Pharmaceutical giant Pfizer has begun testing multiple versions of an experimental coronavirus vaccine in healthy young adults in the United States, the U.S.-based pharmaceutical giant, which is working alongside German drugmaker BioNTech, said Tuesday. The U.S. trial comes after human trials of the potential vaccine, BNT162, began in Germany late last week.
"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, Pfizer, said in a press release. "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 development program consists of four versions of the vaccine, each of which represent a different combination of mRNA format and target antigen. Pfizer is testing the vaccines side by side, which "allows for the evaluation of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers."
The first stage of the trial involves testing the vaccine in adults ages 18 to 55. Once safety and immunogenicity has been established, testing will begin on a second age group consisting of participants between the ages of 65 and 85. The trials will take place at four locations – 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 set to begin enrollment soon – with hopes to test up to 360 people.
"It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine program in such a short period," CEO and Co-founder of BioNTech, Ugur Sahin, said. "We are optimistic that advancing multiple vaccine candidates into human trials will allow us to identify the safest, most effective vaccination options against COVID-19."
In anticipation of a successful vaccine candidate, Pfizer and BioNTech are working to scale up production for global supply and expect to be able to produce millions of vaccine doses in 2020, a number that will increase to hundreds of millions in 2021.