Ready to immediately ship initial doses of the agreed 200 million doses to the 27 EU member states, with an option for the EU to purchase an additional 100 million doses in 2021
The European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for Pfizer and BioNTech’s COMIRNATY (also known as BNT162b2), for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.
This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorise the vaccine earlier in the day. The EC granted this CMA in the interest of public health to help address the COVID-19 pandemic. The CMA is valid in all 27 member states of the European Union (EU).
The vaccine will be marketed in the EU under the brand name COMIRNATY, which represents a combination of the terms COVID-19, mRNA, community, and immunity, to highlight the first authorisation of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible with unprecedented rigour and efficiency – and with safety at the forefront – during this global pandemic. COMIRNATY is the first COVID-19 vaccine to receive CMA in the EU. The distribution of COMIRNATY by the EU member states will be determined according to the populations identified in EU and national guidance.
The EU authorisation is based on the totality of scientific evidence shared by the companies as part of the EMA’s rolling review process and the application for CMA, which the companies submitted on December 1, 2020. This included data from a pivotal Phase 3 clinical study announced last month and published recently in The New England Journal of Medicine.
As per a statement from Pfizer, the Phase 3 data demonstrated a vaccine efficacy rate of 95 per cent in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose. The Data Monitoring Committee (DMC) for the study has not reported safety concerns related to the vaccine. Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored to assess the duration of protection and safety for an additional two years after their second dose.
Following this CMA, Pfizer and BioNTech will initiate delivery of the first vaccine doses immediately across the EU based on a distribution plan defined by the EC and contract terms. In November 2020, Pfizer and BioNTech reached an agreement with the EC to supply 200 million doses of a vaccine for COVID-19 in 2020 and 2021, with the option for up to 100 million additional doses, subject to agreement of the parties. Delivery will begin immediately, and occur in stages, throughout 2020 and 2021, to ensure an equitable allocation of vaccines according to contract terms across the EU. Vaccine doses for Europe will be produced in BioNTech’s manufacturing sites in Germany, and Pfizer’s manufacturing site in Puurs, Belgium.
Pfizer and BioNTech are providing a vaccine transition option that enables trial participants 16 years and over who received the placebo to receive the vaccine as part of the study. This option is voluntary and is being implemented in a phased manner.
With this EU authorisation in all 27 EU member states, the COVID-19 vaccine has now been granted a conditional marketing authorisation, emergency use authorisation or a temporary authorisation in a total of more than 40 countries, as per a statement from Pfizer. Regulatory reviews are underway in several countries, with more authorisations anticipated in the coming weeks.