Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing 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.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” said Acting FDA Commissioner Janet Woodcock, M.D. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
On Nov. 19, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. Today’s action expands the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 16 and 17 years of age at least six months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine. The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) are the only COVID-19 vaccines currently available for the 16- and 17- year-old age group. Individuals who are 16 and 17 years of age should only receive the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty as their booster dose.
“The Pfizer-BioNTech COVID-19 Vaccine has been available to individuals 16 years of age and older for nearly a year, and its benefits have been shown to clearly outweigh potential risks,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group. A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups.”