There were no serious side effects in the volunteers who participated in the studies. The vaccine has therefore been classified as safe.
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Vadim Tarasov, director of the Institute of Translational Medicine and Biotechnology at the First State Medical University of Moscow (also known as Setschenow University) announced on July 12 that test series on the safety of a COVID-19 vaccine manufactured in Russia were completed.
The vaccine was developed at the National Research Center for Epidemiology and Microbiology, named after NF Gamaleja, together with the Russian Ministry of Defense developed (closely). However, the clinical studies were conducted by the First Moscow State Medical University.
The studies aimed to test the safety of the new drug, but not its effectiveness. Scientists plan to complete the next phase of clinical trials to test the effectiveness of the new vaccine by July 28.
Scientists estimate that the drug will go into mass production in early September 2020. A process that requires prior certification by the Russian medical authorities. However, the certification process should not take longer than a few days and could therefore be completed in early August.
However, it is not yet clear when customers can get the vaccine. „I don’t think it will be available in pharmacies in the near future as the government will hopefully procure the drug and distribute it among the hospitals“, says (rus) Alexander Ginzburg, director of the National Research Center for Epidemiology and Microbiology. an institution where the vaccine was made.
Ginzburg hopes that hospitals will then vaccinate people for free. He also expressed hope that private companies will be involved in the vaccine manufacture by early September.
The new COVID-19 vaccine was tested on 38 volunteers. Clinical trials started on June 18. During this phase, the scientists tested the volunteers for the absence of COVID-19 infection and ensured that none of the antibodies had COVID-19 infection. After receiving the desired negative results, the scientists isolated the volunteers for two weeks.
During the second phase, the volunteers were divided into two groups: people in the first group received a single dose of the new drug, while people in the other group received a double dose of the same drug.
The scientists say that while some of the volunteers suffered from high temperatures in the first few days after vaccination, all of the volunteers were in good health, felt great, and the vaccine is safe to use.
“The attempts were successful. They confirmed the safety of the vaccine. It corresponds to the safety of the vaccines available on the market. This phase was a success, ” said (rus) Alexander Lukaschew, Director of the Institute for Medical Parasitology, Tropical Diseases and Vector-borne Diseases. The institute is part of the First Medical University of Moscow.
It has been reported that volunteers who received a single dose of the new vaccine should be discharged from the hospital on July 15 and those with a double dose should be discharged five days later, on July 20.
The researchers also reported that the need to isolate the volunteers affected their psychological state, which led to conflict and emotional stress among them, and psychologists had to intervene.
The First Medical University initially left unanswered questions or requests for comment.
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