WASHINGTON, D.C. — The director of the Food and Drug Administration’s (FDA) vaccine division, Dr. Vinay Prasad, sent a highly contested internal memo to agency staff this week, claiming a link between the COVID-19 vaccine and the deaths of multiple children.
According to sources familiar with the email, and first reported by The New York Times, the memo states that a review “found that at least 10 children have died after and because of receiving COVID-19 vaccination.” Dr. Prasad suggested the deaths were related to myocarditis, or the inflammation of the heart muscle.
Lack of Supporting Data Raises Concerns
The memo has generated immediate controversy because Dr. Prasad did not include any detailed data to support the claim. The document reportedly lacked critical information, including:
- The ages or pre-existing health conditions of the deceased children.
- The vaccine manufacturer is involved in the cases.
- The methodology used by the FDA to conclusively determine a causal link between the vaccination and the deaths.
Crucially, the findings have not been published in a peer-reviewed medical journal, leading experts to question the process and timing of the revelation.
Myocarditis Risk: Infection vs. Vaccine
While myocarditis is a known, rare side effect of the COVID-19 vaccine, particularly in adolescent males, established studies have consistently found the risk of the condition to be significantly higher following a coronavirus infection than after vaccination. Pediatric cardiologists and various studies have also noted that the prognosis and recovery rate for vaccine-induced myocarditis are generally better than for cases caused by the infection itself.
The FDA and CDC have previously warned of the risk of myocarditis or pericarditis (inflammation of the heart membrane), and in April 2025, expanded the warning to include males aged 16 to 25. Data released at that time suggested the rate of these heart conditions was around 8 cases per million doses for children and adults under 65.
The Advisory Committee on Immunization Practices (ACIP) to the CDC finalized its vote on COVID-19 vaccine recommendations in September 2025, adopting guidance that differs from its previous broad recommendations.
Here is the current status of the ACIP’s new guidance:
- ACIP Vote Date: The committee voted on September 19, 2025.
- Key Change: ACIP unanimously recommended that COVID-19 vaccination be determined by individual decision-making (also known as shared clinical decision-making). This recommendation applies to all individuals six months and older.
- Emphasis on Risk: For people under age 65, the recommendation emphasizes that the risk-benefit of vaccination is most favorable for those at increased risk of severe COVID-19 and least favorable for those not at increased risk.
- Adoption: The CDC immunization schedule officially adopted this individual-based decision-making approach in early October 2025.
- Professional Divergence: This new, more conditional CDC guidance stands in contrast to organizations such as the Infectious Diseases Society of America (IDSA) and the American Academy of Pediatrics (AAP), which continue to strongly recommend the vaccine for all children in certain age groups and for all people over six months old.
The ACIP is scheduled to hold another meeting in early December 2025, after receiving public comments in November.
Policy Shifts Under RFK Jr.’s HHS
This internal memo emerges amidst a broader policy shift within the Department of Health and Human Services (HHS) under Secretary Robert F. Kennedy Jr., a known vaccine skeptic.
- Limited Vaccine Approvals: Top HHS officials have reportedly overridden career staff to impose limits on the approval of COVID-19 vaccines from manufacturers such as Novavax and Moderna.
- CDC Guidance Changes: The Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee (ACIP)—whose members have been selected by Kennedy and include vaccine critics—recently voted to update recommendations. The new CDC guidance encourages people to make individual, informed decisions about COVID-19 vaccination, moving away from a broad recommendation for the shot.
This divergence in guidance has created confusion. In contrast to the updated CDC stance, the American Academy of Pediatrics maintains a “strong recommendation” for the shots for children between six months and two years old, and the Infectious Diseases Society of America recommends the vaccine for everyone six months and older.
However, other pediatricians advised parents to “stick to the course” and consult with their doctors to ensure their children receive all necessary vaccinations, including the initial COVID-19 series, despite “a lot of noise out there.”
