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 changes, including layoffs and restructuring, which have raised concerns about disruption in vaccine and drug reviews. Novavax aims to convert its 2022 emergency use authorization into full approval to strengthen its market position.