WASHINGTON — The U.S. government’s top vaccine authority is reevaluating the approval of two COVID-19 vaccines, revealing a departure from the recommendations of agency scientists. Recent documents from the Food and Drug Administration highlight that Dr. Vinay Prasad, the FDA’s vaccine chief, has opted to impose restrictions on vaccines developed by Novavax and Moderna, potentially impacting vaccination strategies as COVID-19 persists as a public health concern.
Approved in May after extensive evaluations, both vaccines were initially recommended for individuals aged 12 and older. However, internal communications reveal that Prasad disagreed with this broad approval, suggesting that the vaccines should instead be reserved for high-risk groups, including seniors and individuals with pre-existing health conditions. He expressed concerns about balancing potential vaccine side effects with the benefits, citing a notable decline in hospitalization and mortality rates from COVID-19.
In a memo detailing his rationale, Prasad wrote that the risks associated with vaccination, even if rare, must now be weighed against the improving public health landscape. He indicated that the rare occurrences of side effects might outweigh the vaccines’ preventive advantages for most healthy individuals.
COVID-19 continues to pose significant dangers, with recent data from the Centers for Disease Control and Prevention indicating that between 32,000 and 51,000 deaths occurred in the U.S. from the virus since last fall. The groups most affected tend to be seniors and children under two years old, particularly infants. The FDA leadership typically refrains from direct involvement in individual product evaluations, making Prasad’s intervention noteworthy amid ongoing disputes within the agency.
Prasad, who took over the vaccine division in May after the previous director’s resignation, earned recognition for his criticisms of existing public health policies throughout the pandemic. He has since collaborated with FDA Commissioner Mark Makary to establish guidelines that would restrict future COVID-19 booster approvals primarily to those at higher risk.
The limitations align with the FDA’s recent decisions regarding the Novavax and Moderna vaccines. Novavax’s product, the only protein-based coronavirus vaccine available in the U.S., and the updated version of Moderna’s mRNA vaccine, both share similar safety profiles and efficacy ratings as their predecessors. Evaluations of the Novavax vaccine, based on data from a study comprising 30,000 participants, affirmed a favorable risk-benefit balance.
Last week, the FDA released updated warning labels for the Moderna and Pfizer mRNA vaccines, outlining the rare but serious risk of myocarditis, an inflammatory heart condition. In his memo, which overturned earlier staff conclusions about Moderna, Prasad emphasized the need for further studies on myocarditis to inform future approvals.
Concerns regarding myocarditis have led to additional scrutiny of vaccine safety. However, many researchers have noted that such cases generally resolve quickly and are typically less severe than complications linked to COVID-19 itself, which can also cause myocarditis.
In light of these developments, the U.S. administration has reiterated its commitment to ensuring that scientific integrity underpins all vaccine-related decisions. As the public health landscape evolves, officials continue to navigate the complexities of vaccine approval amid ongoing debates about their benefits and risks.