Summary

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• Rotateq (rotavirus vaccine, live, oral, pentavalent) is indicated for the prevention of rotavirus gastroenteritis caused by types G1, G2, G3, G4, and G9.
• This summary is based on the review of 13 systematic review(s)/meta-analysis(es). ^[1-13]
• The overall vaccine effectiveness (VE) of RotaTeq (RV5) against rotavirus infection is 84% (95% CI: 80-87%) in high-income countries, significantly reducing the risk of rotavirus gastroenteritis (RVGE) and hospitalization due to RVGE.
• In high-mortality settings, VE for Rotarix (RV1) and RotaTeq (RV5) decreases to 63% and 66%, respectively, in children under 12 months, compared to 86% in low-mortality settings for children under 12 months and 84-86% for those aged 12-23 months.
• Rotarix (RV1) has a VE of 91% (95% CI: 87-94%) against severe RVGE, but reduced VE of 71% (95% CI: 43-85%) against genotype G2P[4], and 63% (95% CI: 40-77%) against fully heterotypic genotypes for any-severity RVGE.
• Additional doses of the oral rotavirus vaccine enhance IgA immune response (RR 1.3, 95% CI: 1.15-1.48), but evidence suggests limited clinical benefit in reducing episodes of severe gastroenteritis.
• No increased risk of serious adverse events was detected for RotaTeq (RV5) (RR 0.93, 95% CI 0.86 to 1.01), and meta-analyses do not indicate a significant increase in the risk of intussusception.
• No significant differences in the risk of serious adverse events between Rotarix (RV1) and RotaTeq (RV5) were found, and their safety profiles remain consistent across different settings.
• There were 30 cases of intussusception reported in 53,032 children after RV1 vaccination and 28 cases in 44,214 children after placebo; for RV5, there were 16 cases in 43,629 children, compared to 20 cases in 41,866 children after placebo.
• Vaccine effectiveness is higher in high-income countries compared to low-income regions, with VE for RV1 and RV5 in low-mortality settings at 86% for children under 12 months and 84-86% for those aged 12-23 months. In high-mortality settings, VE drops to 63% for RV1 and 66% for RV5 in children under 12 months. Additionally, children under 12 months have higher VE than those aged 12-23 months in high-mortality settings, and additional doses may improve immune response in seronegative children at baseline.