EC granted a conditional marketing authorization for Pfizer and BioNTech’s COVID-19 vaccine 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.
The approval is valid in all 27 member states of the European Union.
Earlier today, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the use of the COVID-19 vaccine in the EU.
“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,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
The approval was based on pivotal Phase 3 clinical study data, which demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection.
Earlier this month, the European Medicines Agency (EMA) pushed forward a meeting of the CHMP to December 21 to review additional data for the Pfizer/BioNTech vaccine. Originally, the meeting was planned for December 29, but was pushed forward as the vaccine gained emergency approvals in the US, UK and other countries.
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. 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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