Washington: The US Food and Drug Administration (FDA) said in a release that it has expanded the emergency use authorization for the Pfizer-BioNTech coronavirus vaccine to administer to adolescents 12-15 years of age.
“Today, the US Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age,” the release said on Monday. “The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.”
The FDA noted that it decided to expand the emergency use authorization because the known and potential benefits of the Pfizer vaccine in individuals 12-15 years old outweigh the known and potential risks of the vaccine administration.
In a clinical study, the vast majority of adolescents 12 through 15 years of age experienced pain at the injection site, fatigue and headache among other side-effects for for a period between one and three days, the release said.
At present, there is no data to determine how long the Pfizer vaccine will provide protection for children in this age bracket, the release added.