The European Medicines Agency (EMA) approved on Tuesday an additional manufacturing site for 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. The site will allow providing approximately up to 51 million additional doses in 2021, said EMA in a press release. 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. One site, located in Reinbek, Germany, is 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 for the production of Spikevax, the COVID-19 vaccine developed by Moderna. The site is located in Bloomington, Indiana, US, and it will perform finished product manufacturing. — Agencies
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