FDA Restricts Novavax COVID Vaccine to High-Risk Groups Amid Controversy

The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, Nuvaxovid, but with significant usage limitations. The vaccine is now authorized exclusively for individuals aged 65 and older, and for those between 12 and 64 who have at least one underlying health condition that increases their risk of severe COVID-19 illness. The FDA did not specify what qualifies as an underlying condition. 

This decision comes after a delay past the FDA’s April 1 target date for approval, attributed by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. to concerns about the vaccine’s composition.  Unlike mRNA-based vaccines from Moderna and Pfizer, Novavax’s vaccine employs a traditional protein-based technology. Due to earlier manufacturing and regulatory challenges, Novavax was unable to capitalize on the initial surge in COVID-19 vaccine demand.

Critics argue that the restrictions reflect Kennedy’s vaccine skepticism, raising concerns among health professionals. Dr. Camille Kotton, an infectious disease expert, condemned the move as “incredibly disappointing” and “a dark day in American medicine.” 

The FDA has also mandated Novavax to conduct additional post-approval studies to further evaluate safety and efficacy, including potential heart-related risks and benefits for adults aged 50-64 without high-risk conditions. 

Novavax CEO John Jacobs hailed the approval as a major milestone that paves the way for broader access to the vaccine.