Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY®, the companies' COVID-19 vaccine, to the European Union (EU), with an option for the EC to request up to an additional 900 million doses.
This new agreement is in addition to the 600 million doses that have already been committed to the EU through 2021. The additional 900 million agreed doses are expected to be delivered on a monthly schedule beginning December 2021 and continuing into 2023. As part of the agreement, the EC also has an option to increase the number of doses delivered by up to an additional 900 million, bringing the total number of potential doses delivered to the EC, inclusive of all agreements, to up to 2.4 billion. All doses for the EC are planned to be manufactured in the European Union.
"Ongoing vaccination beyond 2021 is critical as COVID-19 continues to spread rapidly throughout Europe and the globe," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "More than a year later, we continue to learn about COVID-19 and are working to determine if, similar to seasonal influenza, annual vaccination may provide the most enduring protection. We are proud to be in a position to be a long-term partner in the EU's fight against this devastating pandemic and remain steadfast in our commitment to potentially produce and deliver billions more doses of our vaccine each year."
"There is growing evidence that COVID-19 will continue to pose a public health challenge for years. This contract with the European Commission will ensure sufficient doses of COMIRNATY are available for all EU citizens in 2022 and 2023," said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "With these additional doses and our continued investments in research and development aimed at adapting our vaccine to address new and emerging variants, we will continue to make a significant impact in the EU’s efforts to protect public health."
Pfizer and BioNTech are committed to the continued development of the vaccine, including evaluation of a potential booster dose, and an updated version of the vaccine to address potential variants.
The distribution of COMIRNATY® by the EU member states will continue to be determined according to the populations identified in the European Union and national guidance. Based on current projections, Pfizer and BioNTech believe they can manufacture at least 2.5 billion doses of the vaccine, in total, by the end of 2021, with the potential to supply up to 3 billion doses.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), 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) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 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) and Full EUA Prescribing Information available at www.cvdvaccine-us.com
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.