Silver Spring, Maryland — The U.S. Food and Drug Administration is negotiating additional trial requirements for Novavax’s Covid-19 vaccine as part of a post-approval commitment, a source familiar with the discussions confirmed. The vaccine, which has been under emergency use authorization since 2022, is currently awaiting a full approval decision from the agency.
While Novavax initially expected to secure full approval by April 1, that timeline was pushed back as the FDA requested further data. The source, who requested anonymity due to the sensitive nature of the discussions, indicated that terms surrounding the additional trial will need to be agreed upon before approval is granted.
In a statement, Silvia Taylor, Novavax’s executive vice president and chief corporate affairs officer, confirmed the company is actively responding to the FDA’s request regarding post-marketing commitments. “We continue to believe that our application is approvable, and we look forward to our continued engagement with the FDA about their request for a PMC and to moving to approval as soon as possible,” she said.
The FDA, which oversees vaccine safety and efficacy through its parent agency, the Department of Health and Human Services, reiterated its commitment to ensuring that all products are safe and based on rigorous scientific research. This diligence comes as the FDA grapples with public sentiment around vaccines, especially amid the ongoing discussions about Covid-19 vaccines and other immunizations.
Novavax’s vaccine employs a more traditional protein-based technology, distinguishing it from the mRNA vaccines developed by Pfizer/BioNTech and Moderna, which have dominated the market. Achieving full FDA approval would make Novavax’s vaccine the third such product to attain this status, potentially offering increased reassurance to vaccine-seeking individuals.
The delay in approval coincided with personnel shifts within the FDA, including the appointment of Dr. Scott Steele as the acting director of the Center for Biologics Evaluation and Research, the segment responsible for vaccine oversight. His predecessor, Dr. Peter Marks, departed amid concerns over public discourse surrounding vaccine safety, highlighting the challenges facing health authorities.
Meanwhile, HHS Secretary Robert F. Kennedy Jr., known for his anti-vaccine advocacy, has labeled Covid-19 vaccines as “the deadliest vaccine ever made,” stirring further controversy. Recent misleading statements regarding the safety of the measles vaccine have also surfaced, particularly in light of an outbreak in West Texas.
As the situation evolves, the outcome of negotiations between the FDA and Novavax remains crucial for public health, underscoring the ongoing efforts to ensure vaccine safety and efficacy amid a backdrop of skepticism and misinformation.