Posted by Michael Wonder on 18 Dec 2021
Pfizer and BioNTech submit supplemental biologics license application for U.S. FDA approval of Comirnaty in adolescents 12 through 15 years of age
16 December 2021 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the U.S. FDA to expand the approval of Comirnaty (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years.
The supplemental biologics license application includes updated longer-term follow-up data from the companies pivotal Phase 3 clinical trial of 2,228 participants 12 through 15 years of age.
