Summary of findings 11. BBV152 – Bharat Biotech 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 BBV152 | |||||
| Confirmed SARS‐CoV‐2 infectionb | 1841 per 100,000 | 575 per 100,000 (322 to 982) |
VE 68.80 (46.70 to 82.50) |
6289 (1 RCT)c | ⊕⊕⊕⊕ Highd | — |
| Confirmed symptomatic COVID‐19b | 1247 per 100,000 | 277 per 100,000 (170 to 434) |
VE 77.80 (65.20 to 86.40) |
16,973 (1 RCT)c | ⊕⊕⊕⊕ Highd | — |
| Severe or critical COVID‐19b | 176 per 100,000 | 12 per 100,000 (0 to 76) |
VE 93.40 (57.10 to 99.80 |
16,976 (1 RCT)c | ⊕⊕⊕⊕ Highd | — |
| All‐cause mortalitye | 78 per 100,000 | 39 per 100,000 (13 to 113) | RR 0.50 (0.17 to 1.46) | 25,753 (1 RCT)c | ⊕⊕⊖⊖ Lowf | — |
| Systemic reactogenicity eventsg | 20 per 1000 | 26 per 1000 (23 to 31) | RR 1.34 (1.15 to 1.58) | 25,925 (2 RCTs)h | ⊕⊕⊕⊕ Highd | — |
| Any adverse eventi | 124 per 1000 | 124 per 1000 (117 to 133) | RR 1.00 (0.94 to 1.07) | 25,753 (1 RCT)j | ⊕⊕⊕⊕ High | — |
| Serious adverse eventsi | 463 per 100,000 | 301 per 100,000 (199 to 449) | RR 0.65 (0.43 to 0.97) | 25,928 (1 RCT)j | ⊕⊕⊕⊕ Highd | 1 additional trial reported this outcome in 175 participants (100 BBV152 versus 75 placebo) (Ella 2021a). There were no events in either group and the trial did not contribute to the pooled effect estimate. |
| Local reactogenicity eventsg | 31 per 1000 | 34 per 1000 (30 to 39) | RR 1.08 (0.95 to 1.24) | 25,750 (2 RCTs)h | ⊕⊕⊕⊕ Highd | — |
| *The risk in the intervention group (and its 95% confidence interval) 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 two weeks after second dose to 3.3 months (median) cElla 2021a dDespite some concerns with deviations from intervention, not downgraded for risk of bias. eFollow‐up: 3.3 months (median) fImprecision: downgraded two levels due to wide CIs consistent with the possibility of benefit and the possibility of harm and low number of events. gFollow‐up: seven days hElla 2021a; Ella 2021b iFollow‐up: 4.9 months (median) jElla 2021b