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Novavax CEO Says Its Coronavirus Vaccine Could Win FDA Approval in May

By Eric Volkman - Mar 1, 2021 at 11:30PM

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Stanley Erck said his company will have at least tens of millions of doses available if and when it's granted authorization.

The U.S. might be only a few weeks away from getting a fourth authorized coronavirus vaccine. 

That, at least, is the opinion of Novavax (NVAX 12.13%) CEO Stanley Erck. On Monday, Erck said that his company's NVX-CoV2373 vaccine candidate could be granted emergency use authorization (EUA) approval by the Food and Drug Administration (FDA). That's conditional on the results of a phase 3 clinical trial involving 15,000 people in the U.K., the analysis of which should be completed in a matter of weeks.

Gloved hands holding a vial of medicine.

Image source: Getty Images.

The CEO added that Novavax will have "in the tens of millions or a hundred million" doses ready to ship in the U.S. if it receives the EUA.

As a caveat, Erck said that the company's discussions with the regulator could take some time. The FDA might also require Novavax to furnish data from the concurrent U.S. trial of NVX-CoV2373; this study could run an additional two months before it is completed.

Although the number of cases and fatalities continue to decline precipitously in the U.S., both figures still number in the thousands. In addition, variants of the virus that appear to be more contagious or virulent -- or possibly both -- pose the threat of a resurgence. Consequently, it is still urgent to get as many effective vaccines to market and into bodies as quickly as possible.

At this stage, Novavax's candidate is extremely promising. Preliminary data from the U.K. study indicate that NVX-CoV2373's efficacy was almost 96% efficacious in preventing the original version of the coronavirus. It is also nearly 86% efficacious against the still-spreading, apparently more contagious, variant discovered recently in that country.


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