How to License a New Vaccine

SPH GH 801

Vaccines are one public health's most powerful tools. Vaccines have controlled many of the worst childhood infectious diseases, including bacterial meningitis, measles, diphtheria, and pertussis. Smallpox has been completely eradicated - and polio may soon follow. But where do vaccines come from? The goal of this course is to open the black box and give students a hands-on introduction to the challenging but fascinating process of clinical development, using the development of a new vaccine as the case study. The class is designed as an extended and competitive simulation -- essentially a game with pedagogic purpose. The students assume the role of clinical development teams at a hypothetical pharmaceutical company working to advance the development of a new vaccine. Each year, the class will select a vaccine candidate to enter development. Over the subsequent sessions, the students will advance their vaccine with the ultimate goal of securing licensure by FDA. In this course, students will acquire a deep understanding of clinical development and the regulatory process, will learn about contemporary and historical aspects of vaccine development, clinical epidemiology, and infectious diseases. By the end of the course, students will have a solid understanding of what it takes to bring a vaccine to market, while honing their skills at working in teams, giving professional presentations, and providing and responding to constructive feedback.

Note that this information may change at any time. Please visit the Student Link for the most up-to-date course information.