A key FDA advisory panel on Tuesday recommended an emergency authorization of Novavax’s COVID vaccine for use in adults 18 and older, boosting prospects for one of America's first big bets under Operation Warp Speed.
Why it matters: The 21-0 vote with one abstention marks a win for the Maryland biotech, which is trying to position its shot as a booster for the vaccinated and an alternative first-line defense for people who've refused mRNA shots.
- If the FDA follows the recommendation, the vaccine would become the fourth COVID shot authorized for use in the U.S.
Catch up quick: Novavax won $1.6 billion in federal backing in 2020.
- Its vaccine uses a protein from the target virus combined with what's called an adjuvant to enhance the body's immune response. It's easier to store than Moderna and Pfizer's vaccines.
- The company ran into early production problems and struggled to meet FDA standards. But it has won approval from regulators overseas.
- An FDA staff review last week found the shot to be 90% effective at preventing new cases in a clinical trial but that it carried the possible risk of causing heart inflammation, particularly in young males.
Go deeper: Regulators on Tuesday said Novavax could fill an unmet need because there aren't non-mRNA COVID vaccines that can serve as first-line defenses. That could persuade some unvaccinated people to get the shots.
- But there was lingering concern over five cases of myocarditis that occurred within 20 days of vaccination in a trial.
- Novavax said it has continued to share data with the FDA since it applied for emergency use on January 31.
