Introduction to the FDA’s Claims on Covid Shots
The director of the Food and Drug Administration’s vaccine division, Dr. Vinay Prasad, has stated in a memo to agency staff that an internal review found that at least 10 children died “after and because of receiving” the Covid vaccine. This 3,000-word memo, obtained by NBC News, was written by Dr. Prasad, who is the 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 on a 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. The memo is a profound revelation, as stated by Prasad, who wrote, “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.
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. Dr. Paul Offit, a pediatrician and the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, called the memo “irresponsible” and “dangerous,” saying, “This is sort of science by press release.” 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.”
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, including revisiting how annual flu shots are evaluated and requiring pneumonia vaccine makers to show their products reduce pneumonia. 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.
Conclusion
The FDA’s claims that Covid shots killed 10 children have sparked controversy and debate among experts. While the memo presents a troubling picture, many experts argue that it misuses information from VAERS and ignores the extensive research that has found the Covid vaccines to be safe for children. The proposed changes to how the FDA evaluates vaccines have also raised concerns, with some arguing that they are based on ideology rather than science. As the FDA and CDC continue to review the safety of Covid vaccines, it is essential to rely on credible sources and peer-reviewed research to inform decisions.
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: How many of these deaths were determined to be related to Covid vaccination?
A: According to the memo, at least 10 of these deaths were determined to be related to Covid vaccination. - Q: What is the basis for the claim that Covid vaccines are linked to myocarditis?
A: The memo suggests that the child deaths were tied to myocarditis, but it does not include evidence to support this claim. - Q: What are the proposed changes to how the FDA evaluates vaccines?
A: The proposed changes include revisiting how annual flu shots are evaluated and requiring pneumonia vaccine makers to show their products reduce pneumonia. - Q: What is the reaction of experts to the memo?
A: Many experts have pushed back against the memo, arguing that it misuses information from VAERS and ignores the extensive research that has found the Covid vaccines to be safe for children.
