FDA Approves Pfizer Boosters for Teens Aged 16 to 17

The U.S. Food and Drug Administration on Thursday approved the emergency use of the Pfizer COVID-19 booster shots for Americans aged 16 and 17 years old.

The move comes as the delta variant is fueling surges in infections and hospitalizations in some pockets of the country and the highly contagious omicron variant starts to spread across the United States.

Peter Marks, M.D., director of the FDA Center for Biologics Evaluation and Research, said expanding the availability of booster shots makes sense. "The Pfizer-BioNTech COVID-19 vaccine has been available to individuals 16 years of age and older for nearly a year, and its benefits have been shown to clearly outweigh potential risks," he noted in an agency news release. "Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group. A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups."

Pfizer first sought the approval for using the boosters in this age group at the end of November, and it becomes the first booster shot approved for Americans this young.