The U.S. Food and Drug Administration (FDA) has missed its deadline for making a decision on traditional approval for Novavax's COVID-19 vaccine, adding uncertainty to the future regulatory status of the protein-based shot.
The FDA had set an April 1 deadline to decide on full approval for the vaccine, which currently holds Emergency Use Authorization (EUA) status. Novavax confirmed the delay in a statement, noting that they "continue to wait on action from the agency" and have not yet received an official decision.
"As of today, we have responded to all of the FDA's information requests as of April 1 and believe our application is ready for approval," the company stated.
Regulatory Challenges Amid Leadership Changes
The missed deadline coincides with significant leadership changes at the FDA. Peter Marks, the agency's top vaccine scientist who played a pivotal role in expediting COVID-19 vaccine approvals during the pandemic, recently resigned from his position at the FDA's Center for Biologics Evaluation and Research. His departure, effective April 5, reportedly came under pressure and has created uncertainty in the regulatory landscape.
According to The Wall Street Journal, senior FDA officials have indicated that Novavax's application requires additional data and is unlikely to receive approval soon. This assessment contradicts Novavax's position that they have fulfilled all information requirements.
Novavax's Market Position
Novavax's COVID-19 vaccine offers an alternative to the mRNA-based vaccines developed by Pfizer-BioNTech and Moderna. The company's protein-based technology represents a more traditional vaccine approach that some vaccine-hesitant individuals might prefer.
In September 2023, the FDA granted Emergency Use Authorization to Novavax's updated COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) for individuals aged 12 and older. The vaccine was subsequently included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on June 27, 2023.
Despite these regulatory milestones, Novavax has struggled to gain significant market share in the United States. The company reported fourth-quarter 2023 sales of $88.31 million, a substantial decrease from $291 million in the same period the previous year, though still exceeding analyst expectations of $84.35 million.
Broader Implications for Vaccine Manufacturers
The regulatory delay comes at a challenging time for vaccine manufacturers. Vaccine stocks recently faced pressure following reports that the incoming Trump administration plans to end financial support for vaccine alliance Gavi, which helps purchase vaccines for children in developing countries.
Industry analysts suggest that Marks' departure from the FDA could put additional pressure on companies with therapies currently under regulatory review, potentially slowing approval timelines and creating market uncertainty.
For Novavax, securing full approval would represent an important milestone in establishing its COVID-19 vaccine as a permanent option in the U.S. immunization landscape, rather than one authorized only for emergency use during the pandemic.
The FDA and the Department of Health and Human Services have not provided official comments regarding the delayed decision or a revised timeline for Novavax's application review.
