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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 announces change to future Covid-19 vaccine approvals that will limit fall boosters
The agency is changing the standard of evidence required for Covid-19 vaccine approval in the US, Dr. Vinay Prasad, the new ...
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 ...
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 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 Plans to Limit COVID-19 Vaccines to High-Risk Groups
In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...
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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 ...
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 sets stricter approval standards for COVID vaccines
The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...
FDA approves Novavax COVID-19 shot but with unusual restrictions
Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to ...