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FDA signals sweeping changes in vaccine policy

FDA vaccines chief says internal review found 10 child deaths linked to Covid shots
Shift would remake flu immunization strategy and tighten standards for all vaccines
Public-health experts question the claims and warn of confusion, lack of evidence

The Food and Drug Administration is moving ahead with plans to upend its approach to immunizations for respiratory illnessesincluding seasonal flu vaccines. Health Secretary Robert F. Kennedy Jr., an attorney with no medical training, is a longtime vaccine skeptic.

The latest development is an email sent to FDA staff by the agencys vaccines division director, Dr. Vinay Prasad, claiming that 10 children had died as a result of Covid vaccination, the Wall Street Journal reported. He did not provide evidence, methodology or case details to support the claim, which he said was based on initial analysis of reports submitted to an FDA safety-monitoring system. Such reports, experts note, can be incomplete, unverified or inaccurate.

Prasad wrote that the revelation marked the first time the U.S. FDA will acknowledge that Covid-19 vaccines have killed American children, adding: The truth is we do not know if we saved lives on balance. The email also criticized Biden-era vaccine mandates.

Policy shift follows broader changes under HHS leadership

The proposal is the latest in a series of dramatic shifts on vaccine policy under Kennedy's leadership.

Kennedy has already announced that the U.S. would drop recommendations for pregnant women and children to receive Covid shots. In September, a vaccine advisory panel he reassembled voted to scrap affirmative recommendations for adults; instead, Covid vaccination would be left to individual decision-making between clinicians and patients.

The changes outlined in Prasads email would have far-reaching effects. He said the FDA will revise the annual flu vaccine framework, calling the current model a catastrophe of low-quality evidence. Manufacturers would be required to submit larger studies on multiple vaccines administered at once, and the agency would demand broader clinical trials before expanding approvals to populations such as children and pregnant women.

Prior promises will be null and void, he wrote regarding vaccine approvals in pregnancy.

Experts question data and warn of public confusion

The claims also drew pushback from infectious-disease specialists. Dr. Paul Offit, a vaccine expert at the Childrens Hospital of Philadelphia, said Prasad should have published any findings in a peer-reviewed journal where scientists could vet the evidence.

You dont know what data he has. What does this do? All it does is scare people, Offit said. Its just dangerous and irresponsible.

Previous analyses by the U.S. government, the World Health Organization and independent researchers have found serious side effects from Covid vaccines to be rare, with benefits generally outweighing risks. A 2023 meta-analysis reviewed four reported child deaths following Covid vaccination; two involved children with complex medical histories, one childs autopsy showed a flu infection, and a fourth case remained under review.

Vaccine makers respond cautiously

A spokesman for Moderna pointed to a September statement saying the company was aware of no new safety concerns, including deaths, related to its Covid vaccine. Pfizer and Novavax, which also supply vaccines to the U.S., did not respond to inquiries.

The proposed FDA overhaul is likely to reshape how vaccines are evaluated, developed and recommended in the U.S.and to spark fierce debate over the evidence used to guide those decisions.