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Session 4: Challenges in COVID-19 Vaccine Development for Adults and Pediatrics: A Journey from Clinical Trials to Real-World
Session Chair(s)
Shiowjen Lee, PhD
Deputy Director, Division of Biostatistics, OBPV, CBER
FDA, United States
Satrajit Roychoudhury, PhD
Executive Director, Statistical Research and Innovation
Pfizer, Inc., United States
Vaccine development is a lengthy and expensive process. It typically takes multiple candidates and many years to produce a licensed vaccine. Conducting vaccine efficacy trials during an outbreak such as the COVID-19 pandemic poses unique challenges. It will generate simultaneous demand for vaccines around the world. Therefore, a strategic rollout plan for vaccines is required. An accelerated development plan requires innovations from all aspects of research and development including strategic design of clinical trials, defining clinical endpoints, and analyzing the study data. In addition, the development plan for the pediatric population will require additional safety considerations including the choice of appropriate dosing. This session will discuss the approval of vaccines and highlights issues with Covid-19 clinical development and rollout. It will compare the different issues with adult and pediatric development plans. Speakers will discuss the statistical challenges and solutions for the vaccine development and rollout plan.
Learning Objective : - Discuss FDA’s considerations for authorizing Covid-19 vaccines under
- emergency use authorization (EUA) for pediatrics
- Identify statistical issues, safety, and efficacy measures in the design of pediatric Covid-19 vaccine trials
- Discuss potential statistical solutions to the uncertainty of developing vaccines
- Discuss CDC considerations for a fast and effective rollout of the vaccine for the adult and pediatric population
Speaker(s)
Speaker
John Scott, PhD, MA
FDA, United States
Division Director, Office of Biostatistics, CBER
Speaker
Kenneth J. Koury, PhD
Pfizer, Inc., United States
Vice President, Head of Vaccine Clinical Research Biostatistics
Speaker
Dean Follmann, PhD
National Institute of Allergy and Infectious Diseases, United States
Assistant Director for Biostatistics; NIAID Chief Biostatistics Research Branch
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