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Biontech, Pfizer Receive Approval for German Part Of Global Phase 2/3 Study With Covid-19 Vaccine Candidate BNT162B

BioNTech SE (Nasdaq: BNTX) and Pfizer Inc. (NYSE: PFE) today announced that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 2/3 clinical trial in Germany for their BNT162b2 vaccine candidate.

· 09/07/2020 08:26
BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) today announced that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 2/3 clinical trial in Germany for their BNT162b2 vaccine candidate. The study in Germany is part of the global pivotal Phase 2/3 program BioNTech and Pfizer initiated in July this year. The placebo-controlled trial evaluates the safety and efficacy of BNT162b2 in up to 30,000 participants between 18 and 85 years of age. The participants receive either BNT162b2 or placebo. The study will be conducted in approximately 120 sites globally, including regions with significant expected SARS-CoV-2 transmission. As of today, the trial enrollment has exceeded 25,000 participants. "A large, controlled Phase 3 study is a crucial prerequisite to prove the safety and efficacy of a vaccine," said CEO and Co-founder of BioNTech, Ugur Sahin. "The integration of sites in Europe, and now especially in Germany, is aimed at supporting an approval in Europe." "It's great news that we have approval from the Paul-Ehrlich-Institut to extend this pivotal study to Germany and draw upon the expertise of the German scientific community to support our efforts," said Peter Albiez, Pfizer Germany Country Manager. BNT162b2 remains under clinical study and is currently not approved for distribution anywhere in the world. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.