FDA Signals Tougher Scrutiny of Vaccines Amid Internal Disputes Over COVID Shot Risks

NEW YORK  – The Food and Drug Administration is preparing to tighten its standards for evaluating vaccines, as senior officials raise new questions about COVID-19 shots for children.

In an interview on Fox News, FDA Commissioner Marty Makary said the agency would no longer “rubber-stamp” vaccines without strong evidence, arguing the old approach “undermined public trust.”

His remarks followed an internal message from Dr. Vinay Prasad, the FDA’s top vaccine regulator, outlining sweeping changes to how the agency reviews immunizations. According to the email, circulated to the agency’s statistics and safety teams and later obtained by reporters, regulators plan to revise flu-shot criteria, overhaul vaccine labeling, and impose stricter requirements for products targeting pregnant women. Companies making pneumonia vaccines would also face tougher proof-of-benefit requirements.

Prasad additionally questioned the long-standing practice of administering several childhood shots during one visit — a cornerstone of modern pediatric immunization.

Public health specialists warn the proposed overhaul could slow approvals and raise costs, potentially reducing vaccine availability. They note that surveillance systems like VAERS and post-marketing studies have long served as guardrails to identify rare problems after shots reach the public.

Internal Review Cites 10 Pediatric Deaths; Experts Demand Evidence

Makary claimed on air that FDA analysts linked the COVID vaccine to 10 deaths among children during the Biden administration, though he did not provide supporting data. Millions of minors have received the shot.

According to Prasad’s email, staff examined 96 reported fatalities between 2021 and 2024 and concluded that 10 were “caused by” the vaccine — while suggesting the true number could be higher. No further documentation has been released.

Several vaccine experts immediately challenged the assertion.
Dr. Paul Offit of the Children’s Hospital of Philadelphia said Prasad has offered “zero proof,” calling the claim irresponsible without the underlying evidence.

Dr. Jesse Goodman, a former head of the FDA’s biologics division, defended the agency’s traditional reliance on antibody responses when evaluating pneumonia and influenza vaccines, noting that these measures are backed by decades of science and follow-up studies.

Epidemiologist Michael Osterholm also pushed back, saying the email “mischaracterizes the real toll of COVID-19 on children” and that none of the alleged vaccine-linked pediatric fatalities have been reviewed by outside experts or published in medical literature.

Surveillance Data and Vaccine Policy Under Review

VAERS, the federal database tracking adverse events, is publicly accessible but does not confirm cause-and-effect. FDA guidance cautions that reports alone cannot establish whether a vaccine is responsible for an outcome.

Makary argued the early COVID shots delivered strong protection for vulnerable adults in 2020 but said the scientific basis for continued childhood boosters is weak. “We need solid evidence before approving annual doses for healthy young kids,” he said.

The debate comes as the CDC’s Advisory Committee on Immunization Practices prepares for a pivotal meeting Dec. 4–5, where members will re-examine the childhood vaccination schedule. Officials appointed by Health Secretary Robert F. Kennedy Jr. have suggested adjustments that could stagger doses or alter formulations — moves critics warn could reduce childhood coverage and invite the return of preventable diseases.

Industry Pushes Back

A Moderna spokesperson, responding to the claims about pediatric deaths, said the company has seen no evidence supporting them and cited multiple peer-reviewed studies affirming the shot’s safety. With over a billion doses administered worldwide, the company said international health authorities in the U.S., Europe, Canada, Australia, and elsewhere have not identified new safety concerns for children or pregnant women.