FDA committee OKs Novavax's late-to-the-game COVID-19 vaccine

A committee of independent Food and Drug Administration vaccine experts has voted to advance a COVID-19 vaccine made by American biotech company Novavax.

Following an hours-long meeting Tuesday, the FDA's Vaccines and Related Biological Products Advisory Committee voted that the health benefits of Novavax's two-dose vaccine outweighed the risks for adults in the U.S. The committee voted 21-to-0, with one abstention.

The FDA could decide as soon as this week whether to issue "emergency use authorization" for the shots, which have already been approved in 41 countries outside of the U.S. 

If cleared for use in the U.S., the shot will be the fourth FDA-approved coronavirus vaccine on the market. Shots from Pfizer, Moderna and Johnson & Johnson have already been cleared for use in adults in the U.S. for well over a year. 

Novavax shares, which have fallen 67% this year, edged up in morning trade on Wall Street. The company first filed for emergency use authorization in late January, behind schedule, after running into manufacturing hurdles.

By now, roughly three-quarters of Americans are vaccinated, making it unclear if Novavax's new tool in the fight against COVID-19 will be able to find a market.

Novavax's shot is a protein vaccine, similar to inoculations that have for years been used to prevent hepatitis B, shingles and other diseases. Pfizer and Moderna's mRNA vaccines, on the other hand, give the body genetic instructions to make copies of the coronavirus' outer coating, prompting the immune system to create antibodies against the virus.

"The Advisory Committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," Novavax CEO Stanley C. Erck said in a statement. "We have heard in today's VRBPAC meeting the significant support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. We look forward to the FDA decision."

"Very serious" problem

The FDA's vaccine chief, Dr. Peter Marks, told the Associated Press that another vaccine option in the U.S. may entice at least some holdouts to consider rolling up their sleeves.

"We do have a problem with vaccine uptake that is very serious in the United States," Marks said. "Anything we can do to get people more comfortable to accept these potentially life-saving products is something that we feel we are compelled to do."

Maryland-based Novavax has distributed more than 40 million doses of its vaccine across Asia, Europe and elsewhere, and insists that its manufacturing challenges are history. The shot was developed in Novavax's research lab but is produced by the Serum Institute of India.

Data from clinical trials is promising. The Novavax shots were found to be 90.4% effective at preventing mild, moderate or severe infection with early variants of COVID-19. The vaccine was 100% effective at preventing moderate or severe infection in clinical trial participants. 

In documents released Friday, the FDA said 6 out of roughly 40,000 trial participants experienced a form of heart inflammation and determined that the cases "raise the concern for a causal association with the vaccine." 

—The Associated Press contributed to this report.