First participants dosed in phase I/II trial of BNT 162 vaccine to prevent COVID-19. Pfizer + BioNTech SE

Pfizer Inc. and BioNTech SE announced that the first participants have been dosed in the U.S. in the Phase 1/II clinical trial for the BNT 162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week.

The Phase 1/II study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study. The dose level escalation portion (Stage 1) of the Phase 1/II trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age). The first subjects immunized in Stage 1 of the study will be healthy adults 18-55 years of age. Older adults will only be immunized with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity.

Sites currently dosing participants include 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 to begin enrollment shortly.

Pfizer and BioNTech’s development program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. The novel design of the trial 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, in a manner that will facilitate the sharing of data with regulatory authorities in real time.

Comment: Pfizer and BioNTech are the latest companies to initiate clinical testing of a COVID-19 candidate. Moderna Inc. launched a Phase I open label trial of its messenger-RNA based vaccine candidate in March 2020 and has filed an investigational new drug application to begin Phase II trials. The University of Oxford, has joined up with AstraZeneca PLC, also began clinical testing of its adenovirus-based vaccine candidate, which could be available by September.