CHEN Lingping,SUN Xiaoyu,WEI Jingjiao, et al. Active and passive surveillance on post-marketing safety of enterovirus 71 inactivated vaccine[J]. JOURNAL OF WEZHOU MEDICAL UNIVERSITY, 2020, 50(2): 149-153.
Abstract：Objective: To evaluate post-marketing safety of enterovirus 71 inactivated vaccine (EV71 vaccine), and provide scientific basis for formulating immunization strategy. Methods: The adverse reactions of EV71 vaccine in Wenzhou city were collected by a combination of active and passive surveillance methods and analyzed statistically by SPSS23.0 software. Results: The incidence of adverse reactions of EV71 vaccine was 4.2/10 000 doses in passive surveillance, of which the incidence of abnormal reactions was 0.5/10 000 doses. The incidence of adverse reactions was 156.7/10 000 doses in active surveillance, of which the incidence of abnormal reactions was 12.0/10 000 doses. The incidence of adverse reactions and abnormal reactions in active surveillance were both higher than those in passive surveillance, with statistical difference (P<0.05). Active surveillance showed that adverse reactions mainly occurred within 30 min-3 d (62.4%) after immunization, and the main clinical symptom was fever. With the increase in age, the incidence of adverse reactions showed a downward trend (P<0.05). There was a significant difference in the rate of adverse reactions between different genders, i.e. higher in women than in men (P<0.05). Conclusion: The incidence of adverse reactions of EV71 vaccine was low, the symptoms were common and mild, and the overall safety was good. Active surveillance was more sensitive and accurate than passive surveillance.
