Table 3.
Vaccine efficacy based on COVID-19 infection in both scenarios: without censoring for COVID-19 vaccination and with censoring for COVID-19 vaccination.
| Scenario | All | Unvaccinated | Revaccinated with BCG |
|---|---|---|---|
| COVID-19 – without censoring for COVID-19 vaccination | |||
| Number of COVID-19 cases, n | 19 | 11 | 8 |
| Cumulative incidence, n/total (%) | 19/131 (14.5) | 11/67 (16.4) | 8/64 (12.5) |
| Number censored, n (%) | 112 (85.5) | 56 (83.6) | 56 (87.5) |
| VE based on HR (95.0% CI)* | 30.0 (-78.0 to 72.0) | ||
| Person-Years | 59.8 | 30.4 | 29.4 |
| IR per 100 Person-Years (95.0% CI) | 31.8 (19.1-49.6) | 36.2 (18.1-64.7) | 27.2 (11.7-53.6) |
| VE based on IRR (95.0% CI) † | 31.0 (-74.0 to 74.0) | ||
| COVID-19 – with censoring for COVID-19 vaccination | |||
| Number of COVID-19 cases, n | 16 | 9 | 7 |
| Cumulative incidence, n/total (%) | 16/131 (12.2) | 9/67 (13.4) | 7/64 (10.9) |
| Number censored, n (%) | 115 (87.8) | 58 (86.6) | 57 (89.1) |
| VE based on HR (95.0% CI)* | 26.0 (-107.0 to 73.0) | ||
| Person-Years | 42.2 | 21.2 | 21.0 |
| IR per 100 Person-Years (95.0% CI) | 37.9 (21.7-61.6) | 42.5 (19.4-80.6) | 33.3 (13.4-68.7) |
| VE based on IRR (95.0% CI)† | 32.0 (-89.0 to 77.0) |
The primary endpoint was COVID-19 defined as the presence of positivity by RT-PCR or IGM or IgG serology defined as presented in methods.
IRR, incidence rate ratio; HR=hazard ratio; VE, vaccine efficacy; CI, confidence interval. *Vaccine efficacy based on 1-HR obtained in Cox proportional model adjusted for age and sex. †Vaccine efficacy based on 1-IRR obtained in Poisson model adjusted for age and sex, with the natural logarithm (log[n]) of time at risk as offset variable.