Vaccine candidates for poor nations are going to waste

Nature 
Volume 564 Issue 7736, 20 December 2018
http://www.nature.com/nature/current_issue.html

Comment | 18 December 2018
Vaccine candidates for poor nations are going to waste
Promising immunizations for diseases that affect mostly people in low- and middle-income countries need help getting to market, urge David C. Kaslow and colleagues.
David C. Kaslow, Steve Black, David E Bloom, Mahima Datla, David Salisbury & Rino Rappuoli
[Excerpt]
…A way forward
So what should be done? In our view, the main stakeholders must come together to define a new path for the sustainable development of vaccines that are socially justified but that have no business case, an uncertain one, or that require considerable public funding to reach the clinic.
Participants should include funding agencies such as the Wellcome Trust, the Bill & Melinda Gates Foundation and the NIH; early-development partners such as PATH and the International Vaccine Institute in Seoul; vaccine manufacturers from wealthy and emerging economies; and organizations that recommend and procure vaccines for poor countries, such as the WHO and Gavi, the Vaccine Alliance.

The first aim should be to assess all the candidates in the pipeline. To ensure the best use of limited resources, the focus must be the most favourable candidates that face uncertain business cases. Those that are unlikely to have a significant impact socially and economically must be deprioritized.

Ultimately, the stakeholders must specify which organization, or alliance, should drive development for the prioritized vaccines from beginning to end, and what role each partner should have. They must also lay out the practical steps that are most likely to lead to the successful late-stage development and use of these vaccines — including schemes for resourcing.

Money is the main limiting factor. In principle, subsidies from governments, such as those of the G20 countries, and philanthropic organizations such as the Bill & Melinda Gates Foundation, could remedy the market failure threatening vaccine development for LMICs. Gavi provides one form of subsidy (see ‘Spreading the cost’). Support to develop vaccines or to make them available during epidemics is also provided by public organizations, such as the Coalition for Epidemic Preparedness Innovations in Oslo and the Biomedical Advanced Research and Development Authority, part of the US Department of Health and Human Services.

Such schemes need to be expanded and rethought to give vaccine developers more certainty and upfront financial backing. For instance, Gavi could commit to purchasing a vaccine before it has been developed, on the condition that the developers meet certain regulatory milestones. At present, the alliance buys vaccines to distribute to LMICs after they have been licensed or recommended by the WHO for general use.

Regulation is another hurdle. Stakeholders should define clear pathways. They should negotiate more alignment between the various organizations involved in planning, development and oversight. Finally, they should identify what infrastructure and human capacity are needed to ensure that a reliable supply of vaccines can be provided long-term to the people who need them.

Only with this kind of leadership will the global community secure vaccines for some of the world’s most debilitating diseases.