The rotavirus vaccine (ROTASIIL) may reduce the incidence of hospitalization for rotavirus gastroenteritis in children

1. In this observational case-control study, children who received a complete ROTASIIL vaccination series had significantly reduced hospitalization rates for rotavirus gastroenteritis. 

Evidence Rating Level: 2 (Good)

Rotavirus remains an important cause of severe gastroenteritis and hospitalization among young children, particularly in countries with substantial pediatric diarrheal disease burden. This study assessed the real-world effectiveness of ROTASIIL, a pentavalent oral rotavirus vaccine introduced into India’s Universal Immunization Program in 2018. The investigators pooled data from two multicentre observational studies conducted across 32 hospitals in 7 Indian states between July 2019 and December 2023. Using a test-negative case-control design, they evaluated children aged 3–23 months who were hospitalized with acute gastroenteritis and compared vaccine receipt between children with and without laboratory-confirmed rotavirus gastroenteritis. Among 2,243 hospitalized children, 638 were positive for rotavirus by ELISA. For children who had received the complete 3-dose series, adjusted vaccine effectiveness against hospitalization for rotavirus gastroenteritis was 52% (95% CI, 32%-66%). Effectiveness was particularly high among infants aged 3–5 months, reaching 88% (95% CI, 53%-97%). The adjusted effectiveness was 56% (95% CI, 11%-79%) against moderate rotavirus gastroenteritis and 54% (95% CI, 31%-70%) against severe disease. Genotype-specific effectiveness was highest against G1P rotavirus at 62% (95% CI, 29%-80%), while receipt of at least one vaccine dose provided 45% effectiveness (95% CI, 26%-60%) among children aged 1–23 months. The study therefore provides real-world evidence that completing the ROTASIIL series reduces hospitalization for rotavirus gastroenteritis, with particularly strong protection when vaccination occurs early in infancy.

Click here to read this study in Nature Communications

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