This archive report was first published on 22 April 2020.
On April 22, 2020, Germany took a significant step towards developing an efficacious and safe COVID-19 vaccine, as the Paul-Ehrlich-Institut, German regulatory authority, approved the first clinical trials of a COVID-19 vaccine on humans.
Biotechnology company BioNTech's vaccine program was authorized for human clinical trials after a careful assessment of potential risks and benefits, according to the Paul-Ehrlich-Institut.
"This is the fourth authorized clinical trial worldwide in which a preventive specific COVID-19 vaccine candidate is tested in humans," the institute stressed, adding, "Considering the serious consequences of the COVID-19 pandemic, this is a significant step toward developing an efficacious and safe COVID-19 vaccine available in Germany and making it available worldwide as soon as possible."
Ugur Sahin's BioNTech company and pharma giant Pfizer are jointly developing vaccine candidates, as part of a global development program.
"We are pleased to have completed pre-clinical studies in Germany and will soon initiate this first-in-human trial ahead of our expectations," Sahin said in a statement. "The speed with which we were able to move from the start of the program to trial initiation speaks to the high level of engagement from everyone involved."
According to the Paul-Ehrlich-Institut, the first part of the clinical trial in Germany will involve 200 healthy volunteers aged between 18 and 55 years.
Further trials involving people with increased infection risk are planned for the second part of the clinical trial, subject to additional study data being submitted in advance.
