The Food and Drug Administration announced Tuesday that it will limit access to Covid-19 vaccines going forward to people 65 years of age and older and others who are at high risk of becoming seriously ill if they are infected, and will require manufacturers to conduct clinical trials to show whether the vaccines are of benefit to healthy younger adults and children.
After weeks of signaling a shift in thinking, the new leaders of the FDA and the agency’s division that regulates vaccines published a commentary in the New England Journal of Medicine laying out their plan for future use of Covid vaccines.
Commissioner Marty Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research, argued that the U.S. approach to recommending Covid vaccination for everyone ages 6 months and older is out of step with the rest of the world and may no longer be needed, given that many people have developed some immune protection to the SARS-CoV-2 virus through vaccinations, infections, or both.
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