Novavax Inc.’s COVID-19 vaccine was cleared by U.S. regulators, giving Americans another tool against the virus as cases start to rise again.
The U.S. Food and Drug Administration’s nod makes Novavax’s the first vaccine authorized for adults that mimics the protein that the coronavirus uses to enter cells.
The authorization gives unvaccinated adults “another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” said FDA Commissioner Robert Califf in a statement.
While millions of Americans have received shots from Moderna Inc. and the Pfizer Inc.-BioNTech SE partnership, health officials have reported falling demand as concerns about the pandemic wane. FDA advisers hope Novavax’s shot could be attractive to those who are wary of the current crop of vaccines.
Some of the vaccine-hesitant have cited the speed with which Pfizer and Moderna’s mRNA shots were developed as a safety concern. Rare clotting side effects linked to a shot from Johnson & Johnson have also raised anxiety. Novavax’s shot is considered more similar to classic vaccines that present the immune system with killed or weakened viruses.
The company secured $1.6 billion in federal government funding in exchange for 100 million doses of the shot but confronted headwinds along the way to market. Manufacturing delays during the early days of the pandemic pushed Novavax’s US clinical trial back to December 2020. By that time, vaccines developed by Pfizer and Moderna were already ready for use.
Novavax’s vaccine has been authorized in countries including the U.K. and Japan. In Europe, regulators are evaluating it as a booster for adults, and the company is studying a combination shot to protect against the flu and COVID-19.
“This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues,” said Stanley Erck, Novavax’s chief executive officer in a statement Wednesday.
The company’s shares were down 1.8% in after-market trading in New York.
