EU Adds New COVID-19 Manufacturing Capacity

Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--The European Union (EU) expects to boost the availability of leading COVID-19 vaccines by more than 460 million doses this year after granting permission for new manufacturing capacity in France, Germany and the U.S.

The region's drug regulator, European Medicines Agency (EMA), has approved an additional manufacturing site for the production of the Comirnaty vaccine developed by BioNTech and Pfizer. The site, located in Saint Rémy sur Avre, France, is operated by Delpharm and will manufacture finished product, adding roughly 51 million additional doses in 2021. It has also approved a new manufacturing line at BioNTech's manufacturing site in Marburg, Germany, which increases the active substance manufacturing capacity by approximately 410 million doses in 2021.

It has also approved an additional manufacturing site for the production of Spikevax for the European market, the COVID-19 vaccine developed by Moderna. The site, located in Bloomington, Indiana, is operated by Catalent and will perform finished product manufacturing. It has also approved several alternative sites responsible for batch control/testing and packaging of the finished product manufactured by Catalent. It has previously approved a scale-up of the active substance manufacturing process at two U.S. sites. All together, it will enable the production of 40 million additional doses of Spikevax for the EU market in the third quarter of 2021.

"These recommendations do not require a European Commission decision and the sites can become operational immediately," the EMA stated. "EMA is in continuous dialogue with all marketing authorisation holders of COVID-19 vaccines as they seek to expand their production capacity for the supply of vaccines in the EU. The Agency provides guidance and advice on the evidence required to support and expedite applications to add new sites or increase the capacity of existing sites for the manufacture of high-quality COVID-19 vaccines."

Earlier this year Industrial Info reported that the EMA had fast-tracked increased manufacturing capacity for COVID-19 vaccines at sites in Belgium and Spain as it sought to overcome notable shortages in vaccine delivery. For additional information, see May 3, 2021, article - Europe Green Lights More COVID-19 Production Capacity.

Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info's quality-assurance philosophy, the Living Forward Reporting Principle, provides up-to-the-minute intelligence on what's happening now, while constantly keeping track of future opportunities. Follow IIR on: Facebook - Twitter - LinkedIn.