All eyes on new TB vaccines – but what’s next after the HLM on TB?

Last month’s 78th United Nations (UN) General Assembly was a major week for global health, with back-to-back High-Level Meetings (HLMs) on Pandemic, Preparedness, and Response (PPR), Universal Health Coverage (UHC), and the second HLM on Tuberculosis (TB). This time round, TB vaccines were firmly in the spotlight – a sea change in support compared to the first HLM on TB in 2018. With the dust now settling, we’ve been reflecting on what this milestone event means for TB vaccines moving forward.

HOW DID TB VACCINES FARE IN THE POLITICAL DECLARATION ON TB?

We’ve come a long way since the Zero Draft was published back in May. Following an extended period of negotiations, the Political Declaration on TB was adopted at the TB HLM on Friday 22 September. The Resolution formally endorsing the declaration was later adopted on Wednesday 5 October.

While we may have not achieved everything we set out for, there are multiple paragraphs that specifically address different facets and dynamics of TB research. The declaration includes commitments to mobilize $5 billion a year by 2027 for TB research and innovation (a regression on our call for the target to be reached for each year of the period 2023-2030) and a standalone paragraph calling for the delivery of new TB vaccines, preferably within five years, linked to sustainable local, regional, and global manufacturing once available. This is also notably the first ever political declaration on health to recognize the human right to scientific progress and the right to access the benefits of scientific progress.

The TB declaration, regarded as the strongest of the three health declarations, will serve as a useful tool for advocacy and accountability. But ambitious action beyond the commitments in the declaration will be critical to meet goal of ending TB as a public health challenge by 2030, in line with the UN Sustainable Development Goals. With new TB vaccines, diagnostics, and drugs crucial to meeting this target, all eyes will be set on reaching robust agreements to ensure equitable and affordable access to all new TB tools.

WHAT DID PEOPLE SAY ABOUT TB VACCINES AT THE HLM?

Many member states expressed unreserved support for TB vaccines throughout the week, with many interventions during the HLM, including from the Group of African States, France, and Indonesia, reflecting demands laid forth by the TB Vax ARM and global TB community this last year. Discussions around vaccines and research and development (R&D) more broadly were noticeably more inclusive of the breadth of innovations needed, calling for innovation across the scientific, financial, regulatory, and manufacturing environments to deliver new TB vaccines this decade. Central to all of this was the issue of access, with attention firmly set how to ensure universal, affordable, and equitable access to new TB tools.

Representatives from academia, product development, civil society, and affected communities gave powerful interventions at UN HQ during Panel 2 on scaling up financing, including for R&D. In his introductory remarks, Prof. Mark Hatherill, South Africa TB Vaccine Initiative, called for a program of investments in the whole pipeline to mitigate risk and reduce commercial uncertainty so that we can “do the trials that are necessary, not the trials we think we can afford.” To achieve this, investments can’t be left to a small number of funders in low burden countries. Prof. Hatherill called for stakeholders in high TB burden countries to contribute their fair share of funding for vaccine development to ensure an equitable say in the research agenda and ensure the voices of affected communities are truly heard. Read the TB Vax ARM T20 Policy Brief Investment Toolbox to Advance TB Vaccine Development through Joint Action to learn how this could take shape.

Speakers from TB Alliance, Treatment Action Group, We Are TB, and IAVI built on Prof. Hatherill’s calls with demands for member states to significantly increase investments in TB R&D in line with fair share targets. With public sector funding making up 70% of TB research funding, access conditions must be attached to public sector funding to ensure affordable and equitable access. Support must also extend beyond financial investments by leveraging domestic research, manufacturing, and regulatory capacities.

Ultimately, the choice lies with governments. As Hon. Ricardo B. Leite, UNITE Parliamentarians Network, said, “To end TB is not a scientific challenge. To end TB is a political choice.”

Click here for the list of 127 countries and representatives who spoke in the HLM Plenary Session (including 1 Head of State, 61 Ministers of Health, and 7 Ministers of Foreign Affairs).

Click here for the list of written plenary statements that were submitted to the PGA (not all countries submitted written statements).

WHAT CAN MEMBERS STATES DO NOW?

The week was rich in crisscrossing conversations on the sidelines of the three HLMs. The urgent need for a stronger vaccine R&D effort, alongside opportunities for TB innovation at large, and the need to seriously step up investments to achieve results and ensure equitable access, were ever-present themes. This included Tuesday’s TB Innovation Summit, as well as the New TB Tools side event organized by TB Alliance, FIND and IAVI.

Speaking at the Summit, Emilio Emini from Gates MRI argued for a reassessment of our collective approach to risk, stating that “We need to take greater risk, greater regulatory risk, greater policy risk, greater technical development risk.” But as Gavi’s Aurélia Nguyen asked before him, ”What’s the risk appetite and who’s going to step into that gap?”

To deliver on the promise of new TB vaccines, member states can act on several key priorities that were reiterated throughout the week:

• Mobilize multilateral, joint funding for TB research
• Address the last mile, first to ensure fast and universal access
• Use innovative trials designs for faster, cheaper, and equally reliable efficacy testing
• Implement innovative regulatory pathways, not just in times of crisis
• Strengthen regional research and manufacturing capacities in high burden regions
• Position TB as a core global security issue, especially in PPPR and AMR agendas

WHAT ABOUT THE WHO TB VACCINE ACCELERATOR COUNCIL?

On Wednesday 20 September, we saw the formal launch of the much-anticipated WHO TB Vaccine Accelerator Council. Co-chaired by the governments of Brazil and Indonesia, the Council seeks to facilitate the development, licensing, and use of new TB vaccines. The Council will be composed of a Ministerial Board, a Principal Group, and technical and strategic working groups.

Civil society seats will also be included in both the Ministerial Board and Principal Group. Interested individuals can submit their expression of interest by sending their CV to the Secretariat at TBVaccines@WHO.int by 18 October 2023 (11:59 PM CET). Learn more here.

We look forward to accelerated progress of and substantive outcomes from this urgently needed initiative and we will continue to explore opportunities to leverage dialogue between the Council and the TB Vax ARM network.

SO, WHAT’S NEXT FOR TB VACCINES?

We find ourselves in a markedly different environment than five years ago. Alongside fresh opportunities for political engagement (i.e., the TB Vaccine Accelerator Council), this last year has seen a slew of new and planned clinical trials, record-breaking funding announcements (albeit almost all philanthropic), and forward-looking activities to lay the ground work for vaccine preparedness. Together, as researchers, product developers, civil society and affected communities, and other TB vaccine stakeholders, we can catalyze this momentum and make sure that this time round Member States fulfil their promises to finally deliver the vaccines we need to end TB.