New Clinical Trial Mandate Clouds Novavax COVID-19 Vaccine Journey

Novavax faces uncertainty as FDA requests a new clinical trial for its COVID-19 vaccine, the last protein-based option in the U.S., amid administrative changes. This move complicates efforts to update vaccines for new strains and raises concerns regarding similar requirements for mRNA vaccines by Pfizer and Moderna.

The Trump administration's decision to impose new testing requirements on Novavax's COVID-19 vaccine has ignited uncertainty regarding similar updates for other vaccines. Novavax reported Monday that the FDA seeks a new clinical trial for the vaccine, despite plans to grant it full approval.

These unexpected changes, relayed via FDA Commissioner Marty Makary's social media post, stipulate a new trial before any annual strain updates, casting doubt on how this might impact mRNA vaccines like Pfizer and Moderna. This move follows the controversial departure of FDA's vaccine chief amid disagreements with Health Secretary Robert F. Kennedy Jr.

Amid concerns over politicization of the vaccine approval process, experts warn that bypassing established procedures can lead to legal challenges. Novavax remains under emergency authorization, while efforts to update COVID-19 vaccines face increased scrutiny despite prior effectiveness in significant clinical trials.

(With inputs from agencies.)