Pfizer and BioNTech to Supply the European Union With 200 Million Additional Doses of COMIRNATY®

• New agreement brings total supply to the European Union to 500 million doses, with delivery expected by the end of 2021
• European Commission has the option to request an additional 100 million doses

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the European Commission (EC) to supply an additional 200 million doses of COMIRNATY^®, the companies’ COVID-19 Vaccine, to the 27 European Union (EU) member states. The EC has the option to request supply of an additional 100 million doses.

This new agreement is in addition to the 300 million doses that have already been committed to the EU through 2021 under the first supply agreement signed last year. The additional 200 million doses are expected to be delivered in 2021, with an estimated 75 million to be supplied in the second quarter.

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

“We recognize that more people must be vaccinated as soon as possible to help defeat this virus and control the global pandemic. We are working relentlessly to support the further roll-out of vaccination campaigns in Europe and worldwide by expanding manufacturing capacity,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With this new agreement with the European Commission, we now expect to deliver enough doses to vaccinate at least 250 million Europeans before the end of the year.”

“Broad access to well-tolerated and highly efficacious vaccines is essential to halt the pandemic. We have taken additional steps to expand our manufacturing capacity to two billion doses in 2021,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We will initiate production at our Marburg facility this month and have strengthened our manufacturing network with additional partners. We are continuing to evaluate, together with governments, authorities and partners at all levels, how we might address an even higher future supply requirement for our vaccines.”

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 two billion 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 U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) 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&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com.