Novavax's COVID-19 Vaccine Wins FDA AdCom Blessing, Removing 'Major Overhang'

Novavax, Inc. (Nasdaq: NVAX) announced late Tuesday that the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommends that the FDA grant Emergency Use Authorization (EUA) for its COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.

"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 CEO Stanley 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."

The Novavax COVID-19 vaccine is not yet authorized for use in the U.S. If approved, it would join vaccines that have been on the market for over a year and a half from Pfizer (NYSE: PFE)/BioNTech SE (NASDAQ: BNTX), Moderna, Inc. (NASDAQ: MRNA), Johnson & Johnson (NYSE: JNJ), and others.

Cowen analyst Georgi Yordanov weighed in on Novavax following the news, saying they continue to expect EUA approval by the end of June/early July.

"It does appear that the risk of myocarditis will likely be noted on the label, similarly to the mRNA vaccines' labels, but we don't expect it to have a commercial impact," Yordanov commented. "This removes a major overhang for the stock."

By Davit Kirakosyan

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