Summary of findings 6. AD26.COV2.S – Janssen Pharmaceutical Companies compared to placebo for vaccination against COVID‐19a.
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with AD26.COV2.S | |||||
| Confirmed SARS‐CoV‐2 infection | Outcome not yet measured or reported | |||||
| Confirmed symptomatic COVID‐19b | 1796 per 100,000 | 594 per 100,000 (478 to 735) |
VE 66.90 (59.10 to 73.40) |
39,058 (1 RCT)c | ⊕⊕⊕⊕ Highd | — |
| Severe or critical COVID‐19b | 409 per 100,000 | 97 per 100,000 (51 to 172) |
VE 76.30 (57.90 to 87.50) |
39,058 (1 RCT)c | ⊕⊕⊕⊕ Highd | — |
| All‐cause mortalityb | 91 per 100,000 | 23 per 100,000 (8 to 61) | RR 0.25 (0.09 to 0.67) | 43,783 (1 RCT)c | ⊕⊕⊕⊕ High | — |
| Serious adverse eventsb | 448 per 100,000 | 412 per 100,000 (309 to 546) | RR 0.92 (0.69 to 1.22) | 43,783 (1 RCT)c | ⊕⊕⊕⊖ Moderatej | — |
| Systemic reactogenicity eventse | 34,575 per 100,000 | 63,273 per 100,000 (44,602 to 89,896) | RR 1.83 (1.29 to 2.60) | 7222 (2 RCTs)f | ⊕⊕⊕⊕ Highd,g | — |
| Any adverse eventh | Outcome not pooled due to considerable heterogeneity (I² = 96%) between included studies: Sadoff 2021a (RR 1.09, 95% CI 0.96 to 1.24; n = 6736); Sadoff 2021b (RR 2.31, 95% CI 1.80 to 2.97; n = 486) | — | 7222 (2 RCTs)f | ⊕⊕⊖⊖ Lowd,i | — | |
| *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: 1.9 months (median) cSadoff 2021b dDespite some concerns with deviations from intervention, not downgraded for risk of bias. eFollow‐up: seven days and 14 days fSadoff 2021a; Sadoff 2021b gDespite I² = 83%, not downgraded for inconsistency, as the same direction of effect in both effect estimates. hFollow‐up: 0.23 months and 0.92 months iInconsistency: downgraded two levels (I² = 96%). jImprecision: downgraded one level due to wide CIs consistent with the possibility of no effect and the possibility of benefit. kFollow‐up: seven days lDespite I² = 84%, not downgraded for inconsistency, as the same direction of effect in both effect estimates.