Page Reader AI | FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data

FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data | The Epoch Times

The FDA announced a new policy requiring clinical trial data for COVID-19 vaccine licenses for healthy adults under 65, prioritizing high-risk groups.

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The new policy ‘balances competing values,’ agency leaders said.

The Food and Drug Administration (FDA) will not approve COVID-19 vaccines for many Americans absent trial data showing that the benefits outweigh the risks, top agency officials said on May 20.

“Moving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: On the basis of immunogenicity—proof that a vaccine can generate antibody titers in people—the FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes,” such as asthma or cancer, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, wrote in a New England Journal of Medicine article.

“For all healthy persons—those with no risk factors for severe Covid-19—between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.”

Pfizer, Moderna, and Novavax, which have received licenses for their COVID-19 vaccines, did not immediately respond to requests for comment.

Makary and Prasad planned to talk about the policy update at 1 p.m. on Tuesday.

This is a developing story that will be updated.

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Category: Medicine

Tags: FDA COVID-19 Vaccines Clinical Trials Regulation

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