​Kim: AVANTI: An Alliance for Vaccine Access, New Technology, and Innovation

OVERVIEW

This grant will fund the Alliance for Vaccine Access, New Technology, and Innovation for HIV Vaccines (AVANTI-HIV). AVANTI is a general model for advancing non-incentivized vaccines through the implementation gap between clinical development, successful commercialization, and effective public health utilization. Vaccines for poverty-associated infectious diseases face additional challenges with WHO prequalification, policy recommendation, and stockpiling. Mobilizing financial and operational support is needed to ensure access in low- and middle-income countries (LMIC). AVANTI-HIV is being created to provide a pathway to vaccine supply and utilization through 1) alternative low-cost manufacture; 2) creation of demand through a cogent global health investment case and WHO recommendation for use; and 3) a funding mechanism through Gavi, the Vaccine Alliance. Accomplishing this will first require a detailed post-efficacy integrated product development plan (IPDP) inclusive of regulatory pathways, supplemental clinical trials, effectiveness trials, stockpiles, and Strategic Advisory Group of Experts (SAGE) and National Immunization Technical Advisory Group (NITAG) recommendations. The second key deliverable is an integrated Full Public Health Value Proposition (FPHVP) that contains a business case for potential manufacturers to consider, as well as a global health investment case containing cost effectiveness, social benefit, and intervention models that will justify a SAGE recommendation and provide a compelling case to NITAGs and Ministries of Health in early adopter countries. Success in this key deliverable will create both a supply of vaccine and a requisite demand for vaccine. The third deliverable is an analysis of interested developing country vaccine manufacturers, with down-selection and audits of the top 2-3 firms, and an outline of the agreements, licenses, and technology transfer necessary to proceed with vaccine production. With these documents, if efficacy exceeds the threshold for triggering post-efficacy events, a clear pathway to vaccine uptake/implementation will be available to the members of the Pox Protein Public Private Partnership (P5).