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10.1111/biom.13509 http://scihub22266oqcxt.onion/10.1111/biom.13509 34174097!8444907!34174097     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=34174097&cmd=llinks): Failed to open stream: HTTP request failed! HTTP/1.1 429 Too Many Requests in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 215       Biometrics 2022 ; 78 (3): 825-838 Nephropedia Template TP {{tp|p=34174097|t=2022. Estimating vaccine efficacy over time after a randomized study is unblinded |pdf=|usr=}}{{34174097}} gab.com Text Estimating vaccine efficacy over time after a randomized study is unblinded JO: Biometrics http://www.kidney.de/pget.php?&tw=1&pmid=34174097 #FOAvip The COVID-19 pandemic due to the novel coronavirus SARS CoV-2 has inspired remarkable breakthroughs in the development of vaccines against the virus and the launch of several phase 3 vaccine trials in Summer 2020 to evaluate vaccine efficacy (VE). Trials of vaccine candidates using mRNA delivery systems developed by Pfizer-BioNTech and Moderna have shown substantial VEs of 94-95%, leading the US Food and Drug Administration to issue Emergency Use Authorizations and subsequent widespread administration of the vaccines. As the trials continue, a key issue is the possibility that VE may wane over time. Ethical considerations dictate that trial participants be unblinded and those randomized to placebo be offered study vaccine, leading to trial protocol amendments specifying unblinding strategies. Crossover of placebo subjects to vaccine complicates inference on waning of VE. We focus on the particular features of the Moderna trial and propose a statistical framework based on a potential outcomes formulation within which we develop methods for inference on potential waning of VE over time and estimation of VE at any postvaccination time. The framework clarifies assumptions made regarding individual- and population-level phenomena and acknowledges the possibility that subjects who are more or less likely to become infected may be crossed over to vaccine differentially over time. The principles of the framework can be adapted straightforwardly to other trials. Twit Text FOAVip Estimating vaccine efficacy over time after a randomized study is unblinded ????Biometrics http://www.kidney.de/pget.php?&tw=1&pmid=34174097 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=34174097 #FOAvip English Wikipedia <ref>{{Cite pmid|34174097}}</ref> Estimating vaccine efficacy over time after a randomized study is unblinded #MMPMID34174097 Tsiatis AA; Davidian M Biometrics 2022[Sep]; 78 (3): 825-838 PMID34174097show ga The COVID-19 pandemic due to the novel coronavirus SARS CoV-2 has inspired remarkable breakthroughs in the development of vaccines against the virus and the launch of several phase 3 vaccine trials in Summer 2020 to evaluate vaccine efficacy (VE). Trials of vaccine candidates using mRNA delivery systems developed by Pfizer-BioNTech and Moderna have shown substantial VEs of 94-95%, leading the US Food and Drug Administration to issue Emergency Use Authorizations and subsequent widespread administration of the vaccines. As the trials continue, a key issue is the possibility that VE may wane over time. Ethical considerations dictate that trial participants be unblinded and those randomized to placebo be offered study vaccine, leading to trial protocol amendments specifying unblinding strategies. Crossover of placebo subjects to vaccine complicates inference on waning of VE. We focus on the particular features of the Moderna trial and propose a statistical framework based on a potential outcomes formulation within which we develop methods for inference on potential waning of VE over time and estimation of VE at any postvaccination time. The framework clarifies assumptions made regarding individual- and population-level phenomena and acknowledges the possibility that subjects who are more or less likely to become infected may be crossed over to vaccine differentially over time. The principles of the framework can be adapted straightforwardly to other trials. |*COVID-19 Vaccines[MESH] |*COVID-19/prevention & control[MESH] |Humans[MESH] |Pandemics/prevention & control[MESH] |Randomized Controlled Trials as Topic[MESH] |Research Design[MESH] |SARS-CoV-2[MESH]Estimating vaccine efficacy over time after a randomized study is unbl(epmc).pdf DeepDyve Pubget Overpricing