In March, the companies forged a collaboration to co-develop and supply potential mRNA-based coronavirus vaccines that include BNT162. The early-stage trial for the Covid-19 vaccine candidate is part of a global development programme, with the dosing of the first cohort in Germany completed by the companies last week.
The phase 1/2 clinical trial aims to determine the safety, immunogenicity, and optimal dose level of four mRNA vaccine candidates that will be assessed in a single, continuous study.
The dose level escalation portion, which will be stage 1 of the phase 1/2 trial in the US, will feature up to 360 healthy subjects into two age cohorts of 18-55 and 65-85 years of age.
According to Pfizer, the first subjects immunised in stage 1 of the study will be healthy adults in the 18-55 age group. Older adults will be immunised with only a given dose level of the Covid-19 vaccine candidate once testing of that candidate and dose level in younger adults has delivered initial evidence of safety and immunogenicity.
Pfizer said that during the clinical development stage, BioNTech will handle the clinical supply of the vaccine candidate from its mRNA manufacturing facilities in Europe.
BioNTech and Pfizer said that they will jointly work to commercialise the Covid-19 vaccine across the world in the event of securing regulatory approvals. The collaboration excludes China, where BioNTech has an agreement with Fosun Pharma for BNT162 for clinical development and also marketing.
Pfizer chairman and CEO Albert Bourla said: “With our unique and robust clinical study program underway, starting in Europe and now the U.S., we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most.
“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19.”