International COVID-19 Vaccines Safety Tracking Study (CoVaST-RU): Participation of the Russian Federation

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APARTSIN K.A. SVERDLOVA N. A. KIREEVA V. V. RIAD Abanoub KLUGAR Miloslav

Rok publikování 2021
Druh Článek v odborném periodiku
Časopis / Zdroj Profilakticheskaya meditsina
Fakulta / Pracoviště MU

Lékařská fakulta

Citace
www https://www.mediasphera.ru/issues/profilakticheskaya-meditsina/2021/12/1230549482021121031?clear_cache=Y
Doi http://dx.doi.org/10.17116/profmed20212412131
Klíčová slova COVID-19; vaccination; side effects; Gam-COVID-Vac (Sputnik V); CoviVac; Sputnik Light
Popis Side effects associated with COVID-19 vaccines play a crucial role in the public decision regarding the importance and necessity of vaccination. Objective. Global active surveillance of the safety and efficacy of COVID-19 vaccines. The importance of participation of the Russian Federation is determined by obtaining data on the efficacy and safety of vaccines approved for use in the country, such as GamCOVID-Vac (Sputnik V), EpiVacCorona, CoviVac, and Sputnik Light, and comparing them with vaccines used abroad. Material and methods. The international study includes 3 phases to evaluate vaccine efficacy and safety in target populations. The first phase will study adverse reactions associated with primary vaccination, the second phase will investigate the side effects of booster doses, and the third phase will assess the long-term safety and efficacy of COVID-19 vaccines. Validated electronic questionnaires completed by the target population will be used for data collection. Expected results. The study will provide evidence-based data on the efficacy and safety of domestic vaccines in comparison with foreign vaccines. The study protocol is registered at ClinicalTrials.gov under the identifier NCT04834869. Russian Federation (CoVaST-RU) is included in the study on 26 July 2021.

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