Russia's first new crown vaccine simultaneously carried out Phase 3 clinical trials and observational studies

MOSCOW, Aug. 18 (Xinhua) -- The third phase of the "Satellite V" new crown vaccine research conducted by the Center includes phase 3 clinical trials and observational studies, with the average antibody geometry (geometric average of antibody concentration) inoculated by volunteers exceeding 1:14,000, said Janice Logonov, deputy director of the Russian National Research Center for Epidemiology and Microbiology.
"Satellite V" is Russia's first new crown vaccine, registered on the 11th. Russia's news agency quoted Logonov as saying that the "Gamelea" center is conducting the third phase of the "satellite V" study, the study is carried out in two parts: one is a phase 3 clinical trial of 2,000 volunteers, the purpose is to assess the vaccine's ability to trigger an immune response;
According to Russian media reported on the 17th, "Satellite V" vaccine phase 3 clinical trials began on August 12, "Gamarrea" center is revising 28,000 volunteers to participate in the observational study agreement document, with a view to the next week to launch the study is expected to last four to five months.
Logunov said that each volunteer involved in the third phase of the study will use a mobile app with QR QR code to report their feelings after vaccination to the relevant hospital, which will record all adverse reactions after vaccination.
the registration of the "Satellite V" vaccine is valid until January 1, 2021, according to the website of the Russian National Drug Catalog. Logonov said the registration is a "temporary registration" given by the Russian Ministry of Health, "the purpose of the registration is to give high-risk groups of new crown infection the opportunity to be vaccinated in the third phase of the study, to prevent them from becoming new coronary serious patients or even death", once the abnormality of vaccination can be cancelled at any time.
the third phase of the "Satellite V" vaccine was designed to assess safety and effectiveness in randomized controlled trials with a large number of volunteers, Dzhon logunov stressed. "This study is necessary to obtain a large amount of statistical data to determine all the trial parameters for the 'satellite V' vaccine and to obtain 'permanent registration' in the future."
said 38 volunteers, aged between 18 and 60, participated in clinical trials of the Satellite V vaccine Phase 1 and Phase 2. The average geometric titration of antibodies in the body after inoculation exceeded 1:14,000, and there were no adverse reactions such as fever after vaccination and pain at the injection place that the researchers expected.
Russian media reported that 17 scientific research institutions in Russia so far are developing at least 26 new crown vaccines, of which "satellite V" development progress is the fastest. Phase 1 and Phase 2 clinical trials of the vaccine ended on July 15 and August 3, respectively, and initially met Russian vaccine safety and effective standards.