Novavax’s COVID-19 vaccine is moving closer to full approval following further discussions with the Food and Drug Administration (FDA), the company announced on Wednesday. This update caused the company’s stock to surge by more than 21% in early trading and seemed to alleviate concerns that political factors from the Trump administration might be delaying a decision on the vaccine.
Novavax offers the only traditional protein-based COVID-19 vaccine in the United States, which is still available under emergency use authorization, unlike the mRNA vaccines from Pfizer and Moderna that have already received full FDA approval for specific age groups.
According to Novavax, the FDA recently requested that the company develop a plan to gather additional clinical data from people who have received the vaccine. Novavax expressed its intention to work quickly with the FDA to gain approval “as soon as possible.”
Full approval by the FDA is the highest standard for vaccines. The agency had been expected to approve Novavax’s vaccine by its April 1 deadline, according to two sources familiar with the matter who spoke on condition of anonymity. However, the FDA’s acting commissioner, Dr. Sara Brenner, directed officials to pause the approval process, leading to concerns about potential political interference, particularly after Robert F. Kennedy Jr. was appointed as the new health secretary. Kennedy, known for his anti-vaccine views, had previously led vaccine opposition groups.
The approval of Novavax’s vaccine would allow the company to keep it on the market permanently, as vaccines authorized for emergency use can be withdrawn by the FDA once the public health emergency ends.
All three COVID-19 vaccines used in the U.S. teach the immune system to recognize the spike protein on the coronavirus’s surface. While Pfizer and Moderna use mRNA technology to instruct the body to produce copies of the spike protein, Novavax uses lab-grown versions of the protein, which are combined with an immune-boosting ingredient. Protein-based vaccines, such as Novavax’s, have been used for decades to protect against diseases like hepatitis B and shingles.
Like flu vaccines, the COVID-19 vaccines from Pfizer, Moderna, and Novavax are updated yearly to address the most current virus variants.