Biopharmaceutical New Technologies (BioNTech) and Pfizer jointly announced that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BNT162 vaccine programme, against the COVID-19 infection.
BioNTech and Pfizer have joined forces to develop BNT162, the BioNTech’s vaccine candidate with the potential to prevent the COVID-19 infection.
The clinical study, a part of the global vaccine development programme, marks the first COVID-19 vaccine candidate trial in Germany. Both companies are planning to conduct BNT162 clinical trials in the US, following regulatory approval.
BioNTech CEO and co-founder Ugur Sahin said: “We are pleased to have completed pre-clinical studies in Germany and to have received this important regulatory approval to initiate this first-in-human trial.
“The speed with which we were able to move from the start of the program to regulatory approval to initiate this first-in-human trial speaks to the high level of engagement from everyone involved.”
BioNTech has developed four vaccine candidates under Lightspeed project
BioNTech has initially developed four vaccine candidates under a COVID-19-focused project, dubbed ‘Lightspeed’, and each vaccine will represent different mRNA formats and target antigens.
Two of the four vaccine candidates comprise nucleoside modified mRNA (modRNA), one has uridine containing mRNA (uRNA), and the fourth vaccine candidate features a self-amplifying mRNA (saRNA).
Approximately 200 healthy subjects, aged between 18 and 55 will be administered a dose range of 1µg to 100µg, to determine the optimal dose for further studies, and evaluate the safety and immunogenicity of the vaccine.
The study is also aimed at evaluating the effects of repeated immunization for three of the four vaccine candidates which utilize uRNA or modRNA.
BioNTech is expected to provide the vaccine from its GMP-certified mRNA manufacturing facilities in Europe, to support clinical development. The company is also collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct trials.
Pfizer chairman and CEO Albert Bourla said: “Pfizer and BioNTech’s partnership has mobilized our collective resources with extraordinary speed in the face of this worldwide challenge.
“Now that the work in Germany can commence, we are looking forward to and actively preparing for the potential start of this unique and robust clinical study program in the United States in the near future.”
