Pfizer and its development partner BioNTech have begun dosing the first people in the US with a potential COVID-19 vaccine, as part of their ongoing phase 1/2 clinical trial.
The companies said that the first participants were dosed at the NYU Grossman School of Medicine and University of Maryland School of Medicine.
The goal is to test the safety, immune reaction, and optimal dose of four mRNA vaccine candidates in a single, continuous study.
Mainz-based BioNTech had originally developed one of the vaccines involved codenamed BNT161, as part of the trial that began in Germany at the end of last month.
A dose level escalation stage will recruit up to 360 healthy subjects into two age cohorts – 18-55 years of age and 65-85 years of age.
The first recruits will be in the younger cohort and older adults will only be immunised with a given dose level of a vaccine candidate once it has been shown as safe and effective in the younger group.
Active sites currently include NYU Grossman School of Medicine and the University of Maryland School of Medicine, with the University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center to begin recruitment shortly.
Pfizer and BioNTech’s development programme includes four vaccine candidates, each representing a different combination of mRNA format and target antigen.
The design of the trial allows for the testing of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers, in a manner that will allow the sharing of data with regulatory authorities in real time.
Pfizer and BioNTech are hopeful of success and are already scaling up production for global supply, with the big pharma investing at risk in an effort to produce an approved COVID-19 as quickly as possible for the most in need around the world.
Millions of doses could be available if a vaccine proves safe and effective by the end of this year, increasing to hundreds of millions in 2021.
Pfizer-owned sites in three US states – Massachusetts, Michigan and Missouri – and Puurs, Belgium have been identified as manufacturing centres for COVID-19 vaccine production, with more sites to be selected.
BioNTech plans to ramp up its manufacturing sites in Mainz and Idar-Oberstein in Germany to provide further doses.
BioNTech and Pfizer will work to jointly market the vaccine globally if approved, excluding China where the German biotech has a collaboration with Fosun Pharma for both clinical development and marketing.
According to the latest update from the World Health Organisation, there are now eight potential COVID-19 vaccines in the clinic including Pfizer and BioNTech’s candidate.
