Pfizer and BioNTech announced on Wednesday that the first US participants have been dosed in the Phase 1/2 clinical trial for the BNT162 vaccine programme to combat the coronavirus (COVID-19).
The trial is part of a global development programme, with the first group in Germany receiving doses last week.
The Phase 1/2 study is looking into the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study.
The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the US will enroll up to 360 healthy subjects into two age cohorts, of 18-55 and 65-85 years of age. The first subjects immunised in Stage 1 of the study will be healthy adults between 18 and 55 years of age.
Older adults will only be immunised with a given dose level of a vaccine candidate once initial testing of that candidate and dose level in younger adults has proven to be safe. Sites currently dosing participants include NYU Grossman School of Medicine and the University of Maryland School of Medicine. The University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center will begin enrolment shortly.
“With our unique and robust clinical study programme 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,” Pfizer Chairperson and CEO Albert Bourla said. “That we’ve been able to move from pre-clinical studies to human testing in less than four months 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 various mRNA candidates to be evaluated simultaneously to identify the safest and potentially most effective treatment in a manner that will allow for the real-time sharing of data 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 programme in such a short period,” said CEO and Co-founder of BioNTech, Ugur Sahin, “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.”