The U.S. Food and Drug Administration (FDA) has requested that Novavax conduct an additional clinical trial to obtain full approval for its COVID-19 vaccine. This request comes despite the vaccine’s prior demonstration of 90% efficacy in a 30,000-participant trial and its existing emergency use authorization in the U.S. The vaccine has already received full approval in countries such as Australia, Europe, and Japan .
The FDA’s decision follows interventions from officials under Health Secretary Robert F. Kennedy Jr., raising concerns about added hurdles for drug approval. Conducting a new trial could cost Novavax tens of millions of dollars, potentially straining its resources. However, the FDA may accept a smaller, less costly study, and Novavax has already responded to the agency’s request .
This development has sparked uncertainty about the future of other vaccines, as the FDA’s scrutiny of Novavax’s COVID-19 vaccine—the only traditional protein-based option available in the U.S.—may set a precedent for all COVID-19 vaccines, including those from Pfizer and Moderna. Critics argue that treating updated vaccines as new products could delay timely protection against evolving virus strains .
Despite the setback, Novavax maintains that its application is approvable and is awaiting FDA feedback on the required post-marketing data. The company is seeking to convert its 2022 emergency use authorization into full approval, allowing it to compete more effectively with fully approved messenger RNA vaccines from Pfizer-BioNTech and Moderna .
The situation has also led to patient advocacy efforts, particularly among individuals with long COVID who rely on Novavax’s vaccine due to adverse reactions to mRNA vaccines. With current Novavax booster supplies expiring, access remains critical amid ongoing COVID concerns .
Novavax has announced that its COVID-19 vaccine is on track for full FDA approval following the delay. The company is preparing to collect additional clinical data from vaccinated individuals and is working closely with the agency to obtain full approval .
This unfolding situation underscores the complexities of vaccine approval processes and the impact of regulatory decisions on public health and pharmaceutical innovation.
