Pfizer and BioNTech SE announced that the European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY® (also known as BNT162b2), for active immunization 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 authorize the vaccine earlier today. 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 authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible with unprecedented rigor 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 conditional marketing authorization by the European Commission is an historic achievement. It is the first vaccine which has been developed in a large-scale trial with more than 44,000 participants and approved in less than a year to address this pandemic. This is based on the decade-long pioneering work by many scientists from all over the world. This achievement is also a testament to the successful collaboration with our partner Pfizer,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “As a company founded and headquartered in the heart of Europe, we are looking forward to delivering the vaccine to Europeans in the upcoming days. We believe that vaccinations may help reduce the number of people in high-risk populations being hospitalized. Moving forward, we will continue to collect efficacy and safety data in participants for an additional two years and test the vaccine against additional mutations that might occur.”
“With the pandemic still raging in many countries, we are continuing to work around the clock to bring this vaccine to the world as quickly, efficiently and equitably as possible,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “I am truly grateful for the collaboration with our partner BioNTech, and to the European Medicines Agency and European Commission for their thorough and efficient review to help us defeat a virus that has already claimed the lives of hundreds of thousands of people in Europe. We are grateful that this authorization is bringing hope to people across the continent, as we hopefully turn the corner of this crisis and approach the new year.”
The EU authorization 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
The Phase 3 data demonstrated a vaccine efficacy rate of 95% 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 7 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 today’s 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 appreciate the continued participation of the more than 44,000 trial volunteers, and remain committed to the companies’ pledge to always make their safety and well-being the companies’ top priority. The participants in the companies’ COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic. 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 authorization in all 27 EU member states, the COVID-19 vaccine has now been granted a conditional marketing authorization, emergency use authorization or a temporary authorization in a total of more than 40 countries.1 Regulatory reviews are underway in several countries, with more authorizations anticipated in the coming weeks.
