Pharmaceutical company Pfizer and biotechnology company BioNTech SE have started a human trial of COVID-19 mRNA vaccine candidates in the United States, the companies announced on Tuesday. As part of this trial, multiple people located at the University of Maryland School of Medicine and NYU Grossman School of Medicine have been dosed with potential vaccines for the novel coronavirus.
The doses were given as part of a Phase 1/2 clinical trial, according to Pfizer, under the BNT162 vaccine program. According to the pharmaceutical company, this trial is intended to be used to determine the optimal dose, safety, and immunogenicity of four different mRNA vaccine candidates. All four will be evaluated in the same, single, continuous study, the company says.
Up to 360 adults will be split into two different age groups for the ‘escalation portion’ of the study: 18 to 55 years old and 65 to 85 years old. The younger group will go first in the initial stage of the study, with the older adults only receiving the vaccine candidates after safety and dosage have been initially determined on the younger participants.
Pfizer says that the Cincinnati Children’s Hospital Medical Center and the University of Rochester Medical Center/Rochester Regional Health will both enroll in the study ‘shortly.’ Each of the four vaccine candidates are of the mRNA variety targeting antigen. BioNTech SE is supplying the trial vaccines from its manufacturing facilities in Europe.
Pfizer CEO and Chairman 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.
The two companies are already working to scale up the production of a vaccine in order to supply it globally, according to Pfizer, which expects an ultimately successful ‘clinical development program.’