Please ensure Javascript is enabled for purposes of website accessibility

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

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

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

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.

 

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Novavax, Inc. Stock Quote
Novavax, Inc.
NVAX
$58.43 (12.13%) $6.32

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning service.

Stock Advisor Returns
327%
 
S&P 500 Returns
116%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 05/20/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.