Ongoing positive results for BioNTech and Pfizer’s BNT162 mRNA-based vaccine programme

BioNTech and Pfizer have initiated a worldwide Phase 2/3 efficacy and safety clinical study to assess a nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine programme against SARS-CoV-02.

Upon evaluating preclinical and clinical data from previous studies and in collaboration with the US Food and Drug Administration’s Centre for Biologics Evaluation and Research and other global regulators, the companies have agreed to advance their BNT162b2 vaccine candidate into a trial at a dose level of 30μg in a two-dose regimen.

Phase II/III study should enrol up to thirty-thousand participants between eighteen and eighty-five years of age. The primary endpoints would be COVID-19 prevention amongst those who were not diagnosed with SARS-CoV-2 before immunisation, and COVID-19 prevention irrespective of whether the participants were earlier diagnosed with SARS-CoV-2.

Senior Vice President and Head of Vaccine Research and Development at Pfizer, Kathrin Jansen, stated: “Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D programme involving Pfizer, BioNTech, clinical investigators and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine. 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 programme progresses.”