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赞比亚将轮状病毒疫苗从Rotarix转换为Rotavac过程中面临的挑战及经验教训。

Challenges and lessons learned during the switching of rotavirus vaccine from Rotarix to Rotavac in Zambia.

作者信息

Mpabalwani E M, Sakala C, Kamiji E, Simwaka J, Soko J, Kabwe M, Chisanga Andrew, Chisanga Kelly, Sakala J, Kiulia N M, Sakubita P, Kalesha-Masumbu P, Bakyaita N, Worwui A K, Mwenda J M

机构信息

University of Zambia, School of Medicine, Department of Paediatrics & Child Health, Lusaka, Zambia; University Teaching Hospitals, Children's Hospital, Lusaka, Zambia.

Ministry of Health, Headquarters, Child Health Unit, Expanded Programme on Immunization Secretariat, Lusaka, Zambia.

出版信息

Vaccine. 2025 May 10;55:127012. doi: 10.1016/j.vaccine.2025.127012. Epub 2025 Mar 18.

DOI:10.1016/j.vaccine.2025.127012
PMID:40107130
Abstract

INTRODUCTION

Active Rotavirus diarrhea surveillance has been ongoing in Zambia at three dedicated sentinel sites since 2007, focusing on hospitalized children under five years of age. During 2021 and 2022, many African countries, including Zambia, experienced a severe shortage of rotavirus vaccines. This vaccine shortage resulted in many children who were eligible for vaccination remaining unvaccinated. Consequently, these children were exposed to a higher risk of severe acute gastroenteritis.

METHODS

To ascertain the impact of rotavirus vaccine stock-out and switch in Zambia, a comprehensive desk review was conducted focusing on the switch of the vaccine from Rotarix to Rotavac and the change of the Rotavac formulation. This review encompassed all children under five years of age recruited at the surveillance sites between 2017 and 2023 and the country's comparison of national administrative and WUENIC 2023 rotavirus vaccine coverage rate estimates for 2014 to 2023. March 2022 to April 2023 was defined as the Rotarix vaccine stock-out period. Hospitalization trends, demographic and clinical data, and rotavirus confirmed ELISA results were analyzed.

RESULTS

Following the introduction of rotavirus vaccine, the number of fully vaccinated children increased steadily over the years, reaching 4.73 million in 2023. However, 2.63 million children missed vaccination between 2016 and 2023. The administrative and WUENIC 2023 estimates for rotavirus coverage rates were the same during the period under review. Hospitalized diarrhea cases and rotavirus positivity rates remained essentially the same during the in-stock and stock-out periods of rotavirus vaccine. However, mortality rates increased three-fold during the vaccine stock-out period.

CONCLUSION

The impact of the Rotarix vaccine era was reversed due to the global supply chain disruptions, leading to missed vaccinations, increased diarrhea-related hospitalizations, and higher infant mortality in Zambia. The COVID-19 pandemic may also have further disrupted the vaccination sessions, further impacting rotavirus vaccination. Rotarix shortages likely contributed to rising rotavirus cases. There is an urgent need to completely replace the old under-5 vaccination card with a revised one to improve documentation for new rotavirus vaccines.

摘要

引言

自2007年以来,赞比亚一直在三个专门的哨点开展轮状病毒腹泻主动监测,重点关注五岁以下住院儿童。在2021年和2022年期间,包括赞比亚在内的许多非洲国家都经历了轮状病毒疫苗的严重短缺。这种疫苗短缺导致许多符合接种条件的儿童仍未接种疫苗。因此,这些儿童面临更高的严重急性胃肠炎风险。

方法

为了确定赞比亚轮状病毒疫苗缺货和更换的影响,进行了一次全面的案头审查,重点关注疫苗从Rotarix更换为Rotavac以及Rotavac配方的变化。这次审查涵盖了2017年至2023年在监测点招募的所有五岁以下儿童,以及该国2014年至2023年国家行政和WUENIC 2023轮状病毒疫苗覆盖率估计值的比较。2022年3月至2023年4月被定义为Rotarix疫苗缺货期。分析了住院趋势、人口统计学和临床数据以及轮状病毒确诊ELISA结果。

结果

引入轮状病毒疫苗后,多年来完全接种疫苗的儿童数量稳步增加,2023年达到473万。然而,2016年至2023年期间有263万儿童错过接种。在审查期间,行政和WUENIC 2023轮状病毒覆盖率估计值相同。轮状病毒疫苗有货和缺货期间,住院腹泻病例和轮状病毒阳性率基本保持不变,但疫苗缺货期间死亡率增加了两倍。

结论

由于全球供应链中断,Rotarix疫苗时代的影响被逆转,导致赞比亚错过接种、腹泻相关住院增加以及婴儿死亡率上升。新冠疫情也可能进一步扰乱了接种工作,进一步影响轮状病毒疫苗接种。Rotarix短缺可能导致轮状病毒病例增加。迫切需要用修订后的疫苗接种卡完全取代旧的五岁以下儿童疫苗接种卡,以改善新轮状病毒疫苗的记录。

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