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

A committee of unbiased Food and Drug Administration vaccine consultants 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 well being advantages of Novavax’s two-dose vaccine outweighed the dangers for adults within the U.S. The committee voted 21-to-0, with one abstention.

The FDA may determine as quickly as this week whether or not to difficulty “emergency use authorization” for the photographs, which have already been permitted in 41 nations outdoors of the U.S. 

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

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

By now, roughly three-quarters of Americans are vaccinated, making it unclear if Novavax’s new device within the combat in opposition to COVID-19 will have the ability to discover a market.

Dr. David Agus solutions your COVID questions


Novavax’s shot is a protein vaccine, much like inoculations which have for years been used to forestall hepatitis B, shingles and different ailments. Pfizer and Moderna’s mRNA vaccines, then again, give the physique genetic directions to make copies of the coronavirus’ outer coating, prompting the immune system to create antibodies in opposition to 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 stated in a assertion. “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” drawback

The FDA’s vaccine chief, Dr. Peter Marks, instructed the Associated Press that one other vaccine possibility within the U.S. could entice a minimum of some holdouts to take into account rolling up their sleeves.

“We do have a problem with vaccine uptake that is very serious in the United States,” Marks stated. “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 greater than 40 million doses of its vaccine throughout Asia, Europe and elsewhere, and insists that its manufacturing challenges are historical past. The shot was developed in Novavax’s analysis lab however is produced by the Serum Institute of India.

Data from scientific trials is promising. The Novavax photographs have been discovered to be 90.4% efficient at stopping delicate, reasonable or extreme an infection with early variants of COVID-19. The vaccine was 100% efficient at stopping reasonable or extreme an infection in scientific trial members. 

In documents launched Friday, the FDA stated 6 out of roughly 40,000 trial members skilled a type of coronary heart irritation and decided that the instances “raise the concern for a causal association with the vaccine.” 

—The Associated Press contributed to this report.

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