On Apr. 29, 2021, Pfizer and BioNTech announced they had submitted a variation to the Conditional Marketing Authorization in the European Union (EU) to the European Medicines Agency for the Pfizer-BioNTech vaccine COMIRNATY (BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age.

The companies had already submitted a similar request to the U.S. Food and Drug Administration for the Emergency Use Authorization (EUA) and planned to request additional amendments with other regulatory authorities worldwide.