The Food and Drug Administration (FDA) announced on Tuesday that it will limit access to seasonal Covid-19 boosters for healthy Americans under 65 without clear evidence of clinical benefit – a shift, critics say, that will make access difficult for people who are not high risk but want to be vaccinated against the disease.
Top officials at the FDA outlined a new framework for approving Covid-19 vaccines, saying that the US would make the boosters available for Americans over the age of 65 and for adults and children above the age of 6 months with at least one condition that increases their risk of severe Covid-19.
The newly installed FDA commissioner Marty Makary and Vinay Prasad, the controversial director of the Center for Biologics Evaluation and Research, laid out the new guidelines in a commentary piece published in the New England Journal of Medicine.