安徽省两市18岁及以上人群接种新型冠状病毒灭活疫苗的安全性分析

李涛; 唐继海; 候立娟; 玄坤; 毛雷婧; 徐海洋; 闫建强; 任中杰; 王斌冰

doi:10.16462/j.cnki.zhjbkz.2024.11.011

安徽省两市18岁及以上人群接种新型冠状病毒灭活疫苗的安全性分析

doi: 10.16462/j.cnki.zhjbkz.2024.11.011

1.
安徽省疾病预防控制中心疫苗临床评价中心，合肥 230601
2.
合肥市疾病预防控制中心免疫预防科，合肥 230091
3.
安徽省疾病预防控制中心免疫预防科，合肥 230601
4.
阜阳市疾病预防控制中心免疫预防科，阜阳 236000
5.
太和县疾病预防控制中心办公室，阜阳 236600
6.
谯城区疾病预防控制中心免疫预防科，亳州 236800

基金项目:

安徽省卫生健康科研项目 AHWJ2023A20369

安徽省疾病预防控制中心(安徽省公共卫生研究院)青年科研项目 JKQN20230203

详细信息

通讯作者:
王斌冰，E-mail: 250267563@qq.com

中图分类号: R181.3
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- 文章访问数: 50
- HTML全文浏览量: 21
- PDF下载量: 3
- 被引次数: 0
出版历程
- 收稿日期: 2024-01-22
- 修回日期: 2024-08-15
- 网络出版日期: 2024-12-23
- 刊出日期: 2024-11-10

Safety analysis of inactivated COVID-19 vaccines in people over 18 years of age in two cites in Anhui Province

1.
Vaccine Clinical Evaluation Center, Anhui Provincial Center for Disease Control and Prevention, Hefei 230601, China
2.
Department of Immunoprophylaxis, Hefei Center for Disease Control and Prevention, Hefei 230091, China
3.
Department of Immunoprophylaxis, Anhui Provincial Center for Disease Control and Prevention, Hefei 230601, China
4.
Department of Immunoprophylaxis, Fuyang Center for Disease Control and Prevention, Fuyang 236000, China
5.
Department of Central office, Taihe Center for Disease Control and Prevention, Fuyang 236600, China
6.
Department of Immunoprophylaxis, Qiaocheng Center for Disease Control and Prevention, Bozhou 236800, China

Funds:

Health Research Program of Anhui AHWJ2023A20369

Anhui Provincial Center for Disease Control and Prevention (Anhui Institute of Public Health) Youth Research Program JKQN20230203

More Information

Corresponding author: WANG Binbing, E-mail: 250267563@qq.com

摘要

摘要: 目的评价安徽省两市≥18岁人群大规模接种新型冠状病毒灭活疫苗(简称新冠灭活疫苗)在真实世界中的安全性。方法采用开放性研究，在知情同意的前提下，2021年6月―2022年6月在安徽省阜阳市太和县、亳州市谯城区招募≥18岁人群大规模接种新冠灭活疫苗，将研究对象分为健康组和慢性基础疾病(简称基础疾病)组，评价两组接种每剂次疫苗后的不良反应发生率及其严重程度。结果 (1) 本研究共纳入研究对象12 257人，其中健康组9 984人，基础疾病组2 273人；完成新冠灭活疫苗两剂次接种的研究对象共11 874人，全程接种率为96.88%，基础疾病患病率占比居于前3位的分别为高血压(68.28%)、糖尿病(18.43%)、脑梗死(8.32%)；(2) 总体不良反应发生率为0.42%(51/12 257)，所有不良反应均发生于28 d内，基础疾病组和健康组的不良反应发生率分别为0.40%和0.42%，差异无统计学意义(χ² =0.028, P=0.868)；(3)除硬结/肿胀外，其余不良反应健康组与基础疾病组差异均无统计学意义(均P>0.05)；严重程度以1级为主(45例)，1级不良反应发生率为0.37%，两组的1级、2级不良反应发生率差异均无统计学意义(均P>0.05)；(4)健康组、基础疾病组第1剂次与第2剂次不良反应均以1级为主，2剂次间不良反应等级差异均无统计学意义(均P>0.05)。结论不同年龄、不同健康状况的成年人在接种不同剂次新冠灭活疫苗时均具有较好的安全性。
- 18岁及以上人群 /
- 慢性基础疾病人群 /
- 新型冠状病毒灭活疫苗 /
- 不良反应 /
- 安全性
Abstract: 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 infarction(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 (χ² =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 age /
- People with chronic underlying medical conditions /
- Inactivated 2019-nCoV vaccine /
- Adverse reaction /
- Safety

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表 1 研究对象入组及完成接种情况

Table 1. Study subjects enrollment and completion of vaccination status

入组情况 Enrollment	按年龄分组 Group by age		按健康状态分组 Group by health status		合计 Total
入组情况 Enrollment	成年组 Adult group ^①	老年组 Elderly group ^①	健康组 Healthy group ^①	基础疾病组 Underlying disease group ^①	合计 Total
入组 Enrollment	7 750(63.23)	4 607(37.59)	9 984(81.46)	2 273(18.54)	12 257
完成第1剂接种 Complete the first dose	7 750(63.23)	4 607(37.59)	9 984(81.46)	2 273(18.54)	12 257
完成第2剂接种 Complete the second dose	7 328(61.71)	4 546(38.29)	9 645(81.23)	2 229(18.77)	11 874
注：①以人数(占比/%)表示。 Note: ① Number of people (proportion/%).

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表 2 研究对象的一般基本情况

Table 2. General basic information of the study subjects

一般资料 General information	成年组 Adult group ^① (n=7 650)	老年组 Elderly group ^① (n=4 607)	合计 Total ^① (n=12 257)
年龄/岁 Age /years	41.05±13.66	68.43±5.26	51.60±17.41
汉族 Han	7 618(99.58)	4 598(99.80)	12 216(98.72)
男性 Male	3 504(45.80)	2 272(49.32)	5 776(47.12)
身高 Height/cm	166.11±7.82	161.47±7.99	164.36±8.19
体重 Weight/kg	67.03±11.25	63.75±9.85	65.80±10.86
BMI/(kg·m^-2)	23.77±3.51	23.93±3.11	23.83±3.36
基础疾病 Underlying disease
是 Yes	1 211(15.83)	1 062(23.05)	2 273(18.54)
否 No	6 439(84.17)	3 545(76.95)	9 984(81.46)
基础疾病分类 Classification of underlying diseases
高血压 Hypertension	796(65.73)	756(71.19)	1 552(68.28)
糖尿病 Diabetes	191(15.77)	228(21.47)	419(18.43)
脑梗死 Cerebral infarction	119(9.83)	70(6.59)	189(8.32)
冠心病 Coronary heart disease	83(6.85)	41(3.86)	124(5.46)
慢性胃炎 Chronic gastritis	32(2.64)	64(6.03)	96(4.22)
肥胖 Corpulent	6(0.50)	85(8.00)	91(4.00)
肾结石 Kidney stone	12(0.99)	18(1.69)	30(1.32)
慢性支气管炎 Chronic bronchitis	6(0.50)	35(3.30)	41(1.80)
类风湿性关节炎 Rheumatoid arthritis	27(2.23)	11(1.04)	38(1.67)
其他 Others	28(2.31)	51(4.80)	79(3.48)
注：①以人数(占比/%)或x±s表示。 Note: ① Number of people (proportion/%) or x±s.

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表 3 研究对象不良事件/不良反应发生的总体情况

Table 3. The overall occurrence of adverse events/adverse reaction in the study subjects

变量 Variable	健康组 Healthy group (n=9 984)		基础疾病组 Underlying disease group (n=2 273)		合计 Total (n=12 257)		χ²值 value	P值 value
变量 Variable	例次 Examples	例数(发生率) Number of cases (incidence/%)	例次 Examples	例数(发生率) Number of cases (incidence/%)	例次 Examples	例数(发生率) Number of cases (incidence/%)	χ²值 value	P值 value
总体不良事件 Overall adverse events	180	87(0.87)	43	18(0.79)	223	105(0.86)	0.139	0.710
与试验疫苗无关的不良事件 Adverse events unrelated to the trial vaccine	41	45(0.47)	11	9(0.40)	52	54(0.44)	0.127	0.721
总体不良反应 Adverse effects	79	42(0.42)	20	9(0.46)	99	51(0.42)	0.028	0.868
征集性不良反应 Solicitation	71	41(0.38)	17	8(0.35)	88	49(0.40)	0.161	0.688
全身不良反应 Systemic adverse reactions	7	4(0.04)	4	3(0.13)	11	7(0.06)	―	>0.999
局部不良反应 Local adverse reactions	64	37(0.34)	13	5(0.22)	77	42(0.34)	1.231	0.267
非征集性不良反应 Non-solicitation	8	2(0.02)	3	1(0.04)	22	3(0.02)	―	>0.999
0~28 d	79	42(0.42)	20	9(0.40)	99	51(0.42)	0.028	0.868
0~30 min	11	10(0.09)	0	0(0)	25	10(0.08)	1.216	0.270
0~7 d	60	32(0.29)	17	8(0.35)	176	40(0.33)	0.056	0.813
8~28 d	8	2(0.02)	3	1(0.04)	11	3(0.02)	―	0.460
第1剂次 First dose	46	27(0.27)	13	8(0.35)	59	35(0.29)	0.431	0.511
第2剂次 Second dose	33	16(0.16)	7	2(0.09)	40	18(0.15)	0.259	0.611
注：“―”表示Fisher确切概率法。 Note: "―" indicates Fisher exact test.

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表 4 研究对象不良反应发生严重程度

Table 4. The severity of adverse reaction in the subjects was observed

变量 Variable	健康组 Healthy group (n=9 984)		基础疾病组 Underlying disease group (n=2 273)		合计 Total (n=12 257)		χ²值 value	P值 value
变量 Variable	例次 Examples	例数(发生率) Number of cases (incidence/%)	例次 Examples	例数(发生率) Number of cases (incidence/%)	例次 Examples	例数(发生率) Number of cases (incidence/%)	χ²值 value	P值 value
合计 Total	79	42(0.44)	20	9(0.39)	99	51(0.43)	0.028^①	0.868
1级 Level 1	71	40(0.40)	14	5(0.22)	85	45(0.37)	1.652	0.199
2级 Level 2	8	4(0.04)	6	4(0.17)	14	8(0.07)	3.367	0.067
局部不良反应 Local adverse reactions
疼痛 Pain	56	34(0.34)	6	5(0.22)	62	39(0.32)	0.849	0.357
1级 Level 1	50	33(0.33)	4	3(0.13)	54	36(0.29)	2.492	0.114
2级 Level 2	2	1(0.01)	2	2(0.09)	4	3(0.02)	―	0.090
硬结/肿胀 Induration/swelling	10	6(0.06)	3	2(0.09)	13	8(0.07)	0	0.988
1级 Level 1	10	6(0.06)	2	1(0.04)	12	7(0.06)	0	>0.999
2级 Level 2	0	0(0)	1	1(0.04)	1	1(0.01)	―	0.185
注射部位红斑 Erythema at the injection site	1	1(0.01)	1	1(0.04)	2	2(0.02)	―	0.337
1级 Level 1	1	1(0.01)	1	1(0.04)	2	2(0.02)	―	0.337
2级 Level 2	0	0(0)	0	0(0)	0	0(0)	―	>0.999
瘙痒 Itching	6	4(0.04)	4	2(0.09)	10	6(0.18)	―	0.309
1级 Level 1	2	2(0.02)	4	2(0.09)	6	4(0.01)	―	0.159
2级 Level 2	4	2(0.02)	0	0(0)	4	2(1.00)	―	>0.999
全身不良反应 Systemic adverse reactions
肌肉痛 Muscle pain	1	1(0.01)	3	2(0.09)	4	3(0.02)	―	0.090
1级 Level 1	0	0(0)	1	1(0.04)	1	1(0.01)	―	0.185
2级 Level 2	1	1(0.01)	1	1(0.04)	2	2(0.02)	―	0.337
疲劳乏力 Fatigue	6	5(0.05)	4	4(0.17)	10	9(0.07)	2.468	0.116
1级 Level 1	5	4(0.04)	2	2(0.09)	7	6(0.05)	―	0.309
2级 Level 2	1	1(0.01)	2	2(0.09)	3	3(0.02)	―	0.090
头痛 Headache	1	1(0.01)	0	0(0)	1	1(0.01)	―	>0.999
1级 Level 1	1	1(0.01)	0	0(0)	1	1(0.01)	―	>0.999
2级 Level 2	0	0(0)	0	0(0)	0	0(0)	―	>0.999
恶心 Disgusting	2	2(0.02)	0	0(0)	2	2(1.00)	―	>0.999
1级 Level 1	2	2(0.02)	0	0(0)	2	2(1.00)	―	>0.999
2级 Level 2	0	0(0)	0	0(0)	0	0(0)	―	>0.999
注：“―”表示Fisher确切概率法。 ①表示基础疾病组与健康组不良反应发生总体情况进行比较时，同时进行了单因素和多因素分析，多因素logistic回归分析模型分析结果显示，在校正了性别、年龄、BMI等因素后，健康组与基础疾病组不良反应发生总体情况差异无统计学意义(OR=1.758, 95% CI: 0.803~3.848, P=0.158)。 Note: "―" indicates Fisher exact test. ① Univariate and multivariate analyses were performed at the same time, and multivariate logistic regression analysis model showed that there was no significant difference in the overall occurrence of adverse reactions between the healthy group and the underlying disease group after adjusting for gender, age, BMI and other factors (OR=1.758, 95% CI: 0.803-3.848, P=0.158).

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表 5 研究对象不同剂次间不良反应发生严重程度

Table 5. The severity of adverse reaction between different doses of the subjects was observed

变量 Variable	第1剂次First dose
变量 Variable	健康组 Healthy group (n=9 984)	基础疾病组 Underlying disease group (n=2 273)	合计 Total (n=12 257)	χ²值 value	P值 value
合计 Total	27	8	35	0.432	0.511
1级 Level 1	26	4	30	0.541	0.462
2级 Level 2	1	4	5	―	0.005
局部不良反应 Local adverse reactions
疼痛 Pain	22	1	23	2.205	0.138
1级 Level 1	22	1	23	2.205	0.138
2级 Level 2	0	2	2	―	0.034
硬结/肿胀 Induration/swelling	1	1	2	―	0.337
1级 Level 1	1	0	1	―	1.000
2级 Level 2	0	1	1	―	0.185
注射部位红斑 Erythema at the injection site	0	0	0	―	―
1级 Level 1	0	0	0	―	―
2级 Level 2	0	0	0	―	―
瘙痒 Itching	2	1	3	―	0.460
1级 Level 1	2	1	3	―	0.460
2级 Level 2	0	0	0	―	―
全身不良反应 Systemic adverse reactions
肌肉痛 Muscle pain	1	2	3	―	0.090
1级 Level 1	0	1	1	―	0.185
2级 Level 2	1	1	2	―	0.337
疲劳乏力 Fatigue	5	4	9	2.468	0.116
1级 Level 1	4	2	6	―	0.309
2级 Level 2	1	2	3	―	0.090
头痛 Headache	1	0	1	―	1.000
1级 Level 1	1	0	1	―	1.000
2级 Level 2	0	0	0	―	―
恶心 Disgusting	2	0	2	―	1.000
1级 Level 1	2	0	2	―	1.000
2级 Level 2	0	0	0	―	―

变量 Variable	第2剂次 Second dose
变量 Variable	健康组 Healthy group (n=9 984)	基础疾病组 Underlying disease group (n=2 273)	合计 Total (n=12 257)	χ²值 value	P值 value
合计 Total	16	2	18	0.282	0.595
1级 Level 1	15	2	17	0.185	0.667
2级 Level 2	3	0	3	―	>0.999
局部不良反应 Local adverse reactions
疼痛 Pain	13	2	15	0.044	0.835
1级 Level 1	12	2	14	0.008	0.930
2级 Level 2	1	0	1	―	>0.999
硬结/肿胀 Induration/swelling	5	1	6	―	>0.999
1级 Level 1	5	1	6	―	>0.999
2级 Level 2	0	0	0	―	―
注射部位红斑 Erythema at the injection site	1	1	2	―	0.340
1级 Level 1	1	1	2	―	0.340
2级 Level 2	0	0	0	―	―
瘙痒 Itching	2	1	3	―	0.464
1级 Level 1	0	1	1	―	0.188
2级 Level 2	2	0	2	―	>0.999
全身不良反应 Systemic adverse reactions
肌肉痛 Muscle pain	0	0	0	―	―
1级 Level 1	0	0	0	―	―
2级 Level 2	0	0	0	―	―
全身不良反应 Systemic adverse reactions
疲劳乏力 Fatigue	0	0	0	―	―
1级 Level 1	0	0	0	―	―
2级 Level 2	0	0	0	―	―
头痛 Headache	0	0	0	―	―
1级 Level 1	0	0	0	―	―
2级 Level 2	0	0	0	―	―
恶心 Disgusting	0	0	0	―	―
1级 Level 1	0	0	0	―	―
2级 Level 2	0	0	0	―	―
注：“―”表示Fisher确切概率法。 Note: "―" indicates Fisher exact test.

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参考文献(17)

[1]	Hoffmann M, Kleine-Weber H, Schroeder S, et al. SARS-CoV-2 cell entry depends on ACE2 and TMPRSS2 and is blocked by a clinically proven protease inhibitor [J]. Cell, 2020, 181(2): 271-280. e8. DOI: 10.1016/j.cell.2020.02.052.
[2]	World Health Organization. WHO coronavirus (COVID-19) dashboard [EB/OL]. (2023-12-24) [2023-12-24]. https://covid19.who.int/.
[3]	廖聪慧, 王子晨, 邓强, 等. COVID-19疫苗上市后安全性及有效性的研究进展[J]. 暨南大学学报(自然科学与医学版), 2021, 42(5): 547-556. DOI: 10.11778/j.Jdxb.2021.05.011. Liao CH, Wang ZC, Deng Q, et al. Research progress on the safety and efficacy of COVID-19 vaccine after marketing [J]. Journal of Jinan University(Natural Science and Medical Science), 2021, 42(5): 547-556. DOI: 10.11778/j.Jdxb.2021.05.011.
[4]	黄勇, 李军宏, 宋渝丹, 等. 特殊健康状态人群新型冠状病毒疫苗接种有效性和安全性的真实世界研究进展[J]. 中国疫苗和免疫, 2022, 28(6): 720-729. DOI: 10.19914/j.CJVI.2022134. Huang Y, Li JH, Song YD, et al. Advances in real-world studies of the effectiveness and safety of coronavirus disease 2019 (COVID-19) vaccination in people with medical conditions [J]. Chinese Journal of Vaccines and Immunization, 2022, 28(6): 720-729. DOI: 10.19914/j.CJVI.2022134.CJVI.2022134.
[5]	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) [2023-12-28]. https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20191231111901460.html.
[6]	World Health Organization. COVID-19 vaccine tracker and landscape [EB/OL]. (2023-03-30) [2023-12-28]. https://www.who.int/teams/blueprint/covid-19/covid-19-vaccine-tracker-and-landscape.
[7]	孟彤彤, 孔庆福, 王富珍, 等. 新型冠状病毒灭活疫苗研究进展[J]. 中国疫苗和免疫, 2020, 26(5): 590-596. DOI: 10.19914/j.cjvi.2020.05.023. Meng TT, Kong QF, Wang FZ, et al. Progress on the research and development of inactivated novel coronavirus vaccines. [J]. Chinese Journal of Vaccines and Immunization, 2020, 26(5): 590-596. DOI: 10.19914/j.cjvi.2020.05.023.
[8]	Yang HT, Li Z, Zhang RZ, et al. Safety of primary immunization using inactivated SARS-CoV-2 vaccine (CoronaVac^Ⓡ) among population aged 3years and older in a large-scale use: a multi-center open-label study in China [J]. Vaccine, 2023, 41(7): 1354-1361. DOI: 10.1016/j.vaccine.2023.01.020.
[9]	Wan EYF, Wang Y, Chui CSL, et al. Safety of an inactivated, whole-virion COVID-19 vaccine (CoronaVac) in people aged 60 years or older in Hong Kong : a modified self-controlled case series [J]. Lancet Healthy Longev, 2022, 3(7): e491-e500. DOI: 10.1016/S2666-7568(22)00125-8.
[10]	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, randomised, controlled, phase 1/2 clinical trial [J]. Lancet Infect Dis, 2021, 21(12): 1645-1653. DOI: 10.1016/S1473-3099(21)00319-4.
[11]	穆秋玥, 冯添, 黄飞, 等. 3岁及以上人群新型冠状病毒灭活疫苗接种反应临床观察分析[J]. 中华流行病学杂志, 2023, 44(11): 1738-1743. DOI: 10.3760/cma.j.cn112338-20230328-00189. Mu QY, Feng T, Huang F, et al. Clinical observation on adverse reaction after vaccination of inactivated 2019-nCoV vaccine in population aged 3 years and above [J]. Chin J Epidemiol, 2023, 44(11): 1738-1743. DOI: 10.3760/cma.j.cn112338-20230328-00189.
[12]	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. DOI: 10.3760/cma.j.cn112338-20210325-00249. Yang ZN, Zhao YY, Li L, et al. Evaluation of safety of two inactivated COVID-19 vaccines in a large-scale emergency use [J]. Chin J Epidemiol, 2021, 42(6): 977-982. DOI: 10.3760/cma.j.cn112338-20210325-00249.
[13]	朱立炜, 陈国杰, 姜凌, 等. 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[J]. 中华疾病控制杂志, 2021, 25(7): 802-805. DOI: 10.16462/j.cnki.zhjbkz.2021.07.012. Zhu LW, Chen GJ, Jiang L, et al. Safety analysis of inactivated SARS-CoV-2 vaccine (Vero cells) during emergency vaccination in Hefei [J]. Chin J Dis Control Prev, 2021, 25(7): 802-805. DOI: 10.16462/j.cnki.zhjbkz.2021.07.012.
[14]	国家卫生健康委员会. 新冠病毒疫苗接种技术指南(第一版) [J]. 传染病信息, 2021, 34(2): 97-98. DOI: 10.3969/j.issn.1007-8134.2021.02.001. National Health Commission. Technical guidelines for coronavirus vaccination (1st edition) [J]. Infect Dis Info, 2021, 34(2): 97-98. DOI: 10.3969/j.issn.1007-8134.2021.02.001.
[15]	Zhang YT, Chen HP, Lyu J, et al. Evaluation of immunogenicity and safety of vero cell-derived inactivated COVID-19 vaccine in older patients with hypertension and diabetes mellitus [J]. Vaccines, 2022, 10(7): 1020. DOI: 10.3390/vaccines10071020.
[16]	Ye XX, Ma TT, Blais JE, et al. Association between BNT162b2 or CoronaVac COVID-19 vaccines and major adverse cardiovascular events among individuals with cardiovascular disease [J]. Cardiovasc Res, 2022, 118(10): 2329-2338. DOI: 10.1093/cvr/cvac068.
[17]	Wang JT, Hou ZY, Liu JX, et al. Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): a multicenter study [J]. J Hepatol, 2021, 75(2): 439-441. DOI: 10.1016/j.jhep.2021.04.026.