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FDA Authorizes Bivalent COVID-19 Vaccine for Children as Young as 6 Months

The US Food and Drug Administration has updated the emergency use authorization for bivalent COVID-19 vaccines to be available for children aged 6 months and older.

The bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are now authorized for children as young as 6 months, according to an update in the vaccines’ emergency use authorizations by the US Food and Drug Administration (FDA).

Robert M. Califf, MD, FDA commissioner, has encouraged parents of children eligible to receive the vaccine to update their children’s immunity.

“As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families, and public health by helping prevent severe illnesses, hospitalizations, and deaths,” Califf said.

A booster is available for children aged 6 months to 5 years who received the original Moderna COVID-19 vaccine if it has been at least 2 months since their primary series. For children aged 6 months to 4 years who have not yet started their primary series, an updated Pfizer-BioNTech vaccine is available for their third dose once 2 doses of the original vaccine have been administered.

The booster is not available for children aged 6 months to 4 years who have already received all 3 doses of their primary series. These children are expected to still have protection against the most severe outcomes from the current omicron variant, according to the FDA. An updated booster for this group is expected to be available in January.

The mRNA component of the bivalent COVID-19 vaccines will provide an immune response which can protect broadly against COVID-19, including the omicron variant. Side effects should correspond with those experienced after doses of the original vaccine. Potential side effects and myocarditis and pericarditis risks will be listed on the fact sheets for the vaccines.

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

This article was originally published in Contemporary Pediatrics.

Reference

1. Coronavirus (COVID-19) update: FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age. US Food and Drug Administration. December 8, 2022. Accessed December 8, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-updated-bivalent-covid-19-vaccines-children-down-6-months?utm_medium=email&utm_source=govdelivery


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