Novavax asks FDA to authorize its COVID-19 vaccine

Novavax on Monday said that it submitted a request to the Food and Drug Administration (FDA) for an emergency use authorization (EUA) for its COVID-19 vaccine for adults. 

The request was based in part on results from two large clinical trials of approximately 30,000 participants in the U.S. and Mexico that the company said two doses of the vaccine given three weeks apart demonstrated an overall efficacy of approximately 90 percent, though the trials took place before the omicron variant became dominant.

“We’re extremely proud of the work of our teams and we look forward to FDA’s review of our EUA request. We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Stanley Erck, Novavax president and CEO, said in a statement. 

Novavax originally wanted to ask the FDA for authorization by May 2021, but had to delay the request due to numerous development and manufacturing setbacks.

The company in December said early data showed the vaccine generated an immune response against omicron, and that an additional booster dose further increased people’s immune response to the variant. Booster studies are ongoing.

The vaccine has been granted conditional authorization by multiple regulatory agencies worldwide, including the European Commission, and is listed for emergency use by the World Health Organization. It’s available for use in more than 170 countries.

The protein-based vaccine could provide an alternative to the mRNA shots available from Pfizer and Moderna, as there is a small risk the mRNA vaccines cause heart inflammation in certain adults.

More than 211 million Americans are vaccinated against COVID-19, primarily through two doses of the Pfizer and Moderna vaccines. Both vaccines have been approved by FDA; the Pfizer vaccine is now approved for use in people age 16 and older and the Moderna vaccines is approved for adults.

Updated at 2:35 p.m.