Pfizer Inc. and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022.
This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million. In a separate announcement on June 10, 2021, Pfizer and BioNTech shared plans to provide the U.S. government with 500 million doses of the companies’ COVID-19 vaccine for donation to the world’s poorest nations.
As a long-term partner to the U.S. government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country. Vaccines have been and will remain critical to protecting lives against this devastating disease,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “These additional doses will help the U.S. government ensure broad vaccine access into next year.”
“It has been our consistent goal to supply as many doses of our COVID-19 vaccine as possible to people around the world to help bring an end to this pandemic,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We are honored to support the U.S. and more than 100 countries in their continuing vaccination programs.”
The companies expect to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses to be delivered no later than April 30, 2022. The U.S. government also has the option to acquire an updated version of the vaccine to address potential variants as well as new formulations of the vaccine, if available and authorized.
Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment for free access to COVID-19 vaccines.
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), 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.