FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data

The trials ‘can provide reassurance that the American repeat-boosters in-perpetuity strategy is evidence-based,’ officials said.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

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.

FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, said that the FDA’s new COVID-19 vaccine framework will have two tiers. For people aged 65 or older, and for people who have a risk factor that places them at high risk for severe COVID-19 outcomes, manufacturers will only need to provide proof that a vaccine can trigger antibodies. For everyone else, or those without risk factors, the FDA is requiring data from randomized, controlled trials showing that a vaccine prevents symptomatic COVID-19 and secondary outcomes such as death.