Monitoring System for Adverse Events Following Immunization in Russia and the World. Modern aspects and problems

Author:

Bakhmutskaya E. V.1ORCID,Chernyavskaya O. P.2ORCID,Volkova N. A.3

Affiliation:

1. Center for Hygiene and Epidemiology in Moscow; Sechenov University

2. Sechenov University

3. Center for Hygiene and Epidemiology in Moscow

Abstract

Relevance. During a pandemic, the epidemiological well-being of the population of the whole world depends on the vaccination of each individual person, as cells of the immune layer. Only reliable and open information about adverse events after the use of vaccines, obtained in a timely manner in the process of continuous monitoring, can support the confidence and adherence of the population to vaccination.Aim. To assess the monitoring system for AEFI (Adverse Events Following Immunization) in the Russian Federation and other countries.Materials and methods. A descriptive epidemiological study was conducted with a review of regulatory and methodological documents, forms of federal statistical observation, information from the AIS «DRAID» (Analytical Information System «Department of registration and accounting of infectious diseases» program in Moscow, acts of investigation of post-vaccination complications, which were carried out by specialists from the branches of the Center for Hygiene and Epidemiology in Moscow, sources: eLIBRARU.ru, cyberleninka.ru, information from WHO’s websites, Internet resources for monitoring AEFIs in different countries and websites of manufacturers of COVID-19 vaccines, instructions for vaccines.Conclusion. Thus, it is almost impossible for an epidemiologist working in one of the departments that participates in the monitoring of AEFIs to conduct a full-fledged prospective and retrospective epidemiological analysis and draw unambiguous conclusions about the AEFIs based only on data from open sources and forms of state statistical observation. There is a need for interaction and exchange of information between the subjects of monitoring.

Publisher

LLC Numicom

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,Epidemiology

Reference22 articles.

1. Federal Law No 61 «On the Circulation of Medicines». Available at: http://www.consultant.ru/document/cons_doc_LAW_99350. (In Russian)

2. Guidelines for the detection, investigation, prevention of adverse events after immunization (approved in April 2019). Available at: https://roszdravnadzor.gov.ru/i/upload/images/2019/10/15/1571128320.33652-1-23583.pdf. (In Russ.).

3. Nacharova E.P., Kharit S.M., Lobzin Yu.V., Briko N.I. Principles for monitoring adverse events after vaccination in Russia and the world, Journal of Microbiology, 2017, No. 1: 86–96 (In Russ.).

4. Zatolochina K.E., Snegireva I.I., Ozeretskovsky N.A., Romanov B.K., Mironov A.N. «Foreign Vaccine Safety Monitoring Systems». Epidemiology and vaccine prevention. 2013. No. 4 (71): 89–94 (In Russ.).

5. Shimabukuro T.T., et al. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)/ Vaccine 33 (2015): 4398–4405.

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