• The FDA will require new clinical trials for COVID-19 boosters for healthy people under 65.
• Annual vaccinations will primarily be available for those over 65 or with specific health conditions.
• The change aims to address skepticism around the necessity of boosters for younger, healthy populations.
• Access for many individuals wanting vaccinations may become more limited.
• The decision reflects a strategic shift in U.S. public health policy regarding COVID-19.

The U.S. Food and Drug Administration (FDA) has put forward a significant policy change regarding the approval of COVID-19 vaccines, particularly affecting healthy individuals under 65 years of age. Under the new guidelines, detailed in an article published in the New England Journal of Medicine, the FDA will continue to approve booster shots for those aged 65 and older and for individuals with underlying health conditions that increase the risk of severe COVID-19. However, healthy individuals will now require new randomized clinical trials to demonstrate the efficacy of additional doses before they can be authorized, according to Reuters, LA Times, and NY Times.

This approach signifies a marked shift from previous years when annual booster shots were broadly recommended across multiple age groups. FDA officials have criticized past policies as a "one-size-fits-all" approach, noting that the U.S. has been "the most aggressive" in advocating for COVID vaccines compared to European nations. They cited doubts about the necessity of additional doses for healthy individuals who have previously been vaccinated or have had COVID-19, as stated by Dr. Vinay Prasad and Dr. Martin Makary, according to SFGate, CBS News, and Newsweek.