FDA OKs Bivalent COVID Shots for Children 6 Months and Older

Lisa O'Mary

December 08, 2022

The FDA on Thursday authorized bivalent COVID-19 vaccines for children as young as 6 months old who previously received the Moderna vaccine or who have not yet completed their primary Pfizer vaccine series.

Children ages 4 and under who have already completed their three-dose Pfizer vaccine series won't be eligible for boosters until next year, when more data is available, the FDA said in a news release.

"Children in this age group who already completed their primary [Pfizer] series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant," the news release stated. "The data to support giving an updated bivalent booster dose for these children are expected in January. The agency is committed to evaluating those data as quickly as possible."

The bivalent shots authorized starting today are:

  • The Moderna bivalent booster for children ages 6 months to 5 years old who previously completed the primary Moderna vaccine series. The bivalent booster is a single shot that can be given 2 months after a child completed the primary Moderna vaccine series. 

  • The Pfizer-BioNTech bivalent booster for children ages 6 months to 4 years old who have not completed their three-dose primary Pfizer-BioNTech vaccine series. After receiving two doses of the original (monovalent) vaccine, the third dose will be the updated bivalent vaccine.

The term "bivalent" means the new vaccines are updated to address virus strains that have become more common since the primary vaccine formula was developed.

"Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death. Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19," said Peter Marks, MD, PhD,  director of the FDA's Center for Biologics Evaluation and Research. "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."

The FDA said parents can expect their children to have similar side effects from boosters as the children had from the primary vaccines series.

As of Nov. 30, the CDC reported that 2.7% of U.S. children ages 2 and younger and 4.6% of children ages 2 to 4 completed a primary vaccine series. 

The CDC has updated its guide for parents, explaining the different vaccine and booster options for children and teens ages 6 months to 17 years old.

Sources

FDA: "Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age."

CDC: "Children and teens ages 6 months-17 years," "Trends in Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States."

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