合肥市新型冠状病毒灭活疫苗(Vero细胞)紧急接种期间安全性

朱立炜; 陈国杰; 姜凌; 马春雨

doi:10.16462/j.cnki.zhjbkz.2021.07.012

合肥市新型冠状病毒灭活疫苗(Vero细胞)紧急接种期间安全性

doi: 10.16462/j.cnki.zhjbkz.2021.07.012

朱立炜^{1, 2, ,},
陈国杰²,
姜凌³,
马春雨⁴

1.
230031 合肥，合肥市第一人民医院
2.
230601 合肥，合肥市滨湖医院
3.
230051 合肥，合肥市包河区疾病预防控制中心
4.
230061 合肥，合肥市庐阳区疾病预防控制中心

详细信息

通讯作者:
朱立炜，E-mail: 87407634@qq.com

中图分类号: R186
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出版历程
- 收稿日期: 2021-02-24
- 修回日期: 2021-06-07
- 网络出版日期: 2021-08-13
- 刊出日期: 2021-07-10

Safety analysis of inactivated SARS-CoV-2 vaccine (Vero cells) during emergency vaccination in Hefei

1.
Hefei First People' s Hospital, Hefei 230031, China
2.
Binhu Hospital of Hefei, Hefei 230601, China
3.
Baohe District Center for Disease Control and Prevention, Hefei 230051, China
4.
Luyang District Center for Disease Control and Prevention, Hefei 230061, China

More Information

Corresponding author: ZHU Li-wei, E-mail: 87407634@qq.com

摘要

摘要: 目的探讨合肥市新型冠状病毒灭活疫苗(Vero细胞)(简称新冠疫苗)在紧急接种期间的安全性，为该疫苗后期在全人群中的推广接种提供参考。方法在合肥市抽取19家预防接种门诊作为免疫安全性主动监测点，于2020年12月15日-2021年2月10日对合肥市接种新冠疫苗的18~59岁重点人群进行观察，对疫苗接种后不良反应发生率、不良反应类型及严重程度进行描述性分析。结果有效观察18 574人，累积接种新冠疫苗33 433剂次，接种发生一般不良反应713例次，发生率2.13%，第1剂次不良反应发生率为2.57%，高于第2剂次不良反应发生率1.58%(χ²=38.92, P < 0.001)，2家公司生产灭活疫苗一般反应发生率的差异无统计学意义(χ²=3.08, P=0.082)；在注射部位红肿、注射部位硬结、发热等不良事件中，1、2和3级不良事件发生率分别为0.65%、1.42%和0.06%，未发现≥4级及罕见和极罕见不良事件。结论国产新型冠状病毒灭活疫苗(Vero细胞)具有较高的安全性。
- 新型冠状病毒 /
- 灭活疫苗 /
- 安全性
Abstract: Objective To study the safety of inactivated SARS-CoV-2 vaccine (Vero cells) (SARS-CoV-2 vaccine) in Hefei during the emergency vaccination period, and to provide reference for the promotion and vaccination of this vaccine in the whole population in the later period. Methods A total of 19 vaccination clinics in Hefei were selected as active monitoring sites for immunization safety. Focus groups aged 18-59 years who were vaccinated with SARS-CoV-2 vaccine in Hefei from 15 December 2020 to 10 February 2021 were observed. The incidence, types and severity of adverse reactions after vaccination were descriptively analyzed. Results A total of 18 574 people were effectively observed, and 33 433 doses of SARS-CoV-2 vaccine were inoculated. 713 cases of general adverse reactions occurred, with an incidence of 2.13%. The incidence of adverse reactions in the first dose was 2.57%, which was higher than that in the second dose (1.58%, χ²=38.92, P < 0.001). There was no statistical significance in the incidence of general adverse reactions of inactivated vaccine produced by the two companies (χ²=3.08, P=0.082). Among the adverse events such as redness and swelling at the injection site, induration at the injection site, and fever, the incidence of grade 1, 2 and 3 adverse events were 0.65%, 1.42%, and 0.06%, but there were no ≥ grade 4, rare and extremely rare adverse events. Conclusion Domestic inactivated SARS-CoV-2 vaccine (Vero cells) is great safe.
- SARS-CoV-2 /
- Inactivated vaccine /
- Safety

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表 1 合肥市新冠疫苗接种者基本指标

Table 1. Comparison of basic indicators of SARS-CoV-2 vaccinators in Hefei

分类	接种剂次		P值
分类	第1剂次	第2剂次	P值
性别
男	9 875	8 000
女	8 699	6 859	0.219
年龄(岁)	41.6±11.3	41.8±11.2	0.918

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表 2 合肥市新冠疫苗接种者不同接种剂次和不同厂家疫苗不良反应发生率

Table 2. Comparison of adverse reaction rates of vaccines from different inoculants and manufacturers of SARS-CoV-2 vaccinators in Hefei

分类	接种剂次		χ²值	P值
分类	第1剂次	第2剂次	χ²值	P值
北京生物
接种例数	10 256	8 523
不良反应例数	252	125
不良反应率(%)	2.46	1.47	23.21	< 0.001
北京科兴
接种例数	8 318	6 336
不良反应例数	226	110
不良反应率(%)	2.71	1.74	15.45	< 0.001
总不良反应率(%)	2.57	1.58	38.92	< 0.001

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表 3 合肥市新冠疫苗接种者全身性不良事件发生率

Table 3. Comparison of incidence of systemic adverse events of SARS-CoV-2 vaccinators in Hefei

不良反应种类	第1剂(n=18 574)		第2剂(n=14 859)		χ²值	P值
不良反应种类	例次	不良反应率(%)	例次	不良反应率(%)	χ²值	P值
发热	64	0.34	32	0.21	4.81	0.031 ^a
面色苍白	10	0.05	8	0.05	0.01	0.979
嗜睡	45	0.24	19	0.13	5.66	0.021 ^a
呕吐	8	0.05	7	0.05	0.03	0.863
乏力	108	0.58	61	0.41	4.80	0.030 ^a
头痛	3	0.02	2	0.01	0.04	0.842
肌肉酸痛	32	0.17	11	0.07	6.20	0.011 ^a
胸闷	19	0.10	14	0.09	0.05	0.812
非注射部位皮疹	11	0.05	6	0.04	0.58	0.453
注：^a接种第1剂和第2剂比较，P < 0.05。

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表 4 合肥市新冠疫苗接种者局部性不良事件发生率

Table 4. Comparison of incidence of local adverse events of SARS-CoV-2 vaccinators in Hefei

不良反应种类	第1剂(n=18 574)		第2剂(n=14 859)		χ²值	P值
不良反应种类	例次	不良反应率(%)	例次	不良反应率(%)	χ²值	P值
注射部位红肿	98	0.52	47	0.32	8.54	0.003 ^a
注射部位硬结	52	0.28	38	0.26	0.18	0.671
注射部位皮疹	10	0.05	8	0.05	0.01	0.982
注：^a接种第1剂和第2剂比较，P < 0.05。

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