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Pfizer And BioNTech Start Late-stage Study Of COVID-19 Vaccine Candidate

Pfizer Inc. (PFE) and BioNTech (BNTX) said that they have started a global Phase 2/3 clinical study to evaluate a single nucleoside-modified messenger RNA or modRNA candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2.

The study is expected to include about 120 sites globally except china and could include up to 30,000 participants.

The companies said they have chosen to advance their BNT162b2 vaccine candidate into the Phase 2/3 study, at a 30 g dose level in a 2 dose regimen. BNT162b2, which recently received U.S. Food and Drug Administration Fast Track designation, encodes an optimized SARS-CoV-2 full length spike glycoprotein, which is the target of virus neutralizing antibodies.

"The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic, and we look forward to generating additional data as the program progresses," said Kathrin Jansen, Senior Vice President and Head of Vaccine Research & Development, Pfizer.

The companies plan to manufacture globally up to 100 million doses of vaccine candidate by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021.

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