BRIEF—EMA approves expanded capacity for BioNTech/Pfizer COVID-19 vaccine

The European Medicines Agency’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, Germany, is operated by Sanofi-Aventis Deutschland. The other in Hameln, also in Germany, is operated by Siegfried Hameln. 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.

The EMA is in continuous dialogue with all  marketing authorization 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.