The EU approves Pfizer’s COVID-19 Vaccine for emergency authorization of use.
Germany – Pfizer and BioNTech announced Monday that the European Commission (EC) has granted a conditional authorization of use for immunization to prevent the COVID-19 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 the authorization in the interest of public health to help address the COVID-19 pandemic.
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 Conditional Marketing Authorization (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.”
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.
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