The first American participants in the Phase 1/2 clinical trial of the BNT162 vaccine program, created by Pfizer Inc. and BioNTech SE, have been dosed as the companies ramp up manufacturing capabilities to meet 2020/2021 capacity needs.
That vaccine is meant to treat COVID-19, the disease that has become a global pandemic. Ongoing efforts are part of a global development program, which saw the first cohort of patients dosed in Germany last week. Participants stateside were dosed at the NYU Grossman School of Medicine and the University of Maryland School of Medicine.
Throughout the study, researchers will analyze the safety, immunogenicity, and optimal dose level of the four mRNA vaccine candidates involved. Each represents a different combination of mRNA format and target antigen.
“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,” Albert Bourla, chairman and CEO of Pfizer, said. “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.”
As many as 360 healthy patients could enroll for the trial’s dose level escalation portion. They will be divided into two age cohorts: 18-55 and 65-85 years of age, with the 18-55 bracket immunized first. Additional subjects will be enrolled at the University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center.
BioNTech will provide clinical supply of vaccines through its European manufacturing facilities during the clinical development stage. Expecting things to proceed, the companies have agreed to scale up production and produce millions of potential vaccine doses across 2020, with the ability to scale up to hundreds of millions in 2021. Currently, Pfizer intends to work out of sites in Massachusetts, Michigan, Missouri, and Belgium for such manufacturing. More locations will be selected as efforts move forward.