Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna
CHMP has approved an additional manufacturing site for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. The site, located in Saint Rémy sur Avre, France, is operated by Delpharm and will manufacture finished product. The site will allow to provide approximately 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 COVID-19 vaccine developed by Moderna.
The site, located in Bloomington, Indiana, United States (US), is operated by Catalent. The site 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.
On 30 July 2021, CHMP already approved a scale-up of the active substance manufacturing process at two sites in the US (Moderna TX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, 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. ■