Jan 31, 2022 - Health

Novavax asks FDA for emergency authorization for COVID-19 vaccine

Oriana González

Photo: Artur Widak/NurPhoto via Getty Images

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.

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Novavax asks FDA for emergency authorization for COVID-19 vaccine

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