Pfizer Requests Authorization to Vaccinate Younger Teenagers with COVID-19 Vaccine
Pfizer, Inc. and Germany-based BioNTech SE announced on April 9, 2021, they requested amendments to the U.S. Emergency Use Authorization (EUA) of the experimental Pfizer-BioNTech Vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age.
This request is 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 coronavirus infection, which demonstrated 100% efficacy and robust antibody response after vaccination with the vaccine.
The Pfizer-BioNTech COVID-19 Vaccine was issued the first U.S. Food and Drug Administration EUA for individuals 16 years of age and older on December 11, 2020. However, the Pfizer-BioNTech COVID-19 vaccine has not been Approved or Licensed by the U.S. FDA as of April 9th.
The companies stated they plan to request similar rulings by other regulatory authorities worldwide in the coming days. The mRNA vaccine is known as Comirinaty in various countries.