MIL OSI Translation. Region: Russian Federation –
19 November 2021, 11:05
Photo by Y. Ivanko. Mos.ru
The study is carried out on the basis of 12 medical organizations of the city Department of Health.
During the third phase of the clinical study of the Sputnik M adolescent vaccine, 700 people have already undergone medical examinations, 400 of them received the first vaccination. This was reported by Anastasia Rakova, Deputy Mayor of Moscow for Social Development. According to her, the number of sick children in the capital has increased significantly. At the peak of the incidence in October, there were more than a thousand of them daily.
“If earlier COVID-19 in children, as a rule, proceeded either in an asymptomatic form or with mild manifestations of ARVI, now we are more and more often fixing a moderate or severe form of the disease. Previously, hospitalization of a child was an extremely rare situation, but now we are hospitalizing 25 to 30 children with COVID-19 per day – these are already significant numbers. This is due to the new strain – it is more aggressive. Today, we have 150 children with coronavirus infection in the hospital, of which four are on artificial lung ventilation devices. All this requires us to apply more serious therapy. Already now, we often use drugs that block the development of a cytokine storm. We have worked out a new algorithm, according to which children at risk in the early stages began to use monoclonal antibodies to prevent a severe course of the disease, ”said Anastasia Rakova.
Three thousand volunteers will take part in the third phase of research on the safety and effectiveness of the COVID-19 vaccine for adolescents from 12 to 17 years old, of which 2.4 thousand people will receive the vaccine, and 600 people will receive a placebo. The distribution of adolescents to one group or another will be carried out randomly using a special method – randomization. Neither adolescents, nor parents, nor a doctor will know which particular group a teenager will fall into, and will not be able to influence this.
The study can be attended by adolescents who have not previously had a coronavirus infection and have no contraindications. A temporary contraindication may be postponed two weeks before the expected date of vaccination with ARVI or vaccination against another disease, given less than 30 days before participation in the study. Those wishing to take part in clinical trials must send an application by mail firstname.lastname@example.org.
The study is carried out on the basis of 12 medical organizations of the city Health Department: children’s city polyclinics № 133, 86, 130, 129, 148, 23, 110, 120, 61, 143, the Morozov children’s city clinical hospital and the children’s city clinical hospital named after Z.A. Bashlyaeva.
The research was organized by the National Research Center for Epidemiology and Microbiology named after N.F. Gamalea of the Ministry of Health of the Russian Federation.
Participation in the study of the efficacy and safety of the coronavirus vaccine for adolescents is completely voluntary and carried out in accordance with all international standards and regulations.
EDITOR’S NOTE: This article is a translation. Apologies should the grammar and or sentence structure not be perfect.