The Food and Drug Administration is preparing to overhaul how it evaluates vaccines, signaling a far stricter approach after senior officials publicly questioned the safety of COVID immunizations for children. FDA Commissioner Marty Makary laid out the agency’s new posture during a Fox News appearance, declaring that the FDA would no longer “rubber-stamp new products that don’t work,” adding that doing so made a “mockery of science.”
His remarks followed the leak of an internal message from Dr. Vinay Prasad, the FDA’s top vaccine regulator, who told his staff the agency would tighten its annual influenza vaccine system, revise product labels to be “honest,” and impose tougher standards across multiple vaccine categories. The email, reviewed by NPR and initially reported by PBS News Hour, outlined substantial changes to the agency’s internal framework.
In that message, Prasad informed regulators that authorization for vaccines marketed to pregnant women would now require additional layers of evidence. He also said that companies producing pneumococcal vaccines would have to demonstrate actual reductions in illness rather than rely on antibody data. He raised concerns as well about the long-standing practice of administering several vaccines simultaneously.
Such revisions could greatly extend the time, cost, and difficulty of bringing vaccines to market, potentially shrinking the pool of available products. Public health leaders have long argued that the existing FDA model—requiring extensive pre-approval testing and continuous safety monitoring through mechanisms like the Vaccine Adverse Event Reporting System—has proven that vaccines overwhelmingly protect far more than they harm.
On Fox News, Makary asserted that 10 children died from the COVID vaccine during the Biden administration, though he did not provide evidence supporting how that determination was reached. The vast majority of U.S. children have received the COVID shot without any confirmed fatal complications. Federal health agencies did not immediately comment on Makary’s claim or on the email laying out the FDA’s prospective changes.
According to Prasad’s email, FDA analysts reviewed 96 deaths reported between 2021 and 2024 and concluded that 10 children died “after and because of” the COVID vaccine—a number Prasad wrote was likely an undercount. The message did not include the underlying data or methodology.
The lack of documentation drew sharp criticism from experts. Dr. Paul Offit of the Children’s Hospital of Philadelphia said via text that Prasad has not supplied the evidence behind the alleged 10 vaccine-linked deaths. “Because he doesn’t provide any evidence, he is asking us to trust him on an important issue,” Offit said. “All this will do is scare people unnecessarily. At the very least, he should provide all the evidence he has so that experts in the field can review it and decide whether he has enough data to prove his point.”
Dr. Jesse Goodman of Georgetown University, who previously led the FDA’s vaccine office, also pushed back on Prasad’s assertions. He emphasized that the FDA’s biologics division has long been seen as a worldwide regulatory benchmark and defended the use of “immunologic endpoints like antibody levels” to expedite approvals for pneumonia and flu vaccines. These standards, he said, have reliably delivered safe, effective shots while still being validated by post-approval research: “These approaches have helped provide children and adults with timely access to safe and effective vaccines, saving many lives.”
Michael Osterholm, an epidemiologist at the University of Minnesota, reviewed the internal email and flatly disputed Prasad’s claim that “COVID-19 was never highly lethal for children,” pointing to CDC figures showing 1,597 pediatric deaths from 2020 to 2022. He also questioned the FDA’s conclusion regarding the 10 reported cases. “Prasad’s email is filled with factual mistakes and misrepresents both the severity of COVID in children…,” Osterholm wrote to NPR. He added that none of the cases have ever been published or presented to medical experts and argued, “until these cases have been reviewed by an expert third party, like the National Academy of Science[s], we can not accept the fact they are vaccine-associated deaths.”
The FDA continues to make VAERS data public while consistently warning that the system cannot determine causation. As the agency notes, “it is important to note that for any reported event, no cause and effect relationship has been established.” Prasad acknowledged in his email that assessing causality with case reports often involves subjective judgment.
Makary told Fox News that while the COVID shot proved “amazing” for individuals at high risk early in the pandemic, the scientific landscape has shifted. “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. And so we’re not going to just rubber stamp approvals without seeing some scientific evidence.”
This stance marks the latest chapter in a broader movement by officials in the Trump administration questioning aspects of vaccine safety and regulation. Health Secretary Robert F. Kennedy Jr. has publicly expressed skepticism about vaccines for years. The FDA already moved in August to narrow eligibility for the updated COVID vaccine and announced it would require stronger evidence before future approvals.
The email outlining revised vaccine standards surfaces just as the CDC prepares for a pivotal December 4–5 meeting of its Advisory Committee on Immunization Practices. The panel is reevaluating how children receive critical protections against measles, mumps, rubella, hepatitis B, polio, and other diseases. Many in the medical community fear the committee may consider delaying doses, spacing out the schedule, or recommending changes to formulations—steps that could reduce childhood vaccination coverage and open the door to outbreaks of previously contained illnesses.
Moderna, whose pediatric COVID vaccine is authorized for children as young as six months, responded to Makary and Prasad’s allegations by pointing to a statement the company issued in September. Moderna said extensive peer-reviewed research from numerous sources confirms the shot’s safety and that it is “not aware of any deaths in the last year or pertinent new information from prior years.” The company said it works with regulators in more than 90 countries and that “with more than one billion doses distributed globally… these systems… have not reported any new or undisclosed safety concerns in children or in pregnant women.”
{Matzav.com}
