The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved two additional production sites for making Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty.
Both the facilities are located in Italy at Monza and Anagni. The Monza site will be operated by Patheon Italia, while Catalent Anagni will operate the Anagni facility.
In total, the two sites will produce up to 85 million additional Covid-19 vaccine doses for the EU this year.
The sites can become operational immediately.
Separately, the CHMP has also approved a new ready-to-use formulation of Comirnaty that does not require dilution before administration.
Comirnaty is a messenger RNA (mRNA) based vaccine against Covid-19.
EMA stated that the new formulation dose can be stored at 2-8°C temperatures for up to ten weeks. It will be available in a ten-vial (60 dose) pack size.
Meanwhile, the current formulation can be stored for up to one month at 2-8°C. It also requires dilution prior to administration and is available in a 195-vial (1,170 dose) pack size.
It is also noted that all the other aspects of the new formulation including the antigen and the lipids of the vaccine remain unchanged.
The vials with the new formulation can be transported and stored at 2 °C to 30 °C and need to be used within 12 hours after the first puncture, doubling the current timeframe of six hours.
The changes are expected to generate logistical benefits as well as improve vaccine distribution.
Comirnaty’s new formulation will be rolled out in phases from early 2022.
If authorised, the Covid-19 vaccine for children aged five to 12 years will be developed based on the new formulation.