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Germany to begin first clinical trial of COVID-19 vaccine candidate

24 Apr, 2020
A Phase I/II clinical trial for BioNTech’s BNT162 vaccine programme to prevent COVID-19 infection has been granted approval in Germany.
BioNTech SE, have announced today that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase I/II clinical trial for the company’s BNT162 vaccine programme to prevent COVID-19 infection. 

BioNTech and Pfizer are jointly developing BNT162. The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany and is part of a global development programme. Pfizer and BioNTech will also conduct trials for BNT162 in the US upon regulatory approval, which is expected shortly. 

The four vaccine candidates to be studied each represent different mRNA formats and target antigens. Two of the four vaccine candidates include a nucleoside modified mRNA (modRNA), one includes a uridine containing mRNA (uRNA) and the fourth vaccine candidate utilises self-amplifying mRNA (saRNA). Each mRNA format is combined with a lipid nanoparticle (LNP) formulation. The larger Spike sequence is included in two of the vaccine candidates and the smaller optimised receptor binding domain (RBD) from the Spike protein is included in the other two candidates. The RBD-based candidates contain the piece of the spike that is thought to be most important for eliciting antibodies that can inactivate the virus.