The mission of SAVAC, the Strep A Vaccine Global Consortium, to ensure that safe, effective and affordable Strep A vaccines are available and implemented to decrease the burden of Strep A disease in the most in need.
SAVAC will pursue a strategy based on:
SAVAC has a broader vision and strategy beyond the 2-year horizon of funding from the Wellcome Trust – a strategy that will take the Strep A field further along the current R&D Roadmap with alignment to the WHO Preferred Product Characteristics guidance and the WHO-endorsed Full Public Value of Vaccines (FPVV) evaluation approach (formerly called Full Public Health Value Proposition).
The goal of SAVAC is to reduce the burden of Strep A infection / Strep A-infection-associated diseases through the development and use of safe, effective and affordable Strep A vaccines. To accomplish this goal, SAVAC will pursue a strategy based on the following:
The foundation of this strategy is communication – SAVAC must make Strep A a larger Global Health priority among funders and countries. It will make use of the World Health Assembly resolution calling for a reduction in Strep A burden, highlighting the role that vaccines can play as a cost-effective solution to this problem. Although the Wellcome Trust funding does not specifically fund advocacy per se, SAVAC will retain communication, advocacy and awareness-raising as a critical element of its work, and seek resources from other sources to amplify these efforts. This includes development and maintenance of a website where up-to-date Strep A related news / research may be easily referenced, with a particular focus on Strep A vaccines, and where a clear and informative summary of Strep A as a global problem can be easily accessed. The website will link to available news, resources, advocacy, and social media to enhance the visibility and improve appreciation of the Strep A problem.
The Strep A field is small, so that, to the extent possible, SAVAC will ensure that its efforts and resources will be coordinated to avoid redundancy within the SAVAC community and with other Strep A activities.
Strep A is underfunded relative to disease burden. SAVAC will;
Strep A should also be recognized as a poverty-related disease and as pathogen highly relevant for antimicrobial resistance (AMR) in order to qualify for funding by the European Union, EDCTP and AMR biomedical research programs.
Strep A vaccine development should be grounded in science, mindful of ethical and safety requirements. This includes knowledge of burden, pathogenesis, immunity, auto-immunity, vaccine development, correlates of risk and immune protection, and safety. Of these, only the vaccine safety workstream is supported by the initial funding from the Wellcome Trust, but all workstreams are essential. SAVAC will retain them as critical elements, seeking funding for them where possible.
The common goal of Strep A vaccine development is to reduce the broad Strep A disease burden, and so vaccine developers must be mindful not only of the science but of the downstream elements of vaccine development – manufacturing and supply, demand, cost, policy, and financing. The Consortium will help, through the FPVV, to identify, anticipate and de-risk issues that might impede the efficient adoption of effective Strep A vaccines, aligned with the WHO vision for the future of vaccine life course programs with coverage and equity as central considerations.
The current Wellcome Trust funding is considered as a first step of a longer-term strategy described above. The funding covers 2 years with a possible 12-month no-cost extension for a total budget of US $2.2 million.
There is no Strep A vaccine development activity in major multinational vaccine companies or developing country vaccine manufacturers at this current time. Endorsement of WHO-sponsored consensus documents on a Roadmap for Strep A vaccine R&D and a Preferred Product Characteristics document are initial steps, but a truly global Consortium is needed to fill the remaining gaps and to move the Strep A vaccine agenda beyond the consensus documents to realize Strep A vaccine development. SAVAC will bring together, inform, and organize those parties interested in furthering Strep A vaccine R&D, with the aim of promoting a more focused and efficient use of resources to accelerate vaccine licensure, uptake and use.
Members of the SAVAC Executive Committee will be responsible for different work streams (1. Vaccine safety; 2. Epidemiology; 3. Vaccine landscape; 4. Correlates of protection) and teams of EC members will join different efforts as necessary. The proposed consortium will provide leadership and bring focus to the development of Strep A vaccines.
The key areas under the responsibility of the EC include:
The WHO template for the FVVA (former Full Public Value of Vaccines) will be adapted for Strep A vaccines. The FVVA for Strep A will contain the broadest synthesis of the value of a Strep A vaccine across different stakeholders (normative, research, manufacturing, state-level policy, implementation). It will contain information from the business case and the investment cases.
The key elements of the FVVA were outlined and prioritized during the FVVA Working Group meeting held at TKI, Perth, March 8, 2019.
SAVAC will gather experts (including on regulatory matters) to review what we know, what we would like to know, and what data to collect and for how long about Strep A vaccine safety to guide vaccine design and clinical trial design (e.g., long-term safety assessment, cardio assessment, immediate immune reactions triggered by the vaccine in Step A naïve and immune individuals). This expert review will fill a key gap for the field, providing guidance for vaccine developers.
While not funded under the current grant, advocacy remains a core function of SAVAC. Funding should be secured as an early priority. As outlined above, advocacy needs to target multiple levels, with different approaches.
Epidemiology, disease burden, and prevention
While not funded under the current grant, a key activity of SAVAC will be to re-establish case definitions for Strep A disease entities (with review of previously developed case definitions within the collaborative framework of NIH, US CDC and WHO). Furthermore, a gap analysis of burden of disease data by disease type, region and country will provide a framework for further funding applications to address key missing areas of data. There will be an opportunity to intersect and potentially leverage off disease burden work being undertaken as part of the FVVA.
Correlates of protection
While not funded under the current grant, a key activity of SAVAC will be to advocate for futher work in standardizing immune correlates of risk and protection and providing technical advice to any efforts toward this goal.
While not funded under the current grant, SAVAC will maintain an up-to-date landscape analysis of any vaccine candidates in pre-clinical and clinical development.