EMA Approves Two New Manufacturing Sites and a New Formulation for Comirnaty

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has approved two new manufacturing sites and a ready-to-use formulation of the BioNTech-Pfizer COVID-19 vaccine, Comirnaty.

Announced in an Oct. 18, 2021 press release, the two new manufacturing sites are both located in Italy—one in Monza, operated by Patheon, and the other in Anagni, operated by Catalent Anagni. Both sites are set to manufacture finished product and are expected to be able to produce up to 85 million addition doses of the COVID-19 vaccine to the European Union before the end of 2021.

The ready-to-use formulation that has been approved by CHMP does not require dilution prior to administration and will be available in a 10-vial (60 dose) pack size. The new formulation can be stored at 2–8 °C for up to 10 weeks. Currently, the concentrated formulation of Comirnaty needs to be diluted before use and can only be stored for up to one month at 2–8 °C. So, the new formulation should provide better storage, transport, and logistic options for distribution and administration.

According to the press release, the new formulation will be rolled out in a phased way commencing in early 2022.

Source: EMA