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Pfizer & BioNTech’s COVID-19 vaccine approved in the EU

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the conditional marketing authorization (CMA) of the Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older.

“We are pleased with the Committee’s strong vote of confidence in our data,” says Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “If the European Commission issues an authorization, we are ready to start delivering this vaccine to government-designated sites all across the EU where cases of disease continue to rise and several countries are managing lockdowns.”

“We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light.”

The purpose of a CMA is to allow for medicinal products to be authorized on a conditional basis for seriously debilitating or life-threatening diseases or for use in emergency situations in response to public health threats recognized either by the World Health Organization or the European Union (EU).

“Today is a particularly personal and emotional day for us at BioNTech. Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic. We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light,” says Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

Data from a Phase 3 clinical study

The CHMP advisors based their positive opinion on the scientific evidence supporting the Pfizer-BioNTech COVID-19 Vaccine, including data from a Phase 3 clinical study announced last month and published in The New England Journal of Medicine on December 10, 2020. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on the conditional marketing authorization in the near future. If the EC grants the CMA, the decision will be immediately applicable to all 27 EU member states.

To date, the vaccine has been authorized or approved for emergency use in more than 15 countries. Regulatory reviews are underway in several countries, with more submissions anticipated.

Photo: BioNTech