Introduction to Vaccine Development

Catalog description

Vaccine development is the process by which new vaccines are discovered, studied in laboratory and preclinical models and investigated clinically in patients to determine if they are safe and efficacious. Assuming the vaccine under investigation passes systematically defined milestones, submission of all documentation to regulatory authorities (e.g., US FDA and equivalent global regulatory authorities) can ensue and, pending a favorable review, market access can be granted. The process is highly regulated and there is significant cost involved for pharmaceutical sponsors to research and develop vaccines with the entire process averaging around 12 years once a product is discovered. This introductory course lays the foundation for conducting vaccine research in many ways. It begins with a brief review of the history of vaccine discovery and development and explains the phases of vaccine development in detail. Global Health history and impact of vaccines is described as well as the various stakeholders (e.g., WHO and World Bank) involved which distinguish vaccine from drug development. The decision-making process, vaccine development milestones and compound progression metrics are defined and explained with examples. At the conclusion of this course, students should have a working knowledge of the vaccine development process, understand the regulatory basis by which new vaccines are evaluated, ultimately approved, and distributed around the world. This course is directed and taught primarily by Dr. Jeff Barrett formerly Professor Pediatrics at the Perelman School of Medicine who has over 35 years’ experience in pharmaceutical research and development experience, 17 years of which were spent in the pharmaceutical industry from 1990 to 2003 and 2013-17.