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

Novavax’s updated COVID-19 vaccines need 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.’”
Makary was reacting to a report that the FDA was asking Novavax, a Maryland-based firm, to conduct a randomized clinical trial for its COVID-19 vaccine….