In a move that has sent ripples through the medical and scientific communities, the U.S. Food and Drug Administration (FDA) acknowledged in an internal memo that at least 10 children died after receiving COVID-19 vaccines between 2021 and 2024. The revelation, detailed in a memo signed by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), has sparked intense debate about vaccine safety, regulatory transparency, and the future of immunization policy in the United States.
According to Straight Arrow News, the memo circulated on December 4, 2025, stated: “These deaths are related to vaccination (likely/probable/possible attribution made by staff). This is a profound revelation. For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.” The children, aged seven to sixteen, were identified through an FDA analysis of the Vaccine Adverse Event Reporting System (VAERS), a national surveillance platform that collects reports of potential side effects following vaccination.
VAERS, jointly run by the FDA and the Centers for Disease Control and Prevention (CDC), is an open-access database where anyone—including healthcare providers, parents, and even the general public—can submit a report of an adverse event after vaccination. However, these reports are unverified and require further investigation to determine causality. As noted by Straight Arrow News, the database is “an imperfect source,” and raw reports do not automatically indicate that a vaccine caused a particular outcome.
The FDA’s internal review considered 96 child deaths reported to VAERS between 2021 and 2024, ultimately concluding that 10 were related to COVID-19 vaccination. Yet, the memo did not provide details on the children’s cases, the type of vaccines administered, or the methods used to establish causality. “Currently, this is a completely unfounded claim unless they publish the report with data, methods and procedures to establish causality,” said Domenico Motola, an associate professor of pharmacology in Italy who has analyzed VAERS data, in comments to Straight Arrow News.
Further scrutiny came from Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, who told Stat News, “It’s irresponsible science at best and it’s dangerous to the public at the very least.” Peter Marks, the FDA’s former vaccine chief, was even more blunt, telling NBC News, “This memo conveys a very troubling mixture of misrepresentation and lies. The climate within the agency is incredibly toxic right now.”
The lack of transparency has drawn criticism from both inside and outside the agency. Paul Offit, an infectious diseases physician at Children’s Hospital of Philadelphia, told The Guardian, “When you make that kind of sensational claim, I think it’s incumbent upon you to provide evidence that supports that claim. He didn’t supply any evidence.” The memo, sent to all FDA staff without prior consultation with the Vaccines and Related Biological Products Advisory Committee (VRBPAC) or public data release, was described as highly unusual by Dan Jernigan, former director of the National Center for Emerging and Zoonotic Infectious Diseases.
Adding to the controversy, Prasad’s memo suggested that the actual number of child deaths could be higher, stating, “That number is certainly an underestimate due to underreporting, and inherent bias in attribution.” Yet, as critics pointed out, VAERS is susceptible to both underreporting and overreporting, and the lack of clear methodology or peer-reviewed data leaves the true risk uncertain.
Straight Arrow News conducted its own analysis of VAERS data from 2021 to 2025, identifying 83 reports of children dying within two weeks of vaccination, including 34 following COVID-19 vaccines (26 Pfizer, 8 Moderna). The analysis excluded cases with unrelated causes such as car crashes or suicide. In comparison, 12 deaths were reported following flu vaccination and 9 after Hepatitis A vaccination during the same period. However, as the news outlet emphasized, these are reports, not confirmed cases of causality.
Prasad’s memo also referenced myocarditis, an inflammation of the heart that has been observed as a rare side effect of COVID-19 vaccination, particularly among adolescent boys and young men. In June 2025, the FDA required both Pfizer and Moderna to update their warning labels to reflect this risk, and Pfizer later acknowledged that the risk of myocarditis after COVID-19 infection was about 42 times higher than from vaccination. Multiple studies, including large randomized trials, have generally concluded that COVID-19 vaccines are safe, with serious side effects being rare. A review of several studies estimated that between 12 and 118 children per million experienced myopericarditis after vaccination.
Despite the memo’s implications, the broader context is stark: over 1 million Americans died from COVID-19 between 2019 and 2023, including more than 1,600 children, according to the CDC. National seroprevalence studies have estimated that the risk of death from COVID-19 infection among children is extremely low, with one international study reporting just three deaths per million infections among those aged 0–19 years. As Motola told Straight Arrow News, “It’s always a balance of benefits versus possible risks. Zero risk doesn’t exist in nature.”
Tracing the origins of the FDA’s new approach, Prasad credited FDA commissioner Marty Makary for identifying the child deaths and promised regulatory changes to prevent similar oversights in the future. Tracy Beth Høeg, a sports medicine physician and now senior adviser for clinical sciences at the FDA, led the investigation over the summer, according to The Guardian. Yet, the lack of detail about the investigation’s findings and future regulatory changes has left many experts worried. “The ultimate outcome will be fewer vaccines and more vaccine-preventable illness,” Jernigan warned.
Prasad’s memo also touched on topics frequently cited by vaccine skeptics, such as the potential risks of administering multiple vaccines simultaneously, though he offered no evidence for harm. Dorit Reiss, professor of law at UC Hastings College of Law, told The Guardian, “Concomitant vaccines have been used with the existing system for a long time with no evidence of harm. Changing that without evidence of harm will make it harder to put vaccines on the market.”
Moderna, in a September 2025 statement, reaffirmed the safety of its COVID-19 vaccine, citing “multiple, overlapping safety monitoring systems” and more than one billion doses distributed globally without new or undisclosed safety concerns in children. The CDC and FDA declined to comment to Straight Arrow News and The Guardian regarding the specifics of the memo or the evidence behind it.
As the debate continues, the stakes remain high. Offit emphasized, “Children are getting hospitalized and children are still dying from this virus.” Jernigan echoed the sentiment, noting that the confusion makes it harder for both the public and physicians to know which recommendations to follow and whom to trust. With the regulatory landscape in flux and public confidence on the line, the future of vaccine policy in the United States is anything but certain.
