From R&D to FDA Authorization and Approval: An Inside Look at the Vaccine Development Process

Explore the intricate process of vaccine development, from research and development to FDA authorization and approval, in this 48-minute talk from The Aspen Institute. Gain insights from former FDA Commissioner Dr. Peggy Hamburg and current FDA Commissioner Dr. Stephen Hahn as they discuss the challenges of developing COVID-19 vaccines at "warp speed" while ensuring safety and efficacy. Delve into topics such as vaccine skepticism, public trust, the importance of clinical trials, and the FDA's role in vaccine approval. Learn about the complexities of vaccine constructs, antibody response duration, and the need for multiple doses. Understand the significance of postmarketing surveillance and real-world data in monitoring vaccine safety and effectiveness. This comprehensive discussion, moderated by Fortune's Editor-in-Chief Clifton Leaf, provides a valuable inside look at the vaccine development process and addresses key concerns surrounding COVID-19 vaccines.

Introduction
Introductions
Vaccine skepticism
Polling data
Trust and confidence
Information war
Importance of vaccines
Public health and vaccines
Vaccine constructs
A good news story
Challenges of vaccine development
Are there any corners cut
Why clinical trials matter
Will the vaccine protect us as the virus evolves
How long does the antibody response last
Five vaccines require two doses
Should people with COVID19 get the vaccine
Postmarketing surveillance
Real world data
What the FDA does
FDAs workload