Scoop: FDA vaccine chief’s memo cited 10 pediatric Covid-19 vaccine deaths—but the agency’s own analysis found 0–7.
Deep Dives
Explore related topics with these Wikipedia articles, rewritten for enjoyable reading:
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Vaccine Adverse Event Reporting System
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VAERS is central to this article's discussion of how vaccine deaths are tracked and investigated. Understanding how this passive surveillance system works, its limitations, and how reports are evaluated would help readers critically assess claims about vaccine safety data.
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Myocarditis
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Four of the seven possible/probable deaths in the FDA memo involved myocarditis, a known vaccine side effect. Understanding this heart inflammation condition—its causes, symptoms, diagnosis, and typical outcomes—provides essential medical context for evaluating the risk profile discussed.
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Center for Biologics Evaluation and Research
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Dr. Prasad directs this FDA center, which is responsible for regulating vaccines in the United States. Understanding CBER's role, authority, and how it evaluates biological products helps readers understand the institutional context of this controversy.
We have some breaking news that I believe we are first to report, right here in Inside Medicine. My thanks to the HHS employees who continue to bravely speak out. It is important that we amplify them. Thank you for your help in that—by reading, sharing, and supporting this work.
In a November 28 memo, Dr. Vinay Prasad, the FDA’s top vaccine regulator, informed staffers that the agency’s “career staff have found that at least 10 children have died after and because of receiving COVID-19 vaccination.”
That is false, Inside Medicine has learned.
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.
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.”
Under the hood…
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.
From this, it appears that the real number of deaths that FDA officials have linked to pediatric Covid-19 vaccines might be as low as zero—but probably rests in the range of 2-5. This means that Dr. Prasad’s memo opened with a number of deaths that is 200%-500% of the number that the scientists he assigned to study the problem reported.
Since the December 5 memo was posted internally at the FDA, Prasad has not corrected his earlier statements to agency staff.
The December 5 memo does not provide an analysis of the risk-benefit ratio for pediatric Covid-19 vaccines. However, it apparently covers
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