A financial and global demand analysis to inform decisions for funding and clinical development of GBS vaccines for pregnant women.

BACKGROUND Despite Group B streptococcus being a leading cause of maternal and infant morbidity and mortality, no vaccine is currently available to prevent this disease. To inform vaccine developers, countries, and funders, we analyse in this paper the key factors likely to influence the demand for a GBS vaccine and the long-term financial sustainability for a commercial entity considering the development of such a vaccine. METHODS By using population-based forecasting, we estimated the demand for a GBS vaccine based on the burden of disease, the strength of the maternal immunisation systems, the fiscal space, and the track record in introducing new vaccines. Furthermore, we estimated the financial viability for a vaccine developer by estimating the Net Present Value of the vaccine development project using a Discounted Cash Flow model. RESULTS Demand for this vaccine can be significant if policy recommendations for use are adopted by countries, in particular the largest ones, most of which have a burden that justifies the use of the vaccine and if financing for the vaccine will be made available either by countries themselves or by funding mechanisms such as Gavi, the Vaccine Alliance. Different administration schedules may result in even larger demand. With a widespread policy recommendation, the commercial viability of this vaccine can be achieved. The cost of clinical development - particularly the type of pivotal trial required - and the number of competitors are the factors that can strongly influence the long-term financial sustainability and hence the interest of vaccine developers. CONCLUSIONS This analysis suggests the potential for full financial and commercial viability for a manufacturer pursuing the development and commercialization of a GBS vaccine. Risks exists in relation to the clinical trial design and costs, the level of competition, countries' ability to pay, the administration schedule and the availability of policies that encourage use of the vaccine. To reduce those risks and ensure equitable access to a GBS vaccine, the role of donors or financers can prove very important; as can a coordinated operational research agenda that aims at clarifying those areas of uncertainty.