“The [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,” FDA Commissioner Marty Makary and top vaccine regulator Vinay Prasad wrote in a New England Journal of Medicine commentary.
About 74 percent of adults 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).
What’s not clear is whether otherwise “healthy” people who want an updated COVID shot will be able to get one without paying out of pocket this fall.
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.
That panel has already been weighing limitations on COVID vaccines 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.
Makary and Prasad also said they will require companies to conduct lengthy clinical trials to compare the vaccine against a placebo before approving shots for healthier people. The agency will “encourage manufacturers” to complete such trials after they get approval for a vaccine for high-risk groups, Makary and Prasad wrote.
The journal commentary said between 100 million and 200 million people 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’s not needed.
“We simply don’t 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,” the FDA leaders wrote.
