FDA authorizes omicron boosters for young children
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The FDA on Thursday expanded its emergency use authorization of Moderna and Pfizer-BioNTech’s omicron-targeting bivalent COVID-19 boosters to include children aged as young as 6 months in the United States.
In October, the agency granted emergency use authorizations (EUAs) for Pfizer’s bivalent booster for children aged 5 to 11 years and Moderna’s bivalent booster for children aged 6 to 11 years and adolescents aged 12 to 17 years.
“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,” Robert M. Califf, MD, FDA commissioner, said in a press release.
As of Nov. 30, the CDC reported that approximately 1.8 million children aged 6 months to 4 years in the U.S. had received a single dose of COVID-19 vaccine, representing just 10% of that population. About 15.3 million children in that age group have yet to receive their first dose.
According to the AAP, 28,604 new pediatric COVID-19 cases were reported in the U.S. during the week ending Dec. 1, representing 10.8% of all weekly reported cases. This amount brings the total number of child cases reported to 15,036,663.
“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release.
References:
Children and COVID-19: State-level data report. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Published Dec. 1, 2022. Accessed Dec. 8, 2022.
Summary of data publicly reported by the Centers for Disease Control and Prevention. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/. Published Nov. 30, 2022. Accessed Dec. 8, 2022.