Interpreting vaccine efficacy trial results for infection and transmission.
Interpreting vaccine efficacy trial results for infection and transmission.
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DOI：
10.1016/j.vaccine.2021.06.011
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发表时间：
2021-07-05
期刊：
影响因子：
5.5
通讯作者：
Kahn R
中科院分区：
文献类型：
--
作者：
Lipsitch M;Kahn R
随机对照试验（RCT）显示多种疫苗对SARS-CoV-2疾病（COVID-19）的有效性很高，最近的研究表明这些疫苗对感染也有效。这些疫苗中的每一种对病毒传播能力的影响的证据也开始出现。我们描述了一种方法来估计这些疫苗对病毒阳性的影响，这是一种流行率测量，在合理的假设下，接种疫苗的个体感染性并不比未接种疫苗的个体更强，从而形成了对传播有效性的下限。具体来说，我们建议单独分析由症状触发的阳性检测（通常是主要RCT结果）和无论症状如何获得的阳性检测的横截面患病率。在某些假设下，疫苗与安慰剂的携带优势比提供了疫苗对病毒阳性有效性的无偏估计，我们通过模拟表明，可能偏离这些假设仅会使该估计产生适度偏差。将这种方法应用于Moderna疫苗RCT的已发表数据，我们估计一剂疫苗可将传播潜力降低至少61%，甚至更多。我们描述了如何将这些方法转化为疫苗有效性的观察性研究。
Randomized controlled trials (RCTs) have shown high efficacy of multiple vaccines against SARS-CoV-2 disease (COVID-19), and recent studies have shown the vaccines are also effective against infection. Evidence for the effect of each of these vaccines on ability to transmit the virus is also beginning to emerge. We describe an approach to estimate these vaccines’ effects on viral positivity, a prevalence measure which under the reasonable assumption that vaccinated individuals who become infected are no more infectious than unvaccinated individuals forms a lower bound on efficacy against transmission. Specifically, we recommend separate analysis of positive tests triggered by symptoms (usually the primary RCT outcome) and cross-sectional prevalence of positive tests obtained regardless of symptoms. The odds ratio of carriage for vaccine vs. placebo provides an unbiased estimate of vaccine effectiveness against viral positivity, under certain assumptions, and we show through simulations that likely departures from these assumptions will only modestly bias this estimate. Applying this approach to published data from the RCT of the Moderna vaccine, we estimate that one dose of vaccine reduces the potential for transmission by at least 61%, possibly considerably more. We describe how these approaches can be translated into observational studies of vaccine effectiveness.
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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：
7.2
作者：
Hernan, Miguel A.;Sauer, Brian C.;Shrier, Ian
通讯作者：
Shrier, Ian
Covid-19的疫苗优化：谁先接种疫苗？
影响因子：
13.6
作者：
Matrajt L;Eaton J;Leung T;Brown ER
通讯作者：
Brown ER
影响因子：
4.2
作者：
Lipsitch, M;Goldstein, E;Fireman, B
通讯作者：
Fireman, B
影响因子：
7.7
作者：
Bar-On, Yinon M.;Flamholz, Avi;Milo, Ron
通讯作者：
Milo, Ron