Pfizer Inc. and BioNTech SE announced that the U.S. government has exercised its option for an additional 100 million doses of the Pfizer-BioNTech COVID-19 Vaccine. This brings the total number of doses to be supplied by the companies to the U.S. government to 300 million.
“We support the new administration’s plan to vaccinate as many people as quickly as possible because there is an urgent need to help protect people from this virus, here in the U.S. and across the globe,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are pleased to work with the administration to provide these additional vaccines, so that more Americans receive their first and second doses as soon as possible.”
“It is our objective to supply as many doses of our COVID-19 vaccine as possible to people in order to help end this pandemic, reduce the hospitalization of especially elderly people and bring us back to our normal lives,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
Consistent with the agreements for the prior 200 million doses, the U.S. government will pay $1.95 billion for the additional 100 million doses. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment for free access for COVID-19 vaccines.
Pfizer’s facility in Kalamazoo, Michigan, remains the primary manufacturing site of the Pfizer-BioNTech COVID-19 Vaccine in the U.S. The 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 U.S., 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.
