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Novavax’s COVID-19 Vaccine Wins FDA AdCom Blessing, Removing ‘Major Overhang’ -Breaking


© Reuters Novavax’s COVID-19 Vaccine Wins FDA AdCom Blessing, Removing ‘Major Overhang’

By Davit Kirakosyan

Novavax, Inc., (NASDAQ:), announced Tuesday night that the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee(VRBPAC) recommended that the FDA issue an Emergency Use Authorization for (EUA), for the COVID-19 vaccine (NVXCoV2373) to individuals 18 and older.

Stanley Erck CEO stated that “The positive recommendation of the advisory board acknowledges the strength and importance of our data” We heard from many people today, including doctors and healthcare providers, that our vaccine is being supported by the majority. We have submitted to FDA an amended with the latest manufacturing information to support the EUA, in line with worldwide submissions. We are looking forward to cooperating with the FDA in its final decision.

It Novavax COVID-19 is currently not authorized to be used in the U.S. It would be the first vaccine to join those that are on the market since at least a year. Pfizer (NYSE:)/BioNTech SE (NASDAQ:), Moderna, Inc. (NASDAQ:), Johnson & Johnson (NYSE:), and others.

Georgi Yordanov, Cowen’s analyst, commented on Novavax after the news. She said they expect EUA approval at the end of June/early Jul.

Yordanov stated that “It appears that the risk for myocarditis may be noted on label, similar to the mRNA vaccinations’ labels but it doesn’t appear to have any commercial impact.” This removes an important overhang from the stock.