Summary of findings 9. WIBP‐CorV – Sinopharm‐Wuhan compared to placebo for vaccination against COVID‐19a.
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants | Certainty of the evidence (GRADE) | Comments | |
Risk with placebo | Risk with WIBP‐CorV | |||||
Confirmed SARS‐CoV‐2 infectionb | 912 per 100,000 | 328 per 100,000 (231 to 467) |
VE 64.00 (48.80 to 74.70) |
25,449 (1 RCT)c | ⊕⊕⊕⊕ Highd | — |
Confirmed symptomatic COVID‐19b | 746 per 100,000 | 203 per 100,000 (131 to 313) |
VE 72.80 (58.10 to 82.40) |
25,480 (1 RCT)c | ⊕⊕⊕⊕ Highd | — |
Severe or critical COVID‐19 | Outcome not yet measured or reported | |||||
All‐cause mortality | — | — | — | — | — | 1 trial reported on this outcome in 26,917 participants (13,464 WIBP‐CorV versus 13,453 placebo) (Al Kaabi 2021). There were no events in either group and no effect estimate could be calculated for this outcome. |
Systemic reactogenicity eventse | 278 per 1000 | 275 per 1000 (264 to 286) | RR 0.99 (0.95 to 1.03) | 27,029 (2 RCTs)f | ⊕⊕⊕⊕ Highg | — |
Any adverse eventh | 504 per 1000 | 484 per 1000 (469 to 494) | RR 0.96 (0.93 to 0.98) | 27,029 (2 RCTs)f | ⊕⊕⊕⊕ High | — |
Serious adverse eventsi | 579 per 100,000 | 480 per 100,000 (347 to 665) | RR 0.83 (0.60 to 1.15) | 27,029 (2 RCTs)f | ⊕⊕⊖⊖ Lowg,j | — |
Local reactogenicity eventsk | 290 per 1000 | 255 per 1000 (247 to 267) | RR 0.88 (0.85 to 0.92) | 27,029 (2 RCTs)f | ⊕⊕⊕⊕ Highg | — |
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). COVID‐19: coronavirus disease 2019 CI: confidence interval; RCT: randomized controlled trial; RR: risk ratio; SARS‐CoV‐2: severe acute respiratory syndrome coronavirus 2; VE: vaccine efficacy. | ||||||
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. |
aLast updated: 4 May 2022 bFollow‐up: from 2 weeks after the second dose up to 2.6 months (median) cAl Kaabi 2021 dDespite some concerns with deviations from intervention, not downgraded for risk of bias. eFollow‐up: seven days and 28 days fAl Kaabi 2021; Guo 2021 gDespite some concerns with adequate randomisation, not downgraded for risk of bias. hFollow‐up: one month iFollow‐up: 1.6 and 2.6 months (median) jImprecision: downgraded two levels due to wide CIs consistent with the possibility of no effect and the possibility of benefit and few events. kFollow‐up: seven days