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First clinical trial of corona vaccine approved in Germany
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First clinical trial of corona vaccine approved in Germany
The Paul Ehrlich Institute has approved for the first time the clinical trial of a candidate for a Corona vaccine in Germany. Mainz-based company Biontech received approval to test its active ingredient in healthy volunteers.
The Paul Ehrlich Institute in Germany approved the clinical trial of a corona vaccine for the first time. A Mainz company can test its resources on volunteers. There is also an evaluation of the time horizon.
DThe Paul Ehrlich Institute (PEI) has granted approval for the clinical trial of a candidate coronavirus vaccine for the first time in Germany.
Mainz-based company Biontech is therefore approved to test its active ingredient, as PEI announced on Wednesday. According to Biontech, there will be tests on around 200 healthy volunteers.
“Testing of vaccine candidates in humans is an important milestone on the road to safe and effective vaccines against Covid-19 for the population in Germany and beyond,” said PEI. Approval is the result of a careful evaluation of the potential risk-benefit profile of the vaccine candidate.
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Biontech is cooperating with the pharmaceutical company Pfizer in the development of the vaccine.
In the phase I / II clinical study, among other things, the tolerability and safety of the vaccine candidate must be tested fundamentally.
The active ingredient developed by Biontech belongs to the group of gene-based vaccines. These contain genetic information about the pathogen. From this proteins are produced in the body, against which the immune system forms antibodies. Biontech has been primarily working on the development of immunotherapies against cancer.
According to the Research-Based Pharmaceutical Manufacturers Association, at least 80 vaccine projects have been started since the outbreak of the Covid-19 epidemic, and four drugs have already been tested in clinical studies in China and the United States.
According to PEI President Klaus Cichutek, a total of four clinical trials with a vaccine candidate in Germany are expected to start this year. Cichutek believes that the first vaccine approved for the general population will be available this year.
