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BioNTech and Pfizer have secured approval from the German regulatory authority, Paul-Ehrlich-Institut, to conduct a Phase I/II clinical trial of a Covid-19 vaccine candidate.
The candidate, BioNTech’s BNT162, is intended to prevent Covid-19 infection. BioNTech and Pfizer are co-develping the vaccine programme.
Said to be the first Covid-19 vaccine trial to launch in Germany, the study is part of a global development programme.
The partners expect to receive US Food and Drug Administration (FDA) approval and conduct a trial in the country shortly.
Pfizer chairman and CEO Albert Bourla said: “Pfizer and BioNTech’s partnership has mobilised 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 programme in the United States in the near future.”
BioNTech’s Covid-19-focused project includes four vaccine candidates.
Two of these candidates consist of a nucleoside modified mRNA (modRNA), one includes a uridine containing mRNA (uRNA), and the fourth candidate has self-amplifying mRNA (saRNA).
The company has included a larger spike sequence in two of the vaccine candidates and the spike protein’s smaller optimised receptor binding domain (RBD) in the remaining two.
BioNTech CEO and co-founder Ugur Sahin said: “We are pleased to have completed pre-clinical studies in Germany and will soon initiate this first-in-human trial ahead of our expectations.
“The speed with which we were able to move from the start of the programme to trial initiation speaks to the high level of engagement from everyone involved.”
The Phase I/II trial’s dose escalation part will enrol around 200 healthy participants aged 18 to 55.
Participants will receive a dose range of 1µg to 100µg and the trial will potentially establish the optimal dose for further studies. In addition, the study will assess the vaccine candidate’s safety and immunogenicity.
BioNTech will be responsible for clinical supply of the vaccine from its mRNA manufacturing facilities in Europe during the clinical development stage.
The company also partnered with Fosun Pharma to develop BNT162 in China, with plans to conduct clinical trials in the country.