Pfizer begins US Covid-19 vaccine trial

Pharmaceutical companies Pfizer and BioNTech have announced the start of a new clinical trial to prevent Covid-19.

The companies have now dosed the first participants involved in the US Phase 1/2 clinical trial for the BNT162 vaccine programme. The trial, which is part of a global development programme, completed the dosing of the first cohort in Germany in late April.

The study will determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates. The dose portion of the trial will enrol up to 360 subjects across two age groups (18-55 and 65-85 years of age). Older adults will only be given a dose after the testing of that particular vaccine candidate and dose level has provided initial evidence of safety and immunogenicity in younger adults.

Pfizer and BioNTech are working on four vaccine candidates, with one representing a different combination of mRNA format and target antigen. The trial has been designed to evaluate all four candidates simultaneous, in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers.

“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. 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.

BioNTech is providing clinical supply of the vaccine from its sites in Europe during the clinical development stage of the trial. Both companies are also working to scale up production for global supply, in anticipation of a successful clinical development programme. Pfizer’s sites in Massachusetts, Michigan and Missouri, as well as its site in Puurs, Belgium, have been identified as manufacturing centres for Covid-19 vaccine production

“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.