105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a new vaccine supply agreement with the U.S. government to support the continued fight against COVID-19. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg). This may include adult Omicron-adapted COVID-19 vaccines, subject to authorization from the U.S. Food and Drug Administration (FDA). The doses are planned to be delivered as soon as late summer 2022 and continue into the fourth quarter of this year.
The U.S. government will pay the companies $3.2 billion upon receipt of the first 105 million doses. Under this agreement, the U.S. government also has the option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million.
“As the virus evolves, this new agreement will help ensure people across the country have access to vaccines that may provide protection against current and future variants,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Vaccines have been and will remain critical to protecting people of all ages against COVID-19. We remain proud of our long-term partnership with the U.S. government in helping to address this pandemic, and of the ongoing impact of vaccination efforts in the U.S. and around the world.”
“This agreement will provide additional doses for U.S. residents and help cope with the next COVID-19 wave. Pending regulatory authorization, it will also include an Omicron-adapted vaccine, which we believe is important to address the rapidly spreading Omicron variant,” said Sean Marett, Chief Business and Chief Commercial Officer of BioNTech. “We appreciate the continued partnership of the U.S. government in our shared goal to help end this pandemic.”
Pfizer and BioNTech reported pivotal data demonstrating the safety, tolerability and immunogenicity of two Omicron-adapted vaccine candidates. These data have been shared with regulators, including the FDA, and a request for U.S. Emergency Use Authorization is planned. The companies have begun manufacturing the Omicron-adapted vaccine candidates at risk so that they can begin deliveries rapidly upon authorization or approval and subsequent recommendation by the U.S. Centers for Disease Control and Prevention’s (CDC), if received, and as directed by the U.S. government. 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’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.