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Young boy getting vaccine

Bivalent COVID vaccines authorized for children as young as 6 months

December 9, 2022

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Health officials have bivalent COVID-19 vaccines for children as young as 6 months, a move that comes as hospitalizations are rising.

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so — especially as we head into the holidays and winter months where more time will be spent indoors,” Food and Drug Administration (FDA) Commissioner Robert M. Califf, M.D., said in a press release.

The FDA amended emergency use authorization of the bivalent Pfizer-BioNTech and Moderna vaccines Thursday, and the Centers for Disease Control and Prevention (CDC) provided the following clinical guidance on Friday, which can be found at

  • Children ages 6 months through 4 years who complete a Moderna primary series (two doses separated by four to eight weeks) can receive one bivalent Moderna booster dose at least two months after completion of their primary series.
  • Children 5 years of age who complete a Moderna primary series may receive either a bivalent Moderna booster or a bivalent Pfizer-BioNTech booster at least two months after completion of the primary series.
  • Children ages 6 months through 4 years who are being vaccinated with the Pfizer-BioNTech vaccine should receive the Pfizer-BioNTech monovalent vaccine for their first two doses (separated by three to eight weeks) followed by the bivalent Pfizer-BioNTech vaccine as their third primary series dose at least eight weeks after the second monovalent primary series dose. Children in this age group who have received three Pfizer-BioNTech monovalent primary series doses are not eligible for a booster dose.

The AAP supports administration of all COVID vaccine primary series and booster doses recommended by the CDC.

The bivalent COVID vaccines already are recommended as a booster dose for people ages 5 years and older. They contain the original SARS-CoV-2 strain and an omicron BA.4/5 spike protein. Omicron continues to circulate, although 67.9% of the strains are BQ.1.1 and BQ.1, while 14.8% are BA.5. BA.5.2.6 and BA.4.6, according to CDC data.

The FDA authorizations were based on data from clinical studies in adults using a bivalent booster containing the original SARS-CoV-2 strain and an omicron BA.1 strain as well as clinical studies on monovalent boosters in children. Side effects are expected to be similar to the monovalent doses.

“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., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.

Over the past eight weeks, the number of children with COVID-19 at hospital admission increased 68%, according to an AAP analysis of data gathered by the U.S. Department of Health and Human Services. New weekly COVID admissions for children under 5 years nearly doubled during that time.

Vaccine uptake among young children has been slow, CDC data show. About 9.4% of children ages 2-4 years have received at least one dose, and 4.7% have completed their primary series. Among children under 2 years, 6.5% have received at least one dose, and 2.9% have completed their primary series.

“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death,” Dr. Marks said.







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