Food and Drug Administration plans to require new clinical trials before approving annual COVID-19 vaccine boosters for healthy Americans under 65 years old.
The plan appears in a paper published Tuesday in the New England Journal of Medicine, in which FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the FDA’s vaccine chief, wrote any new COVID shot must undergo placebo-controlled clinical trials, NBC News reported.
This means that the release of updated COVID vaccines for healthy children and adults this fall will likely be delayed.
While the original COVID shots underwent placebo-controlled trials, the updated boosters only went through smaller studies.
Makary and Prasad wrote that the COVID shot policy “has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations.”
“We reject this view,” they added.
