The Trump administration on Tuesday said it plans to limit the approval of updated COVID-19 vaccines to adults over 65 and people who are high risk for severe infections, raising questions about whether healthy people will continue to have access to the vaccines. <\/p>\n\n\n\n
\u201cThe [Food and Drug Administration (FDA)] will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,\u201d FDA Commissioner Marty Makary<\/strong> and top vaccine regulator Vinay Prasad wrote in a New England Journal of Medicine commentary<\/u><\/a>. <\/p>\n\n\n\n About 74 percent of adults<\/strong> have at least one condition that puts them at higher risk of severe illness from COVID-19, according to the Centers for Disease Control and Prevention (CDC).<\/p>\n\n\n\n What\u2019s not clear is whether otherwise \u201chealthy\u201d people who want an updated COVID shot will be able to get one without paying out of pocket<\/strong> this fall. <\/p>\n\n\n\n The job of the FDA is to review vaccines for approval based on safety and efficacy; deciding who should get the shots is the purview of the CDC and its independent advisory panel of experts. <\/p>\n\n\n\n That panel has already been weighing limitations on COVID vaccines<\/strong> and is scheduled to meet and vote on recommendations June 25. If the panel recommends the shot for a specific group of people, insurance plans have to cover it. <\/p>\n\n\n\n Makary and Prasad also said they will require companies to conduct lengthy clinical trials<\/strong> to compare the vaccine against a placebo before approving shots for healthier people. The agency will \u201cencourage manufacturers\u201d to complete such trials after they get approval for a vaccine for high-risk groups, Makary and Prasad wrote. <\/p>\n\n\n\n The journal commentary said between 100 million and 200 million people<\/strong> would be eligible for COVID vaccines under the new approach. The U.S. has the most generous eligibility for COVID vaccination, and Makary and Prasad said it\u2019s not needed. <\/p>\n\n\n\n \u201cWe simply don\u2019t know whether a healthy 52-year-old woman with a normal BMI who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose,\u201d the FDA leaders wrote. <\/p>\n\n\n\n