Russian scientists, as well as the Ministry of Defense and the Ministry of Health spoke about the clinical trials of a vaccine against SARS-CoV-2, developed by the N. Gamaleya Research Center for Epidemiology and Microbiology, which started today.
The N. Gamaleya Research Center for Epidemiology and Microbiology, with the support of the Russian Ministry of Defense, announced the start of human trials of the Covid-19 vaccine, writes TASS. The testing was approved by the Ministry of Health.
“In the near future, upon completion of the two-week isolation, the first group of volunteers will be vaccinated, the main purpose of which is to check the safety and tolerability of the vaccine components,” the Defense Ministry said.
The testing was approved by the Ministry of Health. The department also agreed on the number of volunteers who will take part in the research: among them there will be both civilians and the military. They will be divided into two groups of 38 people. Testing will take place in two medical institutions in Moscow: the First Moscow State Medical University named after Sechenov and the Main Military Clinical Hospital named after academician N.N.Burdenko. As part of the research, it is planned to study the effects of two types of coronavirus vaccines - in liquid and freeze-dried forms.
Earlier, the head of the Gamaleya center, Alexander Gunzburg, reported that the tests would take about one and a half months. All participants will receive a dose of the drug on day zero and on day 21, then they will be in the hospital for 28 days. After discharge from the hospital, their health will be monitored for another six months.
“After signing informed consent and getting insurance, the study participant is screened. They take a blood test, urine test, check for chronic diseases, HIV infection, hepatitis, coronavirus infection. Only after being tested for eligibility for inclusion in the study, the volunteers are given the vaccine. The first volunteers will be vaccinated on June 18-19. The entire procedure accompanying a clinical trial is aimed at ensuring the rights and safety of the research participants. This is only the first stage of studying the efficacy and safety of the drug,”the Ministry of Health said.
At the end of the tests, all the data will be transferred to the Ministry of Health: there, specialists will conduct an additional check of the risks and effectiveness of the vaccine. Only after this stage it will be possible to understand when the drug will go into circulation. According to the Minister of Health Mikhail Murashko, starting samples may appear by the beginning of this fall.
At the end of May, the staff of the Gamaleya Center tested their promising vaccine based on the adenovirus vector on themselves. Soon they found protective antibodies against SARS-CoV-2.
Upd.On Thursday, June 18, at the Burdenko hospital, the first 18 volunteers received the vaccine. Thus, clinical trials of the Russian drug against the SARS-CoV-2 coronavirus have officially begun.
“According to the results of the survey and examination of the volunteers, there are no adverse reactions or complications, there are no complaints from the participants in the experiment about their health. After the vaccine is administered, all volunteers will continue to be under continuous medical supervision. Regular screenings, taking of the necessary samples and analyzes will be carried out,”the Ministry of Defense said.
Later, the vaccine was administered to 18 subjects at the Sechenov University. A few days later, the drug will be tested on the following groups in both institutions.