FDA Commissioner Says Novavax’s COVID-19 Vaccine Requires Clinical Study

Dr. Marty Makary commented as regulators consider Novavax’s application for a vaccine license.

FDA Commissioner Dr. Marty Makary in Washington on April 22, 2025. Andrew Harnik/Getty Images

Novavax’s updated COVID-19 vaccine needs further study, the commissioner of the Food and Drug Administration (FDA) said on April 26.

“To be clear, this is a new product that Novavax is trying to introduce to the market with a study of a different product from 2021. New products require new clinical studies,” Dr. Marty Makary wrote on the social media platform X. “Under this administration, we are prioritizing the Gold Standard of Science—not what saves pharma companies ’tens of millions of dollars.'”