More Young Kids Can Get Bivalent COVID Booster

More children under age 5 are now eligible for a COVID-19 booster, the FDA announced on Tuesday.

Kids ages 6 months to 4 years who completed their primary vaccination with three doses of the monovalent Pfizer-BioNTech shot can now get a booster with the companies’ bivalent COVID vaccine — which targets the Omicron BA.4/5 subvariants — as long as 2 months have passed, the agency said.

“Today’s authorization provides parents and caregivers of children 6 months through 4 years of age who received the three-dose primary series with the monovalent [Pfizer shot] an opportunity to update their children’s protection by receiving a booster dose with the [bivalent vaccine],” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research (CDER), said in a statement.

Since December 2022, children in this age group who got their first two doses with the companies’ monovalent shot could complete their three-dose primary series with the bivalent vaccine. (At the time, Moderna’s bivalent vaccine was authorized as a booster dose as well, for kids ages 6 months to 5 years following a two-dose primary series.)

Children who have received Pfizer’s bivalent vaccine as their third dose will not be eligible for a booster dose of a bivalent vaccine at this time “and are expected to have protection against the most serious COVID-19 outcomes,” according to an agency press release.

The updated emergency use authorization to allow for the fourth dose comes after reviewing immune response data from 60 children in this age group who had three doses of the monovalent vaccine and a bivalent booster, FDA said.

One month after the bivalent booster, these kids “demonstrated an immune response to both the original SARS-CoV-2 virus strain and to Omicron BA.4/BA.5,” the agency said in its release.

Evidence of safety of a bivalent booster dose in this age group comes from previous data, FDA said, including studies evaluating the safety of an original strain/BA.1 booster in adults age 55 and up; the monovalent primary series in kids 6 months and older; monovalent boosters in those age 5 and up; and postmarketing safety data with the monovalent and bivalent shots.

Additional safety data come from two clinical studies involving pediatric patients that showed no new safety concerns and no previously unrecognized side effects with a bivalent booster, the FDA said.