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Evidence summaries

Vaccines for Preventing Rotavirus Diarrhoea: Vaccines in Use

RV1 and RV5 vaccines are effective for the prevention of rotavirus diarrhoea. Level of evidence: "A"

A Cochrane review cd008521 (abstract , review [Abstract]) included 60 studies with a total of 228 233 subjects. The review was limited to the vaccines approved for use and it evaluated three vaccines compared to placebo: a monovalent rotavirus vaccine RV1 (Rotarix®, 36 studies), a pentavalent rotavirus vaccine RV5 (RotaTeq®, 15 studies), and another monovalent vaccine (Rotavac®, 4 trials), which are used in many countries.

In low-mortality countries up for 2 years of follow-up, RV1 prevents 90% of severe rotavirus diarrhoea and RV5 prevents also 96% of those cases. In high-mortality countries RV1 probably prevents 35% to 48% of severe rotavirus diarrhoea cases and RV5 57% respectively.

Rotarix® compared to placebo for preventing rotavirus diarrhoea in low-mortality countries

OutcomeRelative effect (95% CI)Assumed risk - PlaceboCorresponding risk - RV1 (95% CI)Number of participants (studies) Certainty of the evidence
Severe cases of rotavirus diarrhoea Follow-up: up to 1 yearRR 0.07 (0.03 to 0.18)13 per 10001 per 1000 (0 to 2)1 976 (4) HIgh
Severe cases of rotavirus diarrhoea Follow-up: up to 2 yearsRR 0.10 (0.07 to 0.14)29 per 10003 per 1000 (2 to 4)18 145 (6) High
All serious adverse events Follow-up: 2 months to 2 yearsRR 0.89 (0.72 to 1.10)44 per 100039 per 1000 (32 to 48)18 971 (12) High

Rotateq® compared to placebo for preventing rotavirus diarrhoea in low-mortality countries

OutcomeRelative effect (95% CI)Assumed risk - PlaceboCorresponding risk - RV5 (95% CI)Number of participants (studies) Certainty of the evidence
Severe cases of rotavirus diarrhoea Follow-up: up to 1 yearRR 0.03 (0.01 to 0.11)23 per 10001 per 1000 (0 to 3)7688 (5) High
Severe cases of rotavirus diarrhoea Follow-up: up to 2 yearsRR 0.04 (0.01 to 0.11)32 per 10001 per 1000 (0 to 4)5442 (2) High
All serious adverse events Follow-up: 2 months to 2 yearsRR 0.92 (0.84 to 1.01)26 per 100024 per 1000 (22 to 68)70 690 (5) High

No increased risk of serious adverse events or intussusception was detected with any of the vaccines.

    References

    • Bergman H, Henschke N, Hungerford D et al. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev 2021;(11):CD008521. [PubMed]

Primary/Secondary Keywords