The director of the Food and Drug Administration's vaccine division told agency staff in a memo that an internal review found 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 agency officials determined that “at least 10” of the 96 child deaths reported to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024 were “associated” with Covid vaccinations. He said the true numbers could be higher, accusing the agency of ignoring safety concerns for years.
The note sent Friday did not specify the children's ages or medical histories, time frames or documentation of the deaths it referred to, and did not identify the vaccine manufacturer. The FDA's findings have not been published in a peer-reviewed journal.
Experts retreat
Experts who reviewed the memo say it misuses information from VAERS, an unverified reporting system that allows anyone, including doctors, patients and caregivers, to submit records of adverse events they believe are related to vaccines. System own website warns that the materials may contain inaccurate, incomplete or biased information.
“It's kind of science in 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 note. “For the first time, the US FDA admits that COVID-19 vaccines killed American children.”
Prasad suggests that the infant deaths were related to myocarditis, an inflammation of the heart muscle, but provides no evidence to support this claim.
The FDA referred all media inquiries to the Department of Health and Human Services. An HHS spokesman did not immediately respond to a request for comment.
Dr. Peter Marks, the FDA's former vaccine chief who was fired earlier this year by HHS Secretary Robert F. Kennedy Jr., said the agency is misusing the database and the allegations are directly consistent with what he calls the “anti-vaccine agenda.”
The FDA uses the database to look for early “signals” – patterns that may indicate a possible safety problem, Marks told NBC News. It was one of the tools the agency used to identify a rare bleeding disorder associated with the Johnson & Johnson Covid vaccine, he said.
The Pfizer and Moderna mRNA Covid vaccines are also associated with a small but increased risk of myocarditis in younger men. Most cases turned out to be easy and decide within a few days.
Marks said the FDA is not reviewing new safety reports, but is instead reviewing old 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 is a very disturbing mixture of distortions and lies,” Marks said. “The climate within the agency right now is incredibly toxic.”
Proposed Changes
The memo uses highly ideological language, repeatedly characterizing Covid vaccination requirements for schools and employers as “coercive,” calling past agency decisions “dishonest” and arguing that regulating vaccines “may have harmed more children than we have saved.” At one point, Prasad orders employees who disagree with his conclusions to resign.
He laid out a number of proposed changes to how the FDA evaluates vaccines. He said the agency would overhaul how annual flu shots are evaluated, calling the current process “a disaster based on low-quality evidence.”
He also said that pneumonia vaccine makers “will have to demonstrate that their products reduce pneumonia (at least in the post-market phase) rather than simply create antibody titers.”
He also said the Biden administration had dismissed initial safety concerns and criticized former Centers for Disease Control and Prevention Director Rochelle Walensky for what he called “dishonest and manipulative” public comments.
The memo comes ahead of a two-day CDC vaccine advisory committee meeting next week, when officials it is planned to discuss the schedule of childhood vaccinations and hepatitis B vaccination.
Earlier this year, the FDA and CDC limited who is eligible to receive a Covid vaccine this fall and winter, focusing on people 65 and older and people with medical conditions that put them at increased risk of severe illness.
Kennedy, anti-vaccine activist downplayed the benefits of vaccines and called vaccines made with mRNA especially dangerous, name of mRNA Covid vaccine “the deadliest vaccine ever created.”
In September FDA Commissioner Marty Macari told CNN that the agency is investigating deaths of healthy children from Covid vaccinations.
Extensive research has shown that Covid vaccines are safe for children and protect against severe disease.
A 2023 analysis in JAMA Pediatrics analyzed 17 studies covering more than 10 million children aged 5 to 11 years 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.
2024 study in Natural communications also found no increased risk of serious side effects in young children following Covid vaccination. There was a slight increase in the risk of developing myocarditis in teenage boys after the first two days.
