Dr. Vinay Prasad, the top vaccine official at the Food and Drug Administration (FDA), recently overruled internal recommendations from FDA scientists regarding two COVID-19 vaccines. Despite months of analysis and the endorsement of the shots for individuals aged 12 and older, Prasad imposed restrictions limiting the use of vaccines from Novavax and Moderna to those considered high-risk—such as seniors and people with underlying health conditions. These internal decisions, revealed in newly released federal documents, show a shift in the FDA’s vaccine approval policy under the oversight of Health Secretary Robert F. Kennedy Jr.
Prasad Prioritizes Caution, Overrides FDA Scientists Amid Declining COVID Risk Levels
Prasad argued that the current context of the pandemic—marked by declining hospitalizations and death rates—necessitated a reevaluation of the risks versus benefits of the vaccines. He highlighted concerns about rare but possible side effects, such as myocarditis, noting that even infrequent adverse effects could now outweigh the benefits for the general population. In a five-page memo, Prasad emphasized the need for a cautious approach, particularly given the reduced threat posed by the virus to most people.
FDA Vaccine Chief Limits COVID Shot Access, Overruling Scientists Amid Myocarditis Concerns and Waning RiskIt is rare for FDA leadership to override the conclusions of scientific review teams, and such actions are typically contentious. However, Prasad, who took charge in May following the resignation of Dr. Peter Marks, has already made significant changes to vaccine policy.
His decisions have aligned with efforts led by Commissioner Mark Makary to limit future COVID-19 booster approvals to high-risk groups. The overrides have drawn attention not only because of their immediate impact but also due to the broader implications for the FDA’s decision-making processes.
Vaccine Oversight Tightens Amid Myocarditis Concerns and Shift Toward Risk-Based Approvals
The vaccines affected by Prasad’s decision include Moderna’s updated mRNA shot and Novavax’s protein-based shot—the only one of its kind available in the U.S. FDA review teams had determined both vaccines to be safe and effective, but their approval was scaled back.
Prasad cited concerns about myocarditis as a significant factor and required Moderna to conduct additional studies on the condition. The FDA also issued updated warning labels for both Moderna and Pfizer’s vaccines regarding the heart inflammation risk.
The changes under Prasad reflect a broader shift in vaccine oversight, driven by concerns about side effects and a more cautious public health strategy. Outside experts acknowledge that myocarditis cases tend to be mild and resolve quickly, especially when compared to complications from COVID-19 itself.
Nonetheless, the administration maintains that all decisions will be guided by the “gold standard of science.” These developments highlight ongoing tensions between public health caution and vaccine accessibility, particularly as the pandemic’s urgency evolves.
