FDA to limit COVID-19 vaccine to people over 65, others at high risk for serious illness

Leaders of the Food and Drug Administration May 20 announced new guidelines for administering the COVID-19 vaccine in a paper published by the New England Journal of Medicine. The agency will limit availability of the vaccine to individuals aged 65 and older and those aged 6 months or older with one or more risk factors that put them at high risk of serious outcomes from the virus. The paper’s authors, FDA Commissioner Marty Makary and Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, recommended randomized clinical trials to obtain evidence showing whether the vaccines are beneficial for individuals not at high risk before granting full approval.