The U.S. Food and Drug Administration (FDA) is facing its most significant reckoning in years as it moves to tighten vaccine approval standards, following an internal review that has ignited fierce debate within the medical and regulatory communities. The controversy centers on an internal memo, authored by Dr. Vinay Prasad, the FDA’s director of vaccine regulation, which claims that COVID-19 vaccines were linked to the deaths of at least 10 children—a claim that has both alarmed and infuriated public health experts, vaccine manufacturers, and former FDA officials.
On November 29, 2025, FDA Commissioner Marty Makary publicly announced on Fox News that the agency would no longer “rubber-stamp” vaccines without robust supporting evidence. Makary argued that previous fast-track approvals “undermined public trust,” and he pledged a more rigorous, transparent approach going forward. According to Fox News, Makary said, “We need solid evidence before approving annual doses for healthy young kids.”
This announcement followed the circulation of Dr. Prasad’s 3,000-word internal memo, which was obtained by several U.S. media outlets. In the memo, Prasad revealed that FDA analysts had reviewed 96 reported fatalities among children between 2021 and 2024, concluding that 10 of these deaths were “caused by” COVID-19 vaccines. He cited myocarditis, an inflammation of the heart muscle, as a key factor. Prasad wrote, according to The New York Times, that the FDA would “for the first time” acknowledge that COVID-19 vaccines have killed American children, calling it “a profound revelation.”
Prasad’s memo did not stop at linking vaccines to these deaths. He proposed a sweeping overhaul of the FDA’s vaccine approval protocols, including reassessment of annual flu shot frameworks, increased scrutiny of simultaneous vaccine administration (a mainstay of modern pediatric immunization), and demands for more comprehensive safety and efficacy data from manufacturers. He argued that companies producing pneumonia vaccines should be required to demonstrate reductions in actual pneumonia cases, not just increases in antibody levels.
The proposals also include stricter requirements for vaccines targeting pregnant women and revised protocols for reporting adverse reactions. Prasad’s message was unequivocal: staff who disagreed with his core principles should consider submitting their resignations. According to The Washington Post, Prasad’s recommendations could force manufacturers to run significantly larger studies, potentially slowing vaccine development and deterring innovation.
The FDA’s internal debate comes at a pivotal moment. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is scheduled to review the entire childhood vaccination schedule on December 4–5, 2025. Some officials, appointed by Health Secretary Robert F. Kennedy Jr.—a known vaccine skeptic and supporter of Prasad’s views—have suggested changes that could stagger vaccine doses or alter formulations. Critics warn these moves could reduce childhood coverage and risk the return of preventable diseases.
Public health experts have responded with alarm to the FDA’s internal findings and Prasad’s proposals. Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told NPR that Prasad’s memo amounted to “science by press release,” describing it as “irresponsible” and “dangerous.” Offit emphasized that Prasad had offered “zero proof,” adding, “Because he doesn’t provide any evidence, he is asking us to trust him on an important issue. All this will do is scare people unnecessarily.”
Other experts echoed Offit’s concerns. Dr. Jesse Goodman, former head of the FDA’s biologics division, defended the agency’s traditional standards, explaining to NPR that existing rules are already “quite strict.” Goodman noted, “It’s not like these things are being approved without strong scientific evidence. They’re being approved with strong scientific evidence.” He also pointed out that the FDA’s use of antibody responses as approval benchmarks is supported by decades of follow-up studies and post-marketing surveillance.
Michael Osterholm, an epidemiologist at the University of Minnesota, criticized the FDA’s internal analysis for mischaracterizing the risk COVID-19 poses to children and for not subjecting the alleged vaccine-linked deaths to independent scrutiny. He told The New York Times, “We can not accept the fact they are vaccine-associated deaths” until an independent third party reviews the cases. Osterholm also questioned the timing of Prasad’s memo, suggesting it was deliberately released ahead of key internal meetings: “This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events.”
Critics have also highlighted the memo’s reliance on the Vaccine Adverse Event Reporting System (VAERS), a federal database that tracks vaccine-related adverse events but does not confirm causality. As NBC News noted, VAERS reports can be inaccurate, incomplete, or biased. The FDA’s own guidance cautions that these reports alone cannot establish whether a vaccine is responsible for an outcome.
Meanwhile, vaccine manufacturers have pushed back against the FDA’s internal findings. A spokesperson for Moderna stated that the company has seen “no evidence” supporting claims of vaccine-linked pediatric deaths and cited multiple peer-reviewed studies affirming the shot’s safety. Moderna emphasized that more than a billion doses have been administered worldwide and that international health authorities—including those in the U.S., Europe, Canada, and Australia—have not identified new safety concerns for children or pregnant women.
Healthcare providers and vaccine manufacturers now face the challenge of adapting to the FDA’s stricter standards. The new regulations call for greater transparency, increased scrutiny of vaccine data, stronger child safety requirements in trials, and revised protocols for reporting adverse reactions. The FDA has signaled it will no longer accept minimal evidence for vaccine approvals, especially for vulnerable populations like children and pregnant women.
As the agency navigates these changes, the stakes are high. Public trust in vaccines has already been tested by the COVID-19 pandemic and the proliferation of misinformation. While the FDA’s stated goal is to protect vulnerable groups and restore confidence in the regulatory process, some experts worry that the heightened scrutiny could inadvertently slow the rollout of life-saving vaccines and undermine decades of progress in public health.
For now, all eyes are on the upcoming CDC advisory meeting and the FDA’s next steps. The outcome could reshape not only how vaccines are approved in the United States but also how the public perceives their safety. One thing is clear: the debate over vaccine standards is far from settled, and its impact will be felt for years to come.
