The director of the Food and Drug Administration’s vaccine division told agency staff in a memo that an internal review found that at least 10 children died “after and because of receiving” the Covid vaccine.
The 3,000-word memo, obtained by NBC News, was written by Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research. In it, Prasad claims that agency staff determined that “no fewer than 10” of 96 child deaths reported to the Vaccine Adverse Event Reporting System, or VAERS, between 2021 and 2024 were “related” to Covid vaccination. He said the true numbers could be higher, accusing the agency of ignoring the safety concerns for years.
The memo, sent Friday, did not include the children’s ages or medical histories, timelines or documentation for the deaths he references and does not identify the manufacturer of the vaccine. The FDA’s findings have not been published in a peer-reviewed journal.
Experts push back
Experts who reviewed the memo say it is misusing information from VAERS, an unverified reporting system that allows anyone, including doctors, patients and caregivers, to submit entries about adverse events they believe are linked to vaccines. The system’s own website warns that submissions can contain inaccurate, incomplete or biased information.
“This is sort of science by press release,” said Dr. Paul Offit, a pediatrician and the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, calling the memo “irresponsible” and “dangerous.”
“This is a profound revelation,” Prasad wrote in the memo. “For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children.”
Prasad suggests that the child deaths were tied to myocarditis, an inflammation of the heart muscle, but doesn’t include evidence to support the claim.
The FDA directed all media inquiries to the Department of Health and Human Services. An HHS spokesperson did not immediately respond to a request for comment.
Dr. Peter Marks, the FDA’s former vaccine chief who was ousted by Health Secretary Robert F. Kennedy Jr. earlier this year, said the agency is misusing the database and the claims are right out of what he calls the “anti-vaccine playbook.”
The FDA uses the database to look for early “signals” — patterns that might suggest a possible safety issue, Marks told NBC News. It was one of the tools the agency used to identify a rare blood clotting condition linked to Johnson & Johnson’s Covid vaccine, he said.
The mRNA Covid vaccines, from Pfizer and Moderna, have also been linked to a small but increased risk of myocarditis in young men. Most cases have been found to be mild and resolve within a few days.
Marks said the FDA is not reviewing new safety reports but instead re-examining older ones and appears to be classifying some of them as vaccine-related. He added that Covid infection is also associated with myocarditis — and is often more severe than cases seen after vaccination.
“This memo conveys a very troubling mixture of misrepresentation and lies,” Marks said. “The climate within the agency is incredibly toxic right now.”
Proposed changes
The memo uses highly ideological language, repeatedly characterizing Covid vaccine requirements for schools and employers as “coercive,” calling past agency decisions “dishonest,” and arguing that vaccine regulation “may have harmed more children than we saved.” At one point, Prasad instructs staff who disagree with his conclusions to resign.
He outlined a series of proposed changes to how the FDA evaluates vaccines. He said the agency would revisit how annual flu shots are evaluated, calling the current process an “evidence-based catastrophe of low quality evidence.”
He also said pneumonia vaccine makers “will have to show their products reduce pneumonia (at least in the post-market setting), and not merely generate antibody titers.”
He also claimed the Biden administration dismissed early safety concerns, and criticized former Centers for Disease Control and Prevention Director Rochelle Walensky for what he described as “dishonest and manipulative” public comments.
The memo comes ahead of a two-day CDC vaccine advisory committee meeting next week, when officials are scheduled to discuss the childhood vaccine schedule and the hepatitis B shot.
Earlier this year, the FDA and CDC limited who is eligible to get a Covid vaccine this fall and winter, focusing on people 65 and older and those with medical conditions that put them at increased risk of severe illness.
Kennedy, an anti-vaccine activist, has downplayed the benefits of vaccines and has singled out vaccines made with mRNA as particularly dangerous, calling the mRNA Covid vaccine “the deadliest vaccine ever made.”
In September, FDA Commissioner Marty Makary told CNN that the agency was looking into the deaths of healthy children from the Covid shots.
Extensive research has found that the Covid vaccines are safe for children and protect against severe illness.
A 2023 analysis in JAMA Pediatrics reviewed 17 studies covering more than 10 million children ages 5 to 11 who got Pfizer’s or Moderna’s Covid vaccines. Vaccinated kids had a lower risk of infection and hospitalization compared to those who weren’t vaccinated.
A 2024 study in Nature Communications also found no increased risk of serious adverse events in young kids after Covid vaccination. It did identify a small increased risk of myocarditis in teen boys after the first two days.
