Impact of rotavirus vaccination in Malawi from 2012 to 2022 compared to model predictions.

Rotarix® vaccine was introduced into the Malawi national immunization program in October 2012. We analyzed data on children <5 years old hospitalized with acute gastroenteritis from January 2012 to June 2022, and compared to pre-vaccination data from 1997 to 2009. We estimated vaccine coverage before, during, and after the COVID-19 pandemic using data from rotavirus-negative children. We compared the observed weekly number of rotavirus-associated gastroenteritis (RVGE) cases by age to predictions from a previously developed mathematical model to estimate overall vaccine effectiveness. The number of RVGE and rotavirus-negative acute gastroenteritis cases declined substantially following vaccine introduction. Vaccine coverage among rotavirus-negative controls was >90% with two doses by July 2014, and declined to a low of ~80% in October 2020 before returning to pre-pandemic levels by July 2021. Our models captured the post-vaccination trends in RVGE incidence. Comparing observed RVGE cases to the model-predicted incidence without vaccination, overall effectiveness was estimated to be modest at 36.0% (95% prediction interval: 33.6%, 39.9%), peaking in 2014, and was highest in infants (52.5%; 95% prediction interval: 50.1%, 54.9%). Our mathematical models provide a validated platform for assessing strategies to improve rotavirus vaccine impact in low-income settings.