=BioNTech (BNTX) and Pfizer (PFE) : first clinical trial of COVID-19 vaccine candidates

BioNTech and Pfizer (PFE) announce regulatory approval from German authority to commence first clinical trial of COVID-19 vaccine candidates

BioNTech and Pfizer have announced that the German regulatory authority the Paul-Ehrlich-Institut has approved the Phase 1/2 clinical trial for BioNTech's BNT162 vaccine program 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 program. Pfizer and BioNTech will also conduct trials for BNT162 in the US upon regulatory approval, which is expected shortly.

The four vaccine candidates are the first candidates from BioNTech's COVID-19-focused project "Lightspeed", each representing different mRNA formats and target antigens. Two of the four vaccine candidates include a nucleoside modified mRNA, one includes a uridine containing mRNA, and the fourth vaccine candidate utilizes self-amplifying mRNA. Each mRNA format is combined with a lipid nanoparticle formulation. The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized 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.