2009年流行性感冒大流行期间上海市大规模接种甲型H_1N_1流行性感冒病毒裂解疫苗的安全性观察

Investigation on Safety of Influen A H_1N_1 Split Virus Influenza Vaccine Vaccination During the Epidemic of Pandemic Influenza A in Shanghai, 2009

目的了解2009年甲型H1N1流行性感冒(甲流)大流行期间,上海市大规模接种甲流病毒裂解无佐剂疫苗的安全性。方法对2009年10～12月上海市接种甲流疫苗的情况,不良反应发生率、程度和转归等进行调查分析。结果上海市2009年10月15日～12月31日,共有1373496人接种了甲流疫苗,报告疑似预防接种异常反应(Adverse Events Folowing Immunization,AEFI)620人,AEFI报告发生率为45.14/10万人,95%可信区间:42/10万人～49/10万人。其中一般反应531人,占85%,报告发生率38.66/10万人,以发热为主要表现;异常反应37人,报告发生率2.69/10万人,临床表现主要是过敏性反应。多数不良反应于发生后48h内,可自愈消退或治疗后痊愈。无严重不良反应发生。结论接种甲流疫苗后不良反应报告发生率低,且多为症状轻微的一般反应,无严重不良反应,比较安全。

Objective To investigate the Influen AH1N1 split virus influenza vaccine safety of mass vaccination during pandemic influenza The Influen AH1N1 influenza vaccine in Shanghai in 2009, Methods A survey on the vaccination of influenza AH1N1 influenza vaccine was conducted in Shanghai from Oct to Dec 2009. At the same time, the information of incidence, characteristics and outcome of adverse reactions were collected. Results From Oct 15 to Dec 31, 2009, 1 373 496 doses Influenza AH1N1 influenza vaccine were administered in Shanghai. The total reported adverse events following immunization （AEFI） were 620 cases, reported incidence was 45.14 per 100 000, 95%. Confidence Interval （CI） was 42 per 100 000 ～ 49 per 100 000. Mild adverse reaction were 531 cases, account for 85 % , reported incidence was 38.66 per 100 000. The major syndrome of mild adverse reaction was fever. The reported moderate adverse reaction were 37 cases, reported incidence was 2.69 per 100 000. The major syndrome of moderate adverse reaction was allergy. Most of the adverse reaction disappeared or cured within 48 hours. There was no severe adverse reaction had been reported. Conclusion The influenza AH1N1 vaccine was safe. The reported incidence of AEFI was low, the most cases were mild adverse reaction, and no reported severe adverse reaction.