Pfizer teamed up with mRNA-based German biotech BioNTech backed by German billionaire Thomas Strüngmann for a COVID-19 vaccine study known as “Project Lightspeed.” Pfizer recently reported that the first patient was dosed in this critically important large study investigating the mRNA-based vaccine called BNT162. The first cohort was dosed in Germany in early May.
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 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. With Project “Lightspeed” moving another competitive group pursuing the vaccine answer to COVID-19, one of the world’s largest pharma companies and an innovative, well-funded mRNA-based innovator could be a potent combination.
The two companies launched a Phase I/II, randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study in healthy adults. The team will evaluate the safety and tolerability, immunogenicity, and potential efficacy of up to 4 different SARS-CoV-2 RNA vaccine candidates against COVID-19. These include A) as a 2-dose or single-dose schedule, B) at up to 3 different dose levels, and C) in three age groups (18 to 55 of age, 65 to 85 years of age, and 18 to 85 years of age).
Consisting of three stages, the study includes 1) to identify preferred vaccine candidate(s), dose level(s), number of doses, and schedule of administration (with the first 15 participants at each dose level of each vaccine candidate comprising a single cohort) in 360 participants; 2) an expanded -cohort stage; and 3) a final candidate/dose large-scale stage.
The vaccine-based clinical trial will ultimately target up to 7,600 participants. The study started April 29, 2020, and the estimated primary completion date is targeted for August 11, 2021, and estimated study completion data March 8, 2023.
Vaccine Research Centers
The following research centers (sites) are involved in this study:
University of Maryland
· University of Maryland General Clinical Research Center (Baltimore, MD)
· University of Maryland Medical Center Investigational Drug Service Pharmacy (Baltimore, MD)
· University of Maryland, Center for Vaccine Development and Global Health (Baltimore, MD)
NYU Langone Health (New York, NY)
Rochester Regional Health/Rochester General Hospital (Rochester, NY)
Cincinnati Children’s Hospital Medical Center
· In China, BioNTech has partnered with Fosun to conduct clinical trials.
Pfizer will 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 worldwide. The breadth of this program should allow for the production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021. Pfizer-owned sites in three US states (MA, MI, and MO) and Purs Belgium are manufacturing centers for their COVID-19 vaccine production, with more sites to be selected. Through its existing mRNA production site in Mainz and Idar-Oberstein Germany, BioNTech plans to ramp up its production capacity to provide further capacities for a global supply of the potential vaccine.
Call to Action: Based in New York City, Baltimore, Rochester, or Germany, consider involvement with this important vaccine study.