American pharmaceutical giant Pfizer has announced that its ongoing development of a COVID-19 vaccine could be ready in five months period by October end. Pfizer is working on the vaccine project in collaboration with German firm Biontech.
Pfizer and its vaccine development German partner BioNTech announced on Friday, May 29, that the first participants have been given the doses in the US in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. “If things go well, and the stars are aligned, we will have enough evidence of safety and efficacy so that we can have a vaccine around the end of October,” said Pfizer CEO Albert Bourla.
The trial is part of the dosing of the first cohort in Germany that was completed last week. The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates under 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, said the company.
Older adults will be immunized with a given dose level once testing and dose level in younger adults has provided initial evidence of safety and immunogenicity. Currently,the participants are being given these doses at 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.
“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19,” said Albert Bourla, Chairman and CEO, Pfizer.
Pfizer and BioNTech’s Vaccine Program
Pfizer and BioNTech’s development program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. The ongoing 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.
“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. 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, whose firm will provide the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.
Once this stage is successfully accomplished, both Pfizer and BioNTech plan to rapidly increase production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021. BioNTech and Pfizer will work supply the vaccine worldwide once regulators allow except China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialization.
Pfizer-owned sites in three U.S. states (Massachusetts, Michigan and Missouri) and Puurs, Belgium are being pressed into manufacturing COVID-19 vaccine production, with more sites to be selected once the vaccine rolls out. Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech plans to ramp up its production capacity.