contractpharmaJuly 26, 2021
Tag: Pfizer , BioNTech , COVID-19 vaccine
The U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine, expected to be delivered from October 2021 through April 2022. This brings the total number of doses to be supplied 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.
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.
The vaccine, which is based on BioNTech’s mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the EU, and the holder of emergency use authorizations or equivalent in the U.S. (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).
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