The European Medicines Agency (EMA) has approved an additional manufacturing site to ramp up the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer.
The site, located in Saint Remy Sur Avre, France, will manufacture finished product.
It will also 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.
There are other approved additional sites such as Reinbek, Germany, operated by Allergopharma GmbH & Co. KG.
The other in Stein, Switzerland, is operated by Novartis Pharma.
The sites will perform finished product manufacturing steps at different stages of the process.
The two new sites are expected to support the continued supply of Comirnaty in the European Union.
This recommendation does not require a European Commission decision, and the sites can become operational immediately.
The Amsterdam-based EMA has also approved an additional manufacturing site to produce Spikevax, the COVID-19 vaccine developed by Moderna.
The site is located in Bloomington, Indiana, US, and it will perform finished product manufacturing.
These changes are estimated to allow 40 million additional doses of Spikevax to supply the EU market in the third quarter of 2021.
EMA is in continuous dialogue with all marketing authorisation holders of COVID-19 vaccines as they seek to expand their production capacity to supply vaccines in the EU.
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.
EU Health Commissioner Stella Kyriakides said the work to expand COVID19 manufacturing capacity continues unabated.
“Six weeks ago, we delivered enough vaccines to fully vaccinate 70% of adults.
“EMA approves new manufacturing sites for BioNTech Pfizer and Moderna, more than 500 million doses in 2021”, she tweeted.
