Evaluation of post-introduction COVID-19 vaccine effectiveness: Summary of interim guidance of the World Health Organization.
Evaluation of post-introduction COVID-19 vaccine effectiveness: Summary of interim guidance of the World Health Organization.
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DOI：
10.1016/j.vaccine.2021.05.099
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发表时间：
2021-07-05
期刊：
影响因子：
5.5
通讯作者：
Feikin DR
中科院分区：
文献类型：
--
作者：
Patel MK;Bergeri I;Bresee JS;Cowling BJ;Crowcroft NS;Fahmy K;Hirve S;Kang G;Katz MA;Lanata CF;L'Azou Jackson M;Joshi S;Lipsitch M;Mwenda JM;Nogareda F;Orenstein WA;Ortiz JR;Pebody R;Schrag SJ;Smith PG;Srikantiah P;Subissi L;Valenciano M;Vaughn DW;Verani JR;Wilder-Smith A;Feikin DR
III期随机对照试验提供了COVID-19疫苗有效性的有希望结果，主要终点为50%至95%的症状性疾病，导致几种疫苗获得紧急使用授权/上市。然而，鉴于临床试验期间的随访时间短、严格的合格标准、新出现的令人担忧的变异以及大流行的流行病学变化，有关疫苗性能的许多问题仍然没有答案。引入疫苗后的有效性评估可以帮助我们了解疫苗在现实条件下使用时对减少感染和疾病的影响。它们还可以解决在试验中没有研究或研究不完全的重要问题，并将为不断发展的疫苗政策提供信息，包括评估有效性的持续时间;在关键亚群中的有效性，如非常老或免疫功能低下;预防COVID-19引起的严重疾病和死亡;预防新出现的SARS-CoV-2变异;并且具有不同的疫苗接种时间表，例如剂量数和不同的给药间隔。世卫组织召集了一个专家小组，为COVID-19疫苗有效性评估制定临时最佳实践指南。我们提出了一个临时指南的摘要，包括不同的研究设计的讨论，优先结果评估，潜在的偏见，现有的监测平台，可以使用，并报告结果的建议。
Phase 3 randomized-controlled trials have provided promising results of COVID-19 vaccine efficacy, ranging from 50 to 95% against symptomatic disease as the primary endpoints, resulting in emergency use authorization/listing for several vaccines. However, given the short duration of follow-up during the clinical trials, strict eligibility criteria, emerging variants of concern, and the changing epidemiology of the pandemic, many questions still remain unanswered regarding vaccine performance. Post-introduction vaccine effectiveness evaluations can help us to understand the vaccine's effect on reducing infection and disease when used in real-world conditions. They can also address important questions that were either not studied or were incompletely studied in the trials and that will inform evolving vaccine policy, including assessment of the duration of effectiveness; effectiveness in key subpopulations, such as the very old or immunocompromised; against severe disease and death due to COVID-19; against emerging SARS-CoV-2 variants of concern; and with different vaccination schedules, such as number of doses and varying dosing intervals. WHO convened an expert panel to develop interim best practice guidance for COVID-19 vaccine effectiveness evaluations. We present a summary of the interim guidance, including discussion of different study designs, priority outcomes to evaluate, potential biases, existing surveillance platforms that can be used, and recommendations for reporting results.
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影响因子：
5.5
作者：
Jackson, Michael L.;Rothman, Kenneth J.
通讯作者：
Rothman, Kenneth J.
影响因子：
13.6
作者：
Garcia-Albeniz, Xabier;Hsu, John;Hernan, Miguel A.
通讯作者：
Hernan, Miguel A.
DOI：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
Baden LR;El Sahly HM;Essink B;Kotloff K;Frey S;Novak R;Diemert D;Spector SA;Rouphael N;Creech CB;McGettigan J;Khetan S;Segall N;Solis J;Brosz A;Fierro C;Schwartz H;Neuzil K;Corey L;Gilbert P;Janes H;Follmann D;Marovich M;Mascola J;Polakowski L;Ledgerwood J;Graham BS;Bennett H;Pajon R;Knightly C;Leav B;Deng W;Zhou H;Han S;Ivarsson M;Miller J;Zaks T;COVE Study Group
通讯作者：
COVE Study Group
影响因子：
16.6
作者：
Griffith GJ;Morris TT;Tudball MJ;Herbert A;Mancano G;Pike L;Sharp GC;Sterne J;Palmer TM;Davey Smith G;Tilling K;Zuccolo L;Davies NM;Hemani G
通讯作者：
Hemani G
影响因子：
5.5
作者：
Lipsitch M;Kahn R
通讯作者：
Kahn R