2017-2020年中国人乳头瘤病毒疫苗疑似预防接种异常反应监测

Surveillance for adverse events following immunization with human papillomavirus vaccines in China,2017-2020

目的 分析中国人乳头瘤病毒(Human papillomavirus, HPV)疫苗疑似预防接种异常反应(Adverse event following immunization, AEFI)发生特征。方法 通过中国疾病预防控制信息系统收集2017-2020年HPV疫苗接种剂次数和AEFI个案,描述性分析AEFI报告发生率。结果 2017-2020年中国HPV疫苗AEFI报告发生率为30.38/10万剂(6 910例),其中一般反应、异常反应分别为26.25/10万剂(5 971例)、2.34/10万剂(532例)。在一般反应中,局部红肿、局部硬结、发热报告发生率分别为9.71/10万剂(2 208例)、4.88/10万剂(1 111例)、5.26/10万剂(1 197例);在异常反应中,过敏性皮疹、过敏性休克、血管性水肿报告发生率分别为1.75/10万剂(397例)、0.06/10万剂(14例)、0.04/10万剂(9例)。结论 中国2017-2020年HPV疫苗不良反应绝大多数轻微,严重反应罕见;仍需加强HPV疫苗AEFI监测。

Objective To characterize adverse events following immunization(AEFI)with human papillomavirus(HPV)vaccines in China.Methods We obtained data on AEFIs and HPV vaccine doses administered during 2017-2020 from the Chinese Immunization Information Management System for a descriptive analysis of AEFI reporting incidences.Results The overall incidence of AEFIs reported after HPV vaccination was 30.38 per 100000 doses(6910 cases),with 26.25(5971 cases)of common and 2.34(532 cases)of rare adverse reactions.Incidences of common adverse reactions per 100000 doses administered of injection-site redness/swelling,injection-site induration,and fever were 9.71(2208 cases),4.88(1111 cases),and 5.26(1197 cases),respectively.Incidences of rare adverse reactions of allergic rash,anaphylactic shock,and angioedema were 1.75(397 cases),0.06(14 cases),and 0.04(9 cases),respectively.Conclusions Most adverse reactions following HPV vaccination were mild,and serious reactions were rare during 2017-2020 in China.We need to continue to strengthen surveillance for HPV vaccine AEFIs.