Pfizer and Biopharmaceutical New Technologies (BioNTech) have dosed the first participants in the Phase 1/2 US clinical trial for the BNT162 vaccine programme to prevent Covid-19.

Pfizer and BioNTech have partnered to advance the development of multiple Covid-19 vaccine candidates into human clinical testing. The programme includes four vaccine candidates, each representing a different combination of mRNA format and target antigen.

The clinical trial is part of a global development programme, which has completed the dosing of the first cohort in Germany last week.

Pfizer chairman and CEO Albert Bourla said: “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.”

BioNTech and Pfizer would advance production and commercialise the vaccine

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

The US clinical trial will enrol up to 360 healthy subjects into two age cohorts, at sites including NYU Grossman School of Medicine and the University of Maryland School of Medicine, with the University of Rochester Medical Center/ and Cincinnati Children’s Hospital Medical Center.

For the clinical development, BioNTech is providing a clinical supply of vaccine from its GMP-certified mRNA manufacturing facilities in Europe. Pfizer would leverage its manufacturing network and invest in producing an approved Covid-19 vaccine.

BioNTech and Pfizer would jointly work towards speeding up production and international commercialisation of the vaccine upon regulatory approval. BioNTech has partnered with Fosun Pharma for BNT162 for both clinical development and commercialisation in China.

BioNTech CEO and co-founder Ugur Sahin said: “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.”