Rheumatology Department, National Institute of Cardiology, Juan Badiano 1, 14080, Mexico City, Mexico.
Immunology Department, National Institute of Cardiology, Juan Badiano 1, 14080, Mexico City, Mexico.
Clin Rheumatol. 2017 Oct;36(10):2169-2178. doi: 10.1007/s10067-017-3768-5. Epub 2017 Jul 20.
This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.
本文批判性地回顾了 HPV 疫苗在上市前随机试验和上市后病例系列中描述的严重不良事件。在 PubMed 中确定了 HPV 疫苗随机试验。提取了安全性数据。综述了描述 HPV 免疫接种不良事件的上市后病例系列。大多数 HPV 疫苗随机试验在对照组中未使用无活性安慰剂。两项最大的随机试验发现，研究中接受测试的 HPV 疫苗组有更多严重不良事件。与接受铝制安慰剂的 2871 名女性相比，接受二价 HPV 疫苗注射的 2881 名女性在随访中死亡人数更多（14 比 3，p = 0.012）。与接受四价 HPV 疫苗注射的 7078 名女孩相比，接受九价 HPV 疫苗剂量的 7071 名女孩有更多严重的全身性不良事件（3.3 比 2.6%，p = 0.01）。对于九价剂量，我们计算出需要严重伤害的数量为 140（95%CI，79-653）[剂量错误纠正]。需要接种的人数为 1757（95%CI，131-无限）。实际上，两项研究中任何一组发生的严重不良事件都没有被判断为与疫苗相关。临床前试验、上市后病例系列以及全球药物不良反应数据库（VigiBase）描述了类似的 HPV 免疫接种后症状群。两项最大的 HPV 疫苗随机试验揭示了研究中接受测试的 HPV 疫苗组有更多严重的不良事件。九价 HPV 疫苗的接种人数/需要伤害人数令人担忧。临床前试验和上市后病例系列描述了类似的 HPV 免疫接种后症状。
