Topline
The Food and Drug Administration announced Tuesday it is adopting a new regulatory framework for COVID-19 vaccines that will likely narrow recommendations for the vaccines to people over 65 and those at high risk for severe outcomes—a switch from the vaccination recommendations over the last five years.
Key Facts
FDA Commissioner Marty Makary and Vinay Prasad, the agency’s top vaccine regulator, said in an article published in the New England Journal of Medicine Tuesday the U.S. will no longer follow a “one-size-fits-all regulatory framework” on COVID-19 vaccines.
Makary and Prasad said the FDA expects it will be able to determine whether benefits outweigh risks for adults over 65 and people older than six months with high risk based on “immunogenicity,” or “proof that a vaccine can generate antibody titers in people.”
But for vaccines to receive a green light for the general public between six months and 64-years-old without health risks, the FDA will require “randomized, controlled trial data evaluating clinical outcomes” before a vaccine is approved.
“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” Makary and Prasad wrote in the article.
This story is developing and will be updated.
Crucial Quote
“The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations,” the two FDA leaders wrote in the article, adding: “We reject this view.”
Further Reading
F.D.A. Poised to Restrict Access to Covid Vaccines (New York Times)
FDA to limit covid shot approval to elderly, those with medical conditions (Washington Post)