Comirnaty and Moderna COVID-19 vaccine supply to increase in the EU

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has approved an additional manufacturing site for the production of the Comirnaty COVID-19 vaccine, developed by Pfizer and BioNTech, and an additional site for Spikevax, the COVID-19 Vaccine developed by Moderna, in the European Union (EU).

Comirnaty’s site in Saint Rémy sur Avre, France, operated by Delpharm, will manufacture finished product. EMA states that the site will provide up to 51 million additional doses in 2021. EMA 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.

CHMP has also approved an additional manufacturing site for the production of Spikevax. The site located in Indiana, US, operated by Catalent, will perform finished product manufacturing. In addition to the new manufacturing facility for this vaccine, CHMP has also approved several alternative sites responsible for batch control/testing and packaging of the finished product manufactured by Catalent.

CHMP already approved a scale-up of the active substance manufacturing process at two sites in the US (Moderna in Massachusetts and Lonza Biologics in New Hampshire).  All together, these changes are estimated to allow the production of 40 million additional doses of Spikevax to supply the EU market in the third quarter of 2021.

These recommendations do not require a European Commission (EC) decision and the sites can become operational immediately. According to the EMA, it 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 EMA will provide 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.