The Independent Panel says WHO and Africa CDC Must Coordinate a Diagnostics, Vaccines and Treatments Financing and Access Roadmap
While frontline workers continue to warn that the Bundibugyo Ebola outbreak is outpacing the response, the Co-Chairs of the Independent Panel call for a transparent roadmap showing how promising vaccines, treatments and tests will move from development to delivery if they prove successful. They urge WHO and Africa CDC, together with affected countries and stakeholders, to coordinate a single end-to-end roadmap that clarifies responsibilities and guarantees that products reach the people and communities most at risk.
Overall, responsibility for research, manufacturing, procurement, licensure and delivery currently appears fragmented across multiple organizations. A single transparent end-to-end R&D, financing and access roadmap, co-created with endemic country partners, has not been publicly articulated. Given that WHO and Africa CDC are coordinating the Ebola Bundibugyo operational response, their coordination of a financing and access roadmap, together with affected countries and stakeholders, would provide transparency on financing, ownership, and access guarantees. Such a roadmap should include publication of evidence as it becomes available.
“The work to identify vaccine and treatment candidates, and to fund the next stages of development has been rapid when compared to past Ebola emergencies,” said Her Excellency Ellen Johnson Sirleaf. “However, questions remain regarding financing the full development, manufacturing, procurement, deployment and access should vaccines, treatments or tests prove successful. We also need publicly articulated guarantees that these products will reach the people who need them most.”
“In every outbreak we identify new lessons, but increasingly the challenge is not learning them – it is applying the lessons we already know. Following the inequities of COVID-19, it’s vital to clarify the plans to get Ebola Bundibugyo countermeasures from development through to delivery, including to ensure communities are engaged and have confidence in these products. This has implications for this Ebola outbreak, and it will matter when another epidemic or pandemic-prone pathogen emerges,” said the Right Honourable Helen Clark.
Encouraging scientific progress, but the pathway to access is unclear
To date, the World Health Organization has prioritised three vaccine candidates, three treatments and one post-exposure prophylaxis for further evaluation. Each of these candidates builds on substantial public investment in foundational science, product development and clinical research, including investments by governments, universities and public research institutions, and now through CEPI’s support for vaccine clinical trials.
These candidates now require further clinical evaluation, including Phase 1 studies where appropriate, and country-led Phase 2 and 3 efficacy studies as required – all of which carry substantial costs.
Vaccines: first steps are clear, but what comes next?
Based on announcements, initial Phase 1 vaccine trials are expected to be covered by CEPI funding. At the same time, Gavi has committed up to US$40 million to accelerate access to successful vaccine candidates, including through support for the production of investigational doses and manufacturing readiness.
However, it remains unclear which access terms have been negotiated, where subsequent trial funding will come from, who will take responsibility for conducting and financing later-stage efficacy studies if they are required, or the subsequent manufacturing, supply and access, including community engagement to improve acceptance and uptake.
Treatments: coordinated trials, but who will access successful candidates?
The most efficient way to identify which candidate works best is through a collaborative platform clinical trial in which all candidates are compared to each other, rather than testing different candidates in competing trials. This “portfolio approach” is currently underway for therapeutic candidates through the WHO-sponsored PARTNERS trial. However, it remains unclear who will fully fund this trial and post-trial activities, and whether there are binding commitments with the companies related to timely, equitable and affordable access if candidates are successful.
Diagnostic tests: a gap in leadership and financing
Finally, while laboratory-based tests capable of detecting Bundibugyo virus are available, the most useful tests in the setting of this outbreak would be rapid, point-of-care diagnostics that can be deployed close to affected communities, much as rapid tests were during COVID-19. There is currently no clearly articulated lead organization responsible for advancing the diagnostics R&D, validation, manufacturing and deployment agenda. It is not clear what financing is available for validation, procurement and deployment, or who is responsible for ensuring that an all-Ebola species point-of-care test becomes available.
Access and stockpiling: who gets products first?
Of major concern remains the potential for high-income stockpiling of successful vaccines, treatments or tests before they are made available in endemic countries. While the Pandemic Agreement recommends that access provisions be built into publicly funded products, the Agreement is still not in force, and one of the major public funders of these products – the United States of America – has left both the Agreement negotiation process and the World Health Organization.
The United States also has Memoranda of Understanding with both the Democratic Republic of the Congo and Uganda. These agreements contain pathogen and data-sharing provisions which have not been made public. Questions therefore remain regarding how such agreements may intersect with future access to products developed using shared samples, data and American public funding.
Past experience demonstrates that even when promising Ebola products are identified, tested and licensed, years may pass before they are available at scale on the frontlines where they are needed most. The vaccine developed during and following the 2014–2016 West Africa outbreak was first used experimentally in Guinea in 2015 but was not deployed at scale until subsequent outbreaks, including the 2018–2020 outbreak in the Democratic Republic of the Congo. Similarly, treatments shown to be effective in previous outbreaks have not become routinely available in the countries most at risk, with access still dependent largely on emergency response arrangements.
Therefore, the Co-Chairs call on all parties to ensure transparency and guarantee timely and equitable access to any successful products for the countries and communities most affected.
Questions that require answers now are:
1. How will all phases of clinical trials be efficiently coordinated, implemented and funded for the identified vaccine and treatment candidates?
2. What are the access commitments for each candidate product — including in-country registration, availability, affordability, equitable access — and are additional funds required for their eventual manufacture, procurement and delivery?
3. What can funders do to guarantee access to everyone requiring these products in the Democratic Republic of the Congo, Uganda and any other directly affected countries, and to ensure resources for community engagement to improve uptake?
4. Who is responsible for ensuring these products are licensed in the countries where they will be required?
5. Are indemnification, insurance and no-fault compensation arrangements being established now so that legal and regulatory issues do not delay access?
6. Who is ensuring that a point-of-care rapid test is developed, funded, validated and deployed for Bundibugyo and other ebolavirus species?
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About The Independent Panel
The Independent Panel for Pandemic Preparedness and Response was established to provide an independent review and recommendations on global pandemic preparedness and response in the wake of the COVID-19 pandemic. Co-chaired by former President of Liberia, Ellen Johnson Sirleaf and former Prime Minister of New Zealand, Helen Clark, the Panel continues to monitor progress and advocate for strengthened global health security.
Media Contact: Secretariat@IndependentPanel.org