The company asked the Food and Drug Administration (FDA) to amend their Emergency Use Authorization (EUA) to include 12-15 year olds.
Less than 2 weeks after reported data showing the Pfizer-BioNTech COVID-19 vaccine was 100% efficacious in 12-15 year old children, Pfizer has requested its FDA Emergency Use Authorization be amended to include this pediatric patient group to be eligible for the vaccine.
"These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100 percent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine," Pfizer said in a statement.
The companies reported results of its phase 3 trial showing 100% vaccine efficacy with its COVID-19 vaccine, BNT162b2, in the prevention of the virus is participants 12-15 years old.
The trial completed in the US had 2260 participants aged 12-15 years old, who received either a 2-dose vaccination or a placebo. No one in the former group contracted COVID-19 and 18 participants in the latter group did.
As more school children return to in-person learning, vaccination in the younger pediatric population becomes part of a larger health policy.
The Pfizer-BioNTech COVID-19 vaccine is currently authorized for people 16 years and older.