Novavax’s traditional COVID-19 vaccine has faced a delay in its approval process after the US Food and Drug Administration (FDA) missed its deadline for making a decision on the vaccine. The company had set an April 1 deadline, but the regulator stated that it needed more data to approve the vaccine.
The FDA’s top scientist, Peter Marks, recently resigned, which led to a stock market selloff in pharmaceutical companies and raised concerns about the impact on companies with therapies under review. Novavax claims it has responded to all of the FDA’s information requests, but believes its application is ready for approval.
Novavax’s traditional protein-based COVID shot offers an alternative technology compared to mRNA-based vaccines from Pfizer and Moderna. The vaccine was initially authorized for emergency use in 2022.
Source: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-misses-deadline-decision-novavaxs-covid-19-vaccine-wsj-reports-2025-04-02