14 Feb Maite Suarez /IAVI

IAVI submission to Public consultation: Global Roadmap for research and development for TB vaccines – EDCTP

The suggestion for a multi-stakeholder funding pool or ‘’funding roadmap’’ for TB vaccine trials is an excellent idea that should be pursued. To that end, the field must be able to identify and implement innovative funding mechanisms that ensure adequate incentives for donors – more on that further below. Current modus operandi in the TB vaccine field is not fit for purpose, and the overall TB vaccine strategy is pretty much driven by a single dominant funder. IAVI has already provided ample comments to this paper (note: file exceeded accepted size) https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3711578, which strongly supports the ‘pooled funding’ concept for Global Health R&D.

Given the substantial TB vaccine R&D funding gap, and the small pool of current donors, we would support to use of funding targets to help diversify the funding portfolio and bring new funders to the table, including the use of funding targets for TB R&D more generally (as adopted by WHO i.e. 0.1% of total Gross Expenditure on R&D to be devoted to TB R&D, which if implemented would cover the estimated 2 billion/year for TB R&D needed) and, as part of that, an agreed upon proportion directed to TB vaccine R&D. When adequately instrumented, R&D funding targets for TB R&D are an important political tool to hold donors accountable over time for their international agreements/resolutions. The use of adequate incentives remains, on the other hand, a critical need for the field to also ensure private sector engagement in TB vaccine R&D (more on this below).

Regarding the RoadMap recommendations about IP related issues, IAVI is already implementing an analogous approach, and indeed agrees that for TB vaccines it would be difficult to do differently – unlike Covid vaccines, these will be primarily for Low or Low and Middle-Income Countries. Similarly, IAVI’s approach to Open Science postulates is aligned with the RoadMap recommendations, and already embedded in our existing R&D efforts. For example, IAVI ‘owns’ samples from two ground-breaking [TB vaccine] clinical trials and those samples are to be provided to the groups that come up with the most innovative proposals to progress the TB vaccine field. We will not be holding on to those samples and, we devolve decision making to a group of thought leaders as to where those samples would most productively be used. Analogously, IAVI’s approach to our participation in Open Science pilot projects (Horizon2020 & EDCTP grants), has been supportive of open access of data by other partners / CRC sites for further research purposes (e.g. through a sub-license to these Partners for non-commercial use). For Clinical trial results this appears to be somewhat more complex, where ownership of results being solely for trial sponsor may be defendable to expedite efficient regulatory approvals in country, avoiding high-costs and removing additional obstacles to the commercialization of future products and/or transfer of data back to the donor(s).

More specifically, on funding mechanisms, incentives schemes, and technology transfer issues for TB Vaccine R&D:

– IAVI strongly agrees with RoadMap assertion that a combination of approaches is going to be needed to catalyze access and commercialization of new TB vaccines, with a heavier weighting on push mechanisms that are needed to de-risk R&D; and pull mechanisms backed with financing to support market stability for later stage products. In terms of the more detailed recommendations on “Pull” mechanisms, we feel these could be elaborated upon, as they remain quite general (particularly bolded sections).

Action Line 4: Epidemiology & modelling: 4.1. Country-specific data and projections (Conduct in-depth country-specific value proposition analyses; Modelling to define vaccine development investment cases and potential country-specific vaccine use cases). • Enabling Condition A, Funding: a3. Create mechanisms that attract investment in early stages of development (Market shaping to reduce commercial uncertainty). Enabling condition C: Stakeholder engagement/intersectoral collaboration: c.1. Create a supportive environment for TB vaccines (Advocate for development and uptake; Create innovative incentives).

Unless these are elaborated upon, it could be a missed opportunity to articulate some of the key strategies that could help stabilize vaccine markets, including demand generation, volume guarantees, etc. It’s clear too from our work on the Business Case for TB vaccines, that while forecasts and value proposition statements are helpful, data alone without supplemental backing isn’t going to be sufficient to de-risk commercial investment. It’s not enough to project demand; companies and investors would like forecasts to be backed by commitments in which not only donors, but recipient countries too share risk.

In terms of the Tech Transfer section: While Technology Transfer can facilitate access if the market conditions are right, a range of commercial models likely need to be explored for TB vaccines. Given the lack of a robust high-income market, to remain interested in advancing TB vaccines to through clinical development, companies must have some vehicle for return on investment. If they were to transfer all their rights for LMIC settings, they would be left with limited incentive to be involved at all in TB vaccine R&D. Models are needed that provide innovators enough of an inventive to remain in the market, while ensuring that commercial arrangements do not hinder access. While alternative approaches such as tiered pricing are mentioned briefly in the earlier paragraph as one of 4 solutions to support access (“Experience with other vaccines provides four solutions dealing with these constraints” on p27 of the Roadmap), this content could be fleshed out further and additional alternative models could be described such as Advanced Market Commitments.