FDA Claims Covid Shots Killed 10 Children and Vows New Vaccine Rules

Introduction to the FDA’s Claim

The director of the Food and Drug Administration’s vaccine division, Dr. Vinay Prasad, 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. 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.

Details of the Memo

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.

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.

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.”

Proposed Changes to Vaccine Evaluation

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.”

Reaction from Former FDA Officials

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.

Scientific Consensus on Covid Vaccines

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.

Conclusion

The FDA’s claim that Covid shots killed 10 children has sparked controversy and debate among experts. While the memo presents a troubling picture, many experts argue that it misuses data from VAERS and ignores the scientific consensus on the safety and efficacy of Covid vaccines. The proposed changes to vaccine evaluation may have significant implications for public health policy, and it remains to be seen how these changes will be implemented and what their effects will be.

FAQs

• Q: How many child deaths were reported to VAERS between 2021 and 2024?
  A: 96 child deaths were reported to VAERS between 2021 and 2024.
• Q: What is the FDA’s proposed change to vaccine evaluation?
  A: The FDA proposes to revisit how annual flu shots are evaluated and require pneumonia vaccine makers to show that their products reduce pneumonia.
• Q: What is the scientific consensus on Covid vaccines?
  A: Extensive research has found that Covid vaccines are safe for children and protect against severe illness.
• Q: What is the reaction from former FDA officials to the memo?
  A: Dr. Peter Marks, the FDA’s former vaccine chief, said the agency is misusing the database and the claims are right out of what he calls the “anti-vaccine playbook.”