Table 4.
Benefits and harms of the HPV vaccines: summary of HPV-related outcomes
| Summary of HPV-related outcomesa | HPV vaccine (N = 47,075) | Comparator (N = 48,595) | Risk ratioc [95% CI] |
|---|---|---|---|
| Cancer mortality | |||
| Total | 2 | 1 | 1.44 [0.23, 9.12] |
| Cervical | 1 (50%) | 0 (0%) | 2.99 [0.12, 73.33] |
| Oropharyngeal | 1 (50%) | 1 (100%) | 1.00 [0.10, 9.58] |
| Cancer incidence | |||
| Total | 7 | 3 | 1.68 [0.51, 5.49] |
| Anal | 0 (0%) | 0 (0%) | Not applicable |
| Cervical | 3 (43%) | 2 (67%) | 1.41 [0.19, 10.21] |
| Oropharyngeal | 1 (14%) | 1 (33%) | 1.00 [0.10, 9.58] |
| Penile | Not reported | Not reported | Not applicable |
| Vaginal | 1 (14%) | 0 (0%) | 2.99 [0.12, 73.33] |
| Vulvar | 2 (29%) | 0 (0%) | 3.01 [0.31, 28.89] |
| Not HPV-related | 20 | 23 | 0.90 [0.49, 1.63] |
| Carcinoma in situ incidence | |||
| Total | 367 | 490 | 0.73 [0.53, 1.00] |
| Anal (AIN3) | Not reported | Not reported | Not applicable |
| Cervical | 367 (100%) | 490 (100%) | 0.73 [0.53, 1.00] |
| Adenoid type (AIS) | 9 (2%) | 31 (6%) | 0.32 [0.15, 0.66] |
| Squamous type (CIN3) | 358 (98%) | 459 (94%) | 0.85 [0.61, 1.17] |
| Penile (PIN3) | Not reported | Not reported | Not applicable |
| Vaginal (VaIN3) | Not reported | Not reported | Not applicable |
| Vulvar (VIN3) | Not reported | Not reported | Not applicable |
| Moderate intraepithelial neoplasia incidence | |||
| Total | 538 | 763 | 0.81 [0.59, 1.11] |
| Anal (AIN2) | 0 (0%) | 0 (0%) | Not applicable |
| Cervical (CIN2) | 538 (100%) | 763 (100%) | 0.81 [0.59, 1.11] |
| Penile (PIN2) | Not reported | Not reported | Not applicable |
| Vaginal (VaIN2) | Not reported | Not reported | Not applicable |
| Vulvar (VIN2) | Not reported | Not reported | Not applicable |
| Carcinoma in situ or worse incidence | |||
| Total | 372 | 498 | 0.79 [0.59, 1.05] |
| Anal (AIN3+) | Not reported | Not reported | Not applicable |
| Cervical (CIN3+, AIS included) | 372 (100%) | 498 (100%) | 0.79 [0.59, 1.05] |
| Penile (PIN3+) | Not reported | Not reported | Not applicable |
| Vaginal (VaIN3+) | Not reported | Not reported | Not applicable |
| Vulvar (VIN3+) | Not reported | Not reported | Not applicable |
| Moderate intraepithelial neoplasia or worse incidence | |||
| Total | 952 | 1239 | 0.78 [0.66, 0.91] |
| Anal (AIN2+) | 0 (0%) | 0 (0%) | Not applicable |
| Cervical (CIN2+) | 892 (93%) | 1144 (92%) | 0.81 [0.68, 0.97] |
| Penile (PIN2+) | 3 (1%) | 3 (1%) | 1.00 [0.20, 4.95] |
| Vaginal (VaIN2+) | 17 (2%) | 27 (2%) | 0.64 [0.32, 1.27] |
| Vulvar (VIN2+) | 18 (2%) | 36 (3%) | 0.49 [0.18, 1.36] |
| Vaginal or vulvar (VIN2+ or VaIN2+) | 22 (2%) | 29 (2%) | 0.76 [0.44, 1.32] |
| External genital lesion (EGL) incidence | |||
| Total | 289 | 582 | 0.56 [0.39, 0.82] |
| HPV-related referral proceduresb | |||
| Any | 1941 | 2264 | 0.86 [0.81, 0.90] |
| Biopsy | 2449 | 3021 | 0.74 [0.62, 0.88] |
| Endoscopy | 4354 | 4965 | 0.88 [0.85, 0.91] |
| Treatment (surgical and non-surgical) | 1018 | 1416 | 0.71 [0.63, 0.80] |
aSee Additional file 4 sections 1 to 8 for meta-analyses of HPV-related outcomes. It was not feasible to present this summary table for the 16 subgroups (based on age group, gender, type of HPV vaccine and comparator) of the 24 included clinical study reports
bTwo trials (V501-013 and V501-015) reported ‘any’ procedure, while other trials reported individual outcomes, for example, ‘biopsy’
cRisk ratios were calculated with the random-effects inverse variance method