EMA has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in Puurs, Belgium. The recommendation by the Agency’s Committee for Human Medicines (CHMP) is expected to have a significant and immediate impact on the supply of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer, in the European Union.

Based on the review of the data submitted by BioNTech Manufacturing GmbH, EMA’s decision reaffirms that the Puurs facility is capable of consistently producing high-quality vaccines and enables Pfizer/BioNTech to increase the volumes of vaccines produced at this site.

The changes described will be included in the publicly available information on this vaccine on EMA’s website.