Scoop: FDA vaccine chief’s memo cited 10 pediatric Covid-19 vaccine deaths—but the agency’s own analysis found 0–7.

Dr. Vinay Prasad circulated a memo before FDA scientists finished their work. His conclusions overshot what the agency’s own analysts ultimately found.

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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 vaccines given through August of 2025, which would include over 138 million doses of the vaccine to children ages 12 and under, let alone millions more among teens (of the seven deaths in the FDA report, the age range of investigated deaths was 7-16). That implies a per-dose death rate of 1 in 19.7 million at the highest (if all seven possible/likely deaths were in fact due to the vaccines) or 1 in 69 million at the lower end (if only two of the deaths were actually due to the vaccines). For context, these rates are far smaller than the per-dose risk of anaphylaxis deaths from common medications like ibuprofen.

More details.

The December 5 memo contains information about the seven “possible/probable” cases, all of whom received autopsies:

• All cases were among Pfizer recipients. (Around twice as many pediatric Pfizer doses have been administered compared to Moderna).

• The age range was 7-16 years (5 males, 2 females).

• Myocarditis, a known risk of Covid-19 vaccines, appeared in four of the seven possible/probable cases.

• Symptoms occurred between 1-15 days after vaccine doses.

• Three cases occurred after dose #1, while three occurred after dose #2. One case occurred after a bivalent vaccine was given, though I am not aware of whether that was a booster dose, or part of a primary series regimen that used the bivalent formulation. That means that, at most, one case occurred after a booster dose.

• The FDA scientists who worked on the December report emphasized that causality still could not be confidently assigned, based on a description of the methods and available data/information.

What FDA scientists want to do next.

Apparently, FDA scientists are meeting this week to discuss the December 5 memo. The agency may recommend requiring label changes for not just Pfizer’s pediatric vaccine, but Moderna’s as well.

The December 5 memo emphasizes that while the findings do not represent a risk-benefit assessment, the implication is that, because >138,000,000 pediatric doses of the Covid-19 vaccines have been administered, the risk must be very low. It follows that only a completely ineffective vaccine would fail to prevail in a risk-benefit analysis, though this is not explicitly stated in the memo.

It’s the tone.

While the December 5 memo prepared by FDA scientists apparently contains dispassionate scientific descriptions, the same can’t be said about Dr. Prasad’s November 28 memo to his staff. Rather than describe the findings—which he apparently did inaccurately—the memo contains lengthy sections blaming the Biden administration for these deaths, and stating that Covid-19 itself was “never highly lethal” for children. He also devotes some ink to getting ahead of risk-benefit comparisons, dismissing many previous analyses that landed in the pro-vaccine category.

But there’s something to be said for tone and bias beyond this. Prasad is a clear writer, and so his meaning can’t be mistaken. Of the ten deaths he reported to FDA staff (a number which we now know is incorrect), he wrote that “that number is certainly an underestimate due to underreporting, and inherent bias in attribution,” and that, of the 96 cases initially found in VAERS (HHS’s Vaccine Adverse Event Reporting System) between 2021 and 2025, “no fewer than 10 are related….The real number is higher.”

The December 5 memo, written by FDA scientists under Prasad’s direction, contradicts this directly.

Prasad’s memo also invoked two highly respected FDA scientists who left the agency, in part over disagreements on Covid-19 boosters. Speaking to Science this week, one of those scientists, Dr. Phil Krause, said that Prasad’s approach to this was “destructive,” emphasizing that important conversations like this should happen when all the data are available to everyone.

Notably, Prasad’s November 28 memo closed with an admonition to his colleagues. Either wait until the work is done to discuss matters in public, or resign.

“As you can imagine, I believe these debates should be private, internal to FDA, until they are ready to be made public. I don’t endorse selective reporting of our meetings and documents. Some staff may not agree with these core principles and operating principles. Please submit your resignation letters to your supervisor and CC my deputy Katherine Szarama,” he wrote.

Interestingly, Dr. Prasad himself did not wait until the FDA scientists he assigned to work on this topic had completed their tasks before firing off a memo qua manifesto to the staff of his Center.

While there is a difference between prematurely emailing FDA staff with incorrect information and leaking that information to the press, the overall issue remains: until there is full transparency, genuine, level-headed conversations and assessments are simply impossible.

If you have information about any of the unfolding stories we are following, please email me or find me on Signal at InsideMedicine.88.