PDF(1160 KB)
Efficacy and safety of COVID-19 vaccines: a systematic review
XING Kai, TU Xiao-Yan, LIU Miao, LIANG Zhang-Wu, CHEN Jiang-Nan, LI Jiao-Jiao, JIANG Li-Guo, XING Fu-Qiang, JIANG Yi
Chinese Journal of Contemporary Pediatrics ›› 2021, Vol. 23 ›› Issue (3) : 221-228.
PDF(1160 KB)
PDF(1160 KB)
Efficacy and safety of COVID-19 vaccines: a systematic review
Objective To evaluate systematically the efficacy and safety of COVID-19 vaccines. Methods PubMed, Embase, Cochrane Library, Clinicaltrial.gov, CNKI, Wanfang Data, China Biomedical Literature Service System, and China Clinical Trial Registry were searched for randomized controlled trials of COVID-19 vaccines published up to December 31, 2020. The Cochrane bias risk assessment tool was used to assess the quality of studies. A qualitative analysis was performed on the results of clinical trials. Results Thirteen randomized, blinded, controlled trials, which involved the safety and efficacy of 11 COVID-19 vaccines, were included. In 10 studies, the 28-day seroconversion rate of subjects exceeded 80%. In two 10 000-scale clinical trials, the vaccines were effective in 95% and 70.4% of the subjects, respectively. The seroconversion rate was lower than 60% in only one study. In six studies, the proportion of subjects who had an adverse reaction within 28 days after vaccination was lower than 30%. This proportion was 30%-50% in two studies and > 50% in the other two studies. Most of the adverse reactions were mild to moderate and resolved within 24 hours after vaccination. The most common local adverse reaction was pain or tenderness at the injection site, and the most common systemic adverse reaction was fatigue, fever, or bodily pain. The immune response and incidence of adverse reactions to the vaccines were positively correlated with the dose given to the subjects. The immune response to the vaccines was worse in the elderly than in the younger population. In 6 studies that compared single-dose and double-dose vaccination, 4 studies showed that double-dose vaccination produced a stronger immune response than single-dose vaccination. Conclusions Most of the COVID-19 vaccines appear to be effective and safe. Double-dose vaccination is recommended. However, more research is needed to investigate the long-term efficacy and safety of the vaccines and the influence of dose, age, and production process on the protective efficacy.
COVID-19 / SARS-CoV-2 / Vaccine / Systematic review / Efficacy / Safety / Clinical trial
[1] World Health Organization. WHO coronavirus disease (COVID-19) dashboard[EB/OL]. (2021-02-15)[2021-02-16]. https://covid19.who.int/.
[2] Sun JM, He WT, Wang LF, et al. COVID-19:epidemiology, evolution, and cross-disciplinary perspectives[J]. Trends Mol Med, 2020, 26(5):483-495.
[3] 习近平. 在全国抗击新冠肺炎疫情表彰大会上的讲话(2020年9月8日)[J]. 求是, 2020(20):4-15.
[4] Zhu N, Zhang DY, Wang WL, et al. A novel coronavirus from patients with pneumonia in China, 2019[J]. N Engl J Med, 2020, 382(8):727-733.
[5] 中华人民共和国国家卫生健康委员会. 新型冠状病毒肺炎诊疗方案(试行第八版)[J]. 中华临床感染病杂志, 2020, 13(5):321-328.
[6] Oliveira BA, Oliveira LC, Sabino EC, et al. SARS-CoV-2 and the COVID-19 disease:a mini review on diagnostic methods[J]. Rev Inst Med Trop Sao Paulo, 2020, 62:e44.
[7] Wang J, Pan LJ, Tang S, et al. Mask use during COVID-19:a risk adjusted strategy[J]. Environ Pollut, 2020, 266(Pt 1):115099.
[8] Li T, Liu Y, Li M, et al. Mask or no mask for COVID-19:a public health and market study[J]. PLoS One, 2020, 15(8):e0237691.
[9] 中华人民共和国国家卫生健康委员会办公厅. 医疗机构内新型冠状病毒感染预防与控制技术指南(第一版)[J]. 中国感染控制杂志, 2020, 19(2):189-191.
[10] Cao YC, Deng QX, Dai SX. Remdesivir for severe acute respiratory syndrome coronavirus 2 causing COVID-19:an evaluation of the evidence[J]. Travel Med Infect Dis, 2020, 35:101647.
[11] Pardo J, Shukla AM, Chamarthi G, et al. The journey of Remdesivir:from Ebola to COVID-19[J]. Drugs Context, 2020, 9:2020-2024.
[12] Tirupathi R, Bharathidasan K, Palabindala V, et al. Comprehensive review of mask utility and challenges during the COVID-19 pandemic[J]. Infez Med, 2020, 28(Suppl 1):57-63.
[13] Provenzani A, Polidori P. COVID-19 and drug therapy, what we learned[J]. Int J Clin Pharm, 2020, 42(3):833-836.
[14] Romero JR, Bernstein HH. COVID-19 vaccines:a primer for clinicians[J]. Pediatr Ann, 2020, 49(12):e532-e536.
[15] Sharma O, Sultan AA, Ding H, et al. A review of the progress and challenges of developing a vaccine for COVID-19[J]. Front Immunol, 2020, 11:585354.
[16] Korang SK, Juul S, Nielsen EE, et al. Vaccines to prevent COVID-19:a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)[J]. Syst Rev, 2020, 9(1):262.
[17] Wang JL, Peng Y, Xu HY, et al. The COVID-19 vaccine race:challenges and opportunities in vaccine formulation[J]. AAPS PharmSciTech, 2020, 21(6):225.
[18] 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[J]. Lancet, 2021, 396(10267):1979-1993.
[19] 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[J]. Lancet, 2021, 397(10269):99-111.
[20] Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine[J]. N Engl J Med, 2020, 383(27):2603-2615.
[21] Xia SL, Duan K, Zhang YT, et al. Effect of an inactivated vaccine against SARS-CoV-2 on safety and immunogenicity outcomes:interim analysis of 2 randomized clinical trials[J]. JAMA, 2020, 324(10):951-960.
[22] Pu J, Yu Q, Yin ZF, et al. An in-depth investigation of the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine[J]. medRxiv, 2020. DOI:10.1101/2020.09.27.20189548. Epub ahead of print.
[23] Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses:the PRISMA statement[J]. PLoS Med, 2009, 6(7):e1000097.
[24] Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions:explanation and elaboration[J]. Ann Intern Med, 2009, 151(4):W65-W94.
[25] Higgins JPT, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions[M]. 2nd ed. Chichester, UK:John Wiley & Sons, 2019.
[26] Cumpston M, Li TJ, Page MJ, et al. Updated guidance for trusted systematic reviews:a new edition of the Cochrane Handbook for Systematic Reviews of Interventions[J]. Cochrane Database Syst Rev, 2019, 10:ED000142.
[27] 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]. Lancet Infect Dis, 2021, 21(1):39-51.
[28] Che YC, Liu XQ, Pu Y, et al. Randomized, double-blinded, placebo-controlled phase 2 trial of an inactivated severe acute respiratory syndrome coronavirus 2 vaccine in healthy adults[J]. Clin Infect Dis, 2020. DOI:10.1093/cid/ciaa1703. Epub ahead of print.
[29] Ella R, Vadrevu KM, Jogdand H, et al. A phase 1:safety and immunogenicity trial of an inactivated SARS-CoV-2 vaccine-BBV152[J]. medRxiv, 2020. DOI:10.1101/2020.12.11.20210419. Epub ahead of print.
[30] Keech C, Albert G, Cho I, et al. Phase 1-2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine[J]. N Engl J Med, 2020, 383(24):2320-2332.
[31] Mulligan MJ, Lyke KE, Kitchin N, et al. Phase I/Ⅱ study of COVID-19 RNA vaccine BNT162b1 in adults[J]. Nature, 2020, 586(7830):589-593.
[32] Richmond P, Hatchuel L, Dong M, et al. A first-in-human evaluation of the safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 in healthy adults; a phase 1, randomised, double-blind, placebo-controlled trial[J]. medRxiv, 2020. DOI:10.1101/2020.12.03.20243709. Epub ahead of print.
[33] Walsh EE, Frenck RW Jr, Falsey AR, et al. Safety and immunogenicity of two RNA-based COVID-19 vaccine candidates[J]. N Engl J Med, 2020, 383(25):2439-2450.
[34] Zhang YJ, Zeng G, Pan HX, 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[J]. Lancet Infect Dis, 2021, 21(2):181-192.
[35] 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[J]. Lancet, 2020, 396(10249):479-488.
[36] Anderson EJ, Rouphael NG, Widge AT, et al. Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults[J]. N Engl J Med, 2020, 383(25):2427-2438.
[37] Logunov DY, Dolzhikova IV, Zubkova OV, et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations:two open, non-randomised phase 1/2 studies from Russia[J]. Lancet, 2020, 396(10255):887-897.
