FDA Official Alleges COVID-19 Vaccine Link to Child Deaths Without Data
Dr. Vinay Prasad, the director of the FDA’s vaccine division, recently circulated a memo that raised concerns about a possible link between COVID-19 vaccinations and child mortality. According to sources familiar with the memo, it claimed that at least 10 children died following vaccination. However, the memo did not include supporting data or specific details regarding the children involved.
Concerns Over Myocarditis
In his memo, Prasad suggested the deaths might be related to myocarditis, an inflammation of the heart muscle. Despite this claim, he did not disclose any case data, such as the ages of the children or any pre-existing health issues. The link between myocarditis and COVID-19 vaccination is acknowledged, but numerous studies indicate that the risk is significantly higher following a COVID-19 infection.
Prognosis and Risks
- Studies show better outcomes for myocarditis cases due to vaccination compared to those from infections.
- COVID-19 infection has also been associated with long-term complications.
- The risk of myocarditis appears higher when vaccine doses are administered closer together.
- Receiving the vaccine series before age 5 significantly reduces the risk of myocarditis.
Safety Warnings on Vaccines
The Pfizer and Moderna COVID-19 vaccines include warnings about myocarditis and pericarditis, an inflammation of the heart’s protective membrane. In April 2025, these warnings were expanded to include males aged 16 to 25. The FDA reported approximately 8 cases of myocarditis per million doses for both children and adults under 65 years after that season’s vaccinations.
Shifts in Vaccine Guidance
Under the current administration, led by Health and Human Services Secretary Robert F. Kennedy Jr., significant changes to vaccine approvals and recommendations have occurred. High-ranking officials have limited the approvals of certain vaccines, causing tensions within the FDA. Additionally, in June, a CDC official resigned amid controversies regarding updated vaccine recommendations mandated by Kennedy.
Confusing Guidance for the Public
The CDC’s Advisory Committee on Immunization Practices (ACIP) recently voted to alter vaccination recommendations. All committee members have been selected by Kennedy, who has expressed skepticism toward vaccines. The updated CDC guidance encourages individuals to make informed vaccination decisions but stops short of a direct recommendation for the COVID-19 shots.
In contrast, the American Academy of Pediatrics strongly advocates for vaccinations in children aged 6 months to 2 years, while the Infectious Diseases Society of America recommends vaccination for everyone over six months. Various state governments have formed alliances, such as the West Coast Health Alliance and the Northeast Public Health Collaborative, to provide differing recommendations from the CDC.
Expert Advice for Parents
Dr. Céline Gounder, medical contributor for CBS News, noted the ongoing confusion surrounding vaccine information. She advises parents to consult with their healthcare provider to ensure that their children receive all necessary vaccinations, including the primary COVID-19 vaccination series. This guidance aims to clarify the best path forward for public health amid evolving vaccine discussions.