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Who can get updated COVID vaccines this fall? FDA will OK for high-risk groups, calls for new clinical trials
"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at ...
FDA sets new COVID booster guidelines for healthy adults under 65
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
FDA sets new COVID booster guidelines requiring trials for approvals for healthy adults
The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for ...
US FDA advisers to consider if new COVID shots should target LP.8.1 subvariant
Advisers to the U.S. Food and Drug Administration will discuss recommendations for updated COVID-19 vaccines ahead of the ...
FDA to limit future Covid-19 shots to older people and those at risk of serious infection
The agency is changing the standard of evidence required for Covid-19 vaccine approval in the US, Dr. Vinay Prasad, the new ...
FDA to limit covid shot approval to elderly, those with medical conditions
The agency will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...
FDA sets new requirements for COVID vaccines in healthy adults and children
Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...
FDA Shifts How COVID Vaccines Will Be Approved—Here’s What To Know
The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...
FDA offers new guidelines to shift COVID vaccine focus to high-risk groups
The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over ...
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FDA Officials Lay Out New COVID Vaccine Framework
The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 ...