FDA Internal Memo Sparks Controversy Over Child Covid Vaccine Safety

A newly surfaced memo from the director of the FDA’s vaccine division has created significant internal and public turmoil after alleging that Covid-19 vaccines may have caused the deaths of at least 10 children. The 3,000-word memo, obtained by NBC News, was authored by Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research.

What the Memo Claims

Prasad writes that an FDA review found “no fewer than 10” of the 96 child deaths reported to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024 were “after and because of receiving” a Covid vaccine. He suggests the true number could be higher and accuses the agency of ignoring safety signals for years.

However, the memo does not provide:

• Children’s ages

• Medical histories

• Clinical timelines

• Documentation supporting causation

• Vaccine manufacturers involved

The findings have not been published in a peer-reviewed journal.

 Experts Strongly Push Back

Scientists who reviewed the memo argue Prasad is misrepresenting VAERS data. Because VAERS accepts reports from anyone, the entries are unverified and may be incomplete, inaccurate, or biased.

• Dr. Paul Offit, pediatrician and director of the Vaccine Education Center at CHOP, called the memo “irresponsible” and “dangerous,” describing it as “science by press release.”

• Prasad links the deaths to myocarditis but provides no supporting evidence.

The FDA referred all questions to the Department of Health and Human Services, which has not yet commented.

Former FDA Vaccine Chief Responds

Dr. Peter Marks, who led the agency’s vaccine efforts before being removed earlier this year, sharply criticized the memo. He says the analysis mimics the “anti-vaccine playbook” by misusing VAERS reports and revisiting old cases without new evidence.

Marks emphasizes:

• VAERS is designed to detect early signals, not confirm causation

• mRNA vaccines carry a small increased myocarditis risk in young men, usually mild

• Covid infection itself can cause myocarditis, often more severely

He describes the memo as containing “a very troubling mixture of misrepresentation and lies” and says FDA morale has become “incredibly toxic.”

Proposed Policy Shifts Inside the FDA

Prasad’s memo includes a list of sweeping changes to vaccine oversight. The tone is ideological, describing school and workplace vaccine requirements as “coercive” and earlier agency decisions as “dishonest.”

His proposals include:

• Reassessing the annual flu vaccine process, which he calls an “evidence-based catastrophe”

• Requiring pneumonia vaccine makers to prove reductions in actual pneumonia cases, not just antibody titers

• Criticizing the Biden administration and former CDC Director Rochelle Walensky for allegedly dismissing early safety signals

He even instructs staff who disagree to resign.

The timing is notable: the CDC’s vaccine advisory committee meets next week to review the childhood vaccine schedule and hepatitis B recommendations.

Proposed Policy Shifts Inside the FDA

Prasad’s memo includes a list of sweeping changes to vaccine oversight. The tone is ideological, describing school and workplace vaccine requirements as “coercive” and earlier agency decisions as “dishonest.”

His proposals include:

• Reassessing the annual flu vaccine process, which he calls an “evidence-based catastrophe”

• Requiring pneumonia vaccine makers to prove reductions in actual pneumonia cases, not just antibody titers

• Criticizing the Biden administration and former CDC Director Rochelle Walensky for allegedly dismissing early safety signals

He even instructs staff who disagree to resign.

The timing is notable: the CDC’s vaccine advisory committee meets next week to review the childhood vaccine schedule and hepatitis B recommendations.

Covid Vaccines for Children: What the Evidence Shows

Despite the memo’s assertions, large-scale research continues to show that Covid-19 vaccines are safe for children and protect against severe disease.

Key findings:

• A 2023 JAMA Pediatrics review analyzed 17 studies covering 10+ million children ages 5–11. Vaccination reduced infection and hospitalization risk.

• A 2024 Nature Communications study found no increase in serious adverse events among young children after vaccination, though it confirmed a small, short-term myocarditis risk in teenage boys within the first two days.

Earlier this year, the FDA and CDC limited Covid vaccine eligibility for the upcoming season to older adults and those at higher risk.

The Larger Context

The memo arrives at a moment when vaccine regulation is politicized and under intense scrutiny. Health Secretary Robert F. Kennedy Jr., a long-time vaccine critic, has repeatedly called mRNA vaccines dangerous and downplayed their benefits.

FDA Commissioner Marty Makary has said the agency is reviewing reports of deaths among healthy vaccinated children, though no causal connection has been established.

For now, peer-reviewed research continues to support the safety and effectiveness of Covid-19 vaccines in children — and experts warn that misinterpretation of VAERS data can lead to misleading and harmful conclusions.

 Source

https://doi.org/10.1136/bmj.r2546