Initial US Patients Dosed in mRNA Vaccine Trial

May 5, 2020

Trial begins in the US for the Pfizer-BioNTech mRNA COVID-19 vaccine; manufacturing plans announced.

The first participants in a Phase I/II clinical trial for the BNT162 vaccine program to prevent COVID-19 have been dosed in the United States, reported sponsors Pfizer and BioNTech on May 5, 2020. The dosing of the first cohort in Germany was completed in late April.

In anticipation of clinical trial success and approvals, Pfizer announced plans to invest at risk and activate its manufacturing network to produce millions of vaccine doses in 2020, increasing to hundreds of millions in 2021. Pfizer-owned US sites in Massachusetts, Michigan, and Missouri, and its site in Puurs, Belgium have been identified as centers for COVID-19 vaccine production, with more sites to be selected, the company reported. BioNTech plans to ramp up its production capacity at its mRNA production sites in Mainz and Idar-Oberstein, Germany.

Clinical supply of the vaccine will be provided from BioNTech’s GMP-certified mRNA manufacturing facilities in Europe.

The development program includes four vaccine candidates, each with a different combination of mRNA format and target antigen. The trial design allows for the evaluation of the mRNA candidates simultaneously to identify the safest and potentially most efficacious candidate in a greater number of volunteers, Pfizer reported in the press statement.

“With our unique and robust clinical study program 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,” said Albert Bourla, chairman and CEO, Pfizer, in the press statement. “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.” 

“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 the press statement.

Following regulatory approval, the companies will jointly commercialize the vaccine worldwide, except for China, where BioNTech has a collaboration with Fosun Pharma.

Source: Pfizer