COVID-19 vaccine makers Pfizer Inc. and Moderna Inc. received U.S. regulatory clearances for their omicron-targeted boosters for children as young as 5.
Moderna’s vaccine was authorized for use at least two months after completion of primary or booster vaccination in children down to six years of age, according to a statement from the U.S. Food and Drug Administration. The Pfizer shot can be given at least two months after primary or booster vaccination in children as young as five.
While updated booster shots have already been authorized for use in children and adults from the age of 12 and up, uptake of the shots has been slow. Primary vaccinations of children have also gone slowly as parents have seen the risk of infection as low.
“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Advisers to the U.S. Centers for Disease Control and Prevention will meet to discuss the shots next week, and agency Director Rochelle Walensky must give a recommendation before they’re administered nationwide.
When an earlier generation of boosters were cleared for use last year, just half of the eligible population aged five years and older received a shot, according to a recent government study that looked at uptake between August 2021 and August 2022. The youngest age groups had the some of the lowest vaccination rates in the U.S.
Meanwhile, toddlers are still not eligible for a bivalent booster. Moderna is currently working to finalize its application for authorization in children from 6 months to 5 years, according to the statement. The application is expected to be completed later this year. Pfizer is studying its bivalent vaccine across age groups, including children under age 5, the company said.
“As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.,” Albert Bourla, Pfizer’s chairman and chief executive officer, said in a statement.
