Novavax scores narrower Covid vaccine approval
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The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct major new clinical trials before approving them for wider use.
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.
Health experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or whether they should be recommended only for people at increased risk.
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
While the clearance is only for use in certain groups, Novavax’s long-awaited OK is still seen by analysts as a “win” for the company.
In a major policy shift, federal health officials anticipate the shots will be made available to adults 65 and older as well as children and younger adults who have one or more risk factors that make them more vulnerable to severe COVID-19.