EMA - New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer.

ENPNewswire-October 19, 2021--EMA - New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer

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Release date- 18102021 - EMA's human medicines committee (CHMP) has approved two additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer.

One site, located in Monza, Italy, is operated by Patheon Italia S.p.A. The other in Anagni, also in Italy, is operated by Catalent Anagni S.R.L. Both sites will manufacture finished product.

These sites will produce up to 85 million additional doses to supply the EU 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.

Ready-to-use formulation approved

The CHMP has approved a ready-to-use formulation of...

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