Germany has approved first clinical trials of a COVID-19 vaccine on humans, officials announced on Wednesday.
Biotechnology company BioNTech’s vaccine program was authorized for human clinical trials after a careful assessment of potential risks and benefits, the Paul-Ehrlich-Institut, German regulatory authority, said in a press release.
“This is the fourth authorized clinical trial worldwide in which a preventive specific COVID-19 vaccine candidate is tested in humans,” the institute stressed, and added:
“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.”
Turkish professor 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. 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,” Sahin said in a statement.
In the authorized first part of the clinical trial in Germany, 200 healthy volunteers aged between 18 and 55 years will be vaccinated, according to the Paul-Ehrlich-Institut.
Further trials involving people with increased infection risk planned for the second part of the clinical trial, on condition that additional study data submitted in advance.
Scientists and researchers across the world are scrambling to find a vaccine for the novel coronavirus which has infected over 2.58 million people worldwide and killed more than 178,000.
Until such a discovery, health experts are treating patients with anti-malaria drugs, including hydroxychloroquine and chloroquine, which have shown positive results for coronavirus-related lung infection.