In what WHO is describing as a “significant stride towards facilitating and informing priorities in global vaccine development” it has commissioned 16 “Vaccine Value Profiles (VVPs)” to be published in Vaccine. This is a result of “collaborations” with pathogen and vaccine experts directed by the Product Development and Research team in WHO’s Immunisation, Vaccines & Biologicals department. The primary objective is the advancement of the development of vaccines for pathogens that “pose a substantial public health and socio-economic burden, especially in low- and middle-income countries (LMICs)”.
What and why: VVPs
“Despite the recognised public health need for vaccines against the most important pathogens causing disease and death, investment in research and development for many of these vaccines is hindered for reasons including challenging biological and technical feasibility, complex and costly pathways to regulatory approval and policy, and uncertain demand, impact, and uptake.”
So begins the Vaccine Value Profiles editorial in the supplement. The authors suggest that the “hurdles” are “most detrimental” for vaccines without a “substantial high-income country market”, and for which “commitment to product development and commercialisation” relies on “clear articulation and quantification” of the value they bring to countries in need. They identify a need for this value assessment to begin at early development stage to ensure that products “with the greatest value to consumers are developed”.
The intriguingly named “valley of death” between discovery and early clinical development must be avoided. Therefore, the WHO team encourages assessments of vaccine value through two main instruments: the Vaccine Value Profile and the Full Value of Vaccine Assessment (FVVA). The former uses a “templated format” to offer a consistent and holistic overview” of currently available data to define vaccine value for a specific pathogen. VVPs can identify research gaps that must be addressed to assess potential vaccine “impact” as part of an FVVA.
WHO states that VVPs “serve as comprehensive summaries of critical evidence” that inform funding, research initiatives, and clinical and policy development strategies. They are “key resources for multiple stakeholders” in the vaccine community. For example, they are helping to direct Gavi’s Vaccine Investment Strategy (VIS), which we look forward to covering in our forthcoming interview with Gavi’s Dr Marta Tufet Bayona.
What does the supplement offer?
The special issue contains 16 VVPs for vaccines and prophylactic monoclonal antibodies against respiratory syncytial virus (RSV), Shigella, Enterotoxigenic Escherichia coli (ETEC), Group B Streptococcus, Salmonella paratyphi A., norovirus, Neisseria gonorrhoeae, cytomegalovirus (CMV), Chikungunya, invasive non-typhoidal Salmonella (iNTS), hookworm, leishmaniasis, schistosomiasis, malaria, tuberculosis, and herpes simplex virus (HSV).
It will comprise two volumes, the first of which can be read here. Each profile has been developed by “globally diverse independent subject matter experts” according to the VVP template. The second volume is expected later this year. Dr Katherine O’Brien, Director of Immunisation, Vaccines & Biologicals at WHO, hopes to “leverage” lessons from the published profiles to “work in-step” with “key stakeholders”. This will “accelerate vaccine development and ensure access”, fortifying global health and improving equity.
Professor Ruth Karron of Johns Hopkins University identifies in the profiles a “potential to catalyse vaccine development and activate new research collaborations”.
“Our goal is to provide stakeholders, including R&D funders, policymakers, regulators, manufacturers, and the public, with the insights necessary to make informed defcisions and accelerate the development of vaccines that will have the greatest impact.”
Some of our wonderful speakers have contributed to this project, so do let us know your thoughts on their work, and how you think these VVPs can inform your work, if at all. For more insights and updates, and to ensure you don’t miss our interview with Dr Tufet Bayona, make sure you subscribe here.