(WWLP) – The Food and Drug Administration on Monday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for adolescents 12- to 15-years-old.
The administration said expanding the vaccine to include that age group “is a significant step in the fight against the COVID-19 pandemic.”
Acting FDA Commissioner Janet Woodcock, M.D., stated, “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
The FDA said it has determined that the Pfizer vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.
Expert advisers for the CDC are still scheduled to meet Wednesday to recommend whether the vaccine should be used for that age group.
They will begin administering it once the CDC director gives their recommendation the green light.
This is developing breaking news. We’ll bring you the latest when we learn more.