[首批国产甲型H1N1流感疫苗的安全性及流行病学效果]

[Safety and epidemiological effects of the first China-made mass A (H1N1) influenza vaccination].

作者信息

Ji Wen-yan, Lu Li, Lü Min, Miao Liang, Gao Ting, Huang Ruo-gang, Suo Luo-dan, Liu Dong-lei, Ma Rui, Yu Rui, Zhangzhu Jia-zi, Liu Wei-xiang, Zeng Yang, Li Xiao-mei, Wu Jiang

机构信息

Beijing Center for Disease Control and Prevention, Beijing 100013, China.

出版信息

Zhonghua Liu Xing Bing Xue Za Zhi. 2010 May;31(5):481-4.

PMID:21163019

Abstract

OBJECTIVE

To evaluate the safety and epidemiological effects on the first mass vaccination program, using the China-made A (H1N1) influenza vaccine.

METHODS

Descriptive epidemiology and cohort study design were used to assess the influenza A H1N1 vaccine on its safety and epidemiological effects.

RESULTS

95 244 subjects were immunized with A (H1N1) influenza vaccine. 193 adverse events were reported through AEFI Management System, with the Reported rates of AEFI as 2.03‰. Most of the adverse events (137/193, 71.0%) happened during the first 24 hours after immunization was carried out. Of 81 adverse reactions confirmed to be related to immunization, with 78 (96.3%) showed mild reactions. No Guillain-Barre Syndrome related to vaccination was reported through the AEFI Management System. The epidemiological protection rate of A (H1N1) vaccine could reach 80.9% when the coverage was not considered.

CONCLUSION

The A (H1N1) influenza vaccine showed a similar safety profile to seasonal flu vaccine. The vaccine demonstrated a good epidemiological effects against A (H1N1) influenza virus infection.

摘要

目的

评估使用国产甲型H1N1流感疫苗进行首次大规模疫苗接种计划的安全性及流行病学效果。

方法

采用描述性流行病学和队列研究设计来评估甲型H1N1流感疫苗的安全性及流行病学效果。

结果

95244名受试者接种了甲型H1N1流感疫苗。通过预防接种异常反应（AEFI）管理系统报告了193起不良事件，AEFI报告率为2.03‰。大多数不良事件（193例中的137例，71.0%）发生在接种后的头24小时内。在81例被确认为与免疫接种相关的不良反应中，78例（96.3%）为轻度反应。通过AEFI管理系统未报告与疫苗接种相关的格林-巴利综合征。在不考虑覆盖率的情况下，甲型H1N1疫苗的流行病学保护率可达80.9%。