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Abstract:
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The COVID-19 pandemic is responsible for millions of cases and hundreds of thousands of deaths in the U.S. alone. According to the WHO, as of May 2021, over 100 candidate vaccines around the world are currently under clinical evaluation. Efforts to develop a safe and effective vaccine to prevent COVID-19 and address the public health need, aided by Operation Warp Speed, led to the development of vaccines at an unprecedented pace. Clinical studies aimed at demonstrating the safety and efficacy of these vaccines pose many statistical challenges. In this presentation, we discuss various challenges encountered in clinical studies, including the development of study halting rules to monitor for potential vaccine-associated enhanced respiratory disease, determining correlate of protection, modifying ongoing Phase 3 clinical studies to evaluate long-term safety and efficacy when a vaccine becomes available during the study, and designing clinical studies to evaluate safety and efficacy of new candidate vaccines post vaccine authorization or licensure.
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