Novavax Soars
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NEW YORK (Reuters) -The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability later this year to older adults and those at risk of developing severe illness, FDA leaders said on Tuesday.
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.”