EMA approves new Pfizer-BioNTech vaccine manufacturing sites, ready-to-use version of Comirnaty

The European Medicine Agency (EMA)’s human medicines committee—the Committee for Medicinal Products for Human Use (CHMP)—has approved two more manufacturing sites for the production of Comirnaty, Pfizer and BioNTech’s Covid-19 vaccine.

Both sites are located in Italy (Monza and Anagni), and will be run by Patheon Italia S.p.A. and Catalent Anagni S.R.L., respectively. These sites—which will be manufacturing finished product—will produce up to 85 million additional doses to supply the EU with through the remainder of the year.

The CHMP also approved a ready-to-use formulation of Comirnaty, one that does not need to be diluted before being administered. Once it begins a phase rollout in early 2022, it will be available in a 10-vial (60-dose) pack size and can be stored at 2-8°C (36-46°F) for up to 10 weeks. The current concentrated formulation requires dilution prior to administration, and is available in a 195-vial (1,170-dose) pack size, being able to be stored at 2-8°C for up to one month.