FDA To Restrict COVID-19 Vaccine Approval To Seniors, Others At High Risk

The AP (5/20, Perrone, Neergaard) reports the Trump Administration “said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else.” Top FDA officials “laid out new standards for updated COVID shots, saying they’d continue to use a streamlined approach to make them available to adults 65 and older as well as children and younger adults with at least one high-risk health problem.” However, the FDA framework published Tuesday in the New England Journal of Medicine “urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people.” The Washington Post (5/20, A1, Roubein, Sun) reports that “the new guidelines indicate updated vaccines will probably be available in the fall for Americans over the age of 65, as well as those older than 6 months who have at least one condition putting them at higher risk of severe illness, as well as people with conditions such as asthma, diabetes, cancer and obesity, in addition to pregnant women.” According to the Post, the FDA “estimate[s] more than 100 million Americans would be eligible for the shots under the new framework.”