Results of long-term monitoring of the safety of immunization against rotavirus infection


DOI: https://dx.doi.org/10.18565/epidem.2024.14.2.6-12

Shapovalova R.F., Mikheeva I.V., Mikheeva M.A., Akimkin V.G.

Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia
Objective. Assessment of the safety of long-term vaccination of children with a live pentavalent recombinant rotavirus vaccine as part of a pilot project in Podolsk, Moscow region.
Materials and methods. A retrospective analysis of the incidence of intussusception (ICD-10 K56.1) was carried out based on data on hospitalization of children in a city hospital before (2013–2015) and against the background (2016–2022) of vaccinations against rotavirus infection (RVI). The data of expedited reports (form No 058u) and form No 2 of federal statistical observation, as well as reports of investigations of post-vaccination complications received by Territorial Administration of the Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being in the Moscow region in 2013–2022 were also studied.
Results. Over the 7 years, children received 38 144 vaccinations against RVI. No post-vaccination complications were recorded. The background incidence rate of intussusception in the city has not changed since the beginning of the pilot project. Over 10 years, 21 children were diagnosed with intussusception, four of them were vaccinated against RVI: two received the full course of vaccinations, two received only two vaccinations. The duration of the disease ranged from 69 days to 5 years after receiving the last dose of the vaccine, which indicated the absence of a cause-and-effect relationship between the cases of intussusception and the introduction of the rotavirus vaccine.
Conclusion. The results confirmed the published data on the safety of the pentavalent rotavirus vaccine. When organizing vaccine prevention of RVI, it is necessary to monitor adverse events in accordance with current guidelines.

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About the Autors


Regina F. Shapovalova, Junior Researcher, Laboratory of Immunoprophylaxis, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; Serena_13@mail.ru; https://orcid.org/0000-0003-0051-1866
Professor Irina V. Mikheeva, MD, Head, Laboratory of Immunoprophylaxis, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; Irina_Mikheeva@mail.ru; https://orcid.org/0000-0001-8736-4007
Marina A. Mikheeva, Junior Researcher, Laboratory of Immunoprophylaxis, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; mikheeva.m@cmd.su; https://orcid.org/0000-0003-0290-388X
Professor Vasily G. Аkimkin, Academician of the Russian Academy of Sciences, МD, Director, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; vgakimkin@yandex.ru; https://orcid.org/0000-0001-8139-0247


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