BioNTech SE and Pfizer Inc. have announced on April 29th that the first cohort of BioNTech’s Phase 1/2 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 United States 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.
for further information, see BioNTech (https://biontechse.gcs-web.com/news-releases/news-release-details/biontech-and-pfizer-announce-completion-dosing-first-cohort)