EMA’s human medicines committee (CHMP) has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer.
One site, located in Frankfurt am Main, Germany, is operated by Sanofi-Aventis Deutschland GmbH. The other in Hameln, also in Germany, is operated by Siegfried Hameln GmbH. Both sites will manufacture finished product.
These sites will provide up to 50 million additional doses in 2021.
These recommendations do not require a European Commission decision and the sites can become operational immediately.
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. 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.