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Breakthroughs brings you stories of bright ideas and bold innovations in global health.

USAID/Tanzania/Rachel Chilton
November 28, 2023

Report provides insight into USAID health R&D programs; shows increase in funding and projects supported but remaining needs

GHTC breaks down the details of US Agency for International Development (USAID)'s recently released report to Congress on its global health research and development (R&D) programs for fiscal year 2023, which shows both important increases in base funding as well as remaining gaps in investment.

Written by Alex Long / GHTC
Written by Adey Fentaw / GHTC
Read time:
Earlier this year, the US Agency for International Development (USAID) released its latest legislatively mandated report to Congress on its global health research and development (R&D) programs for fiscal year 2023. The report, which was recently shared with global health stakeholders following an October townhall with USAID Assistant Administrator for Global Health Dr. Atul Gawande, provides detailed information on individual products supported by the agency and key research advances in 2022, as well as budgeted funding for R&D across health areas.Because of USAID’s unique role as a key sponsor of global health product development, the Global Health Technologies Coalition (GHTC) closely tracks these annual reports to catalog the agency’s investments in its research pipeline and technological advances for low-resource settings.What has changed from last year?The most recent report, which comes on the heels of the agency’s new Global Health Research and Development Strategy 2023–2028, shows an increase from fiscal year 2021 (FY21) to fiscal year 2022 (FY22) in both products supported by the agency and budget allocated to advancing new lines of research and partnerships.The repeat details that the agency supported at least 63 individual products via its R&D investments in 2022, up 4 from 2021. Not surprisingly, the agency’s R&D portfolio in 2022 looked similar to 2021 in terms of the core health areas and product types financed.The report also revealed that in 2022, USAID budgeted $214 million in total baseline (non-supplemental) funding for global health R&D projects. This represents an increase of roughly $49 million from 2021, with the lion’s share coming from a plus up via the Global Health Security line for the Coalition for Epidemic Preparedness Innovations (CEPI), from $4 million in FY21 to $55 million in FY22. It is worth noting that in FY21, USAID allocated $50 million in COVID-19 supplemental funding from the American Rescue Plan Act for Global Health Security R&D. Thus, with supplemental funds included, FY21 funding numbers were more on par with FY22. This leads us to speculate that the supplemental increase in FY21 funds laid the groundwork for successfully justifying an increase in FY22 base funding for global health security-related R&D.While the $214 million budgeted for R&D in 2022 represents the highest non-inflation-adjusted baseline funding for R&D ever reported by the agency since 2006 (when R&D spending is viewed as a proportion of total USAID global health spending), the picture that emerges is far less rosy. While proportional spending on R&D rose slightly by 0.4 percent from FY21, bringing it to 5.5 percent—this was still far below the 8 percent peak that the agency spent on R&D in 2006 and unfortunately does not fundamentally shift the trajectory of the years-long decline in proportional R&D spending by the agency.The path aheadWhile GHTC is pleased to see the increase in base funding for global health R&D and R&D spending as a proportion of overall global health funding, as GHTC’s analysis indicates, there are still core gaps in the agency’s R&D investment areas and a need to better resource the global health R&D portfolio after years of decreased proportional investment since 2006. GHTC has been advocating for the creation of a new disease-agnostic fund for global health R&D at USAID, deemed the Supporting Innovative Global Health Technologies (SIGHT) Fund, to direct more dedicated resources to R&D. Earlier this month, we welcomed the first step towards that vision, with the House introduction of the bipartisan SIGHT Act (H.R. 6424), which would establish the programmatic structure at USAID for such a fund to be realized. We look forward to advancing the SIGHT Act, as well as what similar calls for greater investment in global health R&D spending can do for advancing health and well-being in all settings.

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USAID/Tanzania/Rachel Chilton
November 28, 2023

Report provides insight into USAID health R&D programs; shows increase in funding and projects supported but remaining needs

GHTC breaks down the details of US Agency for International Development (USAID)'s recently released report to Congress on its global health research and development (R&D) programs for fiscal year 2023, which shows both important increases in base funding as well as remaining gaps in investment.

Written by Alex Long / GHTC
Written by Adey Fentaw / GHTC
Read time:
Earlier this year, the US Agency for International Development (USAID) released its latest legislatively mandated report to Congress on its global health research and development (R&D) programs for fiscal year 2023. The report, which was recently shared with global health stakeholders following an October townhall with USAID Assistant Administrator for Global Health Dr. Atul Gawande, provides detailed information on individual products supported by the agency and key research advances in 2022, as well as budgeted funding for R&D across health areas.Because of USAID’s unique role as a key sponsor of global health product development, the Global Health Technologies Coalition (GHTC) closely tracks these annual reports to catalog the agency’s investments in its research pipeline and technological advances for low-resource settings.What has changed from last year?The most recent report, which comes on the heels of the agency’s new Global Health Research and Development Strategy 2023–2028, shows an increase from fiscal year 2021 (FY21) to fiscal year 2022 (FY22) in both products supported by the agency and budget allocated to advancing new lines of research and partnerships.The repeat details that the agency supported at least 63 individual products via its R&D investments in 2022, up 4 from 2021. Not surprisingly, the agency’s R&D portfolio in 2022 looked similar to 2021 in terms of the core health areas and product types financed.The report also revealed that in 2022, USAID budgeted $214 million in total baseline (non-supplemental) funding for global health R&D projects. This represents an increase of roughly $49 million from 2021, with the lion’s share coming from a plus up via the Global Health Security line for the Coalition for Epidemic Preparedness Innovations (CEPI), from $4 million in FY21 to $55 million in FY22. It is worth noting that in FY21, USAID allocated $50 million in COVID-19 supplemental funding from the American Rescue Plan Act for Global Health Security R&D. Thus, with supplemental funds included, FY21 funding numbers were more on par with FY22. This leads us to speculate that the supplemental increase in FY21 funds laid the groundwork for successfully justifying an increase in FY22 base funding for global health security-related R&D.While the $214 million budgeted for R&D in 2022 represents the highest non-inflation-adjusted baseline funding for R&D ever reported by the agency since 2006 (when R&D spending is viewed as a proportion of total USAID global health spending), the picture that emerges is far less rosy. While proportional spending on R&D rose slightly by 0.4 percent from FY21, bringing it to 5.5 percent—this was still far below the 8 percent peak that the agency spent on R&D in 2006 and unfortunately does not fundamentally shift the trajectory of the years-long decline in proportional R&D spending by the agency.The path aheadWhile GHTC is pleased to see the increase in base funding for global health R&D and R&D spending as a proportion of overall global health funding, as GHTC’s analysis indicates, there are still core gaps in the agency’s R&D investment areas and a need to better resource the global health R&D portfolio after years of decreased proportional investment since 2006. GHTC has been advocating for the creation of a new disease-agnostic fund for global health R&D at USAID, deemed the Supporting Innovative Global Health Technologies (SIGHT) Fund, to direct more dedicated resources to R&D. Earlier this month, we welcomed the first step towards that vision, with the House introduction of the bipartisan SIGHT Act (H.R. 6424), which would establish the programmatic structure at USAID for such a fund to be realized. We look forward to advancing the SIGHT Act, as well as what similar calls for greater investment in global health R&D spending can do for advancing health and well-being in all settings.
Lan Andrian/GHSC-PSM
November 27, 2023

Research Roundup: Severe malaria intervention, New mycetoma drug trial, Neonatal sepsis treatment funding

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

Written by Hannah Sachs-Wetstone / GHTC
Read time:
Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A new phase IV observational study will test whether a novel approach to managing severe malaria, involving interim treatment with rectal artesunate, could address the challenge of treating those with severe cases in isolated rural settings far from a health facility. In the study, patients will be treated with artesunate rectal capsules at the community level and evaluated for clinical outcomes and then will receive follow up treatment with oral artemisinin-based combination therapies once they are well enough to swallow the medicine. The study, led by the newly created Severe Malaria treatment with Rectal artesunate and Arteminisin-based Combination Therapy [in remote settings] (SEMA ReACT) consortium, is intended to generate evidence to inform gaps in guidance on how to approach treatment when it is not feasible to transfer severely ill patients in timely manner to high-level health facilities as current guidance recommends.The results from a new study coordinated by the Drugs for Neglected Diseases initiative (DNDi), the Japanese pharmaceutical company Eisai, and the Mycetoma Research Center in Khartoum found that the oral drug fosravuconazole is up to 85 percent effective in treating the neglected tropical disease mycetoma and has no side effects. Currently, mycetoma is treated with itraconazole, a drug which needs to be taken with food four times a day for a year, has a myriad of side effects, is expensive, and is not available in all endemic countries. In contrast, fosravuconazole, only needs to be taken once a day without food, is inexpensive, and already widely used to treat fungal nail infections—factors that enhance its suitability for widespread use in low-resource settings.The Global Antibiotic Research & Development Partnership (GARDP) has been awarded around $3.07 million from the Research Investment for Global Health Technology Foundation to support an international clinical trial to evaluate three novel antibiotic regimens for neonatal sepsis. This infection affects over 3 million newborns every year, most of whom live in low- and middle-income countries. The trial, run by GARP and partners, is underway in Kenya and South Africa and will expand to more countries next year. The funding will also enable GARDP to collaborate with South Korean Jeil Pharma to explore options to optimize the manufacturing and approval of the novel antibiotics included in the regimens under study to ensure affordable prices and stable supplies of the drugs.
PATH/Ruhani Kaur
November 20, 2023

Research Roundup: New TB drug trial, No-needle vaccine funding, Common antibiotic effective for TB

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

Written by Hannah Sachs-Wetstone / GHTC
Read time:
Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. TB Alliance has launched a new pan-phase 2 clinical trial to evaluate the safety and efficacy of replacing bedaquiline with a new experimental compound, TBAJ-876, in the organization’s three-drug BPaL regimen. The new regimen, composed of novel compounds with minimal pre-existing resistance, could provide a method to treat all patients with active tuberculosis (TB), including drug-sensitive and drug-resistant TB, with a universal treatment that is shorter, simpler, and more people-friendly than current regimens. Results from the preclinical and phase 2 studies showed that TBAJ-876, compared to bedaquiline, eliminated TB bacteria faster and was potentially safer. The study aims to enroll 300 participants with drug-sensitive TB at 21 trial sites in Georgia, the Philippines, South Africa, Tanzania, and Uganda.  Last week, the Bill & Melinda Gates Foundation announced a $23.6 million grant to US-based life science company Micron Biomedical to fund the first-ever mass production of needle-free vaccine technology. The technology, which uses dissolvable microneedles attached to the skin via a patch-like device, has the potential to boost the uptake of a variety of injectables, particularly in low-income countries, because it is simpler to transport and easier to administer. Specifically, the funding will support the development of a manufacturing facility that can make around 10 million doses annually for large clinical trials and hopefully wider use, subject to approval from regulatory authorities.A phase 3 clinical trial in South Africa found that a widely available oral antibiotic, levofloxacin, was safe and substantially reduced the risk of children and adults developing multidrug-resistant tuberculosis (MDR-TB). The trial is the first high-quality study to look at a preventive treatment for MDR-TB in children—there are currently no preventive MDR-TB treatments for adults or children. The researchers hope the new results will lead to updated guidelines from the World Health Organization that will lead to the rapid scale-up of levofloxacin because the drug is already widely available and relatively affordable, with child-friendly formulations already available through procurement agencies.  
USAID
November 13, 2023

Research Roundup: Chikungunya vaccine approval, Kenyan malaria producer gets WHO approval, TB drug resistance

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

Written by Hannah Sachs-Wetstone / GHTC
Read time:
Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last Thursday, the US Food and Drug Administration (FDA) announced its approval of the first vaccine to prevent the disease caused by the chikungunya virus. The Ixchiq vaccine, developed by Valenva, is approved for adults at increased risk of exposure to the virus. It was previously granted fast-track and breakthrough therapy designations from FDA. Chikungunya is a chronic and debilitating disease that has no specific treatment, which has become an increasing global threat due to climate change. FDA is requiring that Valneva perform a post-market study to continue to monitor the vaccine’s safety and side effects.With support from Medicines for Malaria Venture (MMV), Kenyan manufacturer Universal Corporation Ltd has received prequalification from the World Health Organization (WHO) for sulfadoxine-pyrimethamine plus amodiaquine (SPAQ), an antimalarial drug used to prevent seasonal malaria in children during peak transmission periods. This approval, which makes UCL only the sixth African pharmaceutical company to have a product WHO-prequalified, will allow Africa to reduce reliance on imported generic versions of the drug from India and China. In the face of a myriad of barriers to quality local drug production and a persistently high burden of malaria cases and deaths, the approval will also make it easier for other African companies to enter the market and attract major buyers, as well as ensure the accessibility and availability of the drug where it is most needed and free up national resources to dedicate to other aspects of the malaria response.A new study found that more than half of tuberculosis (TB) patients in South Africa receiving treatment with a bedaquiline-containing regimen had isolates resistant to the drug, which was introduced in South Africa in 2012 and has recently become part of all standard drug-resistant TB regimens globally. The study is one of the first to report individual-level bedaquiline resistance gain over time among patients in a setting with a bedaquiline-containing regimen as the standard treatment. The results highlight the need for drug-susceptibility testing capacity to accompany the scale-up of new drugs like bedaquiline to monitor the emergence of drug resistance.