Shares of Novavax (NVAX 1.27%) were rising 4.2% as of 11:27 a.m. ET on Tuesday. The gain came after the company announced on Monday that it had submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of COVID-19 vaccine NVX-CoV2373.
Novavax's filing for U.S. EUA isn't as meaningful as actually winning authorization for its COVID-19 vaccine. However, it's nonetheless an important milestone for Novavax -- especially considering the long road the company has taken to get to this point.
Novavax had hoped to submit for U.S. EUA for NVX-CoV2373 months ago. However, the company encountered manufacturing issues that caused multiple delays for its filing.
So far, Novavax has picked up approvals or authorizations for NVX-CoV2373 from several regulatory agencies across the world, notably including the European Commission. Its vaccine also secured Emergency Use Listing from the World Health Organization, a key prerequisite to distributing the vaccine to many low- and middle-income countries.
It's uncertain how long the FDA will take to review Novavax's EUA submission and make a decision. Novavax's prospects, though, appear to be pretty good, based on the regulatory successes that NVX-CoV2373 has achieved worldwide.
The company is obligated to supply 100 million doses of NVX-CoV2373 to the U.S. government when EUA is obtained. The U.S. could opt to ship most, if not all, of those doses to other countries.
The fortunes of the vaccine stock also depend in large part on the need for regular boosters. Novavax hopes to be in a good position to compete in the market with a combination COVID-flu vaccine. The company is currently evaluating a combo vaccine featuring NVX-CoV2373 and experimental flu vaccine NanoFlu in clinical studies.