Editor in chief at IamExpat Media
A clinical trial of a vaccine against COVID-19 has been given the go-ahead for the first time in Germany. In the first trial, the vaccine will be tested on a group of healthy volunteers.
The vaccine is the result of a collaboration between the Mainz-based company BioNTech and an American pharmaceutical company, Pfizer. On Wednesday, the Paul Ehrlich Institute (PEI) approved their request to start clinical trials for its vaccine. They are also awaiting approval to begin clinical trials in the US as well.
According to the PEI, the vaccine will initially be tested on around 200 healthy adults between the ages of 18 and 55. If successful, the trial will then move onto a further phase, administering the vaccine to around 500 people who are considered coronavirus risk patients - those aged over 55, some of whom have preexisting conditions.
So-called mRNA vaccines work by essentially tricking the body into producing viral proteins itself. The vaccine contains a synthetic blueprint of part of the viral protein that, when delivered into the human body, prompts cells to read its instructions and begin building that protein. These proteins do not assemble to form a virus, but their presence is detected by the immune system, which then produces a defensive response to them.
“We are pleased that the preclinical studies in Germany have been successfully completed and that we will soon begin this first human study, earlier than expected. The speed with which we were able to advance from the initiation of the programme to the start of the study speaks for the high level of commitment of everyone involved,” said BioNTech founder and CEO Ugur Sahin.
PEI assumes that the study will take at least three to five months to complete. This will allow researchers to determine the optimal dose, as well as examining the safety and immunogenicity of the vaccine. They can then move onto a larger study.