WASHINGTON, D.C. — A major policy shift inside the Food and Drug Administration has sparked controversy after top officials appointed under Health and Human Services Secretary Robert F. Kennedy Jr. overrode internal experts to restrict the approval of COVID-19 vaccines for broad public use.
The move, revealed through internal FDA records released this week, shows that newly appointed FDA leadership significantly narrowed approvals for vaccines by Novavax and Moderna, despite contrary recommendations from the agency’s career scientists.
Novavax Approval Limited to Seniors and At-Risk Groups
In May, the FDA approved Novavax’s COVID-19 shot but restricted its use to only seniors aged 65 and older and individuals at high risk of severe illness. The decision marked a departure from the company’s request for broader approval for everyone 12 years and older.
Dr. Vinay Prasad, who replaced longtime vaccine chief Dr. Peter Marks and now serves as the FDA’s Chief Medical and Scientific Officer, wrote in an internal memo that the reduced threat of COVID-19 and potential unknown risks associated with vaccines diminished the overall benefit for younger, healthier individuals.
“Even rare vaccination-related harms, both known and unknown, now have a higher chance of outweighing potential benefits in non-high-risk populations,” wrote Prasad in the memo, citing a “fundamental change in the benefit-risk calculation.”
This decision overruled a recommendation from FDA career scientists, who had concluded the data from Novavax supported approval for all people 12 and older.
Moderna Shot Also Blocked From Broad Approval
The same policy direction was applied to Moderna’s latest COVID-19 vaccine. A separate override memo from Dr. Prasad dated May 30 imposed similar restrictions for seniors and those with underlying conditions, rejecting broader access for the general public.
Both override memos were released by the FDA and reviewed by outlets including CBS News. Critics say this signals an unusual political influence on decisions traditionally made by career civil servants.
“The tradition in 99.95% of FDA decisions about individual products is that those decisions are made by career civil servants,” said former FDA Commissioner Dr. Robert Califf during a public event last year.
Political Appointees Restructure Vaccine Oversight
These actions are part of a broader pattern under Kennedy’s leadership, which has dismantled long-standing FDA and CDC structures guiding U.S. vaccine policy. Among the changes:
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Firing of the CDC’s vaccine advisory committee
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Removal of top FDA scientists and media liaisons
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Appointment of Dr. Tracy Beth Hoeg, a vaccine skeptic, as the FDA commissioner’s special assistant
Despite internal dissent, Kennedy’s HHS has defended these changes, calling the decisions science-driven and aimed at restoring public trust.
“He evaluated the totality of the evidence and made a judgment rooted in gold-standard science. That’s not political — it’s what principled leadership looks like,” an HHS spokesperson told CBS News.
Pushback from Former Officials
Former FDA officials, including Dr. Phil Krause, who resigned under the Biden administration over disagreements with booster policy, are now raising alarms about the current direction under Kennedy.
Critics argue that the administration’s narrow approval policy could undermine public access to vaccines and make the U.S. an outlier compared to other nations.
The FDA’s new framework requires that vaccine makers provide new clinical trial data before gaining broader approval — a standard not typically required for updated vaccines based on existing platforms.
What This Means for Americans
While off-label use of FDA-approved vaccines is still legal, it may not be covered by insurance or protected under liability shields without full CDC recommendation. Experts worry that the added barriers may dissuade providers from offering the shots broadly.
For now, only seniors and high-risk groups are cleared to receive the most recent vaccines — a significant change in national vaccine strategy.
To review the full FDA override memos and analysis, visit the FDA’s official documents and CBS coverage.
What do you think about the new limits on COVID-19 vaccines under the RFK Jr. administration? Should the FDA follow its career scientists or political appointees? Join the conversation now at ChicagoSuburbanFamily.com.
