Pfizer and BioNTech have announced that the first US participants have been dosed in the Phase 1/2 clinical trial for the BNT162 vaccine programme to prevent COVID-19. The trial is part of a global development programme, and participants were also dosed in Germany last week.
The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccines evaluated in a single, continuous study. The Phase 1/2 trial in the U.S. will enrol up to 360 healthy subjects into two age cohorts (18-55 year olds and 65-85 year olds).
The first subjects immunised in Stage 1 of the study will be healthy adults between the ages of 18 and 55. Older adults will only be immunised once testing of that vaccine candidate and the dose level in younger adults has provided initial evidence of safety and immunogenicity. Sites currently dosing participants include NYU Grossman School of Medicine and the University of Maryland School of Medicine, with the University of Rochester Medical Centre/Rochester Regional Health and Cincinnati Children’s Hospital Medical Centre to begin enrolment shortly.
“With our unique and robust clinical study programme underway, starting in Europe and now the U.S., we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulators to bring a safe and effective vaccine to the patients who need it most. The fact that we’ve been able to move from pre-clinical studies to human testing in less than four months demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, to the fight against COVID-19,” says Rhulani Nhlaniki, Pfizer Country Manager South Africa & Cluster Lead sub-Sahara Africa.
Pfizer and BioNTech’s development programme includes four potential vaccines, each representing a different combination of mRNA format and target antigen. The design of the trial allows for the evaluation of the various mRNA vaccines simultaneously in order to identify the safest and potentially most effective vaccine in a greater number of volunteers, in a manner that will facilitate the sharing of data with regulatory authorities in real time.
During the clinical development stage, BioNTech will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.
In anticipation of the clinical development programme being successful, Pfizer and BioNTech are working to scale up production for global supply. Pfizer plans to activate its extensive manufacturing network and invest at risk in an effort to produce an approved COVID-19 vaccine as quickly as possible for those most in need around the world.