Novavax Soars
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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.
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.
The approval of Nuvaxovid for use in older and high-risk adults will generate around $175 million in milestone payments from Sanofi during Q3 and an additional $50 million in the second half of 2025.
The policy change announced Tuesday will likely limit access to the shots to seniors and individuals with pre-existing conditions who are at higher risk of serious infections. The new approach under HHS Secretary Robert F.