"The initial message hammered home to us by the health authorities" on Covid mRNA vaccines

We have been instructed:

@Giltil made the following claim, repeatedly:

@Faizal_Ali, @Rumraket and myself have each requested a quote/citation for this claim.

Given the importance of this issue for the credibility of health authorities, on what is itself still an important heath issue, and its implication for possible future zoonotic pandemics, I feel that settling this issue has “value”. I am therefore creating a new thread for this topic, for Gil to either provide evidence supporting his claim or to retract it.

I have myself attempted to find out if this claim has any factual basis. I could not find anything supporting it – but was somewhat hampered by the fact that information on this topic tends to be updated, rather than timestamped-and-preserved. This would probably mean having to go into something like the Internet Archive, and looking at archived versions of specific webpages. However, as I am not the person making this claim, I do not think that it falls on me to go to these sorts of lengths.

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I do not believe you have summarized @Giltil’s claim with complete accuracy:

Taken at face value, @Giltil is here claiming that “health authorities” had “hammered home” the message that, unlike most drugs, the COVID mRNA vaccine came with no risks.

It is, of course, possible that @Giltil merely misspoke. I am aware English is not his first language. But, if that is the case, he should clarify.

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It absolutely was. I think I’m in a somewhat unique position to comment on this: Me, my wife, and my two kids were ALL in the Pfizer clinical trial (adults first, fall 2020, kids in 2021), and then we were active in setting up vaccine clinics and connecting people with vaccine appointments once they were available (my wife in particular - it was basically a second full time job for a few months). Let me tell you, the disclosures to people in the trial were, as you would expect, A LOT, and the information given out at clinics was at least as robust as with other vaccines. Probably more, based on my experiences getting flu vaccines and such.

To say the risks (which were documented to be lower than other types of vaccines) were not disclosed is either tremendously ignorant or tremendously dishonest.

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Yes, let me clarify. My understanding is that the initial message of the health authorities was that the mRNA vaccines were safe and effective, to the point that nearly every one on this planet should be vaccinated. But given the gaps in our knowledge with these vaccines, especially regarding their long term effects, I believe this message was flawed by its overconfidence, which the available data did not justify. A good example of this overconfidence is the recommendation to vaccinate even the pregnant women, despite the lack of well designed clinical trials on this population. Here is what Retsef Levi, chair of the ACIP’s new Covid immunisation working group, recently said in an interview :

« vaccinating pregnant women is particularly concerning. We tell them not to eat sushi, right? We place many restrictions during this time because pregnancy is a delicate biological process, and any interruption or exposure could have grave implications for the foetus, baby, and mother. Yet with Covid vaccines we gave broad recommendations in pregnancy, with no clinical trials. The original pivotal trials excluded pregnant women, and the only trial ever conducted was very small, underpowered, focused on vaccination in later stages of pregnancy and stopped early. Having researched this topic myself, I can say the literature is mostly retrospective observational studies – methodologically weak for assessing safety. I believe the process we followed failed the principle of ‘first do no harm.’ We need a different approach: be honest about what we know and don’t, and do what it takes to close these gaps, including potentially randomised clinical trials. »

You’re moving the goalposts. Put them down and be honest.

If you’re going to make dramatic claims that the

was the problem, quote THEM, not Retsef Levi.

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Please present the evidence on which you base this belief. So far, you have presented none. Or maybe you do not base your beliefs on evidence, but just on whether you can find quotes from people who share your unfounded beliefs?

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The problem is that the reason we were asking for quotes or citations was that we believed your “understanding” was misinformed.

Merely restating your understanding is thus non-responsive to our request.

Retsef Levi (i) had no involvement in the “initial message hammered home to us by the health authorities”, and (ii) appears to have no expertise whatsoever relevant to vaccines or medicine in general. We therefore have no more reason to believe that Levi isn’t any less misinformed than we have to believe you are.

Levi’s comments are therefore likewise non-responsive to our request.

I would note that it was a similar tendency to misdirect conversation into irrelevancies (in that case QoVAX) that landed you in the ‘Argument Clinic’ in the first place, and you made a further attempt there with the ‘trialsitenews’ article.

I am therefore requesting @moderators to put your posts on this topic under heightened scrutiny for irrelevancies and similar red herrings.

However, as you have seen fit to inflict Levi’s inexpert and unsubstantiated claims on the guidance given to pregnant women on the safety of the vaccine, I would request that you provide a quote or citation (to the original recommendation) substantiating his claim.

I would assume it could not have been too rosy, or we would not have had articles like this (which @thoughtful posted on a thread on the topic):

I would also note that this article also states:

As Texas’ vaccine rollout suggests, pregnant people are more likely than their non-pregnant counterparts to develop severe illness due to the coronavirus.

This heightened risk of severe illness would likely balance out any not-too-major heightened risk of side-effects.

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This just confirms that Levi has neither the expertise nor the intelligence to be in the position he has been given. If there was a deadly illness sweeping the globe that killed pregnant women as commonly as anyone else, and eating sushi had been shown to protect against this illness, health authorities would be justified in recommending that everyone, including pregnant women, eat sushi, absent any strong evidence that the risk of sushi outweighed the risk of the disease for any individual or group.

This is not complicated, but apparently it is for the Trumpists now making health decisions for the US.

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This guy was not in a position to make any recommendations for vaccination policy at the time, and his current recollection of what occurred is not of any value given that he’s really just giving some sort of narrative, rather than quoting any public health officials.

So I have to assume you’re still seaching.

If you come up empty (I’ll be charitable here and give you an entire week from now to find the relevant quotes), I think it would be irresponsible for you not to offer a retraction of your earlier claim, given the importance of this topic.

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I’m a bit loss at this point. Which quotes are you looking for?

Meet our new contender for Sealion of the Year.

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Quotes of the initial message hammered home to you by the health authorities. Predictably, you haven’t provided a single one.

Do you really not understand this?

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To provide context, the Wikipedia article on the history of COVID-19 vaccine development states:

On 11 December 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine.[25][112]

Official recommendations from the months (not years) following that date are what we are “looking for” (this is entailed by the words “initial” and “health authorities”).

A quote made nearly five years later by an individual with no involvement in that initial authorisation, and no expertise whatsoever on vaccine safety, is about as far from what we are “looking for” as the comments of some random blowhard in the pub.

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For what it’s worth, this from a speech from the Canadian Chief Public Health Officer from February 2021 during the initial vaccine rollouts:

As vaccine programs continue to rollout, Federal, provincial and territorial authorities are continuing to monitor vaccine safety. To date, as of February 19th, there have been 1,235 reports of adverse events following immunization (AEFIs). These reports include any medical event that occurs following immunization, but is not necessarily related to the vaccine or the immunization process. A total of 167 of these reports to date - about 1 in 9,000 doses administered - were considered serious, such as a severe allergic reaction. All adverse events are subject to review and all serious events undergo a detailed investigation to determine whether or not they are related to the use of the vaccine. To date, no unexpected vaccine safety issues have been identified.

Remarks from the Chief Public Health Officer on COVID-19, February 26, 2021

There was definitely information from public health authorities about vaccine risks at the time, at least up here in Canada.

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In the argument clinic thread, you requested :

« Please quote even a single health authority who “hammered home” the message that most drugs don’t come with risks. Or, more particularly, that the mRNA vaccine could not have any adverse effects. »

And in this thread:

So what is your request? Is it for quotes supporting the claim I’ve never made that the message hammered home to us by the health authorities was that the mRNA vaccines don’t come with risks or is it for quotes supporting the claim I’ve indeed made that that the initial message hammered home to us was that the mRNA vaccines were safe and effective, without mention of the risks?

That looked to me like his concession.

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In fairness, @Giltil has admitted he misspoke in his earlier claim. It seems he is no longer asserting that health authorities claimed the mRNA vaccine was without any risk of adverse effects. His claim now seems to be that the evidence available at the time did not support recommending its use for the general public.

So now he needs to summarize that evidence and demonstrate that it was misinterpreted and/or misrepresented by health authorities.

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Thanks. That led me to the following:

– Dec 21, 2020

The scale of the COVID-19 immunization response warrants careful attention to vaccine safety to minimize risk and maximize the benefits of COVID-19 vaccine. Despite all the knowledge gained about a product pre-market, it is not possible to detect all adverse events following immunization (AEFIs) at that stage, especially if they are very rare. Rapid and continuous post-market vaccine safety surveillance is critical to capture all reports of serious and unexpected AEFIs for all vaccines authorized in Canada and to act on safety signals in a timely way.

That does not sound like a blanket claim that the vaccine is perfectly “safe” to me.

Given that @Giltil is focusing on the highlighted passage, I would note that I have already posted Canada mentioning the risks above.

Here is what the FDA said:

July 12, 2021

FDA has routinely been using screening methods to monitor the safety of COVID-19 vaccines and to evaluate potential adverse events of interest (AEI) related to these vaccines. One of these methods, called near real-time surveillance, detected four potential AEIs in the Medicare healthcare claims database of persons aged 65 years and older who had received the Pfizer/BioNTech COVID-19 vaccine. The four potential AEI are pulmonary embolism, acute myocardial infarction, immune thrombocytopenia, and disseminated intravascular coagulation. The screening methods have not identified these AEI after vaccination in persons 65 years and older who received the two other authorized COVID-19 vaccines.

These four events may not be true safety concerns, and the screening method cannot establish that the vaccine caused these AEI. FDA is sharing the initial findings of this safety study in the spirit of transparency but does not believe there is a cause for concern. There are alternative explanations for the findings, including the fact that the Pfizer/BioNTech vaccine was given to many high-risk individuals who were older and had significant co-morbidities.

These events have not been identified as safety concerns or signals in the CDC Vaccine Safety Datalink (VSD) or the Veterans Administration (VA) Healthcare data systems screening methods. The Vaccine Adverse Event Reporting System (VAERS), another government monitoring system, also has not identified any association between any COVID-19 vaccine and these AEI.

FDA continues to closely monitor the safety of the COVID-19 vaccines and will further investigate these findings by conducting more rigorous epidemiological studies. FDA will share further updates and information with the public as they become available.

FDA strongly believes that the known and potential benefits of COVID-19 vaccination greatly outweigh the known and potential risks of COVID-19. There is no need to delay vaccination while the FDA continues its investigation.

Source

Yes Gilbert, the “health authorities” did indeed give “mention of the risks”.

The second one. A quote, preferably from health authorities, that said the mRNA vaccine was safe and effective, that didn’t mention risks.