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.
Adams 12 Five Star Schools District RN Tiffany Karschamroon draws a dose from a vial of the Johnson … More
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.
The change will also more closely align the U.S.’ policy to that of other countries, including the United Kingdom, Canada and Australia, according to CNN.
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.”
Key Background
In late 2020, the FDA gave emergency use authorization to two COVID-19 vaccines, one from Pfizer and one from Moderna, and they were recommended first to healthcare workers and people with high risk for severe cases. Initial vaccinations picked up speed in 2021 in an effort to gain herd immunity, and some boosters were recommended by the FDA under emergency use authorization for some people by September 2021. Boosters continue to be recommended, and the CDC recommends that everyone over six months of age—especially those over 65 and those at high risk of severe COVID—get the most recent shot. But data from late April shows that just 23% of adults and 13% of children are vaccinated with the most recent vaccine. In Tuesday’s article, Makary and Prasad wrote that while “the rapid development of multiple Covid-19 vaccines in 2020 represents a major scientific, medical, and regulatory accomplishment,” the benefit of boosters is “uncertain” and the American people are “unconvinced,” citing the low vaccination numbers.
Big Number
25%. That’s around how many Americans received boosters each year over the last two years, according to data from the Centers for Disease Control and Prevention cited in Makary’s article.
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)
