February 4, 2023

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F.D.A. Advisers To Weigh In On Covid Shots by Novavax

2 min read

A federal advisory committee on Tuesday will vote on whether regulators should authorize a Covid-19 vaccine made by Novavax, an early beneficiary of the government’s Operation Warp Speed program.

The experts to the Food and Drug Administration, whose meeting is scheduled to begin at 8:30 a.m. Eastern, will base their recommendation on the company’s clinical trial data, which is strong. But before the agency could authorize the shots, the F.D.A. would also need to sign off on Novavax’s manufacturing process, which has stumbled again and again over the course of two years.

If the F.D.A. authorizes the Novavax two-dose vaccine, it would become the fourth shot to win clearance for adults in the United States. But even if the company does get the green light, it is unclear when or how widely the vaccine might be available. Shots from Pfizer-BioNTech, Moderna and Johnson & Johnson have been authorized for well over a year, and the country is not short of doses. And in a number of countries where Novavax has already earned authorization, uptake has been low.

The federal government is coordinating with Novavax to receive “a limited quantity of vaccine” if it is authorized and recommended in the United States, Jorge Silva, a spokesman for the Department of Health and Human Services, said in an email. “We remain committed to ensuring that any American who wants a vaccine can get one, including those that prefer a non-mRNA option.” (Pfizer and Moderna’s shots are made with mRNA.)

The Novavax vaccine contains nanoparticles made up of proteins from the surface of the coronavirus, a fundamentally different design than the three authorized shots.

In clinical trials, the Novavax vaccine was found to have an efficacy of 90.4 percent 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 percent.

The trial took place before…

Carl Zimmer and Rebecca Robbins

2022-06-07 05:19:36

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