New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer
Additional manufacturing sites approved
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 Comirnaty. This formulation does not require dilution prior to administration, will be available in a 10-vial (60 dose) pack size and can be stored at 2-8°C for up to 10 weeks. The current concentrated formulation requires dilution prior to administration, is available in a 195-vial (1,170 dose) pack size and can be stored at 2-8°C for up to one month).
These differences will provide improved storage, transport and logistic options for vaccine distribution and administration. The new formulation will be available in a phased rollout starting in early 2022.