Tuesday, 16 July 2024
Check out the summary below or watch the recording and read the transcript for updates and insights from speakers on some of the latest developments in the TB vaccine field:
- Update on the WHO TB Vaccine Accelerator Council (Mike Frick, Treatment Action Group)
- Inclusion of new TB vaccines in Gavi’s Vaccine Investment Strategy (Ignacio Esteban & Nidhee Jadeja, Policy Team, Gavi; Peter Ng’ola Owiti, Gavi CSO Steering Committee);
- Advocating for TB vaccines at the HML on AMR (Ishan Bhatkoti, Stop TB Partnership)
Read the recap of the webinar and watch the recording below and read the full transcript here.
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Update on the WHO TB Vaccine Accelerator Council
Mike Frick, Treatment Action Group
The WHO Tuberculosis Vaccine Accelerator Council, launched in 2023, seeks to facilitate the development, testing, authorization, and use of new TB vaccines, by fostering high level coordination and alignment between funders, global agencies, governments and end users.
The Council is guided by three high level objectives:
- Accelerate the diversification of the TB vaccine portfolio by facilitating translational and clinical research. This includes milestones to develop financing strategies for research, specified as push funding, including mechanisms like grants, to catalyze new investments across the research continuum;
- Accelerate the identification of market solutions to incentivize late-stage development, ensure scalable production, procurement, and equitable and affordable access. This includes launching a pull incentive mechanism for vaccine procurement and late-stage development, such as an advance market commitment or financial platform to de-risk manufacturing and supply activities to ensure availability; and
- Accelerate implementation and uptake, including through developing a costed learning agenda, which may feature a suite of research and other readiness activities to support vaccine preparedness
The Council is composed of a Ministerial Board and a Principal Board. The Council is co-chaired by the Ministers of Health of Brazil and Indonesia, supported by representatives on the Ministerial Board of France, Kenya, Vietnam, Pakistan, South Africa, the Philippines, and the United States, via the National Institutes of Health . The Principal Board includes representatives of the European Investment Bank, the World Bank, and the African Development Bank, major funders like the Gates Foundation and Wellcome, multilateral agencies like GAVI, Global Fund, UNITAID, and Stop TB Partnership, and community and civil society representatives. A second civil society seat is intended to be filled in the coming period and may be nominated from the Civil Society Task Force of the WHO’s Global TB Program.
The work of the Council will be undertaken and coordinated by a Secretariat. The WHO recently published a request for proposals (RFP) to identify organizations or groups to assume the function of the Secretariat. The deadline for the RFP is 29 July. The Council anticipates proposals from groups from or with very strong ties to high TB burden countries, as places where vaccine research is likely to take place.
The Secretariat will establish strategic and technical working groups representing four main thematic areas: (1) vaccine science and research; (2) product development, manufacturing and policy; (3) financing and access; and (4) country delivery, readiness, advocacy, and trust.
Regarding developing a pull incentive mechanism, the Council is exploring a potential conference in 2025 on TB vaccine financing that would be aligned with other global events during what will be a busy year for multilateral replenishments.
Gavi includes new TB vaccines in Vaccine Investment Strategy
Ignacio Esteban & Nidhee Jadeja, Gavi; Peter Ng’ola Owiti, Gavi CSO Steering Committee
On June 7, the Gavi Board approved the 2024 Vaccine Investment Strategy (VIS), which includes future vaccination programs and learning agendas for new TB vaccines (adolescent vaccines), along with dengue, group B streptococcus, hepatitis E, and mpox vaccines. Done every five years, the VIS is the prioritization process for inclusion of new and underused vaccines that will be made available to countries through Gavi’s vaccine support programs. This announcement was part of the Gavi’s Board approval of “Gavi 6.0”, Gavi’s 2026-2030 strategy.
The VIS takes an evidence-based approach, using a transparent and publicly available methodology, based on multiple modeling exercises, including price forecasting and health and economic impact, and informed by extensive consultations. The TB vaccine investment case was conducted in close collaboration with multiple technical partners, including WHO, the World Bank, Wellcome, and IAVI, as well as country, civil society, and manufacturing representatives, to provide the most well informed evidence to guide the Board’s decision.
The TB investment case explored different vaccination strategies. The primary scenario, based on ECVP recommendations and lead candidate product profiles for adults/adolescents, was a routine immunization program for 15-year-olds, with two doses separated by one month. An alternative scenario included a single dose for 14-year-olds. Other strategies explored a one-off catch-up campaign for adolescents aged 16-to-18-years-old, and a broader catch-up campaign for 16-to-44-year-olds. Further, the assessment looked at how many countries would be expected to introduce this new vaccine in the next ten years, and the anticipated volumes needed for successful introduction.
Health impact was based on modelling from the London School of Hygiene & Tropical Medicine and the Boston University, which estimates a total of up to 230,000 deaths averted between 2026-2040 in Gavi eligible countries. Between 64-73 million disability adjusted life years (DALYs) could be averted over the same time period.
The Board approved in principle support for a TB vaccine program. Any investment is contingent on the availability of a licensed product for adolescents and adults that has WHO prequalification and SAGE recommendation, which may occur as early as 2028. The current investment case represents the best indicative scenario based on extensive consultations and current lead candidates, but it is not definitive. Gavi’s eventual TB vaccine program will be guided by the clinical trial data of the TB vaccine candidate(s) that reach licensure; as such, the current scenarios are subject to change. Gavi will continue to explore with partners the design of timely market shaping interventions aimed at assuring that TB vaccine supply matches anticipated demand with minimal delay. Further, Gavi eligible countries can apply for health system strengthening support.
The related Learning Agenda will facilitate research to fulfill key evidence gaps, including what are the most likely rollout scenarios and who are the priority target populations. Gavi will also apply lessons from the rollout of other vaccine programs, such as HPV and malaria. A key priority is to generate evidence and data to better understand how new TB vaccines can be integrated into existing TB healthcare and general primary healthcare services and determine the most cost-effective strategies for combining vaccine and non-vaccine interventions.
Many high TB burden middle income countries (MICs) are not Gavi eligible. Since Gavi’s 5.1 Strategy in 2020, Gavi has applied a MICs approach. This is a tool to address equity and sustainability transfer to immunization programs for MICs. The main objective is to prevent backsliding in vaccine coverage in former Gavi eligible countries and to drive sustainable introduction of key vaccines. Gavi provides a range of support through the MICs approach, including technical assistance, flexible funding to cover a one-off cost, catalytic finance, and also discrete support for specific vaccines, including PCV, rotavirus and HPV. Gavi’s VIS analyses models MICs for TB to inform both Gavi’s approach as well as that of other multilateral agencies. The private sector also plays an important but variable role in service delivery in Gavi countries. Gavi’s support for vaccines, however, is largely delivered through the public sector.
Peter Ng’ola Owiti, member of Gavi’s CSO Steering Committee, shared some community perspectives on the latest VIS. Peter called for lessons to be learned from shortcomings in the rollout of COVID-19 vaccines as well as antiretrovirals decades earlier, to ensure new TB vaccines are accessed from port to arm. Key to this will be the issues of price, health system strengthening, including aspects such as cold chain requirements, as well as regulatory harmonization to avoid delays in country-level rollout. Community engagement at an early stage of implementation planning will be critical, not least to support demand generation.
Updates on the United Nations High Level Meeting on Antimicrobial Resistance
Ishan Bhatkoti, Stop TB Partnership
On 26 September 2024, the United Nations will hold a High-Level Meeting (HLM) on Antimicrobial Resistance (AMR). Recognizing the important intersection between TB and AMR, and building on the commitments made during the UNHLM on TB in 2023, the Stop TB Partnership published Key TB Asks for the UN HLM on AMR, including recognizing vaccine development as a critical strategy in addressing AMR.
The formal negotiations on the ARM Political Declaration began in mid-July with the current draft containing around seven mentions of TB, notably in paragraphs 2, 11, 14, 20, 37, 60, and 61. In particular, paragraph 60 includes extended and expanded mentions of language supported by and suggested by Stop TB Partnership. High TB burden countries and the G77 are expressing strong support to ensure that TB remains within the declaration.
There is also a strong mention of vaccines as critical interventions to prevent infections, a broad reference to Universal Health Coverage (UHC), and strong support for an Independent Scientific Panel on AMR, notably from the UK and Saudi Arabia. Colleagues at Stop TB Partnership remain in contact with UN member state missions to stay up to date on the current rounds of negotiations, following which they will assess how best to proceed to support the negotiation process. If negotiations proceed without significant opposition throughout August, the draft will enter the silence procedure. If uncontested at this stage, there will be a motion to formally adopt the Political Declaration by all member states.
To learn more about TB vaccines and AMR, read the TB Vax ARM policy brief.
