In December 2020, the FDA approved an emergency use authorisation (EUA) for the Pfizer/BioNTech COVID-19 vaccine, based on preliminary data from a pivotal Phase III clinical trial.
As part of their Biologics License Application (BLA) for Comirnaty, Pfizer and BioNTech submitted a ‘comprehensive’ data package, including long-term follow-up data from the Phase III trial as well as manufacturing and facilities data.
The companies are also planning to submit an application for approval of a third booster dose of Comirnaty in individuals 16 years of age and older via a supplemental BLA.
