BERLIN: Germany has authorised its first clinical test of a vaccine for the novel coronavirus, the country’s regulatory body said Wednesday, green-lighting trials on human volunteers for an RNA vaccine developed by German firm Biontech and US giant Pfizer.
“The Paul-Ehrlich-Institute […] has authorised the first clinical trial of a vaccine against COVID-19 in Germany,” the regulatory body PEI said in a statement.
The trial, which was only the fourth to have been authorised worldwide, was a “significant step” in making a vaccine “available as soon as possible”, the institute added.
It said that approval was the “result of a careful assessment of the potential risk/benefit profile of the vaccine candidate”.The trials will see “200 healthy volunteers aged between 18 and 55 years” vaccinated with variants of the RNA vaccine, while the second phase could see the inclusion of volunteers who belonged to high-risk groups.
Neither PEI nor the developers specified when the trial will begin, though Biontech claimed in a statement that it would be “soon” and “ahead of our expectations”.
The PEI also claimed that “further clinical trials of COVID-19 vaccine candidates will start in Germany in the next few months”.