Development of Medical Countermeasures to Middle East Respiratory Syndrome Coronavirus

Timothy M. Uyeki; Karl J. Erlandson; George Korch; Michael O'Hara; Michael Wathen; Jean Hu-Primmer; Sally Hojvat; Erik J. Stemmy; Armen Donabedian

Disclosures

Emerging Infectious Diseases. 2016;22(7):e1-e11. 

In This Article

Timelines for Clinical Trials of Medical Countermeasures

Prospective controlled clinical trials (ideally randomized clinical trials) of potential MERS-CoV therapies and vaccines in humans are needed urgently; however, there is uncertainty in estimating timelines for the development of potential MERS-CoV medical countermeasures because of the need to further characterize existing and new animal models, the unpredictability of demonstrating a favorable risk–benefit outcome during preclinical testing, and competition for resources with other emerging infectious diseases. In addition, the risk for antibody-dependent enhancement of disease may interrupt the timeline for conducting human clinical trials of MERS CoV vaccines and immunotherapeutics. Researchers of all potential MERS-CoV medical countermeasures should have preclinical toxicology data available before initiating human clinical trials. Although animal efficacy data are not technically required before implementing human clinical trials of potential countermeasures, such data are considered important for identifying the most promising medical countermeasure candidates, justifying risk in human volunteers, and informing the design of future clinical studies. Timeframes for the production of specimen panels and repositories to aid commercial diagnostic development are also contingent on obtaining adequate funding and clinical samples.

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