FDA reports deaths of 10 children from Covid shots and promises new vaccine regulations.

The director of the FDAs vaccine division circulated a memo to agency staff asserting that an internal review identified at least 10 child fatalities after and due to receiving the COVID-19 vaccine. The 3,000-word document, obtained by NBC News, was authored by Dr. Vinay Prasad, head of the FDAs Center for Biologics Evaluation and Research.

Prasad states in the memo that agency staff determined no fewer than 10 of 96 child deaths reported to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024 were linked to COVID vaccination. He suggests the actual number may be higher and accuses the agency of overlooking safety concerns for years. The memo, dated Friday, did not disclose the childrens ages, medical history, timelines, documentation, or the vaccine manufacturer.

The findings have not been published in peer-reviewed journals. Experts reviewing the memo caution that it misinterprets VAERS, a self-reported database that accepts submissions from anyone, including patients, caregivers, and doctors. The VAERS website warns that reports may be incomplete, biased, or inaccurate.

Dr. Paul Offit, pediatrician and director of the Vaccine Education Center at Childrens Hospital of Philadelphia, criticized the memo, calling it irresponsible and dangerous, noting that it represents science by press release.

Prasad claims the deaths were associated with myocarditis, inflammation of the heart muscle, but offers no supporting evidence. The FDA referred all media inquiries to the Department of Health and Human Services, which has not immediately responded.

Dr. Peter Marks, former FDA vaccine chief, said the agency is misusing VAERS and that the memo follows an anti-vaccine playbook. He emphasized that VAERS is meant to detect early safety signals, citing its role in identifying rare blood clots linked to Johnson & Johnsons COVID vaccine. Marks also noted that COVID infection itself carries a risk of myocarditis, often more severe than post-vaccine cases.

Prasads memo uses strong ideological language, labeling vaccine mandates as coercive and past FDA decisions as dishonest. He urges staff who disagree with his conclusions to resign and outlines proposed changes to vaccine evaluation, including stricter post-market evidence requirements for flu and pneumonia vaccines. He also criticizes the Biden administration and former CDC Director Rochelle Walensky for allegedly dismissing early safety concerns.

The memo precedes a two-day CDC vaccine advisory meeting scheduled to discuss the childhood vaccination schedule and the hepatitis B shot. Earlier this year, the FDA and CDC limited COVID vaccine eligibility to older adults and those at higher risk of severe illness.

Despite the memo, extensive research supports the safety of COVID vaccines for children. A 2023 JAMA Pediatrics review covering over 10 million children aged 511 found vaccinated kids had lower rates of infection and hospitalization. A 2024 Nature Communications study found no increase in serious adverse events, though it noted a slight rise in myocarditis among teenage boys within the first two days after vaccination.

Analysis: The Controversy Surrounding the FDA Memo on Child Fatalities Linked to COVID Vaccines

The recent memo circulated by Dr. Vinay Prasad, director of the FDA's vaccine division, alleging that at least 10 child fatalities were linked to the COVID-19 vaccine, has ignited a heated debate. The document, obtained by NBC News, claims that the deaths were associated with myocarditis, a rare but serious side effect linked to the vaccine. However, several experts have raised concerns about the accuracy and interpretation of the data presented in the memo.

One of the major issues with Prasad's memo is the reliance on the Vaccine Adverse Event Reporting System (VAERS), a self-reported database known for its potential inaccuracies. Experts, including Dr. Paul Offit, have criticized Prasad for presenting unverified information, with Offit calling the memo "irresponsible" and "dangerous." The VAERS system, while useful for identifying early safety signals, is not designed to confirm causal links, and reports are often incomplete or biased.

Additionally, the memo’s lack of supporting evidence for its claims, particularly regarding myocarditis and its connection to the vaccine, has raised further doubts. Although Prasad suggests a link, he does not provide any concrete data or studies to support his assertions. This omission is crucial, especially considering that the scientific consensus, supported by extensive studies, continues to affirm the safety of COVID-19 vaccines in children.

It is also important to recognize that COVID-19 itself carries a risk of myocarditis, often more severe than the cases associated with vaccination. Dr. Peter Marks, former FDA vaccine chief, pointed out that VAERS was instrumental in identifying safety signals like rare blood clots from the Johnson & Johnson vaccine, yet it is not conclusive evidence of harm. This nuance is often overlooked in discussions fueled by ideological rhetoric, as seen in Prasad’s memo, which has been criticized for using inflammatory language against vaccine mandates and past FDA decisions.

In conclusion, while the concerns raised in Prasad’s memo should not be dismissed outright, the broader context and existing scientific evidence strongly suggest that the benefits of COVID-19 vaccination far outweigh the risks, especially when compared to the dangers posed by the virus itself. As health agencies continue to monitor vaccine safety, it is essential to approach such claims with caution and rely on peer-reviewed data to guide public health decisions.

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