The FDA announced Tuesday that, going forward, COVID-19 vaccines would be approved only for people over age 65 or those at risk for severe infection.
The move will streamline the approach to yearly vaccination for the coronavirus, but 100 million to 200 million people with certain conditions would still be eligible, Food and Drug Administration officials outlined in a New England Journal of Medicine editorial. The U.S. Centers for Disease Control and Prevention (CDC) lists dozens of conditions that can put people at higher risk. About three-quarters of Americans over age 6 months have at least one of them.
The editorial authors, FDA Commissioner Marty Makary and FDA vaccine chief Vinay Prasad, said the current “one size fits all” vaccine policy may no longer be viable. They said that extensive, controlled studies should be conducted before the vaccine is even adjusted for new variants — a process that used to simply involve tweaking the already-approved underlying formula.
Prasad replaced Dr. Peter Marks, who resigned in March, citing the “misinformation and lies” promulgated by vaccine skeptic and Health and Human Services Secretary Robert F. Kennedy Jr., whose agency oversees the FDA.
While the new framework seems aligned with policies in the U.K., Canada and Australia, the FDA circumvented input from two advisory panels that were about to meet on those issues—an FDA panel is scheduled to meet Thursday to discuss adjusting the shots to match current circulating coronavirus strains, and a CDC advisory panel next month on who should get the vaccine.
The move “will make vaccines less insurable and less available,” Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, told The Associated Press.
With News Wire Services
