The partners of the German Center for Infection Research (DZIF) and IDT Biologika of Dessau have reached a further significant milestone in the development of a vaccine against COVID-19. After the Paul-Ehrlich-Institut granted approval last week for the clinical phase 1 study of the MVA-SARS-2-S vaccine, now IDT Biologika has received official notification of funding from the Federal Ministry of Education and Research (BMBF).
The biopharma company is to receive 114 million euros for the clinical testing of phases I to III, as well as application for vaccine approval. In total, the BMBF is providing 750 million euros for the national support of the manufacture of vaccines. IDT Biologika is one of three companies in whom the German federal government is placing its hopes for the development of a German vaccine for the world.
Shortly after the outbreak of the corona epidemic the DZIF researchers of LMU Munich, Marburg University and the UKE Hamburg joined with IDT Biologika to begin work on the development of a vaccine. The basis for this was the joint success in researching a vaccine for the related MERS coronavirus. Carrier for the newly developed vector vaccine is the “Modified Vaccinia Ankara Virus“ (MVA), which was already developed over 30 years ago as a safe vaccine against smallpox. The genetic information of a surface protein of the SARS-CoV-2 virus is to be embedded into this. The so-called viral vector is unable to reproduce in the body, but simulates an infection and stimulates production of antibodies as well as cellular protection mechanisms. Preclinical models at the universities in Marburg and Munich have already shown that this immune response is triggered, and therefore the protective effect against an actual infection.
The fact that MVA-SARS-2-S can now begin clinical development is thanks in no small part to the intensive involvement of IDT Biologika. The family-run company of the Klocke Group combines an almost 100-year-old tradition in vaccine research and production with maximum expertise and state-of-the-art technology. As early as this spring a cell line and process for the large-scale production of ultrapure MVA vector vaccines were developed here. Capacity was set aside within the company for the filling of the vaccine candidate, which could already be undertaken in July of this year. “Today I would like to express our great thanks – also on behalf of all partners involved – to the BMBF for the generous support of our efforts in the fight against COVID-19. Vaccines are an important means of protecting people. Together with our partners, we are ideally placed both scientifically and technologically to play our part,” says Dr. Jürgen Betzing, CEO of IDT Biologika.
In the first clinical phase the vaccine is now to be tested at University Medical Center Hamburg Eppendorf on a total of 30 healthy, voluntary test persons aged between 18 and 55 under strict medical observation for its safety, tolerability and specific immune response to the pathogen. If the findings are successful, the phase II clinical study with several hundred participants can begin at the end of the year. If the outcome of all clinical tests is positive, approval is set to be applied for at the end of 2021.
Further information on MVA-SARS-2-S vaccine development can be found on the website of the German Center for Infection Research: https://www.dzif.de/de/entwicklung-eines-impfstoffs-gegen-sars-cov-2.