Résumé
Objective@#To evaluate the safety of enterovirus 71（EV71）inactivated vaccines produced by Wuhan Institute of Bio Products through learning the incidence of adverse events following immunization（AEFI）in children aged 6 months to 3 years old after vaccination.@*Methods@#According to the national requirement for vaccine safety monitoring program，data of AEFI cases after inoculated EV71 vaccines from September 2017 to October 2018 in Zhejiang Province was collected by combining active and passive monitoring. Demographic characteristics，space distribution，dose and incidence of AEFI were analyzed.@*Results@#A total of 107 503 children were included in this study，of which 27 173 were actively monitored and 80 330 were passively monitored. The monitoring results showed that 288 cases of AEFI occurred after inoculated EV71 vaccines，the reported incidence rate was 267.90/100 000. Of 288 cases，266 cases had common reactions（247.43/100 000），14 cases had abnormal reactions（13.02/100 000）and 8 cases had complications（7.44/100 000）；145 cases were passively monitored（180.51/100 000）and 143 cases were actively monitored（526.26/100 000）；150 cases were males and 138 cases were females，with the males to females ratio of 1.09∶1. The AEFI of EV71 vaccines were reported in all the cities of Zhejiang Province，with Jinhua，Taizhou and Hangzhou ranking the top three and accounting for 50.69% of all the reported cases. About 202 cases of AEFI（70.14%）occurred after the first dose of EV71 vaccines，and 163 cases（56.60%）occurred on the day of inoculation.Most of common reactions were fever，swelling and sclerosis. The harm of the reported abnormal reactions was mild，with 8 cases of anaphylactic rash and no other serious abnormal reactions were found. @*Conclusion@#The reported incidence rate of AEFI of the domestic EV71 vaccine in children aged from 6 months to 3 years is 267.90/100 000，without serious abnormal reactions，suggesting that the EV71 vaccine is safe.
Résumé
Objective To evaluate the safety of two types of enterovirus 71(EV71) inactivated vaccine (Vero cell vs. Human Diploid cell) after inoculation. Methods Subjects were children vaccinated EV71 vaccine between November 2016 and May 2017 at vaccination clinics in Xiacheng District. According to the type of EV71 vaccine, subjects were divided into the Vero Cell group and the Human Diploid Cell group. The adverse effects were collected after 30 min, 3 days and 30 days of injection, respectively. Results A total of 3158 vaccinated children were observed, with 1529 in Vero Cell group and 1629 in Human Diploid Cell group. The rates of adverse effects were 0.59％ (9 cases) of Vero cell group and 0.55 ％ (9cases) of Human Diploid Cell group. All of the adverse effects were systemic reactions such as fever, diarrhea and vomiting. No significant differences were observed between the two groups above in the incidence and severity of adverse effects(P >0.05) . The incidence and severity of adverse effects of the first dose were significantly higher than the second dose in two groups (P<0.05) . Conclusion EV71 vaccine was safe to vaccinate, and no statistical difference in the adverse effects was found between the two types of vaccine.