Food and Drug Administration (FDA) Commissioner Marty Makary and his new vaccines chief reportedly boxed longtime bureaucrats out of the recent decision to require more data to support COVID-19 booster shots, the Wall Street Journal reported Tuesday.
Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England Journal of Medicine on May 20 requiring a stronger evidence base for boosters in healthy adults and children — a departure from what they described as the Biden administration’s “repeat-boosters-in-perpetuity strategy.”
This framework was unveiled without input or interference from FDA career staffers, according to the WSJ.
The top FDA officials outlined their expectations to vaccine manufacturers, stating that they do not expect to approve new COVID-19 boosters for use in adults and children with no preexisting conditions without new clinical trials. Many high-income countries like the United Kingdom and Australia do not recommend booster shots for these populations.
Some FDA bureaucrats are looking to exit into the pharmaceutical industry under the new leadership, the WSJ reported. Many drug reviewers have opted to recuse themselves in recent months, a signal they are meeting with drugmakers about new jobs. Makary meanwhile is seeking to shore up morale, frequently lauding staffers on a new FDA podcast.
The FDA also announced on Tuesday more nimble approvals for companies aligned with the administration’s priorities on addressing a health crisis or unmet needs, delivering innovation or increasing domestic manufacturing.
The Department of Health and Human Services (HHS) did not respond to a request for comment.
In another editorial in the Journal of the American Medical Association on June 10, Makary and Prasad said that they intend to improve FDA surveillance of drug side effects missed in pharmaceutical clinical trials with “Big Data.”
In the most recent @JAMA_current, I outline our priorities for a new FDA, incorporating the two guiding principles of our philosophy: gold-standard science and common sense. https://t.co/wQnSnUtCfp
— Dr. Marty Makary (@DrMakaryFDA) June 10, 2025
“Postapproval monitoring in Big Data will allow the FDA and researchers to see safety signals in real time and evaluate effectiveness in the real world,” the editorial reads.
Former FDA Center for Biologics Evaluation and Research Director Peter Marks resigned from his post in March in opposition to what he described as HHS Secretary Robert F. Kennedy Jr.’s “unprecedented assault on scientific truth,” particularly on vaccines.
Yet a recent Senate investigation found that Marks and other longtime FDA officials downplayed the risks of myocarditis and pericarditis — inflammation of the heart — following COVID vaccination. The risk to young men was first flagged to the Centers for Disease Control and Prevention (CDC) by February 2021, but the FDA bureaucrats dithered about a formal warning for months, the Senate committee’s report alleges.
The news comes amid a shakeup of the CDC’s Advisory Committee on Immunization Practices (ACIP) prompted by Kennedy’s concerns about member ties to the pharmaceutical industry.
The @NYTimes and other Pharma-funded MSM outlets contacted my office this morning, feigning indignation that @RWMaloneMD has a conflict that they suggest might impair his scientific judgment as a member of the new ACIP panel.
The NY Times’ sudden squeamishness about conflicts of…
— Secretary Kennedy (@SecKennedy) June 13, 2025
The ACIP is set to meet June 25 to 27.
Editor’s note: This article has been updated to reflect an announcement from the FDA.
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