Izvestia managed to find out about the results of intermediate tests of the second vaccine registered in the Russian Federation – EpiVacCorona, developed by the specialists of the Vector center.
To ensure the effectiveness and safety of the vaccine, the center’s management turned to an independent contract research organization – Clinical Research Laboratories (KRLab). The contract with the company included monitoring, quality control, collection and processing of data from the “Multicenter, double-blind, placebo-controlled, comparative, randomized study of the tolerability, safety, immunogenicity and prophylactic efficacy of the EpiVacCorona vaccine with the participation of 3,000 volunteers aged 18 years and over (II – IV phase)”.
One volunteer dropped out of the trial, and the interim report included 2999 people. Of these, 2253 were vaccinated with EpiVacCorona, 746 received a placebo.
By the 42nd day after vaccination, IgG antibodies were found in 79% of those vaccinated. In the placebo group, the indicator was 11.6% (that is, these people met with coronavirus during the study). Experts recognized this difference as statistically significant.
“It is important to emphasize that if 79% of people with detected IgG antibodies were found in the tests, then this is the so-called immunological efficacy of the vaccine,” explained Tatyana Nepomnyashchikh, deputy head of the Vector Center of Rospotrebnadzor.
According to her, this indicator should not be confused with epidemiological effectiveness, which comes from other data and is calculated using a special formula. When they talk about the effectiveness of a vaccine, they mean precisely its epidemiological effectiveness, she said.
Also vaccinated with IgG antibodies were divided into three subgroups according to the amount of antibodies. A positivity coefficient from 1 to 3.49 was found in 15.3%, an average level of antibodies from 3.5 to 9.99 was recorded in 21% of participants, a high level of 10 or more was found in 40.9% of volunteers.
Read more in the exclusive material from Izvestia:
Enter control: the interim results of the EpiVacCorona tests were published