(CMR) The US Food and Drug Administration announced on Monday that children 12 to 15 years old are now eligible to receive the Pfizer COVID-19 vaccine.
The Pfizer-BioNTech vaccine had been authorized for use in ages 16 and up in December. The FDA has now amended that authorization to include children ages 12 to 15.
Dr. Janet Woodcock, the acting FDA commissioner, said the expansion “brings us closer to returning to a sense of normalcy.”
“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,” Woodcock said.
Pfizer asked the FDA to broaden its emergency use authorization for the vaccine after clinical trials found “100% efficacy and robust antibody responses” in study participants who were 12 to 15 years old.
Moderna and Johnson & Johnson are also currently studying their vaccines' safety and efficacy in teens and younger children but have not yet released results from those trials.
Canada last week became the first country to authorize the Pfizer-BioNTech vaccine for 12- to 15-year-olds. The companies have also sought permission from the European Medicines Agency to market the vaccine to this age group in Europe.