Green light for first clinical trial of corona vaccine

Corona vaccine: First clinical trial approved

© Andreas Arnold / dpa
The Mainz-based company Biontech is to receive approval to test its active ingredient on healthy volunteers.

Dozens of research groups worldwide are looking for a vaccine against Sars-CoV-2 that could curb the corona pandemic. A few substances are already being tested in clinical studies. Now there is also a German company.

Berlin (AP) – The Paul Ehrlich Institute (PEI) has granted approval for the clinical trial of a vaccine candidate against the novel coronavirus for the first time in Germany. The Mainz-based company Biontech therefore receives approval to test its active ingredient, as the PEI announced on Wednesday. According to Biontech, there will be tests on around 200 healthy volunteers.

“The testing of vaccine candidates in humans is an important milestone on the way to safe and effective vaccines against Covid-19 for the population in Germany and beyond,” said the PEI. The approval is the result of a careful assessment of the potential benefit-risk profile of the vaccine candidate.

Biontech is cooperating with the pharmaceutical company Pfizer on the development of the vaccine.

In the phase I / II clinical study, among other things, the tolerability and safety of the vaccine candidate should be tested fundamentally. The active ingredient developed by Biontech belongs to the group of gene-based vaccines. These contain genetic information about the pathogen. Proteins are produced from this in the body, against which the immune system forms antibodies. Biontech has been working primarily on the development of immunotherapies against cancer.

According to the Association of Research-Based Pharmaceutical Manufacturers, at least 80 vaccine projects have 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 are expected to start in Germany this year. Cichutek believes that the first approved vaccine for the general population will be available this year.


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