US Regulatory Considerations for COVID-19 Vaccine Trials

• Activity Number: 150 - COVID-19 Vaccine Statistics: A Reflection on a Year at Warp Speed
• Type: Invited
• Date/Time: Tuesday, August 10, 2021 : 10:00 AM to 11:50 AM
• Sponsor: Biometrics Section
• Author(s): John Scott*
• Companies: FDA / CBER
• Keywords: COVID-19; vaccine; FDA; regulatory; clinical trials

Abstract

The speed, spread, and severity of the COVID-19 pandemic led to unprecedented urgency in vaccine development. In a matter of weeks or months after the start of the outbreak, over a hundred vaccine candidate platforms were in development, with many of them speeding into and through clinical trials. The FDA's Center for Biologics Evaluation and Research provided regulatory guidance, facilitation, and oversight of this process in the U.S., both by working with individual manufacturers and investigators, and by providing broad frameworks for collecting evidence to support eventual COVID vaccine licensure or emergency authorization. In this talk, I'll review CBER's activities in this area, focusing on statistical aspects of clinical trial design and analysis. I'll provide an update on where we are with vaccine development and review as of JSM 2021, and discuss lessons learned about statistical regulatory activities during a pandemic response.