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      The impact of rotavirus vaccination on acute diarrhea in Thai children under 5 years of age in the first year of universal implementation of rotavirus vaccines in the National Immunization Program (NIP) in Thailand: a 6-year analysis

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          Abstract

          Background

          Two types of rotavirus vaccines (RVs), Rotarix (RV1) and RotaTeq (RV5), were licensed as optional vaccines in 2012 and became part of the National Immunization Program (NIP) in the fiscal year 2020 in Thailand. The main objective was to evaluate the impact of rotavirus vaccines on the burden of acute diarrheal severity ranging from outpatient visits, diarrheal-related admission or deaths in the pre-NIP period (fiscal year 2015–2019) and in the fiscal year 2020. The minor objectives were assessed on the monthly admission rate, rotavirus vaccine coverage rate and rotavirus vaccine completed dose (RotaC).

          Methods

          Data regarding OPD, admission, and death cases under the Thailand National Health Coverage (NHC) from fiscal year 2015–2020, which were recorded as International Classification of Diseases and Related Health Problem 10 th (ICD-10), were analyzed.

          Results

          The burden of diarrheal-related disease diminished after the rotavirus vaccine was introduced in the fiscal year 2020 when compared to the previous 5 fiscal years.

          The OPD visit rate decreased from 10.1 to 8.3 visits per 100 person-years ( P < 0.001), or a 17.8% reduction (incidence rate ratio (IRR) = 0.82; 95% confidence interval (CI): 0.81 to 0.82). The admission rate significantly declined from 31.4 to 30.5 cases per 1,000 person-years, ( P < 0.001), or a 2.9% reduction (IRR = 0.97; 95% CI: 0.96 to 0.98). The diarrheal-related mortality rate also subsided from 10.2 to 8.1 cases per 100,000 person-years ( P 0.3), or a 20.0% reduction (IRR = 0.88; 95% CI: 0.50 to 1.22). The major population in both admissions and deaths was infants under 1 year of age ( P < 0.001). Seasonality was seen as a constant bimodal pattern, with a significant decrease in monthly admissions after 6 months of rotavirus vaccine introduction to NIP ( P < 0.001). RotaC was 37.4% in the first year of NIP.

          Conclusions

          The rotavirus vaccine had a potential benefit for reducing the diarrheal disease burden, especially in infants under one year of age. Seasonality outbreaks of acute diarrhea subsided after the rotavirus vaccine was introduced. The RotaC was fairly low in the first year of the NIP. The quality of the rotavirus vaccine should be warranted.

          Trial registration

          Number TCTR20220120003, date of registration: 20/01/2022, site: Thai Clinical Trials Registry.

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          Most cited references55

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          Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980–2017: a systematic analysis for the Global Burden of Disease Study 2017

          Gregory A Roth, Degu Abate, Kalkidan Hassen Abate … (2019)
          Summary Background Global development goals increasingly rely on country-specific estimates for benchmarking a nation's progress. To meet this need, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2016 estimated global, regional, national, and, for selected locations, subnational cause-specific mortality beginning in the year 1980. Here we report an update to that study, making use of newly available data and improved methods. GBD 2017 provides a comprehensive assessment of cause-specific mortality for 282 causes in 195 countries and territories from 1980 to 2017. Methods The causes of death database is composed of vital registration (VR), verbal autopsy (VA), registry, survey, police, and surveillance data. GBD 2017 added ten VA studies, 127 country-years of VR data, 502 cancer-registry country-years, and an additional surveillance country-year. Expansions of the GBD cause of death hierarchy resulted in 18 additional causes estimated for GBD 2017. Newly available data led to subnational estimates for five additional countries—Ethiopia, Iran, New Zealand, Norway, and Russia. Deaths assigned International Classification of Diseases (ICD) codes for non-specific, implausible, or intermediate causes of death were reassigned to underlying causes by redistribution algorithms that were incorporated into uncertainty estimation. We used statistical modelling tools developed for GBD, including the Cause of Death Ensemble model (CODEm), to generate cause fractions and cause-specific death rates for each location, year, age, and sex. Instead of using UN estimates as in previous versions, GBD 2017 independently estimated population size and fertility rate for all locations. Years of life lost (YLLs) were then calculated as the sum of each death multiplied by the standard life expectancy at each age. All rates reported here are age-standardised. Findings At the broadest grouping of causes of death (Level 1), non-communicable diseases (NCDs) comprised the greatest fraction of deaths, contributing to 73·4% (95% uncertainty interval [UI] 72·5–74·1) of total deaths in 2017, while communicable, maternal, neonatal, and nutritional (CMNN) causes accounted for 18·6% (17·9–19·6), and injuries 8·0% (7·7–8·2). Total numbers of deaths from NCD causes increased from 2007 to 2017 by 22·7% (21·5–23·9), representing an additional 7·61 million (7·20–8·01) deaths estimated in 2017 versus 2007. The death rate from NCDs decreased globally by 7·9% (7·0–8·8). The number of deaths for CMNN causes decreased by 22·2% (20·0–24·0) and the death rate by 31·8% (30·1–33·3). Total deaths from injuries increased by 2·3% (0·5–4·0) between 2007 and 2017, and the death rate from injuries decreased by 13·7% (12·2–15·1) to 57·9 deaths (55·9–59·2) per 100 000 in 2017. Deaths from substance use disorders also increased, rising from 284 000 deaths (268 000–289 000) globally in 2007 to 352 000 (334 000–363 000) in 2017. Between 2007 and 2017, total deaths from conflict and terrorism increased by 118·0% (88·8–148·6). A greater reduction in total deaths and death rates was observed for some CMNN causes among children younger than 5 years than for older adults, such as a 36·4% (32·2–40·6) reduction in deaths from lower respiratory infections for children younger than 5 years compared with a 33·6% (31·2–36·1) increase in adults older than 70 years. Globally, the number of deaths was greater for men than for women at most ages in 2017, except at ages older than 85 years. Trends in global YLLs reflect an epidemiological transition, with decreases in total YLLs from enteric infections, respiratory infections and tuberculosis, and maternal and neonatal disorders between 1990 and 2017; these were generally greater in magnitude at the lowest levels of the Socio-demographic Index (SDI). At the same time, there were large increases in YLLs from neoplasms and cardiovascular diseases. YLL rates decreased across the five leading Level 2 causes in all SDI quintiles. The leading causes of YLLs in 1990—neonatal disorders, lower respiratory infections, and diarrhoeal diseases—were ranked second, fourth, and fifth, in 2017. Meanwhile, estimated YLLs increased for ischaemic heart disease (ranked first in 2017) and stroke (ranked third), even though YLL rates decreased. Population growth contributed to increased total deaths across the 20 leading Level 2 causes of mortality between 2007 and 2017. Decreases in the cause-specific mortality rate reduced the effect of population growth for all but three causes: substance use disorders, neurological disorders, and skin and subcutaneous diseases. Interpretation Improvements in global health have been unevenly distributed among populations. Deaths due to injuries, substance use disorders, armed conflict and terrorism, neoplasms, and cardiovascular disease are expanding threats to global health. For causes of death such as lower respiratory and enteric infections, more rapid progress occurred for children than for the oldest adults, and there is continuing disparity in mortality rates by sex across age groups. Reductions in the death rate of some common diseases are themselves slowing or have ceased, primarily for NCDs, and the death rate for selected causes has increased in the past decade. Funding Bill & Melinda Gates Foundation.
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            Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.

            Timo Vesikari, David Matson, Penelope H Dennehy … (2006)
            Rotavirus is a leading cause of childhood gastroenteritis and death worldwide. We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events. The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent). This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.) Copyright 2006 Massachusetts Medical Society.
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              Global Illness and Deaths Caused by Rotavirus Disease in Children

              Umesh D Parashar, Erik Hummelman, Joseph Bresee … (2003)
              To estimate the global illness and deaths caused by rotavirus disease, we reviewed studies published from 1986 to 2000 on deaths caused by diarrhea and on rotavirus infections in children. We assessed rotavirus-associated illness in three clinical settings (mild cases requiring home care alone, moderate cases requiring a clinic visit, and severe cases requiring hospitalization) and death rates in countries in different World Bank income groups. Each year, rotavirus causes approximately 111 million episodes of gastroenteritis requiring only home care, 25 million clinic visits, 2 million hospitalizations, and 352,000–592,000 deaths (median, 440,000 deaths) in children <5 years of age. By age 5, nearly every child will have an episode of rotavirus gastroenteritis, 1 in 5 will visit a clinic, 1 in 60 will be hospitalized, and approximately 1 in 293 will die. Children in the poorest countries account for 82% of rotavirus deaths. The tremendous incidence of rotavirus disease underscores the urgent need for interventions, such as vaccines, to prevent childhood deaths in developing nations.
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                Author and article information

                Contributors
                Busara Charoenwat:
                ORCID: http://orcid.org/0000-0003-4892-4993
                busarcha@kku.ac.th
                Journal
                Journal ID (nlm-ta): BMC Public Health
                Journal ID (iso-abbrev): BMC Public Health
                Title: BMC Public Health
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2458
                Publication date (Electronic): 27 October 2023
                Publication date PMC-release: 27 October 2023
                Publication date Collection: 2023
                Volume: 23
                Electronic Location Identifier: 2109
                Affiliations
                [1 ]Department of Pediatrics, Division of Gastroenterology and Hepatology, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, ( https://ror.org/03cq4gr50) 123 Mitrapap Road, Muang Khon Kaen, Khon Kaen, 40002 Thailand
                [2 ]Clinical Epidemiology Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, ( https://ror.org/03cq4gr50) Khon Kaen, Thailand
                [3 ]Department of Clinical Chemistry, Faculty of Allied Health Sciences, Chulalongkorn University, ( https://ror.org/028wp3y58) Bangkok, Thailand
                Author information
                http://orcid.org/0000-0003-4892-4993
                http://orcid.org/0000-0002-7517-1416
                http://orcid.org/0000-0002-3992-5444
                http://orcid.org/0000-0003-1517-9464
                http://orcid.org/0000-0002-1897-6007
                http://orcid.org/0000-0003-1782-9360
                http://orcid.org/0000-0003-4775-9754
                Article
                Publisher ID: 16958
                DOI: 10.1186/s12889-023-16958-0
                PMC ID: 10604840
                PubMed ID: 37891542
                SO-VID: 8bca55f1-42c4-4c56-aa69-74c23a3cc8d7
                Copyright © © The Author(s) 2023
                License:

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 16 June 2023
                Date accepted : 11 October 2023
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © BioMed Central Ltd., part of Springer Nature 2023

                ScienceOpen disciplines: Public health
                Keywords: acute diarrhea,rotavirus,rotavirus vaccine,children under 5 years of age,children
                Data availability:
                ScienceOpen disciplines: Public health
                Keywords: acute diarrhea, rotavirus, rotavirus vaccine, children under 5 years of age, children

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