(HealthDay News) — The Moderna and Pfizer-BioNTech bivalent COVID-19 vaccine boosters are now authorized for use in children, the US Food and Drug Administration (FDA) announced October 12.

The bivalent booster shots include one part that protects against the original strain of SARS-CoV-2 and another part that targets omicron subvariants BA.4 and BA.5.

The Moderna bivalent vaccine is authorized for children age 6 and older, and the Pfizer-BioNTech vaccine is authorized for children age 5 and older. Either vaccine should be given at least 2 months after children have either finished the primary series of 2 shots or have gotten a booster shot.


Continue Reading

“[A]s the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized,” Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research, said in an agency news release.

“Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”

The FDA said authorization for these bivalent vaccines is based on immune response and safety data from clinical trials of vaccines containing a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1.

“The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages,” the agency said.

More Information