Breakthroughs Blog

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 week, the US Department of Health and Human Services announced a $500 million investment into a vaccine project under a new initiative called Generation Gold Standard, which aims to advance universal influenza vaccines, hoping to get a vaccine into clinical trials next year and approved by 2029. The initiative, funding for which will come from the Biomedical Advanced Research and Development Authority, seems to be replacing Project NextGen, which had previously funded research into potential COVID-19 vaccines and treatments. Some experts and officials have expressed surprise at the direction of the initiative and the size of the investment.Scientists have discovered that a device used to diagnose bacterial meningitis in blood can also measure it in cerebrospinal fluid, helping speed accurate diagnosis and treatment of the illness, which is the most dangerous form of meningitis and a significant global health threat. The device has demonstrated high sensitivity in multiple cohorts of patients and it’s also affordable and delivers results within a half hour after spinal tap. The test was developed at an impressive speed, now available to patients within just a year of its discovery.Newly shared results from a clinical trial from the National Cancer Institute seem to confirm that a single dose of the vaccine used to prevent human papillomavirus (HPV) virus infection is just as effective as two, a finding that could transform efforts to reach the millions of children globally who are not getting vaccinated according to recommendations. Expanding HPV vaccination will also help reduce the global burden of cervical cancer deaths and deaths from other HPV cancers. While two doses are currently recommended, reducing the required dosage could make dissemination much easier and cheaper for many countries.

Earlier this month, GHTC obtained a copy of a report that the US Agency for International Development (USAID) submitted to Congress in November 2024 on its global health research and development (R&D) activities. This report—which was mandated by Congress but never released publicly—provides detailed information on the R&D investments made across health areas and the specific innovations supported by the agency in fiscal year (FY) 2023.Given USAID’s decades-long track record of advancing affordable, high-impact global health innovations, GHTC closely monitors these annual R&D reports to track shifts in the agency’s investments and innovation pipeline and to help ensure that taxpayer resources are strategically directed toward the greatest global health impact. While each year’s report is noteworthy and essential for accountability, this latest report is of particular significance, as it gives the clearest picture we have to date of what health R&D USAID was funding prior to recent funding shifts. It also offers a stark illustration of the scale of promising research that is now at risk.  Our analysis of the report along with circulating lists of active and canceled USAID awards suggest that the vast majority of R&D programs and partnerships highlighted in the report have since been terminated as the United States rapidly scales back its foreign assistance footprint and reorients its approach to foreign policy. What’s changed from FY 2022 to FY 2023?Before analyzing the potential impact of recent political shifts, we first examined what had changed in USAID’s funding approach from the prior reported year. Our analysis shows a slight decrease from FY 2022 to FY 2023 in products and projects supported by the agency but an overall increase in funding allocated to health R&D.The report appendix details 56 individual products or projects supported by USAID R&D investments in 2023, which is down slightly from the 63 listed in 2022. Overall, the agency’s portfolio in 2023 looked similar to 2022 in terms of the health areas and product types financed, with the addition of new investments in diagnostics for emerging infectious diseases. The report also revealed that in 2023, USAID budgeted $252.2 million in funding for global health R&D projects—an increase of $37.4 million, or roughly 17 percent, from 2022. This is noteworthy as it represents the highest non-inflation-adjusted baseline funding for R&D ever reported by the agency since 2006. This a welcome increase, and it also indicates that USAID was following a report language directive from Congress for the agency to increase its annual health R&D spending (for which GHTC had advocated).The largest increases were seen in funding for global health security R&D, which grew by $41.96 million or 68 percent, and funding for “other public health threats,” which grew by $5.86 million or 114 percent from the prior year. The latter is a catchall that appears to include funding for neglected tropical diseases; water, sanitation, and hygiene; health system strengthening research; and anything else that falls outside the groupings of HIV/AIDS, tuberculosis (TB), global health security, maternal and child health, family planning and reproductive health, and nutrition.USAID funding for R&D for TB and nutrition also grew by 14 percent and 44 percent respectively. Meanwhile, funding for HIV/AIDS remained the same, while funding fell for family planning and reproductive health by 54 percent, for malaria by 26 percent, and for maternal and child health by 20 percent. It’s not entirely clear to what degree these changes reflect a shift in political prioritization versus the normal cyclical shifts that can occur in R&D costs as products advance through the R&D process. Other contributing factors may include increased private-sector investment, particularly in areas like HIV; strategic pivots toward later-stage implementation or procurement; and adjustments based on the anticipated regulatory or market readiness of specific technologies.While the $252.2 million budgeted funding for R&D in 2023 represents the highest ever reported by the agency, when R&D spending is calculated as a proportion of overall USAID global health spending, there is far more tempered cause for celebration.While proportional spending on R&D in FY 2023 rose slightly by 0.51 percent from FY 2022, bringing it to just over 6 percent, this is still below the 8 percent peak that the agency spent on R&D in 2006, representing a slight upward slope in an otherwise years-long trajectory of decline in the agency’s proportional R&D spending.A higher proportion investment helped ensure that the United States remained a leader in driving innovation for diseases disproportionately affecting low- and middle-income countries.What’s now at risk?While GHTC is pleased to see the increase in USAID’s FY 2023 global health R&D funding and the increased proportion of overall global health spending it represents, this report highlights the many promising research advancements now at risk and the valuable agency expertise that could be lost amid recent political shifts.It is challenging to determine with certainty which USAID-supported R&D efforts listed in the report have been ended under the US government’s foreign assistance overhaul, given 1) that there have been different and contradictory lists reported of which USAID awards remain active/terminated, and 2) the appendix of USAID-supported health products/projects included in the R&D report does not include associated award IDs, names, or prime recipients, making it difficult to definitively compare and match projects against the aforementioned lists.However, using the descriptions and partners listed and leveraging additional online research, our own sectoral knowledge, and self-reported information from our members and partners, GHTC has attempted to match this information. Based on our analysis, we believe at least 49 of the 56 products/projects listed are associated with USAID awards that have been terminated (six were identified as active and one was affiliated with an award that ended in 2024).Given the recent actions taken to minimize USAID’s footprint and fold its remaining programming into the Department of State, we are unlikely to see a report on R&D investments undertaken in FY 2024—possibly leaving us without a full accounting of what’s been lost and the R&D community without essential data needed to understand the progression of these promising investments.Among the USAID projects we know are canceled from our analysis include efforts to develop the world’s first HIV vaccine, new tools to combat drug-resistant TB, next-generation malaria vaccines, novel insecticides and other vector control products, point-of-care diagnostics for neglected tropical diseases, and new HIV prevention products, including those designed for women and girls who are at high risk of infection.These findings are worrisome on many fronts. First, these changes risk squandering past progress and investments, and jeopardizing the next generation of promising global health breakthroughs. Today, we are still without essential technologies needed to achieve a future where pandemics are prevented and health is within reach for everyone—underscoring the need for donors to sustainably increase, not reduce, their investments.Second, USAID has for decades brought unique value, vision, and capabilities to the global health innovation space by focusing on the late-state development of technologies that are affordable, appropriate for last-mile settings, and prime for widespread global adoption. Career staff at USAID also had very strong subject matter expertise. There is concern that these skills and capabilities could be lost as the US government’s foreign assistance structure is reimagined and rebuilt, meaning that terminations and the broader foreign aid overhaul will have an outsized impact on the R&D ecosystem.Finally, these investments also deliver substantial returns to the United States by strengthening our economy, creating American jobs, and keeping Americans safe from deadly diseases—benefits that could now be lost as the United States draws back its support. Between 2007 and 2002, $46 billion in US government investment in global health R&D led to $104 billion in direct economic activity and the creation of more than 600,000 jobs nationwide. The follow-on effects from US-backed global health research are projected to generate $255 billion for the US economy.As the US government overhauls and reimagines what the future of US foreign assistance will look like, we believe it is critical that science, technology and innovation remain a cornerstone of its global health mission. These are strategic, win-win investments that bring benefits to the world and to Americans.See the below links to past USAID health R&D reports and strategies, which are no longer available on government websites.20082009201020122013201420152016Strategy (2017-2022)20172018201920202022Strategy (2023-2028)20232024

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 study published in The Lancet Infectious Diseases ahead of World Malaria Day last week found that adding a low dose of the widely available antimalarial drug primaquine to artemisinin-based combination therapy is safe and effective at blocking Plasmodium falciparum malaria transmission in young children in areas of low- and moderate-to-high transmission. The new study fills a gap in knowledge of the safety and efficacy of this approach for young children, who face the highest burden of clinical malaria and are particularly at risk of artemisinin-resistant strains but could face adverse complications from adult formulations of primaquine. The findings highlight the need for child-friendly formulations of primaquine and support the expanded use of the drug in regions with a moderate-to-high transmission rate and the threat of artemisinin partial resistance.The Drugs for Neglected Diseases initiative, the National Health Service University Hospitals of Liverpool Group, and the University of Liverpool have initiated a clinical trial in Liverpool, United Kingdom to test an oral drug for visceral leishmaniasis, one of the world’s deadliest parasitic diseases. Current treatments for visceral leishmaniasis, which is almost always fatal if left untreated, include daily injections for up to 17 days, which can cause immediate pain, as well as nausea, vomiting, and more serious complications. The new oral drug, DNDI-6899, is easier to store, transport, and administer than current treatments. If proven successful, the drug could help make treatment more accessible to those who need it most.DioSynVax and ACM BioLabs have signed a new deal to jointly develop a next-generation avian flu vaccine with the potential for mucosal vaccine delivery, as the virus continues its worrying spread. The mRNA vaccine targets all major clades of the H5 avian flu subtype and could be scaled for rapid distribution globally in the case of a pandemic. The vaccine is also designed to be delivered via nasal spray, which could help increase uptake; to induce mucosal immunity, which helps fight the pathogen before it starts circulating the body; and to be temperature stable, enabling rollout in lower-resource settings.

In 2001, I traveled to Ghana as a graduate student working on a US Agency for International Development-funded decentralization program. I arrived armed with materials on local governance best practices. But the mayors I met were focused on urgent public health issues: clean water, HIV/AIDS, tuberculosis, and malaria. That trip, meant to be an early lesson in governance, became my first and most personal education in global health. It also nearly killed me. I was taking mefloquine weekly to prevent malaria. Toward the end of our stay, my partner and I set off to explore the country. Somewhere along the way, I developed what I believed to be giardia. That infection likely compromised the absorption of the mefloquine and left me dangerously vulnerable. One night in the village of Kokrobite, I woke with a high fever and chills so intense I could barely stand. A local man saw me and immediately recognized it as malaria. He arranged for a taxi to take me back to Accra. Before I left, he handed me a small, crumpled packet labeled in Chinese characters. Inside was a blister pack of pills. The only word written in English on the package was artesunate. He told me it would help, and, in that moment, sick, scared, and weak, I took it. At the hospital, a blood smear confirmed that I had cerebral malaria caused by Plasmodium falciparum, the deadliest strain. Cerebral malaria can cause brain swelling, coma, and death. I drifted in and out of consciousness for days. At one point, hospital staff told my partner that there was nothing more they could do. I should “go home” and be “as comfortable as possible.”My partner worked relentlessly to get me on one of the next flights back to the United States. I was so sick that the airline nearly refused to let me board. Once we arrived home, I was seen right away by an infectious disease doctor at Johns Hopkins Hospital. After reviewing my labs and the herbal remedy package, he said plainly: this saved your life. The artesunate had bought me enough time to survive the journey and begin treatment. At the time, the World Health Organization had not yet formally endorsed artemisinin-based combination therapies (ACTs) as the global standard for P. falciparum malaria. That came in 2006. But the effectiveness of artesunate alone was already well known in many parts of the world. That medicine saved my life.I missed several weeks of school but made a full recovery. Without that drug and the help of my partner (now my husband) and friends in Accra, I wouldn’t be here today. More than two decades have passed, and we've made tremendous progress. Insecticide-treated bed nets, rapid diagnostic tests, and ACTs have saved millions of lives. Two malaria vaccines, RTS,S and R21/Matrix-M, have been approved. Long-acting monoclonal antibodies are showing promise as seasonal protection for children. Newer insecticide-treated nets help counter resistance. And researchers are exploring RNA-based therapeutics and single-dose cures.Many of these breakthroughs are being developed by members of the Global Health Technologies Coalition, where I now serve as Executive Director. These tools represent our best chance not just to control malaria but to end it.But progress is not guaranteed. Cuts to foreign assistance and global health research and development are already slowing the progress of innovations in the pipeline. Some promising tools may be delayed or abandoned. That means more children at risk, more untreated infections, and more drug-resistant strains emerging. The parasite has evolved before. It will do so again if we let it. And malaria is no longer a disease that happens mostly outside of the United States. In the past two years, locally acquired cases have been reported in Florida, Texas, and Maryland. Climate change, global travel, and changing mosquito habitats are making malaria a threat we can no longer treat as distant. I know how thin the line is between surviving this disease and not. For me, it’s not abstract. It’s the memory of a fevered body, the generosity of strangers, and a medicine in the right place at the right time. This World Malaria Day, I urge leaders and policymakers to stay the course. The science is moving forward. But science alone isn’t enough. If we don’t finish what we’ve started, we risk letting malaria surge back and take more lives with it. Science has given us the tools. The question now is whether we will act in time or let the disease outpace us once again.