FDA advisers vote in favor of authorizing Novavax COVID-19 vaccine

Novavax is different from the other available vaccines.

June 7, 2022, 4:56 PM

The Food and Drug Administration's independent panel of advisers has voted in favor of the FDA authorizing Novavax, a protein-based vaccine, which could soon be the fourth vaccine for COVID-19 authorized in the U.S.

Although the U.S. already has three other COVID vaccines, some experts are excited about the Novavax vaccine because it is the first COVID-19 vaccine of its kind to be considered for authorization.

Novavax's COVID-19 vaccine is a more traditional protein-based vaccine, given as two shots. Pfizer, Moderna and Johnson & Johnson vaccine platforms use more modern advances in genetic technology.

The FDA can now issue its authorization for Novavax and then the Centers for Disease Control and Prevention will review the vaccine before giving its recommendation. Novavax is not expected to roll out as quickly as the other vaccines have and instead will take weeks after authorization to get out to the public.

The company asked for authorization for adults over 18 and has yet to ask for authorization for boosters.

During the review on Tuesday, the FDA's advisers pushed Novavax representatives on multiple points.

PHOTO: Signage outside the Novavax facility in Gaithersburg, Md., May 18, 2022.
Signage outside the Novavax facility in Gaithersburg, Md., May 18, 2022.
Bloomberg via Getty Images

Members asked whether there was data to back up the hope that this vaccine will win over people who have been vaccine-hesitant until now.

Novavax didn't have specific data on acceptance among unvaccinated people, but said it was focused on getting through to them.

FDA leadership signaled that it was open to any vaccine that made a dent in the nation's vaccine rates.

"I will use this as a moment on the bully pulpit to say that we do have a problem with vaccine uptake that is very serious in the United States," Dr. Peter Marks, leader of the FDA's vaccine division, told the panel.

"And anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do," he said.

Multiple advisory committee members also harped on the fact Novavax only had data on how its vaccine held up to earlier strains of the virus, but not the omicron variant.

"It is disappointing, and we've discussed this already, that we don't have more updated information because we're looking at the efficacy against strains that don't exist any longer," Dr. Eric Rubin, a member of the committee and professor at Harvard's T.H. Chan School of Public Health, said during the meeting.

"Nevertheless … if there really is a population of patients who are willing to take this and not only existing vaccines, I think it's pretty compelling," he said.

Filip Dubovsky, chief medical officer of Novavax, said the company was confident the vaccine was still protective against omicron.

"Overall, it's factual that we don't have efficacy data against omicron. But, what we do have is a technology that we think generates a broad immune response, demonstrated against a broad array of variants," he said Tuesday.

And there were also concerns over myocarditis cases seen after the Novavax series.

Out of 40,000 vaccine participants to date, there were five cases of myocarditis occurring within 20 days of getting the shots — a very small number but still a concern.

Myocarditis, which is the inflammation of the heart muscle, has also happened to people who got the other authorized vaccines, particularly mRNA vaccines Moderna and Pfizer. Like those cases, these cases were largely among young men.

Many members pointed out that there's no reason to think myocarditis is more common from Novavax than any other vaccine already out there, but the committee still ultimately concluded that more research was needed on a broader group of Americans to better understand how big the risk is.

"I think we need more data from post-authorization use in larger numbers of individuals to really get at what the rate of myocarditis associated with this vaccine is and what exactly the risk is," an FDA representative told the panel.

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