Germany has approved clinical trials for a coronavirus vaccine, authorities announced on Wednesday.
These will be the first clinical trials for a vaccine against the new coronavirus (Covid-19) in Germany and only the "fifth authorised clinical trial worldwide," said the Federal Institute for Vaccines and Biomedicines (Paul-Ehrlich-Institut).
The vaccine was developed by Germany-based company BioNTech and American pharmaceutical corporation Pfizer.
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The clinical trials will initially be carried out on 200 non-infected volunteers aged between 18 and 55 years, the Paul-Ehrlich-Institut said on its website.
These first trials aim to "determine the general tolerance of the vaccine tested and its ability to provide an immune response against the pathogen," they said.
There are four vaccine candidates, according to BioNTech, "each representing different mRNA formats and target antigens." mRNA stands for Messenger Ribonucleic Acid, which is the part of genetic material that transcribes DNA in the making of proteins. Antigens are substances in the body that trigger an immune response.
There will also be clinical trials in the United States "upon regulatory approval, which is expected shortly," BioNTech announced.
“We are pleased to have completed pre-clinical studies in Germany and will soon initiate this first-in-human trial ahead of our expectations," BioNTech CEO Ugur Sahin said. "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.”
Paul-Ehrlich-Institut "assumes that further clinical trials of COVID-19 vaccine candidates will start in Germany in the next few months," they said.
Jason Spinks
The Brussels Times