Safety analysis of inactivated COVID-19 vaccines in people over 18 years of age in two cites in Anhui Province
Objective To evaluate the real-world safety of large-scale vaccination of inactivated novel coronavirus vaccine(inactivated vaccine)for adults aged among ≥18-year-old adults in two cities in Anhui Province.Methods An open-label study was conducted,with informed consent obtained.From June 2021 to June 2022,we recruited individuals aged ≥ 18 years from Taihe County,Fuyang City,and Qiaocheng District,Bozhou City,Anhui Province,for large-scale inactivated vaccine administration.The subjects were divided into healthy group and chronic underlying disease(referred to as underlying disease)group,and the incidence and severity of adverse reactions after each dose of vaccine were evaluated in the two groups.Results(1)A total of 12 257 subjects over 18 years old were included in this study,including 9 984 healthy subjects and 2 273 subjects with underlying diseases,and 11 874 subjects completed two doses of inactivated vaccine,with a full vaccination rate of 96.88％,and the top three underlying diseases were hypertension(68.28％),diabetes mellitus(18.43％),and cerebral in-farction(8.32％).(2)The overall incidence of adverse reaction was 0.42％(51/12 257),all adverse reaction occurred within 28 days,the incidence of adverse reaction in the underlying disease group and the healthy group were 0.40％and 0.42％,respectively,with no statistically significant difference was observed(x2=0.028,P=0.868).(3)Except for induration/swelling,there was no significant difference in adverse reaction between the healthy group and the underlying disease group(all P＞0.05).The severity was mainly grade 1(45 cases),and the incidence of grade 1 adverse reaction was 0.37％,there was no significant difference in the incidence of grade 1 and grade 2 adverse reaction between the two groups(all P＞0.05).(4)The adverse reaction of the first dose and the second dose in the healthy group and the underlying disease group were mainly grade 1,and there was no significant difference in the grade of adverse reaction between the two doses(all P＞0.05).Conclusions Adults over the age of 18 who receive the inactivated vaccine against the novel coronavirus have a good safety profile for different ages,different health conditions,and different doses.
People over 18 years of agePeople with chronic underlying medical conditionsInactivated 2019-nCoV vaccineAdverse reactionSafety
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维普
