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

Pfizer chairperson and CEO Albert Bourla said his company hopes to bring “a safe and efficacious vaccine” to patients who need it most.

“With our unique and robust clinical study programme under way, 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,” Bourla said.

“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.”

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.

mRNA - or messenger Ribonucleic acid - is a molecule, composed of nucleotides linked in a unique order to convey genetic information for the cells to produce the proteins or antigens, which it encodes. 

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

During the clinical development stage, BioNTech will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

In anticipation of a successful clinical development programme, 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 BioNTech and Pfizer programme should allow production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021.

Pfizer-owned sites in three US states - Massachusetts, Michigan and Missouri - and Puurs, Belgium have been identified as manufacturing centres for Covid-19 vaccine production, with more sites to be selected.

Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech plans to ramp up its production capacity to provide further capacities for a global supply of the potential vaccine.

BioNTech and Pfizer will work jointly to commercialise the vaccine worldwide upon regulatory approval excluding in China, where BioNTech has a collaboration with Fosun Pharma for both clinical development and commercialisation.

African News Agency