Vaccine development for emerging virulent infectious diseases

- Emerging Infectious Diseases require novel approaches to vaccine development.
- EID vaccine development typically occurs within a knowledge vacuum.
- Vaccine design may occur with few studies of disease epidemiology and pathogenesis.
- Vaccine development for EIDs is benefitted by a platform technology.
- EID trial design must be fluid and adapt to real-time alterations in epidemiology.
- Societal and cultural norms and ethical concerns require input from key stakeholders.

The recent outbreak of Zaire Ebola virus in West Africa altered the classical paradigm of vaccine development and that for emerging infectious diseases (EIDs) in general. In this paper, the precepts of vaccine discovery and advancement through pre-clinical and clinical assessment are discussed in the context of the recent Ebola virus, Middle East Respiratory Syndrome coronavirus (MERS-CoV), and Zika virus outbreaks. Clinical trial design for diseases with high mortality rates and/or high morbidity in the face of a global perception of immediate need and the factors that drive design in the face of a changing epidemiology are presented. Vaccines for EIDs thus present a unique paradigm to standard development precepts.