Today's News: FDA Proposes Stricter Vaccine Oversight After Claims of Covid Vaccine-Related Child Deaths
The memo did not provide specific details about the children’s ages, health histories, the methodology used to determine causality, or the vaccine manufacturers involved.
Photo: Melina Mara/The Washington Post
Overview
Date: November 29, 2025
Summary: The Food and Drug Administration’s vaccine division director, Dr. Vinay Prasad, issued an internal memo claiming that an agency review linked at least 10 child deaths to the Covid vaccine, primarily due to myocarditis. This revelation, which lacked specific details and peer review, prompted Dr. Prasad to propose a stricter framework for vaccine approvals, including requirements for larger studies, re-evaluation of annual flu shots, and stricter rules for pregnant women and co-administered vaccines. Health Secretary Robert F. Kennedy Jr., a known vaccine skeptic, champions the new policies.
Sources
The New York Times - F.D.A. Seeks More Oversight of Vaccine Trials and Approvals
NBC News - FDA claims Covid shots killed 10 children and vows new vaccine rules
The Washington Post - Blaming some child deaths on covid shots, FDA vows stricter vaccine rules
The Wall Street Journal - FDA Official Pledges New Vaccine Standards
NPR - FDA to raise hurdles for vaccines, faulting COVID shots for 10 kids’ deaths
Key Points
An internal memo from Dr. Vinay Prasad, director of the Food and Drug Administration’s vaccine division, claims an agency review linked at least 10 child deaths to Covid vaccines, primarily due to myocarditis.
Dr. Prasad’s memo outlines proposed stricter vaccine approval measures, including revising the annual flu vaccine framework, requiring larger studies for vaccine co-administration, demanding more robust efficacy data (e.g., proving disease reduction rather than just antibody generation for pneumonia vaccines), and imposing stricter requirements for approving vaccines for pregnant women.
The memo did not provide specific details about the children’s ages, health histories, the methodology used to determine causality, or the vaccine manufacturers involved, and its findings have not been published in a peer-reviewed medical journal.
Public health experts and former FDA officials widely criticize Dr. Prasad’s claims and the memo’s approach, often describing it as “irresponsible,” “dangerous,” “political,” and an example of “science by press release” due to the lack of supporting evidence and bypassing peer review.
Sources indicate that Dr. Prasad’s findings are based on reports from the Vaccine Adverse Event Reporting System (VAERS), an unverified database that allows anyone to submit reports and explicitly states it cannot establish cause-and-effect.
Experts express concern that the proposed changes could significantly slow down the vaccine approval process, increase costs for manufacturers, discourage innovation, and erode public confidence in vaccines, potentially leading to a resurgence of preventable diseases.
The memo and proposed changes are presented within the context of Health Secretary Robert F. Kennedy Jr.’s broader efforts to question vaccine safety and efficacy, with Dr. Prasad’s approach aligning with these skeptical views. Dr. Prasad’s memo also contained ideological language and directed staff who disagreed with his conclusions to resign.
While Dr. Prasad’s memo raises doubts about Covid vaccine safety for children, public health experts and previous FDA leaders emphasize that Covid vaccines have been extensively studied, are generally safe and effective, and their benefits far outweigh the rare risks.
Unique Highlights
The New York Times specifies that Dr. Prasad’s memo took aim at the Biden administration, claiming mandates “coerced” people to get vaccines. It also states that about 2,100 children have died of Covid since the pandemic began, according to the American Academy of Pediatrics.
NBC News details that 10 of 96 child deaths reported to VAERS between 2021 and 2024 were deemed “related,” with Dr. Prasad suggesting the true numbers could be higher. It highlights Dr. Prasad’s claims that the Biden administration dismissed early safety concerns and criticized former Centers for Disease Control and Prevention Director Rochelle Walensky for “dishonest and manipulative” public comments. NBC News also cites a 2023 JAMA Pediatrics analysis of 17 studies covering over 10 million children, which found lower infection and hospitalization risks for vaccinated kids, and a 2024 Nature Communications study that found no increased risk of serious adverse events in young kids.
The Washington Post mentions that the FDA previously planned to link Covid vaccines to 25 child deaths in a presentation that did not happen, and that CDC staff presented data showing at least 25 children had Covid-associated hospitalizations since July 2023, none of whom were up-to-date on vaccination. The article also notes that Tracy Beth Hoeg, one of Commissioner Marty Makary’s top deputies, began investigating reports of children who had died after receiving a coronavirus vaccine.
The Wall Street Journal mentions that Moderna’s spokesman pointed to a September statement saying the company did not know of any new safety concerns, including deaths, related to its product, and that Pfizer and Novavax did not respond to requests for comment. It also references a 2023 analysis of seven studies that found four child deaths following Covid vaccination, detailing that two had complex medical histories, one had a flu infection, and the fourth’s autopsy was under review.
NPR includes a quote from Commissioner Marty Makary on Fox News, where he stated, “Back in 2020, we saw a reduction in the severity of illness and lives saved, but now recommending that a 6-year-old girl get another 70 million COVID shots – one each year for the rest of her life – is not based on science.” It also reports on the appointment of Ralph Abraham, a Louisiana health official and critic of mass vaccination, as the CDC's new deputy director.
The Guardian quotes Dr. Kathryn Edwards, a vaccine expert, emphasizing that determining the cause of death in cases temporally related to vaccine administration is a very difficult task, best done with an autopsy and ruling out other causes of death. She also states, “We also need to remember that Covid disease caused deaths [in kids], many more than 10.”
Contrasting Details
Causality of Child Deaths: Dr. Vinay Prasad’s memo claims “no fewer than 10” child deaths were “after and because of receiving” the Covid vaccine, attributing them to myocarditis (The New York Times, NBC News, The Washington Post, The Wall Street Journal, NPR, The Guardian). However, former Food and Drug Administration vaccine chief Dr. Peter Marks states that potential deaths had been reviewed by teams at the Food and Drug Administration, the Centers for Disease Control and Prevention, and international bodies, and none were definitively linked to the vaccine (The Washington Post, The Guardian). He also notes that these cases are often complex and attributions may be “debatable” (The New York Times, The Guardian). Dr. Kathryn Edwards also emphasizes that determining the cause of death is a “very difficult task” requiring careful assessment and autopsy (The Guardian).
Severity of Myocarditis: Dr. Paul Offit states that children with vaccine-related myocarditis typically show up at the hospital with cases that resolved quickly. In contrast, he notes that children admitted to hospitals with myocarditis from the virus itself experienced “quite severe” cases requiring intensive care unit admissions (The New York Times). Dr. Peter Marks also highlights that Covid infection is associated with myocarditis, often more severe than cases seen after vaccination (NBC News).
Overall Vaccine Safety and Benefits: Dr. Prasad’s memo and Health Secretary Robert F. Kennedy Jr.’s stance cast doubt on the safety and efficacy of Covid vaccines, suggesting they “may have harmed more children than we saved” (NBC News, The Wall Street Journal). Conversely, public health experts, including Dr. Paul Offit, Dr. Jesse Goodman, and Dr. Peter Hotez, as well as previous analyses by the U.S. government and World Health Organization, consistently state that Covid vaccines have been extensively studied, are safe and effective, and their benefits far outweigh the rare risks (The New York Times, NBC News, The Washington Post, The Wall Street Journal, NPR, The Guardian). NBC News specifically cites studies in JAMA Pediatrics and Nature Communications that found vaccines safe for children and protective against severe illness.
Severity of Covid in Children: Michael Osterholm, an epidemiologist, challenges Dr. Prasad’s statement that “COVID-19 was never highly lethal for children,” citing 1597 child deaths from Covid between 2020 and 2022 (NPR). Dr. Kathryn Edwards also reminds that “Covid disease caused deaths [in kids], many more than 10” (The Guardian).
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