Additional manufacturing site for COVID-19 vaccine Janssen
EMA’s human medicines committee (CHMP) has approved an additional manufacturing site for the production of COVID-19 Vaccine Janssen, developed by Janssen-Cilag International NV.
The site, located in Marcy-l’Étoile, France, and operated by Sanofi Pasteur, will manufacture finished product.
The site is expected to support the continued supply of COVID-19 Vaccine Janssen.
Scale-up process for Spikevax from Moderna
The CHMP has also given a positive opinion for an increase in production of Spikevax, the COVID-19 vaccine from Moderna, at the manufacturing site operated by ROVI Contract Manufacturing, located in Madrid, Spain
The increase in production includes a 50% scale-up of the batch size of the finished product and a second fill-and-finish line. These changes will allow the production of around 25 million additional doses of Spikevax every month to the European Union and to third countries through the COVID-19 Vaccines Global Access (COVAX) initiative.
Scale-up process for Comirnaty from BioNTech/Pfizer
An increase in production of the active substance of Comirnaty, the COVID-19 vaccine from BioNTech/Pfizer, at the manufacturing site operated by Wyeth BioPharma Division of Wyeth Pharmaceuticals, located in Andover, MA, USA, was also approved by the Committee.
This increase in production capacity is expected to support the continued supply of Comirnaty in the European Union.
These recommendations do not require a European Commission decision and the changes 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.