Novavax asks FDA for emergency authorization for COVID-19 vaccine
Novavax has formally submitted a request to the FDA to authorize its COVID-19 vaccine for emergency use in the U.S., the company announced Monday.
Why it matters: If approved by the FDA and CDC, Novavax's vaccine — which the company said has an overall efficacy of around 90% — could become the fourth vaccine used in the U.S. to combat coronavirus.
- Novavax's vaccine efficacy data comes from two large clinical trials which also demonstrated a "reassuring safety profile," according to a press release.
- Novavax's vaccine was cleared by the E.U. and the World Health Organization in December for emergency use.
State of play: The company said it is looking for authorization for its vaccine to be used in individuals aged 18 and older.
- Novavax's vaccination regime requires two doses given 21 days apart. It can be stored at normal refrigeration temperatures, between 2°C and 8°C (approximately 35°F to 46°F).
What they're saying: "We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," said Novavax CEO Stanley Erck.