FDA Misses Deadline for Novavax Vaccine Approval

The FDA has missed its deadline to decide on the full approval of Novavax's COVID-19 vaccine, initially set for April 1, 2025. Despite Novavax's confidence in their vaccine as a viable alternative to mRNA vaccines, the FDA is requesting more data before making a decision. This delay follows the resignation of Peter Marks, the FDA's top vaccines expert, creating turbulence in the biopharmaceutical sector. Novavax's vaccine holds Emergency Use Authorization and is recommended by the CDC. The company's stock has been volatile, with a significant year-to-date decline, and the delay is further complicated by potential financial impacts from the planned cessation of U.S. support for global vaccine initiatives.