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MIL OSI Translation. Region: Germany / Deutschland –

Source: Federal Ministry of Education and Research

08.10.2020Press release: 149/2020

Status of the special program for vaccine research and vaccine development against Covid-19 in Germany

Researchers around the world are currently working under high pressure on vaccines against Covid-19. The Federal Ministry of Education and Research (BMBF) supports the development nationally and internationally. In order to be able to further intensify national efforts, the special program to accelerate research and development of urgently needed vaccines against SARS-CoV-2 was launched. The program is intended to increase clinical study capacities in research and to expand production capacities already now. After funding for the companies CureVac AG and BioNTech SE has already been approved, IDT Biologika GmbH from Dessau is now also being supported. Federal Research Minister Anja Karliczek explains: “As a strong research and development location, we – in addition to our international involvement in the vaccine alliance CEPI – also have a national responsibility to support the development of promising vaccines in research institutions in Germany. Our special program serves to accelerate research and development of vaccines against SARS-CoV-2. I am delighted that under this program we can support three projects to develop a vaccine that use different technologies. All companies want to help ensure that vaccines are available quickly and in sufficient quantities. When it comes to development, we want and have to take multiple paths if we want to ensure that vaccines are available quickly, in sufficient quantities and for different population groups. With our funding, we enable the three companies to broaden their projects and move forward faster. It is important that we will use the program to accelerate the development of a vaccine against Covid-19 – but without taking any risks at the same time. Safety is an absolute priority! A vaccine can only be used if the proven benefit is significantly greater than the possible risks. Of course, we all hope that the first vaccines against Covid-19 will be approved in the foreseeable future and then be available as soon as possible to anyone who so wishes are. Research is incredibly fast right now. We are all following the development with great tension. I wish the three funded companies every success in all of our senses. ”Background With the special program to accelerate research and development of urgently needed vaccines against SARS-CoV-2 as well as other funding measures for research into COVID-19, the BMBF is responding directly to the questions of the Dealing with and combating Covid-19. The special program supports a total of three companies in the research-based pharmaceutical and biotechnological industry in Germany. Funding relates to the following areas: clinical vaccine development phases I-III; early expansion of production and filling capacities; expansion of clinical trial capacities in Germany; the funding decision was made by the BMBF with the involvement of an expert advisory board. This body consists of high-ranking representatives from the pharmaceutical industry, clinical research and regulatory authorities. Prof. Dr. Klaus Cichutek, President of the Paul Ehrlich Institute, Funded projects, funding amounts (rounded)

BioNTech

BNT-Covid-19-Vaccine – Accelerated development and delivery of an mRNA-based COVID-19 vaccine (BNT162)

375 million euros

CureVac

ACE-mR-CoV – Development, testing and production of a SARS-CoV-2 vaccine based on mRNA technology

252 million euros

IDT biologics

MSarsCoV2 – Development of a recombinant viral vector vaccine for the active immunization of risk groups against clinical SARS-2 coronavirus infections

114 million euros

BioNTech SE BioNTech SE is a biotechnology company focused on the development and manufacture of active immunotherapies for a patient-specific approach to the treatment of cancer and other serious diseases. BioNTech and Pfizer are currently testing their mRNA-based lead vaccine candidate against COVID-19 BNT162b2 in a global phase 3 registration trial. So far, the study has enrolled 37,000 out of 44,000 targeted participants. At the beginning of September, the Paul Ehrlich Institute approved part of the clinical phase 3 study in Germany as well. The companies have received fast-track status for BNT162b2 from the US Food and Drug Administration (FDA) and initiated what is known as the “rolling review” submission process for ongoing review at the European Medicines Agency (EMA) in early October. Preliminary data from the Phase 1/2 study showed that the vaccine candidate was well tolerated and had mild to moderate side effects in all age groups. BioNTech is expanding its production capacities in order to support a global supply of a potential vaccine in the event of a market approval. In mid-September BioNTech announced an agreement with Novartis to take over a GMP-certified production facility in Marburg. When fully operational, the facility will have a production capacity of up to 750 million doses per year. CureVac AGCureVac is a global biopharmaceutical company specializing in messenger RNA (messenger RNA) technology. With its expertise, CureVac is working to develop and optimize this versatile molecule for medical use. The principle of the proprietary CureVac technology is based on the use of mRNA as an information carrier to guide the human body to produce the correspondingly coded proteins with which a variety of diseases can be combated. The company uses its technologies to develop prophylactic vaccines, cancer therapies, antibody therapies and treatment with protein therapies. CureVac’s COVID-19 vaccine candidate is currently in clinical phase 1. At the end of September 2020, the company also started clinical phase 2a in Peru and Panama. CureVac is headquartered in Tübingen and has additional locations in Frankfurt and Boston, USA IDT Biologika GmbH IDT Biologika GmbH is a pharmaceutical manufacturer approved in Europe and by the US FDA (Food and Drug Administration). It is also a contract manufacturer providing support to biopharmaceutical companies with product development, clinical trial manufacturing, and commercial manufacturing of their products. IDT Biologika is developing a vector vaccine to immunize adults and older risk groups against COVID-19. Clinical development is achieved by creating a broad base for multicenter clinical testing and immunological monitoring of subjects. Here, test persons are immunized with the innovative MVA-SARS-2-S vaccine in Germany, at one location in Africa and one in Asia and, if necessary, at other locations worldwide. IDT Biologika cooperates with the German Center for Infection Research DZIF (here in particular the locations University Medical Center Hamburg-Eppendorf, University Medical Center at the Ludwig-Maximilians-University Munich, University Medical Center Tübingen). The vaccine technology was developed at LMU. DZIF and IDT Biologika are already developing a vaccine against the MERS coronavirus using the same technology. At the end of September, the Paul Ehrlich Institute granted approval to carry out the first clinical phase.

MIL OSI

EDITOR’S NOTE: This article is a translation. Apologies should the grammar and / or sentence structure not be perfect.

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