New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer

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.

European Medicines Agency starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11

European Medicines Agency has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to children aged 5 to 11.

Comirnaty is a vaccine for preventing COVID-19, currently authorised for use in people aged 12 and older. It contains a molecule called messenger RNA (mRNA) with instructions for producing a protein, known as the spike protein, which is naturally present in SARS-CoV-2, the virus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2.

EMA’s human medicines committee (CHMP) will review the data on the vaccine, including results from an ongoing clinical study involving children aged 5 to 11, in order to decide whether to recommend extending its use. The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final decision.

EMA will communicate on the outcome of its evaluation, which is expected in a couple of months unless supplementary information is needed.

Comirnaty was first authorised in the EU in December 2020. More information about the vaccine is available on the EMA website.