FDA Official Overrules Scientists on COVID-19 Vaccine Availability

WASHINGTON — A top official at the Food and Drug Administration (FDA) recently overruled agency scientists regarding the use of two COVID-19 vaccines. This controversial decision was revealed in federal documents released Wednesday.

Dr. Vinay Prasad, the FDA’s vaccine chief, decided to impose restrictions on the vaccines developed by Novavax and Moderna, despite their approval by the agency in May after thorough reviews. Internal communications indicated that Prasad disagreed with FDA staffers who believed the vaccines should be available for everyone aged 12 and older.

The FDA scientists argued that the benefits of the vaccines outweighed the risks associated with COVID-19 and the rare side effects of the vaccines. However, Prasad determined that the shots should only be given to individuals at higher risk, such as seniors and those with underlying health issues.

In a memo, Prasad stated that the benefits of the vaccines needed to be reassessed due to declining rates of hospitalization and death from the virus. He emphasized, “Even rare vaccination-related harms, both known and unknown, now have a higher chance of outweighing potential benefits in non-high-risk populations.” This decision aligns with the views of Health Secretary Robert F. Kennedy Jr., who has expressed skepticism regarding the broader use of vaccines.

Prasad’s decisions follow an alarming trend, as COVID-19 continues to pose a public health threat, resulting in an estimated 32,000 to 51,000 deaths and over 250,000 hospitalizations in the U.S. since autumn. Specific populations at heightened risk include seniors and children under 2, especially infants under 6 months.

FDA leaders typically do not intervene in individual product reviews, making such overrides rare. A New York Times report highlighted Prasad’s willingness to go against agency experts, raising concerns among medical professionals regarding the implications for vaccine access.

In recent communications, Prasad rejected a recommendation from FDA scientists to approve Novavax’s vaccine for those aged 12 and over, citing concerns about safety and limited data. He expressed similar worries in his override memo for Moderna’s updated vaccine.

Prasad pointed specifically to risks of myocarditis, a rare form of heart inflammation associated with some COVID-19 vaccines. This issue has led the FDA to require Moderna to conduct additional studies for its updated vaccine.

Outside researchers have critiqued the agency’s focus on myocarditis, emphasizing that the risk of this condition from COVID-19 infection itself is significantly higher than from vaccination.

Despite the controversies surrounding his rulings, an HHS spokesperson defended Prasad’s decisions, stating he evaluated the totality of evidence and adhered to scientific standards. Meanwhile, the FDA continues to navigate the complex landscape of vaccine regulation amid fluctuating public health priorities.

Prasad, who started as CBER director in May after Dr. Peter Marks resigned, has been an outspoken critic of traditional vaccine approval methods. His decisions mark a significant shift in FDA policy during a critical period in the pandemic response.