All Times EDT
Keywords: COVID-19, vaccines
Coronavirus Disease 2019 (COVID-19) was declared by the WHO as a global pandemic in March of 2020. To combat the pandemic, vaccines to prevent COVID-19 were developed at an unprecedented pace. As of May 14, 2021, 100 candidate vaccines around the world are currently under clinical evaluation (WHO). Three vaccines from Pfizer, Moderna, and Janssen have been authorized in the United States under emergency use. Statisticians play a pivotal role in designing clinical studies to demonstrate vaccine efficacy and safety, as the need to assess the benefit-risk profile of a vaccine in a timely manner poses many statistical challenges. We discuss various issues, challenges, and opportunities encountered in evaluating the efficacy and safety of COVID-19 vaccines.