FDA Requests New Trial for Novavax COVID-19 Vaccine Amid Delayed Approval
GHealth News - The U.S. Food and Drug Administration (FDA) has asked Novavax to conduct a new clinical trial for its COVID-19 vaccine, delaying the company's bid for full approval, according to a Wall Street Journal report. The request comes after intervention by appointees under Health and Human Services Secretary Robert F. Kennedy Jr., sparking uncertainty around the shot’s future.
Novavax, which uses a protein-based vaccine platform as an alternative to mRNA vaccines from Pfizer-BioNTech and Moderna, said its application remains "approvable" and it awaits further FDA feedback. The company is negotiating a smaller, more affordable study and noted its commitment to meeting the agency’s post-marketing requirements.
The delay follows missed regulatory deadlines and internal FDA change...
