The trial is the first clinical trial of a COVID-19 vaccine candidate in Germany and there are plans to initiate trials in the US upon regulatory approval
BioNTech has announced that the first cohort of its Phase I/II clinical trial has been dosed. Twelve study participants were dosed with vaccine candidate BNT162 in Germany since dosing began on April 23, 2020. The trial is the first clinical trial of a COVID-19 vaccine candidate in Germany. Pfizer and BioNTech plan to initiate trials for BNT162 in the US upon regulatory approval, which is expected shortly.
The dose escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg, aiming to determine the optimal dose for further studies as well as to evaluate the safety and immunogenicity of the vaccine.
The study will also assess the effects of repeated vaccination following a prime injection for the three vaccine candidates that contain uridine containing mRNA (uRNA) or nucleoside modified mRNA (modRNA). A fourth vaccine candidate, which contains self-amplifying mRNA (saRNA) will be evaluated after a single dose of vaccine. Subjects with a higher risk of severe COVID-19 disease will be included in the second part of the study.
BioNTech and Pfizer are jointly developing BNT162. During the clinical development stage, BioNTech will provide its partner's clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech is collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct trials.