Meng Fanya, Hu Wenyi, Wang Binbing, Luo Xianwei, Xu Haiyang, Wan Jiangshun, Xue Wenqing, Su Ying, Sun Yong, Wu Jiabing
Anhui Provincial Center for Disease Control and Prevention, Hefei 230601, China.
School of Public Health, Bengbu Medical University, Bengbu 233030, China.
Vaccines (Basel). 2025 Aug 9;13(8):846. doi: 10.3390/vaccines13080846.
The Human Papillomavirus (HPV) vaccine has been globally implemented to prevent HPV-associated diseases. Since its introduction in China in 2017, this vaccine has substantially reduced the burden of HPV-related health conditions. As more people get vaccinated these days, ongoing safety monitoring and evaluation have become critical. This helps to safeguard public trust in immunization programs and ensures the sustainability of immunization programs. Suspected adverse events following immunization (AEFIs) associated with HPV vaccination from 2017 to 2024 were extracted from the Chinese National Immunization Information System (CNIIS). Data on the number of HPV vaccine doses given came from the Immunization Planning Information Management System of Anhui Province. Descriptive statistical methods examined the distribution characteristics of AEFIs, and chi-square tests assessed differences in incidence rates. From 2017 to 2024, the vaccine safety surveillance system in Anhui Province monitored a total of 1149 reports of AEFIs associated with the HPV vaccine. The reported overall rate of AEFIs was 16.32 per 100,000 doses. Specifically, the rates of common adverse reactions were 15.15 per 100,000 doses, while the rates for rare adverse reactions were 0.85 per 100,000. Among the common adverse reactions, the incidence rates of injection-site redness and swelling (diameter >5.0 cm), induration (diameter >5.0 cm), and fever (axillary temperature ≥38.6 °C) were 0.60, 0.33, and 1.34 per 100,000 doses, respectively. For rare adverse reactions, the reported incidence rates of allergic rash, allergic urticaria, and aseptic abscess were 0.50, 0.09, and 0.03 per 100,000 doses, respectively. Most AEFIs occurred within 24 h post-vaccination. The overall reported incidence of AEFIs following HPV vaccination in Anhui Province from 2017 to 2024 was low, with serious rare adverse reaction occurring infrequently. These findings suggest that the HPV vaccine has a favorable safety profile.
人乳头瘤病毒（HPV）疫苗已在全球范围内推广应用，以预防与HPV相关的疾病。自2017年在中国上市以来，该疫苗已大幅减轻了HPV相关健康问题的负担。如今，随着越来越多的人接种疫苗，持续的安全性监测和评估变得至关重要。这有助于维护公众对免疫规划的信任，并确保免疫规划的可持续性。从中国国家免疫信息系统（CNIIS）中提取了2017年至2024年与HPV疫苗接种相关的疑似预防接种异常反应（AEFI）。HPV疫苗接种剂量的数据来自安徽省免疫规划信息管理系统。采用描述性统计方法分析AEFI的分布特征，采用卡方检验评估发病率的差异。2017年至2024年，安徽省疫苗安全监测系统共监测到1149例与HPV疫苗相关的AEFI报告。报告的AEFI总发生率为每10万剂16.32例。具体而言，常见不良反应的发生率为每10万剂15.15例，罕见不良反应的发生率为每10万剂0.85例。在常见不良反应中，接种部位红肿（直径>5.0 cm）、硬结（直径>5.0 cm）和发热（腋温≥38.6℃）的发生率分别为每10万剂0.60例、0.33例和1.34例。对于罕见不良反应，报告的过敏性皮疹、过敏性荨麻疹和无菌性脓肿的发生率分别为每10万剂0.50例、0.09例和0.03例。大多数AEFI发生在接种后24小时内。2017年至2024年安徽省HPV疫苗接种后AEFI的总体报告发生率较低，严重罕见不良反应很少发生。这些结果表明，HPV疫苗具有良好的安全性。
