Table 3.
Benefit-Risk Estimates of Rotavirus Vaccination in Analyzed Studies
| Source | Location | Vaccine(s) | Events | Baseline Incidence RVGE <5 y (N) | Prevented RVGE <5 y (N) | Prevented RVGE <5 y (%) | Baseline Incidence IS <1 y (N) | Caused IS <1 y (N) | Caused IS <1 y (%) | BRR (RVGE/IS) |
|---|---|---|---|---|---|---|---|---|---|---|
| Patel et al [42] | LMIC (117) | Rotarix/RotaTeq | Hosp | NR | NR | NR | NR | NR | NR | NR |
| Death | 517 959 | 194 564 | 37.6a | NR | 1106 | NR | 176a | |||
| Patel et al [18] | Brazil | Rotarix | Hosp | 92 453 | 69 572 | 75.3a | 2146 | 55 | 2.6a | 1265a |
| Death | 850 | 640 | 75.3a | 107 | 3 | 2.8a | 213a | |||
| Mexico | Rotarix | Hosp | 16 086 | 11 551 | 71.8a | 1215 | 41 | 3.4a | 282a | |
| Death | 923 | 663 | 71.8a | 61 | 2 | 3.3a | 332a | |||
| Desai et al [39] | Latin America (14) | Rotarix/RotaTeq | Hosp | 229 656 | 144 746 [128 821–156 707]c | 63.0a | 5556 | 172 [126–293]c | 3.1a | 841 [479–1142]c |
| Death | 6302 | 4124 [3740–4239]c | 65.4a | 326 | 10 [6–17]c | 3.1a | 395 [207–526]c | |||
| Patel et al [43] | LMIC (158) | Rotarix/RotaTeq | Hosp | NR | NR | NR | NR | NR | NR | NR |
| Death | 452 800 [386 600–519 900]a,b | 155 800 [83 300–217 700]b | 34.4a | NR | 253 [76–689]b | NR | 615a | |||
| Carlin et al [17] | Australia | Rotarix/RotaTeq | Hosp | 11 073 | 6528 | 59.0a | 144 | 14 | 9.7a | 466a |
| Death | NR | NR | NR | NR | NR | NR | NR | |||
| Desai et al [38] | United States | RotaTeq | Hosp | 71 175 [50 131–96 802]b | 53 444 [37 622–72 882]b | 75.1a | NR | 45 [21–86]b | NR | 1093 [688–1902]b |
| Death | 33 [23–43]b | 14 [10–19]b | 42.4a | NR | 0.2 [0.1–0.3]b | NR | 71 [48–112]b | |||
| Clark et al [37] | England | Rotarix | Hosp | 14 770 [14 113–15 427]a,b | 13 276 [12 255–14 181]b | 89.9a | 248 | 35.4 [7.0–97.6]b,d | 14.3a | 375 [136–1900]b,d |
| Death | 3.3 [1.7–4.9]b | 2.9 [1.7–4.1]b | 86.7a | 0.3a | 0.1 [0.0–0.2]b,d | 10.6a | 88 [18–852]b,d | |||
| Yung et al [44] | Singapore | Rotarix | Hosp | 808 | 570 | 70.5a | 22 | 3 | 13.6a | 190a |
| Death | NR | NR | NR | NR | NR | NR | NR | |||
| Ledent et al [41] | Japan | Rotarix | Hosp | 20 829 [16 301–26 129]b | 17 925 [11 715–23 276]b | 86.1a | 1571 [1308–1868]b | 50 [7.2–237]b | 3.2a | 350 [69–2510]b |
| Death | 7.3 [5.7–9.3]b | 6.3 [4.1–8.2]b | 86.3a | 0.5 [0.2–1.2]b | 0.1 [0.0–0.1]b | 3.1a | 366 [59–3271]b | |||
| Lamrani et al [40] | France | Rotarix/RotaTeq | Hosp | 11 866a | 10 375 [7802–13 293]a | 87.4a | 214 | 47 [25–81]b | 21.9a | 214 [128–362]b |
| Death | 16 [15–18] | 14 [12–15]a | 87.5a | 0.3 | 0.1 [0.0–0.2]b | 17.8a | 273 [89–1228]b | |||
| Ledent et al [48] | France | Rotarix | Hosp | 15 059 [12 100–18 476]b | 11 132 [7841–14 409]b | 73.9a | 323 [257–400]b | 6.9 [2.3–38.4]b | 2.1a | 1624 [240–5243]b |
| Death | 10.1 [4.6–19.5]b | 7.43 [3.27–14.68]b | 73.3a | 0.5 [0.2–0.9]b | 0.1 [0.0–0.1]b | 2.2a | 743 [93–3723]b | |||
| Bruijning-Verhagen et al [45] | Netherlands | RotaTeq | Hosp | 2700 [2400–3000]a,e | 2000 [1800–2200]a,e | 74.1a,e | NR | 2.9a | NR | 685 [603–767]e |
| Death | 5.5 [3.0–8.8]a,e | 5.2 [2.8–8.3]a,e | 93.6a,e | NR | NR | NR | NR | |||
| Bruun et al [46] | Norway | Rotarix | Hosp | NR | 1768 [1761–1774]a,b | NR | 22 [19–26]a | 1 [1–2]b | 5.7a | 1360 |
| Death | NR | NR | NR | NR | NR | NR | NR | |||
| Clark et al [47] | LMIC (135) | Rotarix/RotaTeq/ ROTAVAC/ ROTASIIL/RV3-BB | Hosp | NR | NR | NR | NR | NR | NR | NR |
| Death | 194 471 [158 603–257 080]b | 62 485 [47 895–83 238]b | 32.1a | NR | 122 [44–322]b | NR | 512 [218–1338]b |
Abbreviations: BRR, benefit-risk ratio; Hosp, hospitalization; IS, intussusception; LMIC, low- and middle-income countries; N, number; NR, not reported; RVGE, rotavirus gastroenteritis; y, years.
aUsing data from original publications.
bMedian values.
c90% CI.
dIS risk period (0–2 years).
eBaseline incidence RVGE <15 years.