May 5, 2020 -- Clinical trials for a COVID-19 mRNA vaccine developed by Pfizer and BioNTech began on May 5 with New York University Grossman School of Medicine and the University of Maryland as the first centers to enroll patients in the U.S., said the companies.
The University of Rochester Medical Center, Rochester Regional Health, and Cincinnati Children's Hospital Medical Center plan to begin enrollment shortly.
As part of the phase I/II clinical trials, patients will receive either one or two doses of the BNT162 vaccine candidate or placebo. The mRNA vaccine contains viral RNA encoding the spike protein used by SARS-CoV-2 to attach to proteins on human cell surfaces, the first step in viral infection. The vaccine will deliver small segments of mRNA, encased in fatty lipid particles, into the arm muscle of participants. Once the mRNA enters the cytoplasm of cells, the protein is created and triggers antibody and cellular immune responses.
Currently, the initial dose escalation phase of clinical trials aims to gather evidence on the safety, dose level, and number of doses required to be effective. By midsummer the companies hope to enroll 360 healthy subjects in two groups (18-55 and 65-85 years of age).
In less than four months, the companies completed preclinical studies and began a clinical study program already underway in Germany. During the clinical development stage, BioNTech is providing the clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.
Pfizer and BioNTech will work together upon successful completion of clinical development to scale up production for global supply with the goal of producing millions of vaccine doses in 2020, increasing to hundreds of millions in 2021. Pfizer will utilize its three existing U.S. sites, in addition to its Puurs, Belgium, location for manufacturing. The companies have also selected additional locations to scale up production. BioNTech will use its two existing mRNA production sites in Germany. Both companies will jointly commercialize the vaccine upon regulatory approval.