CDC backs FDA authorization of boosters for healthy 12- to 15-year-olds despite safety concerns

The Centers for Disease Control and Prevention reinforced federal regulators’ decision earlier this week to authorize Pfizer booster doses for healthy people ages 12-15, a move that comes amid growing concerns that federal regulators are shutting out vaccine experts from decision-making.

The CDC’s Advisory Committee on Immunization Practices voted 13-1 to recommend administering Pfizer booster doses to otherwise healthy adolescents ages 12-17 just hours before CDC Director Rochelle Walensky gave her final approval. The FDA authorized booster shots for 12- to 15-year-olds Monday and for 16- and 17-year-olds last month without convening its committee of vaccine experts, making Wednesday’s the latest authorization in a succession of green lights for extra doses meant to slow down the spread of the highly contagious omicron variant.

“The FDA experts are right in being hesitant to authorize boosters in young people,” said Dr. Marty Makary, a professor at Johns Hopkins University School of Medicine and outspoken critic of the Biden administration’s push for boosters in healthy young people. “We're in a real political quagmire. We've got a rogue FDA bypassing the normal process of convening experts and putting authorization before them for a vote before authorizations are issued.”

In mid-November 2021, the FDA authorized booster shots for all adults, whereas before the boosters were only recommended for people at high risk of getting sick through their jobs or due to underlying health problems. About a week later, the CDC announced that all adults should get booster shots, an upgrade from the recommendation for adults over 50 to get extra doses. Then last month, the FDA authorized Pfizer booster shots for people 16 and 17 years old for the first time. All of these changes were made without first publicly convening panels of vaccine experts. The CDC maintained Wednesday, though, that agency leadership was not purposely sidestepping expert input in favor of expedited shots in arms.