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.
They wrote that manufacturers would have to conduct randomized, controlled clinical trials before updated vaccines would receive approval for healthier people.
Elsewhere in the piece, the officials argued that the US is an outlier among countries in Europe and other high-income countries where Covid-19 boosters are recommended only for older adults and people at high risk. They estimate that more than 100 million Americans will still qualify for the annual shots under the new terms.
Source: The Guardian, 20 May 2025
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