Pfizer Jointly Launches Coronavirus Vaccine Study
BNT162 vaccine candidate aims to prevent COVID-19 disease
Another coronavirus vaccine candidate was launched in the USA today, beginning many months' effort to reach commercialization.
Pfizer Inc. and BioNTech SE announced on May 5, 2020, that the first participants in their innovative Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19.
This study is designed to determine the safety, immunogenicity, and optimal dose level of 4 mRNA vaccine candidates evaluated in a single, continuous study.
The dose level escalation portion (Stage 1) of the Phase 1/2 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.
The 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.
“We are optimistic that advancing multiple vaccine candidates into human trials will allow us to identify the safest, most effective vaccination options against COVID-19,” said CEO and Co-founder of BioNTech, Ugur Sahin, in a press release.
“It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine program in such a short period.”
In anticipation of a successful clinical development program, Pfizer and BioNTech are working to scale up production for global supply. Pfizer plans to activate its extensive manufacturing network and invest at risk in an effort to produce an approved COVID-19 vaccine as quickly as possible for those most in need around the world.
The breadth of this program should allow the production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021.
Additionally, BioNTech and Pfizer said they will work jointly to commercialize the vaccine worldwide upon regulatory approval (excluding China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialization).
To learn more, please visit Pfizer.
Coronavirus vaccine development news published by Precision Vaccinations.