Novavax Soars
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US Food and Drug Administration officials are changing the agency's standards for updated COVID-19 booster shots with focus on seniors, high-risk persons.
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).
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.”