Europe’s medicines regulator has approved additional manufacturing sites for mRNA-based coronavirus vaccines developed by Pfizer-BioNTech and Moderna to help boost production amid a resurgence in infections.
The European Medicines Agency (EMA)
said on Tuesday its human medicines committee had approved a site at Saint Remy sur Avre in France for making the Pfizer-BioNTech vaccine, Comirnaty.
The Delpharm-operated site will help provide up to 51 million additional doses of Comirnaty in 2021, the EMA said.
The regulator also said it had approved a new manufacturing line at BioNTech’s site at Marburg in Germany, which would help boost capacity for the vaccine’s active substance by about 410 million doses this year.
The European Union has been trying to boost and protect supplies after a rocky start to its vaccination campaign by bringing more facilities online and paying more for new COVID shots.
The EMA also gave its go-ahead for an additional site at Bloomington, Indiana, in the United States for Moderna’s vaccine and several other locations involved in testing and packaging.
The Bloomington site is operated by contract drug manufacturer Catalent Inc.
The recommendations do not require a decision by the European Commission and the sites can become operational immediately, the EMA said. —