NEW YORK: BioNTech and Pfizer have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants, which also allows for the enrollment of new populations. Enrollment in the trial has been proceeding as planned and the…
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COVID-19: Pfizer and BioNTech commence pivotal Phase 2/3 global study
NEW YORK: Pfizer Inc. and BioNTech SE announced the start of a global (except for China) Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2. After extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in…