Novavax’s COVID vaccine gets FDA approval
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The policy has been outlined in an editorial in the New England Journal of Medicine (NEJM) by FDA Commissioner Marty Makary and Vinay Prasad, who was just appointed director of the agency's Center for Biologics Evaluation and Research (CBER).
WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.
The U.S. Food and Drug Administration has granted limited approval to Novavax Inc.'s COVID-19 vaccine, restricting its use to people 65 and older and those 12 and up with underlying health conditions that increase risk of severe illness.
It's not clear if recommendation will be removed entirely or people will be told to consult their doctors. Read more at straitstimes.com. Read more at straitstimes.com.
FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.”