Efficacy and safety of the COVID-19 vaccine: a systematic review_Chinese Journal of Evidence-Based Medicine

Authors：

LI Chunhe ¹ , LIU Nan ² , WANG Chaoyu ³ , ZHEN Xinxian ³ ,  CHEN Huimin ⁴

1. Department of Critical Care Medicine, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 51000, P. R. China;
2. Emergency Department, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 51000, P. R. China;
3. Department of Respiratory, Taishan Hospital of Traditional Chinese Medicine, Jiangmen 529200, P. R. China;
4. Department of Traditional Chinese Medicine, the Second Affiliated Hospital of Guangdong Medical University, Zhanjiang 524000, P. R. China;

Corresponding author：

CHEN Huimin, Email: 1192333848@qq.com

Keywords：

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

DOI：

10.7507/1672-2531.202112105

Video：

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Objective To systematically review the efficacy and safety of vaccines for the coronavirus disease 2019 (COVID-19) . Methods The CNKI, VIP, WanFang Data, PubMed, EMbase and Web of Science databases were electronically searched to collect randomized controlled trials (RCTs) on the safety and efficacy of COVID-19 vaccines from their inception to June 30^th, 2022. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.3 software and Stata 12.0 software. Results A total of 13 RCTs involving 139 015 subjects were included. The results of meta-analysis showed that the sero-antibody conversion rate (RR=37.883, 95%CI 8.086 to 177.491, P<0.001) and infection prevention rate (RR=1.011, 95%CI 1.006 to 1.017, P<0.001) of the vaccine group were higher than those of the placebo group. The incidence of adverse reactions in the vaccine group was higher than that in the placebo group (OR=1.839, 95%CI 1.165 to 2.903, P=0.009), which mainly included pain, redness, swelling, fever, headache and itching (P<0.05). However, the incidence of serious adverse reactions was not significantly different from that of the placebo group. Conclusion The current evidence shows that the efficacy of the COVID-19 vaccines is high. The most prevalent adverse reactions are mild and moderate, and severe adverse reactions are the same as those of the placebo group. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusion.

Citation： LI Chunhe, LIU Nan, WANG Chaoyu, ZHEN Xinxian, CHEN Huimin. Efficacy and safety of the COVID-19 vaccine: a systematic review. Chinese Journal of Evidence-Based Medicine, 2022, 22(9): 1027-1032. doi: 10.7507/1672-2531.202112105 Copy

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25.	刘畅, 陈颖安, 赵双雨, 等. 新型冠状病毒肺炎疫苗安全性的Meta分析. 中国循证医学杂志, 2021, 21(6): 676-682.

1. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA, 2020, 323(11): 1061-1069.
2. Zachariah P, Johnson CL, Halabi KC, et al. Epidemiology, clinical features, and disease severity in patients with coronavirus disease 2019 (COVID-19) in a children's hospital in New York City, New York. JAMA Pediatr, 2020, 174(10): e202430.
3. Wang J, Peng Y, Xu H, et al. The COVID-19 vaccine race: challenges and opportunities in vaccine formulation. AAPS PharmSciTech, 2020, 21(6): 225.
4. Baden LR, Rubin EJ. Covid-19 - the search for effective therapy. N Engl J Med, 2020, 382(19): 1851-1852.
5. Juul S, Nielsen N, Bentzer P, et al. Interventions for treatment of COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING Project). Syst Rev, 2020, 9(1): 108.
6. Wu F, Zhao S, Yu B, et al. A new coronavirus associated with human respiratory disease in China. Nature, 2020, 579(7798): 265-269.
7. Kon TC, Onu A, Berbecila L, et al. Influenza vaccine manufacturing: effect of inactivation, splitting and site of manufacturing. comparison of influenza vaccine production processes. PLoS One, 2016, 11(3): e0150700.
8. 王李珏, 刘泽众, 姜世勃. 新冠疫苗的有效性, 安全性和广谱性的商榷. 中国科学基金, 2020, 34(5): 588-593.
9. 曾宪涛, 包翠萍, 曹世义, 等. Meta分析系列之三: 随机对照试验的质量评价工具. 中国循证心血管医学杂志, 2012, 4(3): 183-185.
10. Xia S, Duan K, Zhang Y, et al. Effect of an inactivated vaccine against SARS-CoV-2 on safety and immunogenicity outcomes: interim analysis of 2 randomized clinical trials. JAMA, 2020, 324(10): 951-960.
11. 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.
12. Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet, 2021, 397(10269): 99-111.
13. 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.
14. Keech C, Albert G, Cho I, et al. Phase 1-2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. N Engl J Med, 2020, 383(24): 2320-2332.
15. Wu Z, Hu Y, 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. Lancet Infect Dis, 2021, 21(6): 803-812.
16. 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.
17. Logunov DY, Dolzhikova IV, Shcheblyakov DV, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet, 2021, 397(10275): 671-681.
18. 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.
19. Mulligan MJ, Lyke KE, Kitchin N, et al. Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. Nature, 2020, 586: 589-593.
20. Yang S, Li Y, Dai L, et al. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials. Lancet Infect Dis, 2021, 21(8): 1107-1119.
21. Khobragade A, Bhate S, Ramaiah V, et al. ZyCoV-D phase 3 study investigator group. Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in India. Lancet, 2022, 399(10332): 1313-1321.
22. Chen GL, Li XF, Dai XH, et al. Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Microbe, 2022, 3(3): e193-e202.
23. WHO. WHO target product profiles for COVID-19 vaccines. Available at: https://www.who.int/docs/default-source/blue-print/who-target-product-profiles-for-covid-19-vaccines.pdf?sfvrsn=1d5da7ca_5&download=true2020.
24. Brignardello-Petersen R, Izcovich A, Rochwerg B, et al. GRADE approach to drawing conclusions from a network meta-analysis using a partially contextualised framework. BMJ, 2020, 371: m3907.
25. 刘畅, 陈颖安, 赵双雨, 等. 新型冠状病毒肺炎疫苗安全性的Meta分析. 中国循证医学杂志, 2021, 21(6): 676-682.

Chinese Journal of Evidence-Based Medicine

Efficacy and safety of the COVID-19 vaccine: a systematic review

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