KUALA LUMPUR, May 6 — Pfizer and German pharmaceutical company BioNTech have administered their Covid-19 experimental vaccine to the first human trial participants in the United States.
The Phase I/II trial on the vaccine candidate, called BNT162, by both firms is designed to evaluate the safety and effectiveness of four variations of the vaccine that have different combinations of messenger RNA (mRNA), which is a genetic material that carries instructions for cells to make proteins.
According to The New York Times, by injecting a specially designed mRNA into the body, the vaccine may be able to tell cells how to create the coronavirus’ spike protein without actually sickening the person. As the coronavirus generally uses this protein to take over lung cells, the vaccine may be able to train a person’s healthy immune system to produce antibodies to deter an infection.
The New York Times also reported that if the tests are successful, the coronavirus vaccine could be ready for emergency use in the US by September.
According to American pharmaceutical company Pfizer, the Phase I/II trial in the US will test the potential coronavirus vaccine on up to 360 healthy volunteers, stratified into two age cohorts of 18 to 55, and 65 to 85 years of age.
The first stage of the trial will test healthy adults between ages 18 and 55, while the older adults will only be injected with the vaccine after data from younger adults provides initial evidence of safety and effectiveness from the vaccine.
US study participants that are currently tested with the vaccine include those from NYU Grossman School of Medicine and University of Maryland School of Medicine. Enrolment is set to begin shortly at University of Rochester Medical Centre/Rochester Regional Health and Cincinnati Children’s Hospital Medical Centre.
Phase I/II trial of the BNT162 vaccine programme on human volunteers first began in Germany on April 23, upon German regulatory approval, as cited by European Pharmaceutical Review.
“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 Pfizer chairman and CEO Albert Bourla in a press statement yesterday.
BioNTech is a Germany-based immunotherapy company pioneering new treatments for cancer and other serious diseases.
“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.
The four vaccine variations are evaluated simultaneously to identify the vaccine candidate with the most promising safety and efficacy profile in a two greater number of volunteers, in a way that enables real-time data sharing with regulatory authorities.
“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 BioNTech CEO and co-founder Ugur Sahin in the same statement.
BioNTech will be providing clinical supply of the BNT162 vaccine throughout the clinical development stage from its Good Manufacturing Practice (GMP)-certified mRNA manufacturing facilities in Mainz and Idar-Oberstein, Germany.
Both Pfizer and BioNtech plan to increase the production of the vaccine for global supply in anticipation of successful human trials.
Pfizer plans to invest at risk and activate its manufacturing network to produce an approved Covid-19 vaccine as quickly as possible to supply on a global scale for those most in need.
Pfizer owns manufacturing sites for Covid-19 vaccine production in three US states, including Massachusetts, Michigan, and Missouri, and Puurs, Belgium. More manufacturing centres will be selected.
The extent of this programme is said to be capable of producing millions of vaccine doses in 2020 and increasing to hundreds of millions in 2021.
Pfizer and BioNTech will work jointly to commercialise the Covid-19 vaccine worldwide upon its approval by regulatory agencies. This excludes China, where BioNTech is in collaboration with Fosun Pharma for both clinical development and commercialization of BNT162 vaccine.
As of May 5, more than 3.5 millions of Covid-19 cases have been reported globally with a death toll of nearly 250,000, as reported by the World Health Organization (WHO).