ABSTRACT
Side effects associated with COVID-19 vaccines play a crucial role in the public decision regarding the importance and necessi-ty 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 Gam-COVID-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 (Co-VaST-RU) is included in the study on 26 July 2021.
ABSTRACT
There is 15-year anniversary of Polytrauma journal in 2021. This is a high-quality periodical publication dedicated to various scientific and practical aspects of medicine of injuries on the basis of principles of evidence-based medicine. Agadzhanyan V.V., the founder and chief editor of the journal, professor, academician of RANS, maintains high level of publications. Congratulating the journal with this remarkable date, the author, who is proud for his cooperation with the editorial board, notes that activity of the journal has extended the term polytrauma in comparison with simple combination of severe mechanic injures. Unfortunately, 15th anniversary of the journal coincides with the third wave of the pandemic of the new coronavirus infection, which had led to the term collective trauma, i.e. global psychogenic influence of COVID-19. The article presents an analysis of the event of collective trauma in relation to healthcare workers, shows an association with the phenomenon of hesitancy of vaccination and declares the international observational study for active follow-up of side-effects of vaccines which will allow for the Russian Federation to objectify the data on efficiency and safety of the approved vaccines (Gam-COVID-Vak (Sputnik V), EpiVacCorona, CoviVac and Sputnik Light) as compared to foreign ones. Methods. The part of the three-stage international study, including the cross-sectional trial for testing of short-term side-effects of COVID-19 vaccines in healthcare workers. At the second stage, the side-effects of booster doses will be traced. At the third stage, the safety and efficiency will be studied. The validated self-administrated electronic questionnaire is used for collection of data. Results. The study protocol has been registered on ClinicalTrials.gov, with the identifier NCT04834869. The Russian Federation has connected to the study in July 2021. Conclusion. Vaccination hesitancy overcoming as manifestation of collective trauma in conditions of COVID-19 should be based on results, which will be presented in the Russian segment by CoVaST-RU - the first independent study of monitoring of side-effects of COVID-19 vaccines after booster doses, with estimation of long term safety and efficiency of the vaccines. © 2021 The Charity Fund of Clinical Center of Miners' Health Protection. All rights reserved.