a dangerous disease at all, if you are a child. Only pregnant women who never had Rubella and their fetuses are at risk.

And if a child happened toget rubella and pass it on to a pregnant woman? Is that then a case of “sucks to be you”? Oh, and keep in mind that a woman could be pregnant and several months along without realising it.
We chose mass vaccination because the risks of the vaccine were far lower than pregnant women catching rubella.

@Julian Frost

If you bother reading you would know Rubella is dangerous to the fetus only during the first Trimester when the nervous system of the fetus is developing, not later.

If each child in America was infected with “wild-type” Rubella, no woman would have to fear developing Chronic Arthritis or having a disabled child, remember even the CDC says Rubella is a mild disease.

We decided to vaccinate against Rubella which is a “mild disease”, remember according to the CDC it is mild, because the government became obsessed with the idea of eliminating all infectious disease. They worked for years trying to eliminate the common cold without success.

The idea was to increase productivity by eliminating lost man-hours from sickness. That is why the government invested in supporting vaccines and made vaccines litigation-free. Do you really believe the government is altruistic in any way? No, it was to support industry and production, to increase the GNP (Gross National Product) numbers. I have a Sociology degree in addition to a Respiratory Therapy degree, plus two more, and we covered this exact topic in college

If each child in America was infected with “wild-type” Rubella, no woman would have to fear developing Chronic Arthritis or having a disabled child…

As I pointed out above:

And if a child happened to get rubella and pass it on to a pregnant woman?

We decided to vaccinate against Rubella which is a “mild disease”…

That “mild disease” caused literally thousands of miscarriages and birth defects every year. I am fed up with privileged antivaxxers denying the reality of the harms caused by vaccine preventable diseases.

[T]he government invested in supporting vaccines and made vaccines litigation-free…

You can still sue manufacturers for faults in the manufacturing process.

I am bored with your constant spouting of antivaxx falsities.

@Julian Frost

It was the CDC itself that calls Rubella “a mild disease”.

https://www.cdc.gov/rubella/index.html

As I said if each child was infected with “wild-type” Rubella, they would be immune for the rest of their life, but doing that would be too easy and make no money for the vaccine manufacturers who need multiple return visits for “boosters” to stay super profitable.

Wow, I can sue for faults in manufacturing, really helpful in cases of toxins causing deaths and neurological and other damage. Not.

All they need to do is make vaccines a one-time vaccine without toxins, like the old Small Pox vaccine was, then I will shut up about vaccines.

Until then I will keep at it, either make vaccines safe with toxic materials and as effective in making antibodies as getting the real disease, or I will not go away. I love playing the harp.

We need Phase 3 trials to happen. I am happy to wait for them to be completed. Even if that means I have to stay in our light lockdown until it happens (I haven’t been to the pub or eaten out in 4 months and haven’t seen the airport since March).

What I would be concerned about is that the delivery of a potential vaccine in the US might become massively politicised. It seems that might be the last throw of the dice for Donald Trump. It is clear that his claim that “We’re lower than the World” is not going to resonate with voters. He is likely to try and overide the FDA and foist a dangerous vaccine on the US public if he thinks it will gain him votes.

You’re so right.
Haven’t seen my friends for more than 7 months, not only because of Covid-19, but also thanks to other things.
I’m glad my dad returned home from his stay in a rehabilitation centre, before they went in a lockdown.
I will happy live with our very light lockdown till phase 3 studies for a vaccine have been completed. I rather have a vaccine that is accepted, than a vaccine that would undermine trust in vaccines. (I know, ant-vaxxers will never accept any vaccine, but this is more about the people who will accept vaccins, but will loose their trust if a vaccine has to be pulled, because it doesn’t work as good as expected or has some nasty side-effects.)

@ Christopher Hickie
Very interesting.
Perhaps a must read for those who consider all forms of vaccination as being un-natural.

@ Renate:

I can also tolerate restrictions.
Right now, several areas are experiencing upticks ( here, Rt
0.70 to 1.00 to 1.47) probably because people had house parties or holiday celebrations it is said. So locally, they are limiting the number of participants at indoor events to 25 ( it may have been 100).( I saw a doctor from Berkeley yelling on television about working with ICU patients whilst people were cavalierly spreading the virus at bars, parties, beaches).Other areas report similar changes and shut down indoor dining or bars. It’s very easy to see what activities lead to these changes.

-btw- I can identify with you helping your father: I did the same and he lived to a really advanced age; mostly he did quite well until the last 3 or 4 months. Over his last 10 years, I tried to protect him from colds, flu or other respiratory illness because he had heart arrhythmias and then, heart failure ( controlled through meds) so I made sure he got flu and pneumonia vaccines and I got flu shots as well. He NEVER had a cold or flu at all. That’s why I get angry when I hear anti-vaxxers discourage flu/ pneumonia vaccines for adults: they protect the elderly and people with serious conditions like hiv/aids or reduced immunity due to cancer treatment or other causes. So I didn’t fear every time i brought him to his doctors and the waiting rom was filled with other elderly folk or he went shopping, to a restaurant or visited a relative’s business..

@ Denise
I think my dad sees more people than I do. I do his shopping, take care of his meals, except breakfast and help him with his medicines. Yesterday I clipped his nails, which is really something, one need a lot of force for. I jokingly said I needed something used to clip the hooves of a horse.
But he is doing quite well.
We have very light rules, but still some people are protesting against the rules that we are having at this moment, stating we live in some kind of dictatorship. I should advice those people to move to China, or North Korea, or some other country, which really could be considered a dictatorship.

So locally, they are limiting the number of participants at indoor events to 25

Our limit for private events has just gone down to 10. We do only have 9 active cases in the state. However, there are about 7000 active cases just to the east and that has resulted in over 100 deaths in a couple of weeks. Many of those deaths have been elderly people in nursing homes, resulting from staff bringing the disease in from the community.

Yesterday I clipped his nails, which is really something, one need a lot of force for.

Isn’t there such a scene in My Beautiful Laundrette?

@ Renate

How do you vax an ant?

With a tiny stainless steel pin dunked in a solution of bacteria (or virus).
(like one of these: https://www.finescience.de/en-GB/Products/Pins-Holders/Minutien-Pins/Minutien-Pins)

I’m not joking. It’s how some scientists “challenge” an arthropod in order to study its innate immune response.
Poke it through the cuticle, and then watch (by omics techniques) as specific molecular pathways are lighting up, depending and the pathogen’s nature.
Yes, magnifying glasses and tweezers are required.
And yes, while the answer is not very specific and short-lived, individuals primed by an infection are better resistant to another exposure shortly after the first. Sometimes, some protection seems even to be transmitted to the individual’s offspring (it’s usually called trans-generational immune priming).

@Renate

I am positive the ants did not add any Aluminium or Mercury, or any other chemicals, to their vaccination. 🙂

@Denice Walter

The study results saying the flu and pneumonia vaccines reduce Acute MI are questionable……

https://www.cidrap.umn.edu/news-perspective/2010/09/study-flu-shots-and-heart-attack-risk-questioned

Personally, I have had only one flu shot in my life back in 1986, and it made me sick as a dog, so I never had another. Despite decades working in hospitals I only had the flu two times in my life, once back in 1973 when I was in college and then once in 2014 when a woman turned and coughed directly into my face…I felt the droplets hit my eyeballs. That last one put me in the hospital for 5 days, so now during flu season I avoid anyone who has the slightest sign of illness like the plague.

It may have helped me avoid the flu once I learned back in 1974, when in school for Respiratory Therapy, to never touch my face unless I had just carefully washed my hands thoroughly, to avoid infecting myself with any bacteria, cold or flu virus. It helps now that most stores have cart wipes, as shopping carts are filthy reservoirs of bacteria and viruses.

For the last several days, I’ve been hearing about the Russian vaccine/ vaccines being rushed to regulatory approval ( Reuters, Business Insider, Newsweek, etc) supposedly, scientists injected themselves ( or the military) in order to speed up the process so that it will be available to medical workers by October and to millions soon thereafter. They called it a “Sputnik moment”. They were first.

So another twist of fate for the Donald: Russia is somehow involved and he winds up looking worse..

I’m as pro-vax as they come and I can’t imagine taking that rushed Russian vaccine…

Even if they did ‘phase 3’ tests on the entire military and got a lot of ns, how representative is that population of the population at large, and how much time did they give for AEs/infections to show?

I sure don’t want the one they’re rolling out to the Chinese military either, but that’s because I have some very strong opinions about adenoviurs-based vaccines (I hates them, they’re dumb).

For the last several days, I’ve been hearing about the Russian vaccine/ vaccines being rushed to regulatory approval

All of those sources are US sources and, in term of reporting on Russia, have the same level of credibility as Mercola or Kennedy on vaccines.

On the other hand, if you want to terrify yourself about Russian progress read the first two or three paragraphs or so of this RT article. How did Russia get a possible Covid-19 vaccine so fast?.

Once I stopped hyperventilating, and started rereading, I realized the reporter was basically clueless about the topic, not that Dr Tarasov, head of Sechenov University’s Institute for Translational Medicine and Biotechnology was a mad scientist.

It looks like Sechenov University has a candidate that just successfully finished Phase I and is ready to move into Phase II, as several others around the world are.

There is also a rumour out there somewhere that senior Russian Gov’t officials got early vaccinations in April but I cannot remember where I read it. Heck, I don’t think Trump is that stupid—well maybe not.

The military fairy tale may have come from a report, approximately a month ago, that members of the Peoples Liberation in China were receiving vaccinations. It sounded like a Phase II study.

Some of these stories, like the vaccine espionage done by the Chinese Consulate in Houston are probably pep work so if China or Russia do deliver an effective vaccine before the USA does, the Gov’t and possibly some pharma companies can proclaim “we was robbed”to the US public and in the case of pharma to some aggrieved shareholders.

I also want to bring up the equipoise issue. Right now, we know that masks and social distancing are effective prevention measures when broadly adopted. Until a vaccine has been proven to be safe and effective via Phase 3 trials, we can’t recommend them over current standard of care, yeah?

Because there is a standard of care for prevention, and it sucks, but it works. (And not a penny goes to Big Pharma! Why aren’t the alties all over masks and distancing? Oh – because they don’t profit off of them either.)

Is there any good (accessible) source that has some examples of vaccine development timelines laid out in enough detail to get a clear view of what really happened? I’m thinking particularly of time spent from saying “Go!” to having a concept of what direction the project will take, delays that so often occur with funding, U-turns due to “failures” at any point – all the stuff that makes the time go by in both productive work and delays not due to scientific issues.

The antivaxx crowd keep saying how a safe vaccine take 5 or 10 years and any lesser time surely means the vaccine will be unsafe – not of course that any amount of time will satisfy them. I realized that though I have a general idea of what must be done, I don’t really have a clear notion of what usually eats all the time. I don’t even have a clear idea of how long a typical phase 3 trial of a vaccine takes.

o,dpttu. fpih. I need help.

Enjoy:

opps, I forgptg tjet=0- notg that it matters, dough.

I’m a troll, I d’spm want utp se domte;;ogemt cpmemts mew/

Is there any good (accessible) source that has some examples of vaccine development timelines laid out in enough detail to get a clear view of what really happened?

This I doubt is what you’re looking for, but it’s the best I’ve found so far. The HiB section is perhaps the most detailed.

Moose- I am still not clear about this. I understand the reason for the rubella vaccine for boys and the lack of any direct risk to them personally or their unborn children!.Are you suggesting that all girls are not at a similar risk of harm to their potentially future unborn child because only a small number of them will eventually produce children with CRS?.It seems to me that the risk is equal and relevant to all unvaccinated girls’ offspring at reproduction age.hence the widespread vaccination.Is it known prior to vaccination or infection which babies will only have mild symptoms? Can the risks be apportioned quantitatively to different groups of girls in the population? Any biomarkers?
How widespread is the vaccination for meningococcal or HPV? Is it being suggested that because of the infrequency of these infections, with their serious consequences, that most of those being vaccinated , on say a wide scale, are not at risk prior to the vaccination? I understand that statistically a mathematical number could be apportioned to the level of risk but regardless of the variations depending on the organism and the individual those who work in the field consider it a worthwhile enterprise.

In other Covid 19 news…

I report it because it may be some kind of a record:
(PRN) the hoary old woo-meister “informs” us in just under 5 minutes! ( at 20- 25 minutes in) that 1. a Professor from YALE, Dr Risch ( mispronounced) had simple ,cheap treatments for Covid-19 but is being suppressed by Fauci, Gates et al, 2. a peer reviewed study showed that kids don’t transmit the virus well ( so open those schools NOW!) and 3. a peer reviewed study showed that cloth face masks have no effect on controlling the virus and may even do harm! The taped show will be available on PRN in a few hours.

He and other mis-informers ( Adams, Bigtree) are being “censored” by You Tube, FaceBook, etc. I wonder why?
Null purports: “cancel culture” cancels out “:good health information” like his because he tells the Truth! Wikipedia is a plot against people like him.

It SHOULD be, I say.

Fair enough criticism, Dr. Orac. I was on the receiving end of all of these critiques and many more for about 24 hours, hence my reversal. It’s is frustrating, though, that we have to wait, in phase 3, to see who gets infected in their normal course of life. Some have argued for “challenge trials” to speed that up, but I’ve had enough controversy ;). Still, the phase 1/2/3 system can’t be the only scientifically sound one; it’s just that we don’t yet have an alternative.

Dr. Salzberg, we DO have an alternative. And that alternative is modern large-cohort Expanded Access. The regulatory channel for authorized EA programs were created to provide every seriously ill patient and his/her physician the opportunity to explore a suitable investigational-stage medicines when they cannot participate in the research studies of the particular product. These are technically “treatment-use” clinical trials, and they can be very large; much larger than the large-cohort examples during the AIDS crisis and in the early 2000’s when new receptor-inhibitor drugs were availed to stage 4 cancer patients who could not meet research trial enrollment criteria. It’s true that the regulations were not written for vaccines or prophylactic treatments in healthy patients; but such use is a clear extension of the original spirit of Expanded Access if we consider RISK FACTOR as a health condition. In fact FDA has done exactly this, with past authorizations of at least two large-scale vaccine Expanded Access programs in the United States. For groups with high SARS-COV2 exposure risk (such as pulmonary ICU staffers, nursing home staffers, first responders, etc.) and people expected to be more prone to severe infection-related complications, I doubt the notion of equipoise holds all the way to market approval of a promising vaccine. A red line could be drawn for the degree of clinical evidence required for Expanded Access in these groups, just as it has been drawn for the degree of evidence required for therapeutics for unmet medical needs. For the record, I am in the business of advising life science and Federal policy makers on this topic. But contrary to the implication of Dr. Orac’s note about my work, it’s hardly a conflict of interest. I have launched projects to improve the integration of healthcare and research out of a deep personal commitment to this area of public welfare; not the other way around. Occasionally someone simply sees a problem and devotes a serious part of his life to solving that problem.

Orac didn’t describe you as having a conflict of interest, rather he had to Google you to discover the self-evident zeal for Expanded Access. It would have been conveniently transparent if you would have simply outlined, as you now did above, that “I am in the business of advising life science and Federal policy makers on this topic.” Clearly you don’t consider the possibility of a conflict, though it may explain a certain narrowness in thinking.

In your original post above you claim that “no true Expanded Access program has EVER impeded the enrollment of the particular product’s research trials”. It seems that that is not true for the closely related Emergency Use Authorization, which is clearly interfering with recruiting for trials that include control groups while attempting to accurately demonstrate the point estimate of efficacy due to convalescent plasma (https://www.nytimes.com/2020/08/04/health/trump-plasma.html?surface=home-discovery-vi-prg&fellback=false&req_id=536202708&algo=identity&imp_id=490477730&action=click&module=Science%20%20Technology&pgtype=Homepage). For clinicians that, like you, have “a deep personal commitment”, the difference between Expanded Access and Emergency Use Authorization, both of which lack control groups, is just weasel-wording.

To resolve any confusion, Expanded Access Programs acknowledge the product is still very much investigational, and -not surprisingly- they are intended to be considered earlier in the clinical development process than when an EUA might be considered. Therefore there are strict regulatory and practice guidelines to ensure that they do not enroll patients who could otherwise participate in the product’s research trials. In contrast, an EUA is a virtual (and temporary) market authorization with no data collection requirements, no safety reporting, no protocol submission, and -as you have discovered- no requirements to avoid impeding clinical research trials. So, in fact, EAP and EUA have night-and-day differences with respect to their relationship with ongoing clinical research. I hope this helps you. I believe most would call it clarity, not weasel wording!

“testing the theory that the treatment might work best earlier in the infection.”

Well, duhh. The idea is to get that initial boost to give one more time to ‘ramp up’ their own. But one’s body must recognize the infection first before it is given.

I’m biased; this is my pet favorite — I’d like Trump and Pence to roll up their sleeves and pull down their socks to show those destroyed Herculean veins as proof of concept for why the cavalier attitudes.

also, https://www.nytimes.com./2020/08/04/health/trump-plasma.html

@salzberg1

Personally, I would not take a COVID-19 vaccine even if it were toxin-free……

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0035421

They never made a SARS vaccine, or a MERS vaccine, because every version had terrible negative effects when the vaccinated animals were exposed to the real SARS or MERS virus after full vaccination.

I cringe to think of those thousands of people who signed up for getting the COVID-19 vaccinations, both vaccinated and placebo are going to be exposed to real COVID-19 to see if there is a difference between getting the vaccine and not, in infection rates. The placebo group may be better off, if the COVID-19 vaccine group experiences anything like what happened with the SARS vaccine.

Thanks for reconsidering your position.

What I would find beyond frustrating is jumping the gun on wide-scale administration of a vaccine candidate, only to find that its effectiveness and/or safety profile was substandard, leading large numbers of people to avoid any Covid-19 vaccine and greatly prolong the pandemic. Worse – a scenario in which antivaxers gleefully fan the flames, leading to refusal of other vaccines and a major comeback in vaccine-preventable diseases.

Wonder if there will be “vaccine tourism”, where impatient Americans go abroad to load up on rushed-to-market vaccine(s) available out of places like Russia and China. Include me out.

I’ve also seen the opposite, where people in developing countries are afraid that they will have the leftover vials of an ineffective vaccine dumped on them. (I was asked this straight up by my aunt who lives in Guatemala, who is afraid they’ll just get the broken leftovers and not a real vaccine.)

I don’t think it’s likely, because 1) it would be plain criminal, 2) it would be plain cruel even beyond the usual bounds of evil business people and 3) it would get found out in a heartbeat because just because a country is still developing doesn’t mean people there don’t have the internet and couldn’t get the word out, which would annihilate a company’s reputation.

@ JustaTech – Your aunt sounds like a smart lady and has cause to be concerned.

“Beginning in 1946, the United States government immorally and unethically—and, arguably, illegally—engaged in research experiments in which more than 5000 uninformed and unconsenting Guatemalan people were intentionally infected with bacteria that cause sexually transmitted diseases. Many have been left untreated to the present day.”

The last sentence…many have been left untreated to the present day. So the spread of infection continues? Little if anything has been done to compensate the victims and their families. But hey, maybe it will be different with Covid?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828982/

Everyone knows about the despicable syphilis infections in Guatemala.

But that has nothing to do with pharma companies.

And Guatemala was doing pretty well controlling COVID, mostly by imposing curfews and lockdowns that would shock most people. And you know what? The citizens mostly agreed to it, because they know they don’t have enough hospitals.

And I totally fail to see the connection between the deliberate infection of people by a government and a pandemic. COVID-19 has been getting around fine without anyone’s help.

What is your point?

Another post that is floundering, and it’s actually a pretty interesting topic; let me see if I can spice things up a bit.

<

blockquote>
What I would find beyond frustrating is jumping the gun on wide-scale administration of a vaccine candidate, only to find that its effectiveness and/or safety profile was substandard
<//blockquote>

But Dangerous One, waiting too long for a ‘safe and effective/ vaccine could also be costly. What if — God forbids!– the pandemic sorts itself out on its own, or people get used to living with it? People might start questioning whether vaccines are really the great ‘salvation’ that they’re being pegged as. Perhaps they may even start asking — why are we kicking unvaxx kids out of school for, again?

Sure hordes of geriatrics keeling over after their second booster did not take and they needed a third Covid shot will likely not go over well with the public. I suppose you guys could do what you always do and dismiss such cases as ‘crazy’ antivaxx accusations, but with the entire world watching this time around. it may not be such an easy feat to pull off. Still, as explained, waiting too long will also not bode well for vaccine confidence.

Indeed the pandemic is proving to be a hell of a referendum on vaccines. I can understand why some of you are nervous.

Let me speak on behalf of the Virus

Well played, but I don’t think you were around for his original, protracted round of bad-faith, but occasionally hilariously inept, trolling. This might be the nidus of the “person-years” debacle, but there may be a yet earlier thread.

@ Narad

Well, I must say I do have some kind of “sympathy” for his original round of trolling, as I honestly do not know how to “talk” to doctors on serious matters. Being honest is no good. Being agressive is no good. Being “soothing” is no good either. In fact, when serious shit occurs, there are no communication channels available, and in my case it seems that fists are considered legitimate arguments by the medical community to cower patients into shame/”compliance”. (You know where I’m coming from, and I still cannot get over it.)

But, yes, that thread is hilarious nonetheless.

Is it the same Greg/Gerg that was banned some time ago on “rape apology charges” comparing vaccines to rape?

<

blockquote>Is it the same Greg/Gerg that was banned some time ago on “rape apology charges” comparing vaccines to rape?

Oh, now I remember. It was banned for for obnoxiously demanding to be banned. Four times, if I recall correctly. It might be possible to reasonably assign a 10 log (Gerg∕RIgulars) “gergibel” value to any given thread.

^ The subplot in which he is backed into a corner about being Canadian is something that I will always treasure.

@Narad

Indeed i was wondering how long it would take you to notice my return. Obviously, not long! Indeed I have a crush.

Sorry, stupid tiny logitech keyboard ate my post.

Trump must go, but Biden is a turd. We can only hope he picks a good running mate and then promptly dies {he did sound pretty presidential dressing down trump on coronavirus, so there is that}. Could have been Cory Booker, Andrew Yang, or Pete Buttigieg but, no, greasiest turd that kinda floats. Way to go, DNC; Same as it ever was.

His 1994/5 omnibus crime bill and hang’em’high attitude towards cannabis (a position he has not modified) stood up and stuffed privatized prisons to the brim. I do not like this man.

Kayne 2020! (not really, that guy is ‘tarded)
https://youtu.be/aaw9SAu8-Ac?t=1

@ JustaTech – “While Guatemalans continue to suffer the harmful effects of experiments conducted 70 years ago, the country still serves as a laboratory for the global pharmaceutical industry. Although these days the National Institutes of Health (NIH) and multinational pharmaceutical corporations require that researchers demonstrate their compliance with international regulations by using consent forms in human-subject experiments, local physicians say that ethical problems persist in research practices and the number of clinical trials continues to grow.”

https://nacla.org/news/2016/08/15/experimenting-guatemala

You have a point; Somali immigrants to the U.S. were prime targets for Andrew Wakefield’s antivax preachings.

Apologies if anyone thought I was comparing Guatemalans and southern Californians when it comes to attitudes on vaccination. Guatemalans are far more sensible.

Oh please. Just because someone hasn’t had a chance at a formal education doesn’t mean they’re stupid. Guatemala is doing a pretty good job against COVID, given their lack of resources. And they’re perfectly capable of seeing the benefits of vaccination with their own eyes.

Also, they’re not all impoverished, uneducated, malnourished or easy targets. There are plenty of smart people in and from Guatemala. And I’m not even going to bother trying to explain the difference between the indigenous Guatemalans and the Hispanic (from Spain) Guatemalans.

@Tim

What else is new in the crazy world of COVID-19 vaccines? They could not make a SARS or MERS vaccine, because the vaccinated animals had worse outcomes than the unvaccinated animals when the challenge tests were done.

Now NIAID says they still have to determine if it were safe to run challenge tests on the vaccines. While David Diemert, who is running one of the vaccine program trials in Washington DC for Moderna, is saying why bother, that there is enough community transmission going on that challenge trials are not needed??????

What does it matter, how much damage the vaccine does, as long as the companies get the billions of dollars for the research and vaccine.

It is only 30,000 human beings who volunteered to be guinea pigs, so what if they get harmed, they signed away their tights when they volunteered. I hope they have good life insurance.

With what agency did they sign? I would like to hack their mailing list and arrange a finger-food party with these ‘tightless’ persons.

There used to be a saying in caving: “when the ‘mights come up, the ‘tights come down”. I was rarely, if ever, invited to such spelunking festivities.

“What else is new in the crazy world of COVID-19 vaccines?”

I’m actually pretty stoked about the Moderna mRNA approach; Though I’m not so keen to be an ‘early adopter’ as I was with betamax, Ronco inside the egg shell egg scrambler, Furby, …, or Flex Seal.

They could not make a SARS or MERS vaccine, because the vaccinated animals had worse outcomes than the unvaccinated animals when the challenge tests were done.

This is some powerful stupid, aside from predictably lacking any citations. MERS-CoV didn’t spontaneously arise in camels, and there are too many camels to hope to vaccinate them all, were there a vaccine. (Are there camels in South Korea?) You vaccinate the people after the usual trials. I’ll cop to going no further than this, but I have more pressing concerns.

Don”t you just love “smart”phones, I typed “rights” not tights, but it makes for a good laugh.

FlexSeal, really??!!??#!!!

Did you cut you boat in half and put it back together with FlexSeal, and did it float? 🙂

At least the Furby makes a passable baby present.

@Tim:

“when the ‘mights come up, the ‘tights come down”.

On the off chance that you’re not being sarcastic, that’s the mnemonic to distinguish stalagmites from stalactites. The former rise from the floor, the latter descend from the ceiling.

Ohh. That is a useful mnemonic, thx. Or — the ones hanging on the ceiling must hang on right while the ones on the floor might grow up. — Now if only I could remember what a ‘dripstone column’ was…

“At least the Furby makes a passable baby present.”

“It licks and it wiggles!”, said a passing flame I gifted one… And she was never seen nor heard from again.

Ahh, I see. I hadn’t, uh, correctly divined your attitude toward your babies.

@Narad

“You vaccinate the people ” and “there are too many camels to hope to vaccinate them all”…… Really, I wonder why we vaccinate animals against Rabies but not people in that case.

As for wild camels, there are only about 1,000 wild camels in the Middle East…..

https://www.aramcoworld.com/Articles/November-2018/The-Magnificent-Migration

Wow, how hard would it be to track down and vaccinate 1,000 wild camels? Camels in the Middle East are owned and cared for by people, and vaccinating them would be no different than vaccinating your dog or cat for rabies.

Here is a paper on MERS antibodies found in Sudan Camels, but not the camel handlers nor in bats…….

https://wwwnc.cdc.gov/eid/article/25/12/19-0882_article

According to this paper MERS transmission has occurred between people, and has occurred in both Korea and the Middle East…..

https://www.hindawi.com/journals/jir/2019/6491738/

And here a paper on SARS Vaccine causing Lung pathology on challenge with the real virus ……

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0035421

Amazing, what you do not know about SARS, MERS, and even Camels. There are wild Camels in Australia, but MERS does not exist there.

@Tim

Space camel snot…..what Trumps new Space Force passes when they finally capture a “wild camel” with one of their satellites.

@Tim

Of course, Steve Carell would take Trump “creating” Space Force to the limits of comedy.

Poor Space Force, they were a part of the Air Force and called Space Command for decades as they were founded in 1985, now they are a Star Trek joke. All they do is monitor satellite feeds, and do not have any space capability…..

https://www.spacecom.mil

You can purchase a commemorative coin praising Trump for making Space Force, just $100 and it is yours…..

https://www.whitehousegiftshop.com/product-p/space-force-coin.htm

@Tim

Even worse, his father burdened him with the first name “Baron”.

Baron Trump, his dad must be a fan of Jackson who named his kid “Prince”, I guess it is better than being “Apple”.

Not that I know anything about sock puppetry, but the extra modifiers depend on which funny voices he used.

@Narad

Blame my “smart” phone’s spellcheck. Everytime I type your name, it changes it to “Farad” , Denice becomes “Device”, Dorit turns into Doritos.

That sounds as though it is a common problem commonly remediated by disabling the ‘feature’. God. It is like when your spouse catches all the porn on your device and you try to blame it on the ‘porn virus’ you caught off 3’rd party xhamster adds — Just sayin’.

That sounds as though it is a common problem commonly remediated by disabling the ‘feature’.

It’s probably the only thing standing between letter and word salad. If I weren’t moving in a week, I might just fire up the bot.

@ Aelxa Hill

You know? Maybe you should take it a bit more slowly, focus your thoughts on one main claim instead of a myriad of claims, and wait for you to get back home, and reply with an old-fashioned computer with an old-fashioned keyboard.

That may help everyone trying to make sense of your avalanche of comments.

It’s wrong, F68.10, it’s wrong! You should not post stuff like that without an r/sweatypalms warning. I rode a ladder down 18 ft once and that clip made me feel ‘triggered’.

@Tim

I even took the phone in to the Verizon Store and they could not get that cleared up, can not even transfer info onto the media card in the slot, etc. Sometimes everything is literal in Chinese characters. Their fix was I need a new phone. It is over 8 years old.

“Their fix was I need a new phone.”

I would have pulled’em down and shat upon their floor. The last time I was told such crap, I responded with “that is way too much to pay for a guy to dress up in a suit to listen to me talk on the phone”; at which point, a glairing guy in a suit came out and ‘spoke stuff’ into a non-phone looking device while approaching me as I was retreating. {2003, hearts and minds were a’ragin’}

Man, and here I’ve been raging for years on how GM pays millions to engineers just to clutter stuff up and make sure it is all inaccessible.

Here is Raptor #29 (330 Bar):
https://i.redd.it/rybthw0b8uh51.jpg

{My understanding is that most of the fuss is for testing purposes and will come away after it is ‘tuned’ and operating parameters are dialed in — sample lines, sensors, on-board gas chromatographs, and the like. They are shooting for ‘bolt on’ and easily serviced additive-manufactured (3-d printed, thingyverse) parts.} Please don’t strap one onto your old Chevy.

@Tim

And here I thought I finally found a use for that 1972 powder blue Chevy Monte Carlo taking up space in my yard…Darn.

Well, it is no blue1968 Impala with a 327 but I know people who would be interested. I promise not to strap a half million lbs of thrust to it… ‘unsupervised’.

@Tim

It all worked fine when I parked it long ago, except for the clock which the mechanic said would never work right. Now it would be a labor of love for a real car nut who would love to resurrect the last full metal frame Monte Carlo with a 350 engine. Sigh, I should have treated it better.

I will even trade the car for some yardwork and crawling around the crawlspace work.

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