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.
| Outcome | Relative effect (95% CI) | Assumed risk - Placebo | Corresponding risk - RV1 (95% CI) | Number of participants (studies) Certainty of the evidence |
|---|---|---|---|---|
| Severe cases of rotavirus diarrhoea Follow-up: up to 1 year | RR 0.07 (0.03 to 0.18) | 13 per 1000 | 1 per 1000 (0 to 2) | 1 976 (4) HIgh |
| Severe cases of rotavirus diarrhoea Follow-up: up to 2 years | RR 0.10 (0.07 to 0.14) | 29 per 1000 | 3 per 1000 (2 to 4) | 18 145 (6) High |
| All serious adverse events Follow-up: 2 months to 2 years | RR 0.89 (0.72 to 1.10) | 44 per 1000 | 39 per 1000 (32 to 48) | 18 971 (12) High |
| Outcome | Relative effect (95% CI) | Assumed risk - Placebo | Corresponding risk - RV5 (95% CI) | Number of participants (studies) Certainty of the evidence |
|---|---|---|---|---|
| Severe cases of rotavirus diarrhoea Follow-up: up to 1 year | RR 0.03 (0.01 to 0.11) | 23 per 1000 | 1 per 1000 (0 to 3) | 7688 (5) High |
| Severe cases of rotavirus diarrhoea Follow-up: up to 2 years | RR 0.04 (0.01 to 0.11) | 32 per 1000 | 1 per 1000 (0 to 4) | 5442 (2) High |
| All serious adverse events Follow-up: 2 months to 2 years | RR 0.92 (0.84 to 1.01) | 26 per 1000 | 24 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.
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