Novavax, Inc. (NASDAQ:NVAX) shares surged more than 16% after the company shared a positive update on its COVID-19 vaccine, which it believes is “approvable” based on its conversations with the US Food and Drug Administration (FDA).
The company said the FDA has requested additional data on the vaccine as part of a post-marketing commitment (PMC).
“We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible,” Novavax said in a press release.
The FDA’s request is seen as a sign that the vaccine may be on track for full approval, which would represent a major regulatory milestone for the company.
Novavax’s COVID-19 vaccine is a protein-based vaccine, making it distinct from the mRNA vaccines offered by Pfizer and Moderna.
In clinical trials, Novavax’s vaccine demonstrated about 90% efficacy against symptomatic COVID-19 and 100% efficacy against moderate to severe disease in earlier variants.
Novavax shares added 16.2% at about $7 in the early afternoon on Wednesday.