Vaccine development and trials in low and lower-middle income countries: Key issues, advances and future opportunities.

Over the past 10 years there has been an increase in the number of vaccine clinical studies conducted in resource limited countries. These include vaccine trials for diseases such as malaria and dengue fever which are endemic to many low and lower-middle income countries. Concurrent with the increase in the number of trials, has been the increase and improvement in local infrastructure to enable the appropriate conduct and oversight of trials in these settings, including strengthening of local scientific capabilities, ethical and regulatory oversight. While significant advances have been made, there remain gaps to be addressed including strengthening pharmacovigilance in these regions. There are also opportunities to establish novel collaborations to address diseases specific to these populations including strengthening local manufacturers, new ways to engage established large pharmaceutical companies and leveraging established global infrastructure and pathways to develop innovative products beyond vaccines.