Pfizer-BioNTech Request EUA Expansion for Adolescent Boosters
This week, Pfizer and BioNTech submitted a formal request to the U.S. Food and Drug Administration (FDA) to expand the emergency use authorization (EUA) of a booster dose of the COVID-19 vaccination to include individuals ages 16 and 17. Currently, only people ages 18 and older are eligible for a COVID-19 booster dose in the U.S., and it must be six months after receiving the Pfizer or Moderna vaccine or two months after the Johnson & Johnson vaccine.
Pfizer and BioNTech in October announced results of a randomized study of 10,000 people 16 years of age and older showing a booster dose “restored vaccine protection against COVID-19 to the high levels achieved after the second dose.”
Reports suggest the FDA is anticipated to act promptly on Pfizer’s request, possibly granting approval within the coming week, making booster doses available to several million teenagers in the U.S.