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PFIZER AND BIONTECH CHOOSE LEAD MRNA VACCINE CANDIDATE AGAINST COVID-19 AND COMMENCE PIVOTAL PHASE 2/3 GLOBAL STUDYMonday, July 27, 2020 - 05:15pm

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After extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the U.S. Food and Drug Administration¡¦s Center for Biologics Evaluation and Research (CBER) and other global regulators, Pfizer and BioNTech have chosen to advance their BNT162b2 vaccine candidate into the Phase 2/3 study, at a 30 µg dose level in a 2 dose regimen.

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The Phase 2/3 study is an event driven trial that is planned to enroll up to 30,000 participants between 18 and 85 years of age.


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