Europe Authorizes mRNA Vaccine Production Enhancements

The European Medicines Agency (EMA) announced on April 23, 2021, an increase in vaccine manufacturing capacity and supply for mRNA COVID-19 vaccines produced by BioNTech - Pfizer and Moderna.

The EMA approved an increase in batch size and associated process scale-up at Pfizer’s vaccine manufacturing site in Puurs, Belgium. The Agency’s Committee for Human Medicines (CHMP) recommendation is expected to have a significant impact on the supply of the COVID-19 vaccine (Comirnaty) developed by BioNTech and Pfizer in the European Union.

The CHMP also recommended the approval of a new filling line at Moderna’s vaccine 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.

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