FDA Expands Booster Doses to People 16 Years and Older

The Food and Drug Administration (FDA) now says that 16- and 17-year olds can get a booster dose of the Pfizer-BioNTech COVID-19 vaccine.

The decision expands the agency’s emergency use authorization for booster doses, which it issued on Nov. 19 for adults 18 and older. As with the previous group, the FDA recommends that those receiving a booster should get the additional dose at least six months after getting the first two shots of the vaccine.

The decision comes as concerns about the Omicron variant continue to mount, and as Pfizer-BioNTech announced that the booster dose dramatically increases protection against the new variant compared to the original two doses of the vaccine. The companies reported on Dec. 8 that in lab studies, blood samples from people who had received a booster dose showed higher levels of antibodies able to neutralize the Omicron variant than samples from people who were vaccinated with two doses.

“As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic,” said acting FDA commissioner Dr. Janet Woodcock in a statement announcing the expanded authorization. “With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”

In making its decision, the FDA relied on data about the safety and effectiveness of the additional dose for those 18 years and older, and concluded that the booster would also be safe for those who are 16 and 17 years old. The biggest concern in this younger group is the risk of inflammation of heart tissue associated with the vaccine; the FDA scientists reviewed real-world data from vaccinated young adults and determined that the benefits of the vaccine in protecting against COVID-19 outweighed the small risk of the side effect.

“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,” said Dr. Peter Marks, director of the Center for Biologics and Evaluation and Research at the FDA, in a statement. “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.”