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GERMANY: First clinical trial of COVID-19 vaccine approved

The German biotech companies BioNTech SE and Pfizer Inc. 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. 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. 

The company has designed four vaccine candidates that deliver the genetic code for four different COVID-19 antigens. The dose escalation portion of the Phase I/II trial will include approximately 200 healthy subjects between the ages of 18 to 55 to determine the optimal dose for further studies, as well as evaluating safety and immunogenicity. The study will also evaluate the effects of repeated immunization for three of the four vaccine candidates.

The full press release can be read by clicking here.

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