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LI Min-jie, WANG Lei, WU Zhi-wei, . Safety of inactivated COVID-19 vaccine in 3 – 17 years old healthy children[J]. Chinese Journal of Public Health. doi: 10.11847/zgggws1138965
Citation: LI Min-jie, WANG Lei, WU Zhi-wei, . Safety of inactivated COVID-19 vaccine in 3 – 17 years old healthy children[J]. Chinese Journal of Public Health. doi: 10.11847/zgggws1138965

Safety of inactivated COVID-19 vaccine in 3 – 17 years old healthy children

doi: 10.11847/zgggws1138965
  • Received Date: 2022-04-28
    Available Online: 2022-05-19
  •   Objective  To evaluate the safety of an inactivated coronavirus disease 2019 (COVID-19) vaccine in healthy children and adolescents aged 3 – 17 years.   Methods  Totally 500 healthy children and adolescents aged 3 – 17 years were recruited in Zanhuang county of Hebei province and randomly assigned into a vaccination group (n = 375) and a placebo group (n = 125) during May 2021. Two doses of inactivated COVID-19 vaccine (Sinovac Life Sciences Co., Ltd, Beijing) or placebo (day 0 and day 28) were administered to the participants. The participants were observed for adverse reactions within 30 minutes after each vaccination. The participants′ information on local and systemic solicited adverse events from day 0 to day 7, and unsolicited adverse events from day 0 to day 28 were collected after the vaccination. Serious adverse events were recorded from the beginning of vaccination to 6 months after the second dose vaccination to evaluate the safety of the vaccine.  Results  The incidence of adverse reactions was 19.2% (72/375) in the vaccination group and 15.2% (19/125) in the placebo group, without significant difference between the incidence of the two groups (P > 0.05). The most common adverse reactions were injection site pain and fever. There was no significant statistical difference in the incidence of other adverse reactions between the two groups except for pain at the injection site. Most observed adverse reactions were grade 1 and 2 in severity, only 3 participants reported grade 3 adverse reactions. The vaccination group′s incidences of adverse reactions of grade 1 (14.93% vs. 12.8%), grade 2 (7.73% vs. 4%), and grade 3 (0.53% vs. 0.8%) were not significantly different from those of the placebo group. No serious vaccination-related adverse event was reported in either group. The incidence of adverse reactions (28%) was higher in the 3 – 5 years old participants than those in the participants aged 6 – 11 and 12 – 17 years (16% and 15.5%) and the age-group- specific adverse reaction incidences were not significantly different between vaccination group and placebo group. The incidence of adverse reactions for the first dose vaccination was significantly higher than that for the second dose (14.6% vs. 5.69%, P < 0.05) and there was no significant difference in the dose order-specific adverse reaction incidence between the vaccination group and the placebo group.  Conclusion  The inactivated COVID-19 vaccine is of good safety when administered in 3 to 17 years old healthy children.
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  • [1]
    陈伟, 吴小丽, 李彦坤, 等. 新冠肺炎疫情防控期间儿童家长预防接种态度调查[J]. 中国公共卫生, 2020, 36(6): 916 – 919. doi: 10.11847/zgggws1129384
    [2]
    World Health Organization. WHO Director-General′s opening remarks at the media briefing on COVID-19 – 11 March 2020. [EB/OL][2020 – 03 – 12]. https://www.who.int.
    [3]
    World Health Organization. WHO Coronavirus (COVID-19) Dashboard[EB/OL][2022 – 03 – 27]. https://www.who.int.
    [4]
    Amanat F, Krammer F. SARS-CoV-2 vaccines: status report[J]. Immunity, 2020, 52(4): 583 – 589. doi: 10.1016/j.immuni.2020.03.007
    [5]
    Han BH, Song YF, Li CG, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, rando-mised, controlled, phase 1/2 clinical trial[J]. The Lancet Infectious Diseases, 2021, 21(12): 1645 – 1653. doi: 10.1016/S1473-3099(21)00319-4
    [6]
    原国家食品药品监督管理局. 关于印发《疫苗临床试验技术指导原则》的通知[EB/OL]. [2014 – 12 – 03].https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjyp/20041203010101968.html.
    [7]
    国家药品监督管理局. 国家药监局关于发布预防用疫苗临床试验不良事件分级标准指导原则的通告(2019年第102号)[EB/OL]. (2019 – 12 – 31)[2021 – 08 – 02].https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20191231111901460.html.
    [8]
    Fernandes EG, López-Lopes GIS, Silva VO, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in inadvertently vaccinated healthy children[J]. Revista do Instituto de Medicina Tropical de Sao Paulo, 2021, 63: e83. doi: 10.1590/s1678-9946202163083
    [9]
    Kao CM, Orenstein WA, Anderson EJ. The importance of advancing severe acute respiratory syndrome coronavirus 2 vaccines in children[J]. Clinical Infectious Diseases, 2021, 72(3): 515 – 518. doi: 10.1093/cid/ciaa712
    [10]
    Zhang YJ, Zeng G, Pan HX, et al. Safety, tolerability, and immuno-genicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18 – 59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial[J]. The Lancet Infectious Diseases, 2021, 21(2): 181 – 192. doi: 10.1016/S1473-3099(20)30843-4
    [11]
    Wu ZW, Hu YL, Xu M, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial[J]. The Lancet Infectious Diseases, 2021, 21(6): 803 – 812. doi: 10.1016/S1473-3099(20)30987-7
    [12]
    Zhang MX, Zhang TT, Shi GF, et al. Safety of an inactivated SARS-CoV-2 vaccine among healthcare workers in China[J]. Expert Review of Vaccines, 2021, 20(7): 891 – 898. doi: 10.1080/14760584.2021.1925112
    [13]
    杨中楠, 赵韵芽, 李璐, 等. 新型冠状病毒灭活疫苗(Vero细胞)大规模紧急使用安全性评价[J]. 中华流行病学杂志, 2021, 42(6): 977 – 982.
    [14]
    Xia SL, Zhang YT, Wang YX, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial[J]. The Lancet Infectious Diseases, 2021, 21(1): 39 – 51. doi: 10.1016/S1473-3099(20)30831-8
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