FDA authorizes Pfizer booster dose for 12 to 17 year-olds




As schools across the country return to in-person learning after winter break amid soaring cases of COVID-19 caused by the Omicron (B.1.1.529) variant, the Food and Drug Administration (FDA) this morning authorized the use of a booster dose in children ages 12 to 17 if it has been at least 5 months since completing the primary vaccination series.

The regulatory agency also said children ages 5 to 11 who are immunocompromised can receive a third dose, as well. The booster period was also reduced from 6 months following the primary series to 5 months for adults.

The FDA said no new safety concerns have appeared since May, when the Pfizer/BioNTech vaccine was first approved for use in 12- to 17-year-olds. They also referenced Israeli data in their decision, which showed no new safety concerns in 4.1 million kids in this age-group who received a booster.

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research in a press release.



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