Vaccine maker Novavax announced that its COVID-19 vaccine is nearing full approval from the FDA.
“We believe that our Biologics License Application (BLA) is approvable,” Novavax said in a statement, noting they look forward to engaging with the FDA expeditiously to address the PMC [postmarketing commitment] request and move to approval as soon as possible.”
According to the Associated Press, the announcement raised the company’s stock by 21%. The report explained that Novavax makes the only non-mRNA COVID-19 vaccine available in the United States, and is therefore distinct from the mRNA vaccines produced by Pfizer and Moderna. It is only authorized for emergency use.
Should the vaccine receive the FDA’s approval, it would be available indefinitely.
Novavax said in an April 15 statement that preliminary data indicated that its COVID-19 vaccine “induced lower frequency and severity of short-term side effects and impact on daily life compared with Pfizer-BioNTech mRNA vaccine.”
“This real-world study conducted between September and December 2024 in partnership with the University of Utah Health, also showed that the impact of symptoms on daily activities, including work and family responsibilities, was lower in recipients of Novavax’s vaccine,” the company said.
The vaccine maker’s COVID-19-flu combination vaccine, however, left an individual with nerve damage.
“The clinical hold is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single [COVID-19-Influenza Combination] Phase 2 trial participant outside of the U.S. who received the vaccine in January 2023,” Novavax said in October. The company added that its previous COVID-19 and influenza trials did not show any signs of contributing to motor neuropathy.
