Senior officials at the Food and Drug Administration appointed by the Trump administration, under Health and Human Services Secretary Robert F. Kennedy Jr., went against the agency’s career staff to restrict the approvals of COVID-19 vaccines from Novavax and Moderna, as per FDA records. Following Novavax’s approval in May, the shot’s labeling was narrowed to only include seniors aged 65 and older and those at risk of severe disease, a move that was opposed by the FDA’s Dr. Vinay Prasad. Prasad, who took over from Dr. Peter Marks earlier this year, disagreed with the agency’s career vaccine reviewers. He later assumed the roles of other top FDA officials who had departed during the Trump administration.
Novavax had sought approval for its vaccine for individuals aged 12 and older, transitioning from emergency use authorizations to a traditional approval. However, Prasad raised concerns about the data submitted by Novavax, noting a decrease in the risk of severe COVID-19 in the U.S. population. He highlighted safety issues that he believed changed the risk-benefit assessment for non-high-risk individuals.
A memo from Captain Edward Wolfgang, head of the review team for Novavax’s vaccine, revealed that the decision to limit the approval to certain groups was made following requests from Prasad and the special assistant to the FDA commissioner. This decision contradicted the initial recommendation by the agency’s career scientists, who had suggested broad approval for individuals aged 12 and older based on the data submitted and the ongoing public health threat posed by COVID-19.
Similar rationale was used for the approval of Moderna’s new COVID-19 vaccine for seniors aged 65 and older and individuals with underlying conditions down to age 12. Prasad disagreed with aspects of the review team’s conclusions and intervened to restrict the approval, citing concerns about safety and efficacy.
Reports have indicated that Prasad and his team’s actions led to delays in the approval of Novavax’s vaccine. Under Prasad’s predecessor, Dr. Peter Marks, such interventions were infrequent but not unprecedented within the Center for Biologics Evaluation and Research.
Research is being conducted to influence decisions regarding the approval of vaccines. While it is highly unusual for the FDA commissioner or their political appointees to directly intervene in or question traditional approval processes, FDA officials have stated that the majority of decisions regarding individual products are typically made by career civil servants. The commissioner’s involvement would only occur in cases of internal or external appeals that reach the commissioner level, as explained by Dr. Robert Califf, the former FDA commissioner under the Biden administration.
Criticism of the agency has surfaced in the past, with FDA Commissioner Dr. Marty Makary often referring to a decision made by another official to authorize booster shots during the COVID-19 pandemic, which resulted in the dismissal of two senior vaccines officials who raised concerns. One of these former officials, Dr. Phil Krause, is now criticizing the actions taken by Makary and his associates, fearing that they may undermine the agency’s credibility.
Under new leadership, the FDA has made unprecedented moves to exert control over the country’s vaccine procedures. Before dismissing the Centers for Disease Control and Prevention’s vaccine advisory committee and appointing a new panel, the FDA replaced the career liaison to the CDC with Dr. Tracy Beth Hoeg, who serves as a special assistant to the FDA commissioner. Hoeg, along with Makary, has questioned the FDA’s handling of vaccine approvals during the pandemic.
In response to claims of overruling FDA scientists, a spokesperson for the Department of Health and Human Services defended the decision-making process as rooted in solid scientific evidence rather than political motives. They emphasized the agency’s commitment to evidence-based decision-making and refuted allegations of political interference.
Makary and Prasad, in collaboration with others appointed by the new leadership, have proposed a revised framework that would restrict COVID-19 vaccine approvals to seniors and high-risk individuals unless additional clinical trial data is provided by vaccine manufacturers. This approach aims to rebuild trust in science through data transparency and principled decision-making.
FDA approvals determine whether vaccine manufacturers can distribute their products in the U.S. market. Subsequent CDC recommendations, which are closely linked to federal policies on vaccine access, influence how vaccines are utilized by healthcare providers. While providers can administer vaccines beyond FDA and CDC guidelines, doing so may pose challenges related to insurance coverage and legal liabilities.
House Speaker Mike Johnson spoke following the final passage of the Trump budget bill. The June jobs report showed stronger results than anticipated.
