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The long-term impact and effectiveness of rotavirus vaccination in Malawi: an interrupted time-series and case-control analysis

L. Ndeketa, V. Pitzer, K. Jere, A. Bennett, N. Cunliffe, P. J. Dodd, N. French, D. Hungerford

medRxiv, 2026

1,909 participants

Abstract

Background Rotavirus remains a leading cause of childhood diarrhoeal hospitalisation globally. Malawi introduced the monovalent G1P8 rotavirus vaccine (Rotarix(R)) in October 2012 and in April 2016 switched from trivalent to bivalent oral poliovirus vaccine (tOPV to bOPV). More than a decade after Rotarix(R) introduction, evidence on sustained vaccine effectiveness and population-level impact in high-transmission, low-income settings remains limited, and it is uncertain whether programme changes such as the OPV formulation switch have influenced Rotarix(R) performance over time. Methods We estimated the long-term impact and effectiveness of Rotarix(R) on diarrhoea hospitalisation in Malawi and explored whether OPV type changes Rotarix(R) effectiveness. We used interrupted time-series and test-negative case-control analyses to assess the impact and effectiveness of Rotarix(R), respectively, over seven years post vaccine introduction using data from diarrhoeal surveillance studies in children under five years hospitalised with acute gastroenteritis at Queen Elizabeth Central Hospital, in Blantyre, Malawi, between 1997 and 2019. Stool samples from these children were collected and tested for rotavirus A antigen using enzyme immunoassay (EIA). To assess the effect of concurrent vaccination with OPV, we used a test-negative case-control study to estimate the interaction between the two vaccines. Findings The interrupted time-series was based on 7,952 hospitalisations and showed a…

How strong is the evidence?

Evidence Hub reads this as a case-control, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 1,909 participants or records.

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