Breakthroughs Blog

For the first time, global leaders have come together to lay out a comprehensive plan for pandemic prevention, preparedness, and response. After over three years and 13 formal rounds of negotiations, member states of the World Health Organization (WHO) defied expectations and reached consensus on a Pandemic Agreement. The final draft of this legally binding instrument will lay the groundwork for stronger global cooperation and be a major catalyst for a more robust research ecosystem that ensures that the fruits of innovation are more equitably shared.  A win for multilateralism! This agreement is a major win for multilateralism. At times, there were reasons to think the negotiations might fail, including seemingly intractable disagreements between high-income and low- and middle-income countries on access and intellectual property issues. Then came the announcement in January that the United States intended to withdraw from WHO and would take no further part in the treaty talks. International cooperation has been tested, and it was important for the global health community to clear this hurdle.  While the text agreed upon in Geneva reflects compromise and not all negotiators’ ambitions were met, it represents important progress and lays the groundwork for action toward global readiness and equity in future health emergencies.  What’s in it for R&D? Efforts to accelerate the research and development (R&D) of vaccines, drugs, and other medical countermeasures were at the heart of the negotiations, and member states agreed to the following priorities: Promote technology transfer—which involves the transfer of scientific knowledge and know-how from one party to another to facilitate the broader production and availability of products—under “mutually agreed” terms. While this qualifier was disappointing to some low-income countries who had hoped for stronger commitments to help scale up local manufacturing of lifesaving medical countermeasures, it was ultimately a red line for wealthier countries, which prioritized preserving existing intellectual property frameworks.  In a historic first, the text obligates countries to attach conditions for access to publicly funded R&D contracts, a landmark step toward promoting equity. If implemented effectively, this means countries would be empowered to use contract enforcement measures to ensure public R&D spending ultimately results in products that reach patients. An agreement to promote post-clinical trial access to products for trial populations and for populations at risk in their communities, as well as commitments to support the transparent publication of clinical trials protocols and research results.  A framework for a new Pathogen Access and Benefits Sharing (PABS) system that grants companies access to scientific data, such as pathogen samples and genomic sequences, in return for more equitable sharing of drugs, vaccines, and diagnostics during a pandemic. Countries agreed that 20 percent of the vaccines, drugs, and diagnostics produced by participating manufacturers will be made available to the WHO for distribution. PABS wasn’t finalized during the negotiations and will now have to be fully developed through a new working group and added as a separate annex to the agreement. Establishment of a Global Supply Chain and Logistics Network to coordinate resource allocation, reduce access barriers, and mitigate the practice of hoarding of pandemic products through shared stockpiles. Beyond R&D, other key elements of the proposed agreement include a commitment to a “One Health” approach to pandemic prevention, efforts to strengthen national health systems, and the creation of a coordinating financial mechanism to support implementation of new obligations and capacity-strengthening measures.For a more detailed breakdown of the agreement, check out this briefer!Next steps: World Health Assembly and beyond After three years of intense negotiations and significant progress made toward aligning key provisions, critical procedural steps remain before the agreement can be formally adopted and implemented.   First, the text must be adopted by member states at the World Health Assembly later this month. There will then be an intergovernmental working group that will convene to hash out the details of the PABS system, likely over the course of the next year. Once the PABS annex has been finalized, at least 60 countries must ratify the treaty—in accordance with their own national laws and processes—in order for the Pandemic Agreement to become international law and enter into force. Finally, in order to support implementation and ensure enforcement and accountability, a “conference of parties” will be established to regularly review the agreement’s implementation.  The agreement has now reached an important milestone, but the work is not done. Leaders must carry it across the finish line later this month before committing to the task of ensuring its success through robust implementation. 

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.