Dengue vaccines regulatory pathways

Because a dengue vaccine should be tetravalent in nature and provide protection against all four dengue serotypes, regulatory agencies need to address additional issues associated with multi-valent vaccines such as interference between the vaccine serotypes.Safety assessment needs to account for the potential risk of inducing antibody-enhanced diseases (antibody-dependent enhancement).

Because of the varying epidemiology and disease impact in different countries and regions, dengue vaccines will likely need to be evaluated in diverse populations initially in both the Americas and the Asia Pacific region.