Novavax's COVID vaccine was approved under an emergency use authorization in August 2022, and the company has pursued full licensing with the Food and Drug Administration (FDA), which gave the company a decision date of April 1 based on the Prescription Drug User Fee Act.
Political considerations complicate approval
The FDA missed making a decision by the April 1 target date, an unusual development that raised uncertainties over the approval of the vaccine. It is the only protein-based option and contains the Matrix M adjuvant to boost the body's immune response against SARS-CoV-2, the virus that causes COVID-19. The vaccine is indicated for use in people ages 12 and older.
The path to full approval became even more muddled a few days later when the FDA's deputy commissioner asked for more data on the vaccine, according to earlier reporting by the Wall Street Journal.
The step raised questions about political interference in the vaccine approval process. Typically, FDA career scientists review and manage massive amounts of data that support product reviews, a step designed to shield the process from political interference. A few weeks ago, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said the FDA isn't proceeding with full approval because he claimed without evidence that single-antigen vaccines don't work against respiratory viruses.
Novavax weighs in on FDA stipulations
Since then, the FDA asked the company for information on a postmarketing commitment (PMC) on a study to generate more clinical data, which Novavax on April 23 said it would expeditiously address, raising hopes that the process was back on track.
However, on April 25, the Wall Street Journal, citing people familiar with the situation, reported that the FDA is asking Novavax to conduct an additional randomized clinical trial, which could be prohibitively expensive. And the following day, in response to the newspaper’s reporting, new FDA Commissioner Martin Makary, MD, MPH, on X said Novavax is trying to bring a "new product" to the market with a study of a different product from 2021 and that new products require new clinical studies. "Under this administration, we are prioritizing the Gold Standard of Science--not what saves pharma companies 'tens of millions of dollars.' "
Today, Novavax said in a statement that PMCs by their nature are completed after biologic license application and aren't unusual, with many approved drugs or biologicals having at least one PMC requirement. "We believe our application is approvable upon alignment on the details of the PMC. We look forward to continued engagement with the FDA."
