Germany starts clinical trial for new coronavirus vaccine
The Mainz-based life sciences company Biopharmaceuticals New Technologies (BioNTech) has launched its Phase 1/2 trial of its candidate COVID-19 vaccine, BNT 162. BioNTech is cooperating with the US pharmaceuticals’ giant Pfizer, to develop a vaccine against the novel coronavirus, Sars-CoV-2.
Germany’s Federal Institute for Vaccines and Biomedicines, the Paul Ehrlich Institute (PEI) in Langen, approved the trial on April 22. The first doses of BNT 162 were administered to volunteers the next day. Ultimately, around 200 healthy subjects are to be included in the first two testing phases.
Four candidate vaccines are actually being considered. Of these, three include the ingredients uridine containing mRNA (uRNA) or nucleoside modified m RNA (modRNA). The fourth is based on self-amplifying mRNA (saRNA). During the development stage, BioNTech is providing its partner’s clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.
BioNTech and Pfizer are planning to launch trials for BNT162 in the United States upon regulatory approval. BioNTech is also collaborating with Fosun Pharma to develop BNT162 in China, where the German and Chinese companies expect to conduct trials as well. The CEO and Co-founder of BioNTech, Ugur Sahin, said of the efforts, “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 BioNTech, the company specializes in next generation immunotherapy and pioneering novel therapies for cancer and other serious diseases. It says expertise in mRNA vaccine development and in-house manufacturing capabilities allow it to work with partners in developing multiple mRNA vaccine candidates for a range of infectious diseases. BioNTech has already established relationships with a range of partners including Eli Lilly and Company, Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer.
BioNTech is just one of many companies that reflect the R&D quality and capability of Germany’s dynamic, internationally-active biosciences and medical biotechnology sectors. The export initiative for the German healthcare industry, HEALTH MADE IN GERMANY, is the place to discover more about Germany’s strength in these fields.