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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, Ghana became the first country to approve a new malaria vaccine developed by the University of Oxford’s Jenner Institute. The vaccine, R21, is the second-ever vaccine for malaria authorized for use by regulators. Ghana’s Food and Drugs Authority approved the shot for use in children between 5 and 36 months old based on final data from an ongoing phase 3 trial in almost 5,000 children. The results have yet to be published but were shared with regulatory agencies. The vaccine could become an important tool in the fight against malaria and in reducing child mortality, especially if Ghana’s approval is echoed in other countries and by the World Health Organization. The COVID-19 pandemic revealed the consequences of limited genome sequencing capabilities on the African continent and has pushed national laboratories to ramp up their ability in preparation for future pandemics. Thirty-nine African countries now have the equipment and skilled workforce for sequencing, as part of a continent-wide network with specialized training centers and regional hubs. However, capacity levels across laboratories vary, and there is a need to move beyond sequencing the virus that causes COVID-19 to broader applications and for increased training in data analysis.The Biden administration last week announced the launch of Project Next Gen, the US$5 billion-plus program that succeeds the President Trump-era Operation Warp Speed to accelerate the development of new coronavirus vaccines and treatments to address COVID-19 and future coronavirus threats. The program will primarily focus on three objectives: creating long-lasting monoclonal antibodies, advancing vaccines that produce mucosal immunity, and developing pan-coronavirus vaccines. Administration officials expressed their hope that the program can generate strong next-generation vaccines and treatments, delivering breakthroughs that could also potentially benefit other health R&D areas as well

GHTC submitted written testimony to the State, Foreign Operations, and Related Programs (SFOPS) Appropriations Subcommittee urging them to sustain and protect global health R&D funding at the US Agency for International Development (USAID) in the fiscal year 2024 (FY24) budget.Global Health Technologies Coalition Outside Witness Testimony for the Record Subcommittee on State, Foreign Operations, and Related Programs Jamie Bay Nishi, Executive Director, Global Health Technologies Coalition On behalf of the Global Health Technologies Coalition (GHTC), a group of 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people, I am providing testimony on fiscal year 2024 (FY24) appropriations for global health programs at the US Agency for International Development (USAID). These recommendations reflect the needs expressed by our members working around the globe to develop new and improved technologies for the world’s most pressing health issues. We appreciate the Committee’s support for global health, particularly for continued research and development (R&D) to advance new drugs, vaccines, diagnostics, and other tools for long-standing and emerging health challenges. I am testifying today because we still do not have the technologies that we need to achieve a future where pandemics are prevented, and health is within reach for everyone. In 2019, at least 1.27 million people were killed by antibacterial resistance. In 2021, 1.6 million people were killed by tuberculosis, 1.5 million people were newly diagnosed with HIV, and 247 million people were infected by malaria. Today, more than 1 billion people worldwide are still affected by neglected tropical diseases. Unfortunately, it is women and children who are often most vulnerable. And as we look toward the future, we cannot afford to sit idly and wait for future pandemic threats with the potential to match or exceed the disruption of COVID-19. To develop the technologies that we need to defeat these diseases and to prevent future pandemics, the US government needs to sustainably increase its investments in global health research programs. Public funding is critical for this sector because companies have little commercial incentive to invest in health areas that impact people in poverty. As the world’s leader in biomedical research, the United States has both a responsibility and an opportunity: with relatively small public investments, we have the power to save and improve millions of lives. To continue our progress toward developing lifesaving tools, we respectfully request: Increased or sustained funding levels for every global health program under the US Department of State and USAID. Creation of a new, additive Supporting Innovative Global Health Technologies (SIGHT) Fund under USAID for global health innovation at $250 million in FY24. Inclusion of report language directing USAID to increase global health innovation spending. Inclusion of report language requesting that USAID produce an annual report on its global health research programs. USAID has provided unparalleled support for the late-stage development of global health technologies for decades. It is the only US agency with a mandate to improve global health that supports the development of global health products from early-stage concepts to delivery around the world. USAID identifies innovation gaps, sponsors clinical trials, and scales new technologies to communities in need. Additionally, USAID uses novel financing models, builds interagency and multisectoral partnerships, and applies a business mindset to stretch the US government dollar for maximum impact. The agency’s value-add is driving late-stage research and scale-up of global health products that offer significant public health benefit but are not supported by other public or private funders. Still, USAID’s global health innovation mandate is increasingly constrained by three challenges:  USAID funding for R&D has not kept pace with total global health spending. In 2006, USAID spent 8 percent of its global health budget on R&D. Today, USAID spends 5 percent, and this spending is projected to decline further without a course correction.  USAID funding for R&D is siloed by health area, limiting funding opportunities for products that are novel or needed for emergencies. Funding for innovation today is drawn from disease- and population-specific appropriations accounts, limiting the ability of USAID to fund products that address multiple health issues or emerging challenges. Constrained budgets force leaders in the Global Health Bureau to prioritize immediate impact over innovation. With limited resources, leaders must make difficult decisions between funding programs and funding innovation that could drive greater impact in the future.  To this end, sustained or increased funding for every global health line and a new, additive approach to funding global health innovation is needed at the agency. With an initial appropriation of $250 million, the SIGHT Fund would raise total annual USAID investments in global health innovation to approximately 10 percent of overall Global Health Bureau funding, slightly above the previous peak of 8 percent set in 2006. Filling the cracks, the SIGHT Fund could be tapped for different health challenges as R&D opportunities emerge, especially products currently without a funding source, such as for antimicrobial resistance, malnutrition, and population-specific tools. The SIGHT Fund would improve health research coordination within USAID and with health research agencies across the US government. USAID has long-standing partnerships with many innovators, and the SIGHT Fund would supplement, not supplant, these existing programs and partnerships—expanding the global health pie rather than slicing it further. It would enable USAID to make bolder investments in new technologies while reducing the trade-off between programming and innovation.  In addition, we urge Congress to renew its request for an annual R&D investments report. At the request of Congress, USAID releases an annual report on its health-related R&D investments and programs. These reports provide Congress and the global health community insight into how USAID is investing in global health research and progressing toward its health-related R&D strategy. The strategy is an important articulation of USAID’s health innovation mission and (together with the reports) is an essential accountability tool to ensure that USAID is on track to meet its health R&D goals. This request is critical to ensuring that US investments in global health research are efficient, coordinated, and maximally effective. Global health R&D is unique as a foreign policy goal in that it also supports researchers in the United States. From 2007 to 2020, more than $18 billion in federal funding went to US-based institutions for research on neglected diseases, supporting estimated hundreds of thousands of jobs and generating billions more in economic growth. In addition, many of the tools and technologies developed from this funding benefit people living in the United States either directly or indirectly by strengthening national health security and global prosperity.  As we emerge from a global pandemic subdued by publicly supported science, it is clearer than ever what we can achieve with sustained funding and attention. With increased public funding for global health research, we can achieve a world that is healthier and safer for everyone. GHTC urges the Committee to continue to direct USAID to prioritize science, technology, and innovation to advance its global health and development mission; allocate sufficient resources to support this work; and continue producing detailed, public annual reports on USAID’s 2023-2028 health R&D strategy. We urge the Committee to maintain strong support for the Global Health Programs account under the State Department and USAID—supporting, at minimum, sustained funding at fiscal year 2023 levels for each disease- or population-specific program and supporting increases where possible—and creating a new SIGHT Fund for global health innovation with a new $250 million investment. Global health innovation and implementation must not be seen as competing priorities, but rather part and parcel of the US commitment to improving global health. Global health research that improves the lives of people around the world—while at the same time supporting US interests, creating jobs, and spurring economic growth at home—is a win-win investment. 

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.French researchers are investigating after 59 percent of individuals in a new mpox outbreak cluster claim to be vaccinated, raising fears that the virus has mutated. The investigation will look at various questions, including when the individuals were vaccinated and at what dose, as well as whether they share a common characteristic like having HIV that could impact the effectiveness of the vaccine. If other possibilities are ruled out, French health authorities will start looking at the possibility of a mutation in the virus. The vaccine, Imvanex or Jynneos, is a third-generation smallpox vaccine. There is no specific vaccine for mpox, and this investigation could yield important data about the real-life efficacy of this vaccine for the virus, which is expected to remain a public health issue.This week, German diagnostics startup Midge Medical announced a partnership with the Institut Pasteur de Dakar to offer a rapid molecular diagnostic test for Marburg virus for field testing on the African continent. The collaboration started with a request from the Institut to adapt the startup’s Minoo system, a portable, battery-operated, isothermal amplification instrument with smartphone connectivity enabling data analysis and readout of results, which was previously used for COVID-19 testing. Midge Medical said they integrated the Marburg virus test into the Minoo platform within a month and delivered a prototype assay and provided training to staff at the Institut for field testing, where it has been favorably received.German scientists have reported promising results for a nasal vaccine for COVID-19 tested in hamsters. While this vaccine is not yet close to rollout, other nasal vaccines have been in use in China and India since last fall (although studies about their effectiveness has not yet been published) and at least four other nasal vaccines for COVID-19 are in late-stage clinical trials. While strong data to back up these vaccines is still needed, the hope is that these next-generation vaccines could better prevent people from getting sick and spreading infection by blocking the virus at the point of entry in the nose and throat where it first gains a foothold.

As the G20 Health Working Group meets next week to consider political commitments to better prepare for future health threats and advance health equity, GHTC urges them to prioritize the following actions to bolster global research and development (R&D) capabilities:Support the creation of a new pandemic global medical countermeasures platform: The COVID-19 pandemic has made clear that the world needs a global, end-to-end coordination platform to facilitate the rapid development, manufacturing, and equitable delivery of medical countermeasures during health crises. G20 nations should commit to supporting and financing a new platform that builds on lessons learned from the Access to Tools Accelerator and prioritizes accountability, transparency, agility, and inclusivity in its approach.Fully fund the World Bank Pandemic Fund. To date, the fund has secured just US$1.6 billion in pledges against its $10.5 annual target. G20 leaders should also ensure the fund invests in projects to strengthen laboratory, clinical research, and regulatory capacity to advance the development of and access to health technologies, work that is complementary to that of other international health initiatives. Increase investment in R&D for poverty-related and neglected diseases (PRNDs). The pandemic has diverted critical resources and attention away from battles against longstanding global health challenges like HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases. To reinvigorate these fights, G20 nations should boost funding and incentives for PRND R&D and support product development partnerships, which are uniquely equipped to advance technologies that are affordable, accessible, and adapted to the communities who need them. Center the needs of women, children, and other vulnerable populations in R&D. This includes enacting policies to improve collection and analysis of sex- and gender-disaggregated data and to ensure adequate representation of women, pregnant and lactating individuals, and other underrepresented populations in clinical trials. G20 nations should also work with the World Health Organization to develop target product profiles to advance therapeutic formulations for children, pregnant individuals, and other at-risk populations. Reprioritize R&D to combat antimicrobial resistance (AMR). The G20 has demonstrated past leadership on AMR research through its support of the Global AMR R&D Hub. G20 nations should build on this by continuing to support hub operations and increasing investments and incentives for R&D for new and improved antimicrobials, point-of-care diagnostic devices, vaccines, and other technologies required to stay ahead of this rising threat.Integrate R&D into pandemic prevention, preparedness, and response mechanisms. As negotiations continue on the pandemic accord and reforms to the International Health Regulations (IHR), G20 nations should push for the accord to embrace a holistic approach to supporting end-to-end product development and for the IHR to include new amendments to promote R&D coordination and genetic sequence sharing and new indicators to assess R&D capabilities at the country level.It is our hope that the commitments of this year’s G20 will chart a new path toward realizing a more resilient, fit-for-purpose, and equitable R&D ecosystem.