Since the beginning of last month, clinical trials of the vaccine “Sputnik M” in Moscow have entered the third phase. The vaccination is intended for adolescents between 12 and 17 years of age. According to «Interfax», 2,400 of the 3,000 test subjects will be vaccinated, while the remaining 600 will receive a placebo injection.
In order to be admitted to the study, a teenager must have undergone an antibody test, which must be negative. If this step is passed successfully, the subject is reffered for other analyses: blood, urine, EKG, HIV and hepatitis tests, and PCR tests. The first vaccination of a teenager will only be offered if all the above tests are “normal”.
According to the RBC interlocutor on this issue, a diary will be kept for the child during the annual observation period, and the adolescent will be monitored among other ways remotely. In addition, 500 subjects will be offered to donate their blood for immunogenicity on the first, 28, 42, 90 and 180 day.
After the completion of the vaccine trials, 15,000 roubles will be paid to adolescents who received placebo and who donated blood for immunogenicity. In the Ministry of Health, this payment was called “inconvenience compensation”. The RBC source notes that this practice has already been applied in the “Sputnik V” tests.
Information about the content of the vaccination (vaccine or placebo) will be provided to teenagers on the 28th day of testing. Those who received the placebo will be vaccinated with “Sputnik M” to continue the observation.
The vaccine with the prefix «M» is developed by the Gamalei Center and is based on the same platform as the original “Sputnik”, that is why it is introduced by two components with an interval of twenty-one days. Adolescents aged 12 to 15 may receive vaccines only with the consent of their legal representatives (parents or other persons).
According to Mikhail Murashko, the vaccine “Sputnik M” will be available for civilian usage from mid-December 2021.
