By Vlad Schepkov
It’s official!
The U.S. Food and Drug Administration (FDA) has at last given its affirmative nod to what is now the 4th officially approved COVID-19 vaccine in the United States – Novavax Inc's (NASDAQ:NVAX) NVX-CoV2373.
Known to consumers worldwide as Nuvaxovid and Covovax, the Novavax vaccine has finally received the official US Emergency Use Authorization (EMA) today, on July 13th, following the FDA's advisory committee's (AdCom) favorable 21-0 vote in early June.
"Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality," said FDA Commissioner Robert M. Califf, commenting on the agency’s formal decision.
The company’s COVID-19 vaccine, currently fully approved in 4 countries, Australia, Canada, Japan, South Korea, and conditionally approved (granted EMAs) in another 40, joins the ranks of Pfizer-BioNTech’s Comirnaty, Moderna’s Spikevax, and Johnson & Johnson’s COVID-19 vaccine to become the 4th COVID-19 vaccine officially approved for use in the United States.
The decision comes on the heels of the US Government’s order for 3.2M of the company’s vaccine doses, announced just 2 days prior, on July 11th, 2022.
The company currently projects $4B-$5B of global vaccine sales in 2022, while its biggest competitors Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) forecast $32B and $19 billion in sales, respectively.
Over the past 30 days, global COVID-19 cases have grown from around 560K new daily cases on June 12th to over 1.2M new cases on July 12th, 2022.
Shares of NVAX are trading 2% lower after-hours, PFE and MRNA are losing around 1% each.