First patient dosed with Pfizer’s potential COVID-19 vaccine in US
Pfizer and BioNTech have initiated Phase I/II trials in the US to determine the safety and optimal dose of four mRNA COVID-19 vaccine candidates.
The Phase I/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 of the trial in the US will enrol up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age). The first subjects immunised in the study will be healthy adults at 18-55 years of age. Older adults will only be immunised 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.
“With our unique and robust clinical study programme underway, starting in Europe and now the US, we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most. 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 Chief Executive Officer (CEO) of Pfizer.
The trial is part of a global development programme and the dosing of the first cohort in Germany was completed last week.
The companies’ programme includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. The 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.
“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 programme 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.
During the clinical development stage, BioNTech will provide clinical supply of the vaccine from its good manufacturing practice (GMP)-certified mRNA manufacturing facilities in Europe.
Pfizer and BioNTech say they are working to scale up production for global supply. Pfizer plans to utilise its manufacturing network and invest at risk in an effort to produce the COVID-19 vaccine as quickly as possible. According to the company, the breadth of this programme should allow production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021.
Upon regulatory approval, BioNTech and Pfizer will work jointly to commercialise the vaccine globally (excluding China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialisation).