Pfizer and BioNTech begin human trial for COVID-19 vaccine in US

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Published: May 5, 2020 10:42 PM

The candidate is known as an mRNA vaccine, and it is meant to contain the instructions for making viral proteins that can trigger an immune response in patients infected with the virus. Previously, BioNTech has been developing mRNA-based treatments for cancer.

Pfizer and BioNTech’s development programme includes four vaccine candidates, each representing a different combination of mRNA format and target antigen.

American pharmaceutical giant Pfizer along with German biotech company BioNTech has begun human trials of a potential COVID-19 vaccine in the US. The initial trial will involve 360 volunteers, and the first subjects have already received injections. In addition to the US, some 200 patients have enrolled for trials in Germany.

The candidate is known as an mRNA vaccine, and it is meant to contain the instructions for making viral proteins that can trigger an immune response in patients infected with the virus. Previously, BioNTech has been developing mRNA-based treatments for cancer.

The first participants have been dosed in the US in the Phase 1/2 clinical trial for the BNT162 vaccine programme to prevent COVID-19. The trial is part of a global development programme, and the dosing of the first cohort in Germany was completed last week.

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 a release.

“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 Bourla.

Pfizer and BioNTech’s development programme 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.

During the clinical development stage, BioNTech will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. Pfizer and BioNTech are also 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 the production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021.

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