The development of vaccines, drugs, and diagnostics for infectious diseases that disproportionately affect people in lower-income countries is systematically neglected. These health problems are often massive in scale, but addressing them is not lucrative relative to addressing the health needs of people in higher-income countries. To take one example, around $50 billion per year is spent on cancer R&D, when cancers lead to 242 million years of life lost annually (~$200 per year of life lost). By contrast, tuberculosis had around $17 per year of life lost and diarrheal diseases had less than $3 per year of life lost in R&D in 2020.1
Historically, Open Philanthropy has sought to address global health problems in two ways: service delivery and R&D. We fund service delivery in global health through our partnership with GiveWell. This funding supports health programs that make use of basic commodities such as insecticide-treated bednets, vitamin A supplements, and drugs used as prophylaxis for malaria in children. We also have a science program which invests in a mixture of basic research and product development related to diseases and risk factors that disproportionately affect people in lower-income countries. To date, that has included funding research into infectious diseases, as well as funding the development of new therapeutic drugs, vaccines, diagnostic tests, and vector control tools.
Through the Regranting Challenge, we are supporting the Bill & Melinda Gates Foundation and its grantees in advancing solutions to global health R&D outside of our own existing efforts.
We are supporting the Gates Foundation to fund grantees who are advancing a new vaccine through efficacy trials against tuberculosis (TB) in adults. There is an existing TB vaccine in widespread use for children (BCG), but it is now over 100 years old, and most TB deaths, as well as transmission, occur in adults. The vaccine candidate supported by this funding would target those who are not well protected by BCG. If successful, it would complement other vaccines already in development if they successfully pass their trials, or serve as a critical backup if those vaccines don’t succeed.
Tuberculosis is one of the deadliest infectious diseases in the world. In 2021, it killed 1.6 million people, and the number of people who fell ill with TB, approximately 10.6 million, increased for the first time in two decades.
Late-stage TB vaccine trials are expensive: like all late-stage vaccine trials, they need large numbers of participants to detect an effect. The relatively low incidence of TB at a population level exacerbates this dynamic. Tuberculosis also takes a long time to develop and manifest clinically, which extends the time of a vaccine trial and increases costs.
We do not believe that other funders would move this vaccine candidate forward without our support. There are relatively few funders and little funding available for TB work, even compared to other disease verticals within global health. We estimate that our funding is likely to accelerate the availability of the final result by two to three years. Even with uncertainty about the vaccine’s ultimate success, TB is such a massive problem that we view the program as a valuable effort.
"The Gates team [has] a strong network of researchers and a longstanding dedication to the advancement of TB vaccine research. There are few funding agencies with similar capabilities, scope, and access in this critically needed space."
— Dr. Mireille Kamariza, Assistant Professor of Bioengineering, UCLA
Expeditious completion of a clinical trial would represent a success for this award. Additionally, if the results are promising (and depending on the results from other late-stage vaccine trials, such as those for M72/AS01E), we would hope to see this candidate move towards regulatory approval and widespread deployment.
We are supporting the Gates Foundation to fund grantees who are working to diversify the oral cholera vaccine manufacturing base and increase vaccine supply to better meet global demand. Specifically, the funds will support a new vaccine manufacturer and/or a product development partner to expand the supply of oral cholera vaccine.
The IHME Global Burden of Disease Study estimates that in 2019, cholera was responsible for the deaths of over 117,000 people, 55,000 of whom were children under 5 years of age. The vast majority of this burden (93,000 people) is concentrated in sub-Saharan Africa. Despite this burden, cholera receives little R&D funding, making it one of the most neglected areas of global health R&D.
Cholera afflicts people already burdened by poverty, lack of infrastructure, poor health systems, and malnutrition. The risk for cholera is heightened in times of conflict and climate events. Over the last year, there has been an unprecedented number of large cholera outbreaks. Unfortunately, one of the key interventions — oral cholera vaccine — is extremely limited in supply and unable to meet the high demand.
Vaccine supply issues will be exacerbated in the next few years as one of the two global manufacturers that provide cholera vaccines to low-income countries exits the market in 2023. Cholera vaccines are important because they take effect immediately and prevent cholera for three years, bridging emergency response and longer-term cholera control. We estimate that an additional manufacturer will increase the total vaccine doses available and speed up the rate of their deployment in outbreak settings, potentially saving thousands of lives per year.
"The BMGF team is well connected to all aspects of the cholera world and has a proven track record of being able to fund successful tech transfers, while helping to shape the political side of demand generation through data and advocacy."
— Dr. Andrew Azman, Associate Scientist, Department of Epidemiology, Johns Hopkins University
We expect our funding to help a new vaccine manufacturer and/or product development partner obtain both local licensure and WHO prequalification (to allow the vaccines to be supplied to the global cholera vaccine stockpile). Assuming technical and regulatory success, we hope to help supply tens of millions of vaccines to the global stockpile annually by 2028, and to consequently reach children and adults throughout Africa, South Asia and other regions affected by cholera.