European Union approves Pfizer-BioNTech's COVID-19 vaccine

The European Union has approved the use of Pfizer and BioNTech's COVID-19 Vaccine for individuals 16 years of age or above. The first phase of the mass vaccination in the 27-nation bloc will begin later this week. 

The EU’s executive commission granted conditional marketing authorization (CMA) to Pfizer-BioNTech's vaccine just hours after the European Medicines Agency (EMA) said that the vaccine meets the required safety and quality standards. The approval will be valid in all 27 member states of the EU.

The European Commission President Ursula von der Leyen assured that doses will be available for all EU countries at the same time and on the same conditions. The EU nations including France, Germany, Italy and Austria had announced that they plan to begin vaccinations shortly after Christmas. The COVID-19 vaccinations have already begun in the United Kingdom and the United States. 

Key Highlights 

•The Pfizer COVID-19 vaccine will be marketed in the EU under the brand name COMIRNATY, representing the combination of terms COVID-19, mRNA, community and immunity. It will highlight the first authorization of a messenger RNA (mRNA) vaccine,.

•COMIRNATY is the first COVID-19 vaccine to receive approval for use in the European Union. The distribution of the vaccine will be determined as per the populations of the nations identified in the EU. 

•This is the first vaccine that has been developed in a large-scale clinical trial with more than 44,000 participants and was approved in less than a year.

•This includes data from a pivotal Phase 3 clinical study announced last month and published recently in The New England Journal of Medicine.

•Pfizer and BioNTech will begin delivery of the first vaccine doses across the EU based on a distribution plan defined by the EC and contract terms.

When will the delivery begin?

The delivery of the vaccine will begin immediately and will be done in stages throughout 2020 and 2021 to ensure an equitable allocation of vaccines according to contract terms across the European Commission.

The first batches of the vaccine will be shipped from Pfizer's manufacturing site in Belgium in the next few days, with vaccinations starting on December 27, 2020. The vaccine doses will be produced in BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Puurs, Belgium.

Background

In November 2020, Pfizer and BioNTech had reached an agreement with the European Commission to supply 200 million doses of the COVID-19 vaccine in 2020 and 2021 with an option of 100 million additional doses.