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2018—2022年宁波市人乳头瘤病毒疫苗疑似预防接种异常反应监测分析

Suspected adverse events following human papillomavirus vaccination in Ningbo city, 2018-2022: a surveillance data analysis

  • 摘要:
    目的 分析宁波市人乳头瘤病毒(HPV)疫苗接种后疑似预防接种异常反应(AEFI)发生特征,评价HPV疫苗的安全性。
    方法 通过中国疾病预防控制信息系统收集宁波市2018年1月1日—2022年12月31日HPV疫苗接种后AEFI个案数据,通过浙江省疫苗和预防接种管理信息系统收集HPV 疫苗接种剂次数,分析AEFI 报告发生率、AEFI 分布特征和临床症状等指标,评价 HPV疫苗接种的安全性。
    结果 宁波市 2018年1月1日—2022年12月31日共接种HPV疫苗843 913剂次,报告与HPV疫苗接种后相关的AEFI个案262例,年均AEFI总报告发生率为31.05/10万剂。发生的AEFI个案主要为不良反应,为259例,总报告发生率为30.69/10万剂,其中一般反应253例(96.56%)、异常反应6例(2.29%),报告发生率分别为29.98/10万剂、0.71/10万剂;一般反应主要为局部红肿、发热和局部硬结,报告发生率分别为15.76/10万剂、9.01/10万剂和8.06/10万剂;异常反应主要为过敏性皮疹(3例)和荨麻疹(2例)。无严重 AEFI报告。AEFI主要发生在HPV疫苗接种后0~1 d((217例,82.82%)和第一剂接种后(112例,42.75%),且主要发生在20~39岁年龄组(201例,76.72%)。262例 AEFI 者均痊愈或好转。
    结论 宁波市2018—2022年HPV疫苗AEFI主要为一般反应,异常反应极少,无严重 AEFI报告,HPV疫苗安全性良好。

     

    Abstract:
    Objective To analyze the characteristics of suspected adverse events following immunization (AEFI) with human papillomavirus (HPV) vaccine administered in Ningbo city and evaluate the safety of the vaccine.
    Methods Data on reported AEFI cases after HPV vaccination from 2018 to 2022 were collected from the National Adverse Event Following Immunization Surveillance System. The number of HPV vaccine doses administered was obtained from the Zhejiang Province Vaccine and Immunization Management Information System. Indicators such as the reported AEFI incidence rates, distribution characteristics, and clinical symptoms were analyzed to assess the safety of HPV vaccination.
    Results A total of 843 913 doses of HPV vaccine were administered in Ningbo city over a 5-year period, during which 262 cases of AEFI related to HPV vaccination were reported. The mean annual reporting incidence rate was 31.05 per 100 000 doses. The reported AEFI cases were predominantly adverse reactions (259 cases), with a total reporting incidence rate of 30.69 per 100 000 doses. Among the adverse reactions, 253 cases (96.56%) were common reactions, and 6 cases (2.29%) were rare reactions, with incidence rates of 29.98 and 0.71 per 100 000 doses, respectively. The reporting incidence rates of main common reactions were 15.76, 9.01, and 8.06 per 100 000 doses for local redness and swelling, fever, and local induration, respectively. The reported rare reactions included 3 cases of allergic rash and 2 cases of urticaria. No serious AEFIs were reported. The reported AEFIs mainly occurred within 0 - 1 day after HPV vaccination (217 cases, 82.82%) and following the first dose (112 cases, 42.75%). They were primarily observed in the 20 - 39 age group (201 cases, 76.72%). All 262 AEFI cases recovered or improved during the follow-up observation periods.
    Conclusions From 2018 to 2022 in Ningbo city, the reported AEFIs associated with the HPV vaccine were primarily common reactions, with very few rare reactions and no serious AEFIs reported, indicating a favorable safety profile for the HPV vaccine.

     

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