ANDOVER — Pfizer’s Andover-based manufacturing plant has been designated one of three locations the pharmaceutical giant would mass produce a coronavirus vaccine if it's proven effective.
The first United States participants in a clinical trial for the vaccine developed jointly by Pfizer and BioNTech, a biotechnology company based out of Germany, began Tuesday.
In a press release issued by Pfizer, the company said the dosing of the first round of human participants took place in Germany 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,” said Albert Bourla, Pfizer’s chief executive officer.
Bourla added that it took four-months for the companies to move from pre-clinical studies to human testing.
The first U.S. participants for the so-called “BNT162 vaccine program” were dosed at The New York University Grossman School of Medicine and The University of Maryland School of Medicine.
The vaccine trial began with a Phase ½ study that included just four participants. Pfizer says this phase is designed to determine the safety and optimal dose level of four vaccine candidates evaluated in a single study.
The next phase, called the “dose level escalation portion of the Phase ½ trial,” will enroll 360 healthy people in the U.S. in two age groups. The first will be in the 18- to 55-year-old range and the second ages 65 to 85. According to Pfizer, the older adults will only be tested with the vaccine after its been proven to be safe with the younger age group.
If the vaccine gets regulatory approval, Pfizer and BioNTech plan to ramp up production “for global supply.”
Pfizer plans to use three of its sites throughout the country to manufacture the vaccine.
Its Andover site will be used for “drug substance manufacturing,” a site in St. Louis, Missouri, will be used for “critical raw material manufacturing” and another in Kalamazoo, Michigan, will be leveraged for “formulation and fill,” the company stated.