FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16-, 17-year-olds

By The Science Advisory Board staff writers

December 13, 2021 -- The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. Specifically, the FDA authorized the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 vaccine.

The Pfizer-BioNTech vaccine (which will be marketed as Comirnaty) is the only COVID-19 vaccine currently available for the 16- and 17-year-old age group. The EUA for a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for individuals 16 and 17 years of age is based on the FDA's previous analysis of immune response data that supported the use of a booster dose in individuals 18 years of age and older from 200 participants.

Myocarditis and pericarditis are two risks of using the Pfizer-BioNTech COVID-19 vaccine. The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine, or Comirnaty, outweigh the risks in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur, including hospitalization and death.

The most commonly reported side effects in individuals who received a booster dose were pain, redness, and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following administration of the booster dose than after the second dose of the two-dose primary series.

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