U.S. FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine Boosters for 12- to 15-Year-Olds for Emergency Use

The United States Food and Drug Administration (FDA) on Jan. 3 authorized the Pfizer-BioNTech COVID-19 vaccine booster dose for children aged 12 to 15 years for emergency use.

The FDA expanded the emergency use authorization to include children as young as 12 years after determining that the health benefits of the vaccine outweigh the potential risks, following a review of real-world data from Israel.

Pfizer Chairman and Chief Executive Officer Albert Bourla described FDA’s decision as “critical to help us ultimately defeat this pandemic.”

“We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations,” Bourla said.

The FDA also shortened the interval of Pfizer-BioNTech’s booster shots from six months to five months  after the primary vaccination series, based on data from Israel.

The FDA also authorized a third primary series dose to certain immunocompromised children aged five to 11 years, such as those who have had organ transplants.

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