Pfizer and BioNTech dose first participants for COVID-19 vaccine trial

Pfizer and BioNTech dosed the first participants in the U.S. following Germany in the early phase clinical trial for the BNT162 vaccine program to prevent COVID-19.

Anne Harris, Pfizer Australia & New Zealand Managing Director said “Pfizer is committed to sharing our decades of experience in clinical development and regulatory expertise to support the most promising candidates external organisations can bring forward. It is through strong collaborations such as Pfizer and BioNTech’s COVID-19 vaccine development program, that we believe science will win the fight against COVID-19. Together with our partners we are determined to advance safe and efficacious treatments to COVID-19 patients who need them the most and vaccines to the broader community.”

The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study.

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The first subjects immunised in Stage 1 of the study will be healthy adults 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 program underway, starting in Europe and now the U.S., 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 CEO, Pfizer.

“For now, our only sites for this development program are in Germany and the U.S. As the Phase 1/2 trial moves on, we will be expanding sites, but do not have a specific list at this time.” said Ms Harris.

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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.

“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.

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 production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021.

BioNTech and Pfizer will work jointly to commercialise the vaccine upon regulatory approval.