Tackle priorities essential to clarifying the roadmap for future access to a vaccine.
With late-stage vaccine programmes anticipating efficacy results in 2021-2022, there is a critical need to mobilize now to prepare for all potential trial outcomes, including vaccine efficacy scenarios. The Enterprise has an important role to play in helping the field align on strategies to overcome potential barriers to licensure, scale-up and access to a safe and efficacious vaccine.
Preparing for success means planning for any outcomes of current and future trials; understanding regulatory pathways—particularly in countries with limited capacity for and experience with vaccine licensure; aligning on preferred product characteristics to focus product improvement efforts; developing access strategies aligned with regional needs and resources; and identifying ways to encourage at-risk investment needed for manufacturing scale-up and deployment.
2.1 Clarify regulatory and access pathways. Working with the WHO, regulators, policymakers, communities and product developers and funders, we will facilitate mapping of regulatory and licensure pathways for an HIV vaccine and help advance efforts to forecast demand and define deployment channels. Initial efforts in this area may focus on Sub-Saharan Africa as it is the epicenter of the epidemic and efficacy trial activity.
2.2 Support the development of new business models for late-stage product development. We will convene diverse stakeholders—product developers, industry, research funders, international finance and development agencies, the investment community, local and regional authorities—to catalyze dialogue around novel business models that address the imperatives and risks of late-stage HIV vaccine R&D, scale-up and rollout.
This commitment will help to ensure that, as a field, we are ready to make a safe and efficacious HIV vaccine readily available for the populations that need it most.