Safety of COVID-19 vaccine: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Chang , CHEN Ying’an , ZHAO Shuangyu , DONG Shuheng , ZHANG Yan , ZHAO Yaqi , ZHU Qiuqi , JIN Hui

Department of Epidemiology and Health Statistics, School of Public Health, Southeast University, Nanjing 210009, P.R.China;

Corresponding author：

JIN Hui, Email:

Keywords：

COVID-19 vaccine; Safety; Meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.202102056

Video：

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Objective To systematically review the safety of different types of COVID-19 vaccines in the population.Methods Web of Science, PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect randomized controlled trials (RCTs) which reported safety of COVID-19 vaccines in population. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using RevMan 5.4 software.Results A total of 5 RCTs involving 2 431 subjects were included. The results of the meta-analysis showed that COVID-19 vaccines developed more fever symptoms than placebo (RR=2.21, 95%CI 1.38 to 3.54, P=0.000 9). However, there was no significant difference in the incidence of adverse reactions (RR=1.28, 95%CI 0.96 to 1.70, P=0.10), injection site adverse reactions (RR=1.47, 95%CI 0.65 to 3.36, P=0.36) and systemic adverse reactions (RR=0.96, 95%CI 0.78 to 1.17, P=0.66) between two groups.Conclusions Current evidence shows that COVID-19 vaccines are sufficiently safe. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.

Citation： LIU Chang, CHEN Ying’an, ZHAO Shuangyu, DONG Shuheng, ZHANG Yan, ZHAO Yaqi, ZHU Qiuqi, JIN Hui. Safety of COVID-19 vaccine: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2021, 21(6): 676-682. doi: 10.7507/1672-2531.202102056 Copy

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1. Shereen MA, Khan S, Kazmi A, et al. COVID-19 infection: Origin, transmission, and characteristics of human coronaviruses. J Adv Res, 2020, 24: 91-98.
2. Petersen E, Koopmans M, Go U, et al. Comparing SARS-CoV-2 with SARS-CoV and influenza pandemics. Lancet Infect Dis, 2020, 20(9): e238-e244.238-244.
3. 王宾, 钟一维. 新冠病毒疫苗安全性和有效性的展望. 中国科学基金, 2020, 34(5): 581-587.
4. Amanat F, Krammer F. SARS-CoV-2 vaccines: status report. Immunity, 2020, 52(4): 583-589.
5. 朱瑶, 韦意娜, 孙畅, 等. 新型冠状病毒肺炎疫苗研究进展. 预防医学, 2021, 33(2): 143-148.
6. Che Y, Liu X, Pu Y, et al. Randomized, double-blinded and placebo-controlled phase II trial of an inactivated SARS-CoV-2 vaccine in healthy adults. Clin Infect Dis, 2020: ciaa1703.
7. Ramasamy MN, Minassian AM, Ewer KJ, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet, 2021, 396(10267): 1979-1993.
8. Xia S, Zhang Y, Wang Y, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis, 2021, 21(1): 39-51.
9. Zhang Y, Zeng G, Pan H, et al. Safety, tolerability, and immunogenicity 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. Lancet Infect Dis, 2021, 21(2): 181-192.
10. Zhu FC, Guan XH, Li YH, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet, 2020, 396(10249): 479-488.
11. Folegatti PM, Ewer KJ, Aley PK, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet, 2020, 396(10249): 467-478.
12. Li YD, Chi WY, Su JH, et al. Coronavirus vaccine development: from SARS and MERS to COVID-19. J Biomed Sci, 2020, 27(1): 104.
13. Koo JR, Cook AR, Park M, et al. Interventions to mitigate early spread of SARS-CoV-2 in Singapore: a modelling study. Lancet Infect Dis, 2020, 20(6): 678-688.
14. Korean Society of Infectious Diseases. Report on the Epidemiological Features of Coronavirus Disease 2019 (COVID-19) Outbreak in the Republic of Korea from January 19 to March 2, 2020. J Korean Med Sci, 2020, 35(10): e112.
15. Mavragani A. Tracking COVID-19 in Europe: Infodemiology Approach. JMIR Public Health Surveill, 2020, 6(2): e18941.
16. Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis, 2020, 20(5): 533-534.
17. Wang X, Du Z, Johnson KE, et al. The impacts of COVID-19 vaccine timing, number of doses, and risk prioritization on mortality in the US. medRxiv, 2021, 2021.01. 18.21250071.
18. Rimmer A. COVID-19: 237m vaccine doses to be distributed worldwide over next three months. BMJ, 2021, 372: n631.
19. Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med, 2021, 384(5): 403-416.
20. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. N Engl J Med, 2020, 383(27): 2603-2615.
21. Moore JP, Offit PA. SARS-CoV-2 vaccines and the growing threat of viral variants. JAMA, 2021, 325(9): 821-822.
22. England PH. SARS-CoV-2 variants of concern and variants under investigation in England, 2021. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/975742/Variants_of_Concern_VOC_Technical_Briefing_8_England.pdf.
23. Shen X, Tang H, McDanal C, et al. SARS-CoV-2 variant B. 1.1. 7 is susceptible to neutralizing antibodies elicited by ancestral spike vaccines. Cell Host Microbe, 2021, S1931-3128(21): 00102-5.
24. Hou YJ, Chiba S, Halfmann P, et al. SARS-CoV-2 D614G variant exhibits efficient replication ex vivo and transmission in vivo. Science, 2020, 370(6523): 1464-1468.
25. Starr TN, Greaney AJ, Hilton SK, et al. Deep mutational scanning of SARS-CoV-2 receptor binding domain reveals constraints on folding and ACE2 binding. Cell, 2020, 182(5): 1295-1310.
26. Xie X, Zou J, Fontes-Garfias CR, et al. Neutralization of N501Y mutant SARS-CoV-2 by BNT162b2 vaccine-elicited sera. Res Sq, 2021: rs. 3. rs-143532.
27. Leung K, Shum MH, Leung GM, et al. Early transmissibility assessment of the N501Y mutant strains of SARS-CoV-2 in the United Kingdom, October to November 2020. Euro Surveill, 2021, 26(1): 2002106.
28. Mahase E. COVID-19: Novavax vaccine efficacy is 86% against UK variant and 60% against South African variant. BMJ, 2021, 372: n296.
29. Moore JP. Approaches for optimal use of different COVID-19 vaccines: issues of viral variants and vaccine efficacy. JAMA, 2021, 325(13): 1251-1252.

Chinese Journal of Evidence-Based Medicine

Safety of COVID-19 vaccine: a meta-analysis

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