Germany: New crown vaccine under development is favored

　　Leading the way in trials, giving priority to technology and focusing on safety
　　Germany: The new crown vaccine under development is popular

　　International war "epidemic" operation

　　Li Shan, our reporter in Germany

　　Recently, after the evaluation of the independent scientific advisory committee, among the eight new crown vaccine projects in Germany, BioNTech of Mainz, CureVac of Tübingen and IDT Biologika of Dessau received special funding from the German Federal Ministry of Education and Research. These three new crown vaccine research and development companies have their own characteristics. BioNTech has entered phase II/III clinical trials and won a large number of orders; CureVac insists on technology first and has won the favor of the capital market; IDT Biologika leverages its century-old vaccine experience to provide safety assurance . On the whole, the German new crown vaccine research and development has gradually shown an echelon development trend.

　　BioNTech vaccine receives a large number of orders

　　On July 28, BioNTech and Pfizer announced the launch of Phase II/III clinical trials to test the safety and effectiveness of vaccines, becoming one of the first six new coronavirus vaccines in the world to enter Phase III clinical trials. The first batch of vaccination has been launched in the United States, and will subsequently be expanded to 120 research centers around the world, including 39 US states, as well as research centers in Germany, Argentina, and Brazil. If the trial is successful, the two companies will begin to apply for vaccine marketing approval as early as October. At present, Pfizer has begun production of vaccines at its own risk. It is expected to produce 100 million vaccines by the end of this year and 1.3 billion vaccines next year.

　　Thanks to the good news of R&D progress, BioNTech and Pfizer are favored by governments of various countries. Although clinical trials are still in progress, orders have been flooding in. On July 20, the British government ordered 30 million new crown vaccines code-named BNT162, which are in the development stage, and will be delivered in 2020 and 2021. On July 22, the U.S. government ordered up to 600 million BNT162 new crown vaccines, provided that the vaccine was approved by the U.S. Food and Drug Administration (FDA). On July 31, the Japanese government also ordered 120 million bottles, which will be supplied in the first half of 2021 after the vaccine is approved by the regulatory authorities.

　　CureVac is sought after by the capital market

　　On June 17, CureVac's new crown vaccine project entered the phase I clinical trial, becoming the second company in Germany to carry out clinical trials of new crown vaccine candidates after BioNTech. The preliminary results of the Phase I clinical trial will be released from September to October. The preparations for Phase II and Phase III have been carried out simultaneously. Fortin Mleček, CureVac's chief technology officer, believes that the immune response caused by its vaccine candidate is significantly stronger than that of its competitors. Moreover, CureVac's vaccine requires a lower dose of active ingredients than other similar mRNA vaccines, which will facilitate mass production. The goal of CureVac is not only to prevent disease, but also to prevent infection, so that all vaccinated people are protected.

　　CureVac attracted attention when it was invited to attend the White House vaccine conference in early March. On June 15, the German Federal Government acquired a 23% stake in the company through the KfW Bank for 300 million euros; on July 6, the European Commission provided CureVac with a 75 million euro loan for the development of the new crown vaccine through the European Investment Bank; On July 20, the British pharmaceutical company GlaxoSmithKline acquired about 10% of the company’s shares for 150 million euros. The two parties also signed a cooperation agreement to carry out strategic cooperation in mRNA vaccine and antibody research; on July 21, Qatar invested The bureau and a group of new and old investors invested 110 million euros in the company. Although the results of the Phase I clinical trial have not yet come out, CureVac has raised 635 million euros in funding. On July 25, CureVac submitted an application for listing on the Nasdaq to the American stock exchange regulator.

　　IDT Biologika vaccine enters clinical trials

　　Recently, the new crown vaccine jointly developed by IDT Biologika in cooperation with the German Institute of Infection Research (DZIF), the University of Munich, the University of Marburg and the Hamburg-Ebendorf University Hospital is about to enter the clinical trial phase in Hamburg. The candidate vaccine uses the modified vaccinia virus Ankara strain (MVA) as a delivery vehicle. IDT Biologika has a hundred years of experience in the field of virus and bacterial vaccines, and can mass-produce high-purity MVA vector vaccines through a unique process, thereby overcoming a major obstacle in vaccine development.

　　At present, IDT Biologika has prepared vaccine preparations for clinical trials. After obtaining regulatory approval, it will conduct human trials to test the dose, efficacy and tolerability of the vaccine in three stages. IDT Biologika hopes to obtain rapid market approval in 2021. The chairman of the company’s board of directors, Dr. Jorgen Bessingen, said that the current primary problem is insufficient production capacity to meet the needs of Germany and Europe. Therefore, the vaccine special funding program of the German Federal Ministry of Education and Research will help the company improve its vaccine production and research capabilities.

　　mRNA vaccines need to focus on long-term effects

　　It is worth noting that BioNTech and CureVac are developing mRNA vaccines, and the long-term impact of this new technology is unclear. The nucleotide sequence of the mRNA determines the amino acid sequence of the protein. After being vaccinated with mRNA vaccine, the human body will produce this protein, which in turn triggers the production of human antibodies or immune substances. The use of genetic information has made it possible to accelerate the introduction of vaccines to the market, but the research on its side effects is still insufficient.

　　The Paul Erich Institute, the German vaccine regulatory authority, said that no human mRNA vaccine has been approved so far, so it is very important to clarify this issue in the current clinical trials. The European Medicines Agency stated that the relevant research will not be terminated even after the vaccine is approved for marketing. It should continue to be observed and recorded one or two years after vaccination to ensure long-term safety.

　　Professor Wilt, the associate dean of the Hannover Medical School, believes that the next few months are a critical period. The success rate of vaccine development is usually only 1%, especially for new vaccine development technologies that have never been used. German Federal Member and health expert Karl Lauterbach said that although we now see that they can stimulate an immune response, no one knows whether infection can really be avoided. According to the recent guidelines for vaccine candidates issued by the US FDA, the vaccine should protect at least 50% of the vaccinated population or reduce the severity of the disease. These requirements are designed to ensure that the vaccine undergoes clinical trials as soon as possible so that the drug can be quickly approved and used.