FDA claims Covid shots killed 10 children and vows new vaccine rules

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 because of receipt” of 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 says agency staff determined that “as many as 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 ages or medical histories of the children, timelines or documentation of the deaths it references and did not identify the vaccine manufacturer. The FDA’s findings have not been published in a peer-reviewed journal.

Experts push back

Experts who reviewed the memo say it is a misuse of information from VAERS, an unaudited 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 website warns that submissions may contain inaccurate, incomplete or biased information.

“This is sort of a scientific 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 will acknowledge that COVID-19 vaccines killed American children. »

Prasad suggests that the child deaths were linked to myocarditis, an inflammation of the heart muscle, but does not include any evidence to support this 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 was misusing the database and that the claims were straight out of what he calls the “anti-vaccine playbook.”

The FDA uses the database to look for early “signals” – patterns that could suggest a possible safety problem, Marks told NBC News. It was one of the tools the agency used to identify a rare blood clotting disease 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 turn out to be mild and disappear within a few days.

Marks said the FDA does not review new safety reports, but rather re-examines older ones and appears to classify 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 disturbing 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 calling Covid vaccine requirements for schools and employers “coercive,” calling past decisions by agencies “disingenuous” and arguing that vaccine regulations “may have harmed more children than we have saved.” At one point, Prasad asks staff who disagree with his findings to resign.

He outlined a series of proposed changes to how the FDA evaluates vaccines. He said the agency would review how annual flu vaccines are evaluated, calling the current process “a disaster based on low-quality evidence.”

He also said that pneumonia vaccine makers “will have to show that their products reduce pneumonia (at least post-market) and do not simply 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 meeting of the CDC’s vaccine advisory committee next week, during which officials are expected to discuss the childhood immunization schedule and the hepatitis B vaccine.

Earlier this year, the FDA and CDC limited the number of people eligible for the Covid vaccine this fall and winter, focusing on people 65 and older and those with health conditions that put them at increased risk of severe illness.

Kennedy, an anti-vaccine campaigner, 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 the deaths of healthy children from Covid shots.

Extensive research has shown that Covid vaccines are safe for children and protect against serious illness.

A 2023 analysis in JAMA Pediatrics looked at 17 studies involving more than 10 million children ages 5 to 11 who received Covid vaccines from Pfizer or Moderna. Vaccinated children had a lower risk of infection and hospitalization than those who were not vaccinated.

A 2024 study in Nature Communications also found no increased risk of serious adverse events in young children after Covid vaccination. The study identified a slight increase in the risk of myocarditis in adolescents after the first two days.