Pfizer, BioNTech COVID-19 Vaccine Gets OK from the EMA

By Miranda Greenberg -

December 23, 2020

Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have been granted conditional marketing authorization (CMA) from the European Commission (EC) for their COVID-19 vaccine, making it the first COVID vaccine to receive a CMA in the European Union (EU). The companies also announced supply plans of the vaccine in the EU and provided an update to the supply of the vaccine in the US.

The vaccine received the CMA for preventing COVID-19 in individuals 16 years of age and older and the CMA is valid all 27 member states of the EU. The vaccine will be marketed in the EU under the brand name, Comirnaty. With the CMA in the EU, Pfizer’s and BioNTech’s COVID-19 vaccine has now been granted a conditional marketing authorization, emergency use authorization, or temporary authorization in more than 40 countries (as reported on December 21, 2020), including the US, where the vaccine was authorized for emergency use on December 11, 2020. Regulatory reviews are underway in several countries, with more authorizations anticipated in the coming weeks (as reported on December 21, 2020).

Supply of the vaccine in the EU

Following the CMA, Pfizer and BioNTech will initiate delivery of the first vaccine doses 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 began immediately (as reported on December 21, 2020), 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.

BioNTech is able to produce the Pfizer-BioNTech COVID-19 vaccine for commercial supply after having already produced the vaccine candidate doses for clinical trials. BioNTech will also increase its manufacturing capacity in 2021, once a third site in Marburg, Germany will start manufacturing to provide further capacities for a global supply of the vaccine. Pfizer’s manufacturing site in Puurs, Belgium, one of Pfizer’s largest sterile injectable sites, is being used primarily for European supply but will also serve as back-up supply to Kalamazoo, Michigan, for the US market.

Supply of the vaccine in the US

In a separate development, Pfizer and BioNTech have announced a second agreement with the US government to supply an additional 100 million doses of their COVID-19 vaccine from production facilities in the US. The agreement brings the total number of doses to be delivered to the US to 200 million.

The companies expect to deliver the full 200 million doses to Operation Warp Speed, a US initiative to speed the development and distribution of COVID-19 vaccines and treatments, by July 31, 2021. Consistent with the original agreement announced in July 2020, the US government will pay $1.95 billion for the additional 100 million doses.

Under the terms of the second agreement, the companies will deliver at least 70 million of the additional doses by June 30, 2021, with the remaining 30 million doses to be delivered no later than July 31, 2021. The US government also has the option to acquire up to an additional 400 million doses of the Pfizer-BioNTech Vaccine. Eligible US residents will continue to receive the vaccine for free, consistent with the US government’s commitment to providing free access for COVID-19 vaccines and according to the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommendations for the vaccine’s phased rollout.

Source: Pfizer (EMA), Pfizer (US), BioNTech (EMA), BioNTech (US), and the European Medicines Agency