FDA advisers support Novavax’s Covid-19 vaccine for authorization

Vaccine advisers to the US Food and Drug Administration decided Tuesday that authorizing Novavax’s Covid-19 vaccine – which uses different technology from the three vaccines currently in use in the US – for emergency use in adults would be beneficial.

Most of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to a question of whether the benefits of Novavax’s vaccine, given as a two-dose primary series, outweigh its risks in people 18 and older, based on available evidence. Twenty-one members voted yes, one abstained, and none voted no.

If the full FDA gives the vaccine the green light, it will become the fourth Covid-19 vaccine authorized in the United States.

Novavax’s vaccine is made using small laboratory-built pieces of the coronavirus to stimulate immunity. This protein-based approach is a more traditional one for vaccine development than the mRNA vaccines from Pfizer/BioNTech and Moderna.

Committee member Dr. Jay Portnoy, a professor of pediatrics at the University of Missouri-Kansas City School of Medicine, said he sees the vote as an opportunity.

“This is a different technology. It’s a more traditional protein-based vaccine,” Portnoy said. “The vaccine deserves the opportunity to be given and studied.”

“Certainly, the benefits outweigh the risks for a primary series,” committee member Dr. Michael Nelson, asthma, allergy and clinical immunology division chief at the University of Virginia School of Medicine, said of the vote.

“I think this group was in full recognition that this is probably a three-dose series and then will need to accumulate data supporting the need for booster doses and subsequent doses to probably make it a three-dose vaccine,” he said, hinting at how discussions might continue for the vaccine to be used as a booster shot.

Dr. Nita Patel, Director of Antibody discovery and Vaccine development, lifts a vial with a potential coronavirus, COVID-19, vaccine at Novavax labs in Gaithersburg, Maryland on March 20, 2020, one of the labs developing a vaccine for the coronavirus, COVID-19. (Photo by ANDREW CABALLERO-REYNOLDS / AFP) / The erroneous mention[s] appearing in the metadata of this photo by ANDREW CABALLERO-REYNOLDS has been modified in AFP systems in the following manner: [Gaithersburg] instead of [Rockville]. Please immediately remove the erroneous mention[s] from all your online services and delete it (them) from your servers. If you have been authorized by AFP to distribute it (them) to third parties, please ensure that the same actions are carried out by them. Failure to promptly comply with these instructions will entail liability on your part for any continued or post notification usage. Therefore we thank you very much for all your attention and prompt action. We are sorry for the inconvenience this notification may cause and remain at your disposal for any further information you may require. (Photo by ANDREW CABALLERO-REYNOLDS/AFP via Getty Images)

FDA advisers to weigh risks and benefits of Novavax's Covid-19 vaccine

Ahead of Tuesday’s meeting, an FDA briefing document found that although most adverse reactions to the vaccine were mild to moderate and lasted just a few days, myocarditis and pericarditis – inflammation of the heart muscle and inflammation of tissue surrounding the heart – happened in six people after vaccination. For five of them, the inflammation emerged within just two weeks of getting the vaccine. In one person, it happened 28 days later.

The cases were similar to myocarditis after the mRNA Covid-19 vaccines developed by Pfizer/BioNTech and Moderna, and they raise “concern for a causal relationship” with Novavax’s vaccine, according to the FDA document.

Novavax said in a statement that there wasn’t a substantial difference in rates of myocarditis between clinical trial participants who got the vaccine (0.007%) and those who got a placebo (0.005%).

Novavax seeks US authorization

In November, Indonesia became the first country to grant emergency use authorization of Novavax’s vaccine. It has also been authorized in the European Union, the United Kingdom, Canada, South Korea, Australia, India, the Philippines and New Zealand, among other countries.

In late January, Novavax announced that it had submitted a request for the FDA to authorize its coronavirus vaccine for emergency use.

Novavax is prepared to ship doses of its vaccine from the Serum Institute in India when the FDA authorizes it.