BERLIN — The German biotech company BioNTech will become the first European business to proceed with clinical trials of a Covid-19 vaccine, after receiving regulatory approval for accelerated testing.
The Mainz-based company, which has never produced a market-ready product, has been working on a vaccine since January and has tested an early version on mice. It will now test four variants of a prototype on 200 healthy volunteers aged between 18 and 55, with the aim of being able to manufacture a certified vaccine in less than a year.
Depending on the outcome, thousands of volunteers, some with increased risk of severe Covid-19 symptoms, will be immunised in a second stage of trials. Prof Klaus Cichutek, the president of Germany’s Paul-Ehrlich-Institut, which oversees clinical trials in the country, said the first phase would take between three and five months.
The Nasdaq-listed shares in the 12-year-old company, which has about 400 staff working on the project, rose by almost 45 per cent in pre-market trading. Pharma giant Pfizer, which signed a development and distribution deal with BioNTech last month, will also conduct trials for the vaccine in the US, subject to regulatory approval.
BioNTech, which has also secured a $135m investment from Shanghai-based Fosun to commercialise the product in China, said US approval was “expected shortly”. “The speed with which we were able to move from the start of the programme to trial initiation, speaks to the high level of engagement from everyone involved,” said BioNTech’s chief executive and founder, Ugur Sahin.
Mr Sahin said the company was proceeding as fast as possible and that biotech groups were “racing against time, not against each other”. The Paul-Ehrlich-Institut said on Wednesday that further clinical trials of vaccine candidates would begin in the coming months.
“This is only the fourth approved human trial of preventive, specific Covid-19 vaccine candidates worldwide,” it added. “This is an important step towards developing an effective and safe Covid-19 vaccine in Germany as soon as possible and making it available worldwide.”
BioNTech is one of two German companies developing vaccines that use messenger RNA, which carries instructions for human cells to produce proteins that it is hoped will fight disease. CureVac, based in Tübingen, has also developed a vaccine and received €80m in backing from the European Commission, but is yet to receive regulatory approval for testing.
Both companies are backed by the Bill & Melinda Gates Foundation. Boston-based US rival Moderna has already begun human trials for its mRNA vaccine. The three businesses have attracted the interest of policymakers and investors, who hope that mRNA technology can bring a Covid-19 vaccine to market more rapidly than traditional methods.
BioNTech counts billionaire brothers Andreas and Thomas Strüngmann, the founders of generics giant Hexal that was sold to Novartis for $7.5bn, among its backers. The first UK vaccine candidate, developed by the University of Oxford, is set to begin testing on human volunteers this Thursday.