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The Paul-Ehrlich-Institute (PEI) has for the first time, issued in Germany, an authorisation for the clinical trial of a vaccine candidate against the novel Coronavirus.
The Mainz-based company Biontech receives approval to test its drug, as the PEI said.
According to Biontech, there should be Tests on about 200 healthy volunteers.
Milestone on the way to the safe vaccine
“The testing of vaccine candidates in humans is an important milestone on the path to safe and effective vaccines against Covid-19 for the population in Germany and beyond,” said PEI.
The approval was the result of a careful assessment of the potential risk-Benefit profile of the vaccine candidate. Biontech co-operates in the development of the vaccine with the pharmaceutical company Pfizer.
In the clinical study of Phase I/II, among other things, fundamentally the tolerability and safety of the vaccine is to be checked by the candidates. The Biontech has developed active ingredient belongs to the group of genbasierten vaccines. These contain the genetic information of the pathogen.
In the body it proteins are produced, against which the immune system Defenses against forms. Biontech is working so far, give priority to the development of immune therapies against cancer.
Admission this year unwarhscheinlich
Since the outbreak of the Covid-19-epidemic according to the Association of research-based pharmaceutical manufacturers are running at least 80 vaccine projects, four active ingredients are tested already in clinical studies in China and the United States.
In Germany will start according to PEI President Klaus Cichutek this year, a total of four clinical trials with a vaccine candidate. Already this year, the first approved vaccine for the General population is ready, holds Cichutek unlikely.
Deutsche Presse-Agentur (dpa)
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