Federal advisers back 4th COVID-19 vaccine
A federal advisory committee Tuesday voted to recommend that regulators authorize a COVID-19 vaccine made by Novavax, an early beneficiary of the government’s Operation Warp Speed program.
If the Food and Drug Administration accepts the panel’s recommendation on the Novavax two-dose vaccine, it would become the fourth shot to win clearance for adults in the United States. But before the agency could authorize the shots, the FDA would need to sign off on Novavax’s manufacturing process, which has stumbled again and again over the course of two years.
Those ongoing issues are likely to mean the vaccine will not be available for weeks, in contrast to the already cleared COVID-19 vaccines that became available just days after the same committee recommended their clearance.
Shots from Pfizer, Moderna and Johnson & Johnson have been authorized for well over a year. And in a number of countries where Novavax has already earned authorization, uptake has been low.
The Novavax vaccine contains nanoparticles made up of proteins from the surface of the coronavirus, a fundamentally different design than the three shots available in the United States. Pfizer and Moderna’s shots are made with mRNA, while the shot from Johnson & Johnson, the use of which has been limited in the United States, uses a nonmRNA approach.
At Tuesday’s meeting, Dr. Peter Marks, who oversees vaccine regulation for the FDA, said there was a need for alternative vaccine options.
“We do have a problem with vaccine uptake that is very serious in the United States, and anything we can do to get people more comfortable to be able to accept these potentially lifesaving medical products is something that we feel we are compelled to do,” he said.
In clinical trials, the Novavax vaccine was found to have an efficacy of 90.4% at preventing mild, moderate or severe infection with older variants of the virus. None of the volunteers who got the vaccine experienced moderate or severe infection, translating to an efficacy of 100%. The trial took place before the rise of the delta and omicron variants, which have evaded some of the immunity from other vaccines.