Pfizer and BioNTech select lead mRNA vaccine against COVID-19

Pfizer and BioNTech have started a global Phase II/III safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine programme against SARS-CoV-2.

The companies have chosen to advance their BNT162b2 vaccine candidate into study, at a 30µg dose level in a two-dose regimen, following review of preclinical and clinical data from earlier trials, and in consultation with the US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) and other global regulators.

BNT162b2 encodes an optimised SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralising antibodies.

The Phase II/III study should enrol up to 30,000 participants between 18 and 85 years of age. Its primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunisation, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe COVID-19 in those groups.

“Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase II/III 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,” said Kathrin Jansen, senior vice president and head of Vaccine Research & Development, Pfizer.

“The initiation of the Phase II/III 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.”