FDA Approves Bivalent COVID-19 Boosters for Children 6 Months and Older

THURSDAY, Dec. 8, 2022 (HealthDay News) -- The updated bivalent COVID-19 boosters are now approved for use in children as young as 6 months of age, the U.S. Food and Drug Administration announced today.

Children can receive either a Moderna or Pfizer-BioNTech bivalent booster shot, although the rules differ depending on their age and what type of vaccine they got as their primary series, the FDA said. Children 6 months to 5 years who received the original Moderna vaccine can receive the Moderna booster at least two months after completing their first round of shots. Children 5 years and older also can receive the Pfizer-BioNTech booster at least two months after they have completed their first series of COVID-19 shots.

The new Pfizer-BioNTech booster will replace the third dose of the primary series of shots for that vaccine for children 6 months through 4 years of age, the FDA said. But children 4 years and younger who already completed the three-dose Pfizer-BioNTech primary series will not be eligible for the bivalent booster at this time, the agency said. The FDA will decide on the updated booster for this group of children after January, when fresh data are expected.

The updated boosters contain two components to protect against both the original strain of COVID-19 and widely circulating omicron variants. The FDA based its decision on clinical trials showing that the boosters are safe and effective in young children, the agency said.

"Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing," Peter Marks, M.D., director of the FDA Center for Biologics Evaluation and Research, said in an agency news release.

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