Pfizer and BioNTech have announced that the first participant was administered with the vaccine in the Phase ½ trial. The trial was started at NYU Grossman School of Medicine and University of Maryland School of Medicine.
The study is a multicenter study; the vaccine was administered in Germany along with the patients in the U.S. The study was intended to determine the safety, immunogenicity, and optimal dose level of four mRNA vaccine candidates. The company has considered two age cohorts for the study (18-55 and 65-85 years of age). The first phase is in patients of 18-55 years of age. Once the immunogenicity and safety get determined in the younger adults, doses will be given for older adults.
“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,” said Albert Bourla, Chairman and CEO, Pfizer. BioNTech’s GMP-certified mRNA manufacturing facilities in Europe will provide vaccines. BioNTech and Pfizer will develop and commercialize the vaccine worldwide. However, in China, BioNTech collaborated with Fosun Pharma for BNT162 for clinical development and commercialization.