EMA Adopts Recommendations to Increase COVID-19 Vaccine Capacity

The European Medicines Agency (EMA) announced on March 26, 2021 that its human medicines committee (CHMP) has approved a new manufacturing site in Leiden, the Netherlands for AstraZeneca’s COVID-19 vaccine active substance, bringing the total number of licensed manufacturing facilities available to four.

CHMP also approved a new facility in Marburg, Germany for the production of the Pfizer-BioNTech COVID-19 vaccine. The facility will manufacture the active substance and the finished product. CHMP also gave a positive opinion to allow transportation and storage of the vaccine between -25 to -15˚C for a one-off period of two weeks, an alternative to long-term storage of the vials at a temperature between -90 to -60˚C in special freezers. EMA stated in a press release that this new transportation and storage option will reduce the need for ultra-low temperature conditions throughout the supply chain and increase distribution of the vaccine in the European Union.

Moderna’s COVID-19 vaccine also got an additional manufacturing site approved by CHMP in March for the production of active substance and finished product intermediates. “The addition of the new manufacturing lines at the Lonza facility, located in Visp, Switzerland, together with other changes to the manufacturing processes that were greenlighted by the Committee are intended to scale-up production capacity and increase supply of the vaccine for the EU market,” EMA stated in the release.