FDA to meet on authorizing Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 years of age

Feb. 2, 2022

The U.S. Food and Drug Administration announced a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the request for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.

The FDA authorized the Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age in October 2021 and recently authorized the use of a single booster dose in individuals 12 through 15 years of age and older.

As of Dec. 19, 2021, according the Centers for Disease Control and Prevention (CDC), 8.7 million COVID-19 vaccinations have been given to kids 5 through 11 years of age, which is about one-third of the approximately 24 million U.S. kids this age in the U.S. There are approximately 23 million children less than 5 years of age in the U.S. 

The FDA intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.

FDA announcement

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