Last week, in a previous Chronicle Med/Sci feature, we reported on a new and very large study from France that concluded the increased death rate from taking the COVID-19 vaccine was negligible, and that in fact the vaccine was associated with a 25% lower mortality rate from any cause—was well as a 74% lower death rate from severe COVID-19.
While the study was the largest (22.7 million vaccinated subjects vs. 5.9 million unvaccinated controls) and longest of its kind (with a median followup of 45 months compared to six months for most other studies) its cohort consisted of adults 18 to 59 years of age. The study did not include children.
In our earlier story, we made clear that there were legitimate questions about the safety of any vaccine, including the new mRNA based vaccines, but that resolving such issues depended on evaluating scientific evidence and not partisan politics.
The following day, the EverythingCroton blog, which often links to Chronicle articles, linked to this one as well, although with the brief preface, “The French say…”
While we were happy to have the mention, the blog more prominently linked to a post by the COVID-19 vaccine skeptic Alex Berenson, a former New York Times reporter turned spy novel writer, who also writes about medical and public health issues. Since the beginning of the pandemic, Berenson has produced a steady stream of often demonstrably false claims about the disease and the vaccine developed to fight it.
(Despite the blog’s apparently snarky reference to French research, in fact that nation is one of the world’s scientific powerhouses, basically equivalent to the United States in that regard.)
Berenson’s post repeated a claim by Vinay Prasad, the Food and Drug Administration’s current top vaccine regulator, that at least ten children had died from the COVID-19 vaccine. The claim was made in an internal FDA memo dated November 28 that was leaked to the press and is now under wide discussion by experts in the field.
Berenson is a darling of right-wing media, and since the EverythingCroton blog is unabashedly very conservative politically, it often features links to his Substack newsletter “Unreported Truths.” Yet while we respect the free speech right of this blogger to post whatever they want, we also think that disinformation about health matters—including vaccines—is a danger to our community and sometimes needs to be called out.
This is one of those times. Not only is there no clear factual basis for Prasad’s claim, but it appears that his contention seriously misstates what FDA reviewers had actually found. And while any possible evidence of harm to children (or anyone else) from a vaccine must obviously be rigorously investigated, Prasad’s statements in the memo have been sharply contested not only by outside scientists, but apparently by scientists within the FDA itself.
While readers are invited to access the full six page memo at the link given above, certain features stand out. The memo is overtly political, at one point blaming the Biden administration for coercing young children who were healthy and supposedly faced “a low risk of death” into receiving the COVID-19 vaccine “via school and work mandates.” (The majority of such mandates came at the state and local level, although some federal mandates were enacted.)
But the most contentious claim concerned the alleged ten or more child deaths that Prasad claims can be directly related to the vaccine. Prasad, who is head of the FDA’s Center for Biologics Evaluation and Research (CBER), asked a biostatistical team to do a detailed analysis of suspected vaccine-related deaths voluntarily reported to the Department of Health and Human Services’s Vaccine Adverse Event Reporting System (VAERS.) In the memo, Prasad claimed:
“The team has performed an initial analysis of 96 deaths between 2021 and 2024, and concludes that no fewer than 10 are related. If anything, this represents conservative coding, where vaccines are exculpated rather than indicted in cases of ambiguity. The real number is higher.”
Prasad then added: “This is a profound revelation. For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
But once the memo was leaked, it came under immediate attack by other scientists for a very simple reason: Prasad did not provide any details in this internal memo about how this conclusion was reached, including the all important question of what methodology was used. The suspicions were no doubt fueled in part by the fact that Prasad, like Berenson, is a well-known critic of the way the FDA approves vaccines in general, and the approval process for COVID-19 vaccines in particular. There is little question that this is why the Trump administration appointed him.
Less than a week after the memo was leaked, 12 former FDA commissioners published a Perspective in the New England Journal of Medicine that, among other things, questioned the basis for concluding that the COVID-19 vaccine was responsible for the child deaths. To quote the article at some length:
“Any death that could be related to vaccination is tragic and warrants extensive investigation. Previously, all the cases reported to the Centers for Disease Control and Prevention (CDC) and to the FDA had been carefully reviewed by FDA staff, who drew different conclusions. Adjudication of individual case reports is sensitive and subjective, and it relies on the rigor and goodwill of the people doing the evaluation. The memo offered no explanation of the process and analyses that were used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation.1
The reanalysis relied on adverse event reports filed in the Vaccine Adverse Event Reporting System (VAERS), a passive postapproval surveillance system that collects unverified reports, from any source, of events occurring after vaccination. VAERS reports, by themselves, cannot be used to determine whether a vaccine caused a particular event. The system’s primary purpose is to flag potential safety signals that must then be evaluated in carefully designed investigations. VAERS data have well-recognized challenges, including reporting bias and a lack of control groups.5 The FDA therefore relies on many other data systems and methods as well, including medical record review, active surveillance programs, and independent peer review.”
A lot of the rest of the Perspective questioned using these unproven assertions to justify the sweeping changes in FDA’s regulatory scheme for approving vaccines—even updates to long-used vaccines such as against influenza—which are currently the subject of much discussion and controversy, and which we will not cover here. The former commissioners also challenged a number of what they saw as overt threats by Prasad against FDA scientists who speak out against its new policies, whether publicly or anonymously via leaks to the press.
Other publications, including mainstream media and medical and public health media, quoted a number of scientists expressing similar concerns. Many of these experts are well known, but also the targets of criticism by Berenson and other conservative critics of vaccines, along with outright anti-vaxxers whose positions are based on politics and emotion rather than solid science.
(In contrast, The Atlantic, on December 8, published a piece entitled “Yes, Some Children May Have Died From COVID Shots” (behind a paywall) arguing that “denial only serves the aims of anti-vaxxers.”)
But perhaps the most dramatic development in this saga is one that, so far at least, has received little media attention. On December 11, Jeremy Faust—an emergency physician at Brigham and Women’s Hospital in Boston and an assistant professor at Harvard Medical School—published what he called a “Scoop” on his Substack newsletter “Inside Medicine.” The report, soon after republished in the prestigious medical publication MedPage Today—was entitled “FDA vaccine chief’s memo cited 10 pediatric Covid-19 vaccine deaths—but the agency’s own analysis found 0–7.”
Faust, relying on FDA insiders as he often does, was apparently briefed on a December 5 memo that, as we write, has not yet been leaked to other media.
Faust wrote:
“According to a December 5 post-marketing safety memo prepared by FDA scientists assigned to study the issue, agency scientists concluded that the actual number of deaths linked to Covid-19 vaccines in the United States is somewhere between zero and seven.”
Faust adds:
“Asked for comment, HHS spokesperson Andrew Nixon said, ‘the FDA’s investigation into deaths caused by Covid vaccines is still ongoing and there’s no final count yet of those deaths.’”
Faust goes on to give a lot of detail about what the memo says, although he does not link to it directly. For example:
“How did Prasad, who is the Director of the Center for Biologics Evaluation and Research, make such a mistake? Apparently, rather than waiting for the finalized report that he had ordered, he sent staff the November 28 memo before the scientists had completed their assigned work.
The final December 5 memo, according to FDA employees with knowledge of the situation, states that under an established WHO framework, zero deaths were deemed ‘certain’ to have been caused by Covid-19 vaccines, two were judged to be ‘probable/likely,’ while five were ‘possible.’
Probable/likely cases are those determined to have been ‘unlikely’ due to another cause. But for the ‘possible’ category, an alternative explanation was determined to have been equally likely, meaning that the chance that vaccines were responsible for those deaths was 50-50 at most.”
There is a lot more detail still about the FDA findings in Faust’s article, and we recommend that readers who really want to get into the weeds—or at least to see how misleading Berenson’s original post about the alleged ten deaths might have been, and how the EverythingCroton blog helped to spread what may well be unsupported claims—look over it closely. If the memo Faust cites becomes public, as seems quite possible, we will update this post with the link.
As we discussed in our previous article, the key question is to determine the risk-benefit ratio of any vaccine, that is, whether the risk of dying from COVID-19 is more or less than the risk of dying from the vaccine. While the most common side effect of the mRNA vaccine is myocarditis—inflammation of the heart muscle—the death rate from that relatively rare complication in adults is extremely low. On the other hand, death from myocarditis related to infection with the COVID-19 virus is much higher.
Nor is it established, as Prasad wrote in his memo, that children are at very low risk for death from the disease. Hundreds of young children have died from COVID-19 over the course of the pandemic. A risk-benefit analysis for children must be based on valid evidence and not emotional or politically biased considerations, which is why so many scientists are insisting on clear evidence for the ten or more child deaths he is claiming.
To sum up, vaccine safety is a very contentious topic, and anyone—including any scientist—who claims that they have definitive answers should be regarded with skepticism. On the other hand, lay vaccine safety discussions are rife with disinformation—the alleged link between vaccines and autism still touted by HHS Secretary Robert F. Kennedy Jr. being a leading example—and the temptation to let politics rather than science take the lead appears to be very great.
We started this Chronicle Med/Sci feature for that very reason, so that members of the Croton community can have access to accurate information and balanced analysis that directly affects their lives and the lives of their children. This column will always be written by experienced science writers, although we invite contributors to submit ideas for Guest Editorials on these and any other topics of relevance to our area.
To do that, please contact us at TheCrotonChronicle@gmail.com
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CIVICS 101 in action! Thanks for the article. Public advocacy is a cornerstone of a healthy democracy. Time and again this begins at the local level. Local engagement is crucial for a healthy national democracy and directly impacts citizens' daily lives.
Good for you to respond to the health/vaccine misinformation. Well written. I wish that the people who need the correct information would see your article, but I fear not.