Research & Development
Pfizer, BioNTech to Supply the European Union with 200m Additional Doses of COVID-19 Vaccine
18 February 2021 - - US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) and German biotechnology company BioNTech SE (NASDAQ: BNTX) have inked an agreement with the European Commission to supply an additional 200m doses of Comirnaty, the companies' COVID-19 Vaccine, to the 27 European Union member states, the companies said.

The EC has the option to request supply of an additional 100 m doses.

This new agreement is in addition to the 300 m doses that have already been committed to the EU through 2021 under the first supply agreement signed last year.

The additional 200 m doses are expected to be delivered in 2021, with an estimated 75m to be supplied in 2Q21.

The total number of doses to be delivered to the EU member states by the end of 2021 is now 500 m, with the potential to increase to 600m based on the option granted in the new agreement.

Comirnaty is being produced in BioNTech's and Pfizer's manufacturing sites in Europe. The distribution of Comirnaty by the EU member states will continue to be determined according to the populations identified in EU and national guidance.

Globally, Pfizer and BioNTech aim to manufacture approximately 2bn doses in total by the end of 2021, assuming continuous process improvements, expansion at current facilities and adding new suppliers and contract manufacturers, and the updated six-dose labeling.

The vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorizations Holder in the EU, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the US Food and Drug Administration, but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD and C Act unless the declaration is terminated or authorization revoked sooner.

The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.