FDA authorizes Pfizer-BioNTech COVID-19 vaccine for children 5-11

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5.11.2021 | FDA authorizes Pfizer-BioNTech COVID-19 vaccine for children 5-11

The Food and Drug Administration has issued an emergency authorization for the use of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11.

The FDA's authorization follows the recommendation of its independent advisory committee, which earlier this week voted nearly unanimously in favor of authorizing the vaccine. The committee of 18 voting members voted 17-0 in favor, with one abstention.

A clinical trial run by Pfizer and BioNTech involving about 2,250 children ages 5 through 11 suggested that the vaccine was about 91 percent effective at preventing symptomatic disease. Data from around 3,100 children found no serious side effects.

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