Research & Development
Pfizer, BioNTech to Provide US government with an Additional 200m Doses of COVID-19 Vaccine
26 July 2021 - - The US government has purchased an additional 200m doses of the Pfizer-BioNTech COVID-19 Vaccine, US-based biopharmaceutical company Pfizer Inc. (NYSE: PFE) and German biotechnology company BioNTech SE (NASDAQ: BNTX) said.

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 US government under its existing supply agreement to 500m.

In a separate announcement on June 10, 2021, Pfizer and BioNTech shared plans to provide the US government with 500m doses of the companies' COVID-19 vaccine for donation to the world's poorest nations.

The companies expect to deliver 110 m of the additional doses by December 31, 2021, with the remaining 90 m doses to be delivered no later than April 30, 2022.

The US 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 US residents will continue to receive the vaccine for free, consistent with the US 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 US Food and Drug Administration, but has been authorized for emergency use by FDA under an Emergency Use Authorization 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 and C Act unless the declaration is terminated or authorization revoked sooner.

The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
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