According to Interfax , clinical trials of a coronavirus vaccine by the Chumakov Federal Scientific Center of the Russian Academy of Sciences have been carried out. To date, the volunteers have not recorded undesirable effects from the administration of the drug, and there is still no information on the immune response.
The head of the department of general virology of the organization, Georgy Ignatiev, comments: “We are now in clinical trials. clinical trials We are in clinical trials phase I / II.
We will have 300 vaccinated, one hundred of them will be vaccinated with placebo. The completion of the entire clinical protocol, I think, will be in February. We will have much more statistics on vaccine safety and immunogenicity. Preliminary data for 200 volunteers will be in mid-January.
If with safety we are almost sure that the vaccine is safe, then now, of course, the key question is immunogenicity. Now clinical research is not our problem, it is a global problem. They are all being conducted in a pandemic state. In another situation, volunteers are not at risk of contracting the virus constantly, as is the case with a pandemic, which complicates their monitoring.
This phase should end in mid-February, but we will continue to monitor our volunteers, despite the fact that according to the protocol, this part will be completed in order to determine the effectiveness of the vaccine - indicators three months and six months after they received the first vaccination. that is, up to six months. "
After the II phase of clinical trials on 300 volunteers, which should be completed at the beginning of December, the documents for the vaccine will be submitted to the Ministry of Health. The third phase should begin at the beginning of next year, with the expected number of 3000 volunteers. Scientists do not exclude the start of post-registration studies and on more people.
To date, two vaccines are available in Russia: the development of the Institute. Gamaleis of the Russian Ministry of Health - Sputnik V (a stage of post-registration studies in Moscow with the participation of 40,000 people) and the EpiVacCorona vaccine of the Vector Scientific Center of Rospotrebnadzor (they will also be tested for 40,000 people and separately for 180 elderly volunteers).