One site, located in Monza, near Milan, is operated by Patheon Italia S.p.A. The other in Anagni, outside of Rome, is operated by Catalent Anagni S.R.L.
Both sites will manufacture finished product: producing up to 85 million additional doses for the EU in 2021.
Ready-to-use formulation approved
The CHMP has also approved a ready-to-use formulation of Comirnaty, which does not require dilution prior to administration.
It will be available in a 10-vial (60 dose) pack size and can be stored at 2-8°C for up to 10 weeks. In contrast, the current concentrated formulation requires dilution prior to administration, is provided in a much larger 195-vial (1,170 dose) pack size and can be stored at 2-8°C for up to one month.
All other aspects, including the antigen and the lipids of the vaccine, remain unchanged. The thawed vial contains six doses, which can be administered directly.
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 for the currently approved population of ages 12+.
If authorized, the vaccine for the younger population from 5 to <12 years of age will be based on the new formulation, which will be adapted to allow a lower dose level of 10 µg after dilution.
