Tuesday, June 7, 2022

BCG beats Novavax

 The us makes COVID vaccines as if it is making a porn film


Live

F.D.A. advisers recommend the authorization of Covid shots by Novavax, a latecomer in the vaccine race.

Image
Dr. Stephaun Wallace, a participant in a Novavax clinical trial, receiving a shot at the University of Washington Virology Research Clinic last year.
Credit...Karen Ducey/Getty Images
Dr. Stephaun Wallace, a participant in a Novavax clinical trial, receiving a shot at the University of Washington Virology Research Clinic last year.

A federal advisory committee on 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 F.D.A. 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 would not be available for weeks, in contrast to the already cleared Covid vaccines that became available just days after the same committee endorsed those shots. The Centers for Disease Control and Prevention must also recommend use of the shots before they could become available.

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.”

The government would most likely buy several million doses, according to two people familiar with the plan. As part of its initial support for Novavax’s research in 2020, the United States had agreed to buy 110 million doses of the vaccine if it won authorization. But two years later, with the country already flush with effective vaccines, the government has little need for more.


No comments:

Post a Comment