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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine
The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.” ....

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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID-19 Vaccine

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced the initiation of a Biologics License Application with the U.S. Food and Drug Administration for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act …
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescrip ....

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Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at 2020 Tokyo Games

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Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at 2020 Tokyo Games
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a Memorandum of Understanding (MoU) with the International Olympic Committee (IOC) to donate doses of the companies’ COVID-19 Vaccine to help vaccinate athletes, and their delegations, participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to begin on July 23, 2021.
Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. Delivery of initial doses to participating delegations is expected to begin at the end of May where possiblewith the aimto ensure participating delegations receive second doses ahead of arrivals in Tokyo. Un ....

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Pfizer Inc.: Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games

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Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a Memorandum of Understanding (MoU) with the International Olympic Committee (IOC) to donate doses of the companies COVID-19 Vaccine to help vaccinate athletes, and their delegations, participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to begin on July 23, 2021.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210506005580/en/
Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations participation in the Games. Delivery of initial doses to participating delegations is expected to begin at the end of May where possible ....

United States , United Kingdom , Thomas Bach , Suga Yoshihide , Albert Bourla , Amy Rose , Fosun Pharma , Sylke Maas , Chuck Triano , Ugur Sahin , International Olympic Committee , Bayer Animal Health , Pfizer Inc , European Union , Centers For Disease , National Olympic Committees Nocs , Drug Administration , International Paralympics Committee , Exchange Commission , Roche Group , Vaccine Administration Under Emergency Use Authorization , Paralympic Games Tokyo , National Olympic Committees , Paralympic Games , Chief Executive Officer , Prime Minister ,

Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games

Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games
Pfizer Inc. and BioNTech SE today announced the signing of a Memorandum of Understanding with the International Olympic Committee to donate doses of the companies’ COVID-19 Vaccine to help vaccinate athletes, and their delegations, participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to begin on July 23, 2021. This press release features multimedia. View the full release here: Under …
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a Memorandum of Understanding (MoU) with the International Olympic Committee (IOC) to donate doses of the companies’ COVID-19 Vaccine to help vaccinate athletes, and their delegations, participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to begin on July 23, 2021. ....

United States , United Kingdom , Thomas Bach , Suga Yoshihide , Albert Bourla , Amy Rose , Fosun Pharma , Sylke Maas , Chuck Triano , Ugur Sahin , International Olympic Committee , Bayer Animal Health , Pfizer Inc , European Union , Centers For Disease , National Olympic Committees Nocs , Drug Administration , International Paralympics Committee , Exchange Commission , Roche Group , Vaccine Administration Under Emergency Use Authorization , Paralympic Games Tokyo , National Olympic Committees , Paralympic Games , Chief Executive Officer , Prime Minister ,