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我们为什么仍然需要对COVID-19疫苗开展安慰剂对照试验
Placebo-Controlled Trials of Covid-19 Vaccines — Why We Still Need Them


WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation 呼吸系统疾病 • 2021.01.14
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近期发布的新消息指出一些COVID-19疫苗估计具有较高短期效力,这给我们带来了疫苗将很快帮助我们控制疫情的新希望。最初推出的有限数量的在研疫苗将使我们有机会以符合伦理的方式获得关键数据,协助监管机构和公共卫生机构做出决策,进而提高公众和专业人士对这些疫苗和其他疫苗的信心。

3期试验对参与者进行相对短期随访后,即使疫苗效力看似较高,我们仍然需要关于疫苗长期安全性和防护力持续时间的可靠信息。其他方面的信息缺口包括:更全面的短期安全性评估;疫苗防护力减弱后,如果疫苗接种者因暴露于SARS-CoV-2而感染,上述情况是否会导致疫苗加重疾病;疫苗对临床重症COVID-19的防护力;防护程度与接种者年龄或合并症之间的关联。即使最早研发成功的几种疫苗上市后,为了满足全球需求,继续对其他疫苗进行评估仍很重要1





作者信息

WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation
The affiliations of the members of the WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation are the Office of Vaccines Research and Review, Food and Drug Administration, Silver Spring (P.R.K.), the School of Medicine, University of Maryland (M.M.L.), and Johns Hopkins University (S.P.), Baltimore, and the National Institute of Allergy and Infectious Diseases, Bethesda (M.N.) — all in Maryland; the Department of Biostatistics (T.R.F.), Fred Hutchinson Cancer Research Center (T.R.F., E.H.), University of Washington, Seattle; the Department of Biostatistics, University of Florida, Gainesville (I.M.L.); the Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (R.P., V.B.); the Indian Council of Medical Research, New Delhi (B.B.); the Faculty of Medicine of the Universidad Nacional Autónoma de México, Mexico City (A.C.); the Coalition for Epidemic Preparedness Innovations, London (J.P.C.); the University of Pennsylvania, Philadelphia (S.S.E., S.P.); the University of the West Indies, Kingston, Jamaica (J.P.F.); the World Health Organization, Geneva (A.M.H.-R., M.J.R., S.S.); the Department of Health Security, Finnish Institute for Health and Welfare, Helsinki (H.M.N.);and the Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg (H.R.), and the Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban (J.S.) — both in South Africa.

 

参考文献

1. Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R. COVID-19 vaccine trials should seek worthwhile efficacy. Lancet 2020;396:741-743.

2.Collins R, Bowman L, Landray M, Peto R. The magic of randomization versus the myth of real-world evidence. N Engl J Med 2020;382:674-678.

3.Fleming TR, Ellenberg SS. Evaluating interventions for Ebola: the need for randomized trials. Clin Trials 2016;13:6-9.

4.World Health Organization. Preliminary results on the efficacy of rVSV-ZEBOV-GP Ebola vaccine using the ring vaccination strategy in the control of an Ebola outbreak in the Democratic Republic of the Congo: an example of integration of research into epidemic response. April 12, 2019 ((https://www.who.int/csr/resources/publications/ebola/ebola-ring-vaccination-results-12-april-2019.pdf. opens in new tab).

5.Eapen ZJ, Lauer MS, Temple RJ. The imperative of overcoming barriers to the conduct of large, simple trials. JAMA 2014;311:1397-1398.

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