IDT Biologika filled the second clinical batch of a newly-developed vaccine candidate against the coronavirus SARS-CoV-2 in Dessau. Now, around 1,000 individual vaccine doses with the highest intended dosage level are to be inspected, tested in quality control, labelled and packed before being sent to Hamburg. There, the study of clinical phase 1 will begin at Universit?tsklinikum Eppendorf (UKE), with the presentation of all official approvals and the agreement of the ethics commission. In a total of three phases, the safety, dosing, effectiveness and tolerability will be examined over the course of the coming months.

“We are delighted that we have succeeded in developing a vaccine in such a short time, which is now ready for the clinical test phases,” said CEO Dr. Jürgen Betzing. “Our employees have put in an enormous amount of effort over the past few months to get the development of the vaccine and filling up and running. The path that we are now taking will also aid us in future battles against pandemics. Experience shows that in drastic situations we are capable of responding swiftly in joint interaction with partners and a global network.”

In the past months scientists at the German Center for Infection Research (DZIF) and partners IDT Biologika, LMU Munich, Marburg University and the UKE Hamburg have been working to research a new vaccine against SARS-CoV-2. The aim of the alliance is to make safety and probability of effectiveness the utmost priority.

The vaccine candidate currently entering the clinical phase is a so-called vector vaccine. For this, genetically-altered and harmless viruses are equipped with genetic information from the coronavirus as carriers. The viruses are not capable of reproducing, but the gene information smuggled in tricks the immune system into identifying an infection and triggering the production of antibodies and a cellular immunity.

About the Vaccine

The vector vaccine filled at IDT was developed under the leadership of Prof. Gerd Sutter, virologist at LMU Munich, at the DZIF and is based on the “Modified Vaccinia Ankara Virus” (MVA), which was developed as a vaccine against smallpox over 30 years ago. According to IDT Biologika, it has also been used successfully and with very good tolerability in the development of a vaccine against the MERS coronavirus, which occurs on the Arabian peninsula, is transmitted from dromedaries to humans with often fatal consequences, and is closely related to SARS-CoV-2.

Based on nearly 100 years of experience in the development and approval of viral and bacterial vaccines, IDT Biologika developed a cell line and a procedure that enabled the large-scale production of an ultrapure MVA vector vaccine, clearing one of the greatest obstacles in vaccine development. Parallel to this, LMU Munich solved the challenge of producing stable MVA vectors.

Prior to the approval process, the clinical study now aims to demonstrate how effective it actually is, how many vaccinations are required, whether and for how long immunity is triggered and what side-effects may occur.

“We have filled the vaccine candidates in low and high concentrations of the active ingredients, so that we can determine the right dosage for the future vaccine,” Dr. Neubert explained. In phase I the vaccine will be tested at UKE Hamburg in a first stage on healthy volunteers aged between 18 and 45, who were selected from thousands of applicants. Whilst the safety of the vaccine is the primary focus of the study, the second phase investigates the dosage, tolerability, and effectiveness of the preparation with hundreds of volunteers.

In the coming months IDT Biologika aims to continue working with its partners to swiftly bring the vaccine candidate against SARS-CoV-2 into the next clinical phases.