Novavax's COVID-19 Vaccine For Adults Over 18 Backed By FDA Advisors: What's Next?

Novavax, Inc. (NASDAQ: NVAX) announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.

What Happened:  The FDA considers the recommendations of VRBPAC when making decisions on EUA.

"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," said Novavax’s President and CEO Stanley C. Erck.

"In today's VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision."

If EUA is granted by the FDA, it would be the first protein-based COVID-19 vaccine available in the U.S. According to CNBC, the agency could clear Novavax's vaccine for distribution in the U.S. as soon as this week. 

The Novavax vaccine would become the fourth COVID-19 vaccine authorized in the U.S. if the FDA approves it.

Why It Matters: The Novavax COVID-19 vaccine has already received authorization for use in individuals aged 18 and over from more than 40 countries in addition to Emergency Use Listing from the World Health Organization. If the EUA is granted by the FDA, the vaccine can be administered in the U.S.

NVAX Price Action: Novavax shares closed Tuesday up 22.74% at $47.54 a share.

Photo: Courtesy Novavax