Germany has authorized the first clinical trial of a coronavirus vaccine with more than 2.5 million people infected with the COVID-19 pandemic worldwide. The first human tests will begin before the end of April.
German Health Minister Jens Spahn has announced the first clinical trials of a coronavirus vaccine. The Paul Ehrlich Institute (PEI), the regulatory authority which helps develop and authorizes vaccines in Germany, has given the go-ahead for the first clinical trial of BNT162b1, a vaccine against the SARS-CoV-2 virus. It was developed by cancer researcher and immunologist Ugur Sahin and his team at pharmaceutical company BioNTech, and is based on their previous research into cancer immunology. Sahin previously taught at the University of Mainz before becoming the CEO of BioNTech.
In a joint conference call on Wednesday with researchers from the Paul Ehrlich Institute, Sahin said BNT162b1 constitutes a so-called RNA vaccine. He explained that innocuous genetic information of the SARS-CoV-2 virus is transferred into human cells using lipid nanoparticles, a non-viral gene delivery system. The cells then transform this genetic information into a protein, which should stimulate the body’s immune reaction to the novel coronavrius.
In addition to BNT162b1, which is currently in the stage 1 testing phase, BioNTech is working with Pfizer on three other similar mRNA vaccines. Meanwhile, PEI chief Klaus Cichutek said that other pharmaceutical companies are also developing vaccines against SARS-CoV-2, which are based on a large number of vaccine platforms in Europe, China and the US.
The first BNT162b1 medical tests will involve 200 healthy volunteers between the ages of 18 and 55. The aim is to determine the immune response and to determine whether the vaccine is causing unwanted side effects. “Trials with vaccine candidates in humans are an important milestone on the road to safe and efficacious vaccines against COVID-19 for the population in Germany and internationally,” the PEI said in a statement.