EMA begins rolling review of Pfizer-BioNTech’s Covid-19 vaccine

The European Medicines Agency (EMA) has commenced a rolling review of Pfizer and BioNTech’s variant-adapted version of their Covid-19 vaccine, Comirnaty. This review is preliminarily based on chemistry, manufacturing, and controls (CMC) data submitted to the EMA recently. As the development of the adapted vaccine advances and clinical data become available, including findings on immunogenicity against Omicron and its subvariants, it will be included in the rolling submission. By initiating a rolling review, the regulatory agency will be able to analyse these findings when they become available. The rolling review will progress until sufficient data for a formal application is obtained.