The European Commission (EC) has granted Pfizer/BioNTech’s COVID-19 vaccine a conditional marketing authorisation (CMA), under the new name Comirnaty.
The vaccine, also known as BNT162b2, has been authorised for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 16 years of age and older.
The authorisation follows a positive opinion for Comirnaty issued yesterday by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The authorisation is based on scientific evidence shared by Pfizer/BioNTech as part of the EMA’s rolling review process and the application for the CMA.
This included data from a phase III clinical trial of the vaccine, which demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection.
Pfizer/BioNTech will begin to deliver the first vaccine doses immediately across the EU based on a distribution plan defined by the EC and contract terms.
The EC has previously signed a deal with Pfizer/BioNTech for 200 million doses of a vaccine for COVID-19 in 2020 and 2021, with the option for up to 100 million additional doses.
The Comirnaty doses for Europe will be produced in BioNTech’s manufacturing sites in Germany and in Pfizer’s site in Puurs, Belgium.
“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 hospitalised. 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,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.
“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,” said Albert Bourla, chairman and chief executive officer of Pfizer.