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Human trials of two forms of COVID-19 vaccines began in Russia - Ministry of Health
Studies of the vaccine in the form of liquid and powder for the preparation of a solution will be carried out at the Burdenko Military Hospital and the Sechenov University.
Photo: Karolina / Kaboompics / Rawpixel
According to the Russian Ministry of Health, both vaccines are intended for intramuscular administration. The research will involve two groups of volunteers, 38 people each. The department notes that conducting a clinical trial of a vaccine during a pandemic is a unique case, therefore, unprecedented measures have been taken to ensure the safety of research. In particular, all volunteers were placed on observation for two weeks.
“The key point is the voluntariness of participation in research - each participant makes a decision independently. Participants were provided with all the information about the procedure, possible benefits, risks and inconveniences associated with participation in the study,”the Ministry of Health said.
The department added that before the start of the test, each volunteer receives informed consent, which he studies and signs before the start of the screening procedures. The document describes the nature of the research, objectives and potential risks. Each participant can withdraw from research at any time without giving any reason. Volunteers are also provided with life and health insurance services.
After signing the documents, participants must pass tests, including for HIV infection, hepatitis, coronavirus infection. Only then will they be given doses of the vaccine. Presumably, the first volunteers will be vaccinated tomorrow. After vaccination, all participants will be placed in isolation in a hospital for 28 days, during which doctors will monitor their health and assess the formation of an immune response. Monitoring the condition of the participants in the trials will continue for six months after discharge. After the end of the tests, the study of the effectiveness and safety of the vaccine will continue, the Ministry of Health said.