The Tübingen-based biotech company Curevac intends to start a broad field trial on the efficacy of its coronavirus vaccine this year. “We expect to start Phase IIB/III in the fourth quarter,” a company spokesperson said on Monday, September 28th.
According to the plans, the corresponding vaccine candidate will be tested in different dosages on approximately 20,000 to 30,000 volunteers, the Curevac spokesperson said. This phase will probably take “several months”.
If the results are positive, an application for approval will be submitted to the responsible Paul-Ehrlich-Institute. From today’s point of view, the Curevac vaccine could thus “be launched on the market in summer or autumn.”
If you want to read more about the biotech company Curevac and its plans to launch its coronavirus vaccine as early as possible, download for free the Born2Invest mobile app. Our companion app brings you the most important business news and the latest breakthroughs in the biotech sector.
Curevac wants approval as soon as possible for its coronavirus vaccine
However, the vaccine could possibly be available earlier. Depending on the results of Phase IIB/III, an application for conditional approval will also be considered. According to the Paul Ehrlich Institute, conditional approval (“approval subject to special conditions”) is intended for diseases that lead to “serious weakening or even life-threatening” and is initially limited to one year.
Curevac had only started Phase I testing of its coronavirus vaccine in June. The basic tolerability of a vaccine is tested in a group of 10 to 30 people. In Phase II, the immune response after injection is tested and the optimal dose is determined. The size of the test groups is usually extended to 50 to 500 persons.
In the final Phase III test with more than 10,000 subjects, the protective effect of the vaccine is controlled. To accelerate development, Phase II and Phase III may overlap. That is exactly what Curevac plans now.
Similar to the Mainz-based competitor Biontech, for example, the Tübingen-based company has also specialized in the development of messenger nucleic acids (mRNA). In this novel approach, messengers are supposed to bring genetic blueprints for the production of unimaginably tiny amounts of antigens into the cells. The proteins produced should trigger a defense reaction of the immune system, which should then also protect the body against viruses such as the coronavirus SARS-CoV-2.
Corona vaccine: Curevac focuses on lowest possible dosage
Curevac focuses on mRNA at comparatively low doses. One test doses of two to 20 micrograms, said the Curevac spokesman. That would be two to 20 millionths of a gram. The company hopes that the low dosage will lead to particularly good tolerability in the volunteers who will take part in the test. This has also been shown in initial tests during the development of a rabies vaccine. According to the initial results, immunization was already achieved with a quantity of one microgram. In addition, Curevac said that a low dosage enables a considerable quantity of advantages per batch during later production.
Should mRNA specialists such as Curevac or Biontech be successful with their approach, this should also be of far-reaching significance for numerous other areas of application. For example, Curevac is also working on mRNA against yellow fever, malaria, skin and lung cancer.
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First published in Merkur.de, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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