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 due to 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 the 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 real numbers could be higher, accusing the agency of ignoring safety concerns for years.
The memo, sent Friday, did not include the children’s ages or medical histories, timelines or documentation of the deaths it references and does not identify the vaccine manufacturer. The FDA’s findings have not been published in a peer-reviewed journal.
Experts reject
Experts who reviewed the memo say it is a misuse of information from VAERS, an unverified reporting system that allows anyone, including doctors, patients and caregivers, to submit entries about adverse events they believe are related to vaccines. The system’s own website warns that submissions may contain inaccurate, incomplete or biased information.
“This is kind of science based on a press release,” said Dr. Paul Offit, a pediatrician and director of the Vaccine Education Center at 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 US FDA will acknowledge that COVID-19 vaccines have killed American children.”
Prasad suggests that the infant deaths were related to myocarditis, an inflammation of the heart muscle, but includes no 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 former FDA vaccine chief who was ousted by Health Secretary Robert F. Kennedy Jr. earlier this year, said the agency is misusing the database and that the claims are taken from what he calls the “anti-vaccine playbook.”
The FDA uses the database to look for early “signals” — patterns that could suggest a potential safety problem, 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 Covid mRNA 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 rather 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 mix of misrepresentations 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 the agency’s past decisions “dishonest,” and arguing that vaccine regulation “may have harmed more children than we saved.” At one point, Prasad orders staff who disagree with his conclusions to resign.
He outlined a series of proposed changes to the way the FDA evaluates vaccines. He said the agency would review how annual flu vaccines are evaluated and called the current process a “catastrophe based on low-quality evidence.”
He also said that pneumonia vaccine manufacturers “will have to demonstrate that their products reduce pneumonia (at least in the post-marketing environment) and do not simply generate antibody titers.”
He also claimed that the Biden administration dismissed early security 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 meeting of the CDC’s vaccine advisory committee next week, when officials are scheduled to discuss the childhood immunization schedule and the hepatitis B vaccine.
Earlier this year, the FDA and CDC limited who is eligible to receive the Covid vaccine this fall and winter, focusing on people 65 and older and those with medical conditions that put them at higher risk of becoming seriously ill.
Kennedy, an anti-vaccine activist, has downplayed the benefits of vaccines and singled out mRNA vaccines 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 investigating deaths of healthy children from Covid shots.
Extensive research has found that Covid vaccines are safe for children and protect against serious illness.
A 2023 analysis in JAMA Pediatrics reviewed 17 studies covering more than 10 million children ages 5 to 11 who received the Pfizer or Moderna Covid vaccines. Vaccinated children had a lower risk of infection and hospitalization compared to those who were not vaccinated.
A 2024 study in Nature Communications also found no increased risk of serious adverse events in young children after the Covid vaccine. It identified a small increased risk of myocarditis in adolescents after the first two days.
