EMA Authorizes Expanded Manufacturing for Pfizer/BioNTech Vaccine

The European Medicines Agency (EMA) has approved a new Pfizer/BioNTech vaccine production line at BioNTech’s facility in Marburg, Germany, boosting active substance manufacturing capacity by an estimated 410 million doses this year.

The EMA has also authorized a new manufacturing site in Saint Rémy sur Avre, France, which will be operated by Delpharm and produce up to 51 million additional vaccine doses this year.

In addition, the European regulator has approved a new finished product manufacturing site for the Moderna vaccine in Indiana, owned by Catalent. The EMA said it has also approved several alternative Catalent sites responsible for batch control and testing and packaging.