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EMA approves increased COVID vaccine production from Pfizer, Moderna

Christian Fernsby |
EMA has approved an increase in batch size and associated process scale up at Pfizer’s vaccine manufacturing site in Puurs, Belgium.

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The recommendation by the Agency’s Committee for Human Medicines (CHMP) is expected to have a significant 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, the application to increase the batch size of the finished product manufactured at the Puurs site has been approved. EMA’s decision reaffirms that the Puurs facility is capable of consistently producing high-quality vaccines and enables Pfizer/BioNTech to scale up the production process at this site.

The CHMP also recommended the approval of a new filling line at Moderna’s finished product manufacturing site for the EU in Rovi, Spain. The new line will enable an increase in finished product fill activities, to synchronize with the active substance scale-up process at the active substance manufacturing site (Lonza, Visp) approved last month.

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