News

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. The US Food and Drug Administration (FDA) on Thursday approved updated COVID-19 vaccines from Pfizer and Moderna that target the KP.2 virus strain, which emerged from the highly contagious JN.1 variant that began circulating widely in the United States last winter. The new shots are expected to be available within days amid spiking case rates and hospitalizations for COVID-19. Experts also hope the vaccines will provide cross-protection against closely related subtypes of the virus, including KP.3.1.1 and KP.3, which are now spreading rapidly and account for 36 and 17 percent of all new cases, respectively. The FDA has not yet approved a third vaccine from drugmaker Novavax.The World Health Organization (WHO) this week recommended three new oral regimens for multidrug-resistant or rifampicin-resistant tuberculosis (TB) that can cure patients more quickly and successfully than the current painful injectable regimens. These regimens—which include the use of new and repurposed medicines like bedaquiline, pretomanid, linezolid, and delamanid—can be offered to nearly all patients and can improve treatment success by shortening treatment time to six to nine months, rather than the usual 18 months, while reducing treatment toxicity and the spread of drug-resistant forms of TB. WHO’s recommendations are based on results from the BEAT-TB clinical trial conducted in South Africa and the endTB trial conducted in seven countries between 2017 and 2023 by Médecins Sans Frontières, Partners In Health, and Interactive Research and Development and funded by Unitaid.  A new study found that giving azithromycin to all children up to five years old can greatly reduce childhood mortality in sub-Saharan Africa, more so than by limiting the distribution of the antibiotic to younger children, as recommended by WHO. The study, published Wednesday in the New England Journal of Medicine, found that twice-yearly distribution of azithromycin to children ages 1 to 59 months in rural communities in Niger reduced childhood mortality by 14 percent when compared with children who received a placebo. Further, the study found that targeting only children ages 1 to 11 months (recommended by WHO in 2020) did not lead to a significant reduction in childhood mortality. However, concerns remain about the effect of routinely distributing the antibiotic to all children under five on antimicrobial resistance. 

CALL TO ACTION The Future of Global Health Diplomacy in a Changing World The Power of Cohesiveness in the G7 & G20 The H20 Summit attendees and the organizers - G20&G7 Health and Development Partnership (G20&G7 HDP) - congratulate the Governments of Brazil and Italy for their inclusive approach to the health track of the 2024 G20 and G7 programs and for taking stock of existing G20 and G7 legacy health Initiatives that have been established since 2017 with health having been integrated into the G20 process. It is imperative that we maintain the continuity of these initiatives to keep health at the highest levels of policymaking to ensure our common goals are met in the long-term and aligned with the UN SDG 2030 commitments. At a time of significant economic and fiscal challenges for Governments worldwide, the G20&G7 HDP recognizes the trend in many countries to freeze and reduce investments in Global and Public Health since the COVID-19 pandemic. Therefore, it is essential to foster a wider and more integrated dialogue across many sectors of society, encouraging the creation of new partnerships at international, national, and local levels. We support the focus of the G20 this year on the social determinants of health in addressing the growing disease burden and acknowledging the climate and health nexus by building further evidence of the impacts of climate change on health. This societal approach is crucial for overcoming the global and public health challenges we face today triggered by leading infections including TB, Malaria, dengue, and HIV/AIDS, and the growing burden of noncommunicable diseases. We support the coordination of the G20 and the G20 Joint Finance and Health Taskforce (JFHTF) to enhance global and multisectoral coordination promoting initiatives to assess social, economic, and health vulnerabilities as well as response financing mechanisms while exploring innovative paths for resource mobilizations in the health sector. We support the G7 Apulia Leaders Communique that calls on strengthening the global health architecture (GHA) via a stronger pandemic preparedness and response agenda and the better integration of the One Health Approach to contain the rising level of antimicrobial resistance, representing a key global public health threat worldwide to our ecosystems. We also welcome the G7 initiative created between DFIs to build institutional capacity to ensure financing to procure, produce, and deliver for Medical Countermeasures (MCMs) in low and low-middle-income countries (MCMs). We generally welcome the G7 call on better alignment across the global health financing ecosystem in support of country-led priorities toward achieving Universal Health Coverage. While the increasing frequency of UN High-Level Meetings in global health is a positive development, with the focus in 2023 on TB, 2024 on AMR, and 2025 on NCDs, the G20&G7 HDP recognizes that the plethora of declarations from these high-level meetings is driven mainly by Ministries of Foreign Affairs. There is a need for the global health community to create a more structured dialogue with foreign ministries, in a similar way to the inclusion of finance ministries regularly in the health ecosystem. Global health governance and public policy The G20&G7 HDP therefore welcomes that a number of G20 countries have appointed global health ambassadors. Yet the G20&G7 HDP believes that for other G20+ countries appointing global health envoys or ambassadors within foreign ministries can enhance the impact of the development of clear and impactful negotiations, declarations on a multilateral level, and create a bridge between relevant ministries that make up the global health ecosystem and its challenges. Those countries that have appointed global health ambassadors, and in the case of AMR, AMR Envoys, contribute significantly to the shaping of the final drafts of heads of Government and ministerial declarations. The G20&G7 HDP strongly believes that addressing the triple planetary challenges—climate change, pollution, and biodiversity loss—requires stronger cooperation between national ministries, including health, finance, environment, and agriculture. This collaboration should be institutionalized within the “One Health” spectrum. Where Governments are adopting this cross-departmental approach, outputs are improved. If many of the health challenges facing the world today are to be addressed, and multilateral declarations fully implemented, then engaging with a wider range of cross-sectoral stakeholders both in the evolution of public policy and in the delivery of impactful initiatives is necessary and the health community needs to step out of its comfort zone and build innovative new partnerships. The G20 and G7 Presidencies offer a unique forum to provide visions, guidelines, and recommendations. However, it is essential to strategically involve and integrate non-state actors, the private sector, parliaments, influencers, patient organizations, and academia in the delivery and accountability of actionable health policies. Evidence-based policy-making We are at a golden moment for progress in science. However, bridging the gap between science and policymakers and promoting evidence-based policymaking is crucial. Evidence-based data is the foundation of all health policies, including those addressing non-communicable and infectious diseases. Strengthening health systems and achieving Universal Health Coverage requires a data-driven approach to create accountability among communities, policymakers, relevant stakeholders, and multilateral fora. Building on the momentum created through the WHO’s 2nd NCD Financing Dialogue this year and the upcoming UN High-Level Meeting on NCDs in 2025, we encourage the Presidencies to prioritize sustainable investment in healthcare infrastructure and systems to address NCDs by driving domestic resource mobilization, implementing underutilized fiscal policies, and leveraging financing. To facilitate communication between governments and investors, we propose developing a taxonomy for health that integrates within existing G20/G7 climate change taxonomy frameworks, enabled by the 2025 Presidencies of the G20 in South Africa and G7 in Canada. Regarding the 2024 UN High-Level Meeting on AMR, this is an opportunity to promote measures that bridge the gap between science and policy makers. Collection of Data on AMR needs to be improved so policy makers better understand the health burden and economic cost of AMR and Leaders can more effectively communicate its impact to the broader community. The G20&G7HDP believes that an Independent Panel on Evidence for Action against Antimicrobial Resistance established with the support of the Quadripartite organizations following appropriate consultation with all Member States on its composition, mandate, scope, and deliverables will provide Member States with regular guidance on the science, data, and evidence across all sectors related to antimicrobial resistance. Integrated accountability mechanisms within the G20 and G7 through the Legislators' framework In the international health space Parliaments are largely overlooked, yet they are the bridge between the public and their government. The G20&G7 HDP has now created with the Commonwealth and Francophone Parliamentary Associations, representing around 150 Parliaments together with the European Parliament a new structured dialogue on AMR, to hold governments not only into account on progress in tackling AMR but also bring a broader understanding of why AMR is an ecosystem challenge beyond health. This model will be used in 2025 to encourage Parliaments to look at the challenge of NCDs in preparation for the 2025 UN High-Level Meeting on NCDs. Future cross-sectoral partnerships The experience of many LMICs during the COVID pandemic has led many countries and regions to consider the benefits of local research and product development through new partnerships. This trend presents complex challenges, including around strengthening global supply chains. However, the G20&G7 HDP sees merit in building on sustainable voluntary initiatives and collaborations that aim to strengthen national, regional and global capacities and capabilities for Pandemic prevention, preparedness and response, including for existing G7/20 workstreams to accelerate research and development, enhance equitable access to medical countermeasures, and support sustainable local and regional manufacturing. The role of Multilateral Development Banks (MDBs) and Development Finance Institutes can and must play a more central role in promoting domestic initiatives to tackle both climate change and the growing disease burden. Through support for innovative financing initiatives in collaboration with other initiatives including the Japan G7 Impact Investment Initiative launched in 2023, MDBs can create an environment that will attract domestic public finance, private sector funding, and philanthropic support via blended finance initiatives. Given the challenges of climate change, sovereign indebtedness, and increasing global insecurity the G20&G7 HDP believes that countries, regional organizations, and the G20 and G7 must keep public and global health at the center of the political agenda as both and benefit for society and a valuable investment that delivers significant long term socioeconomic returns. Women’s, Maternal, and Child Health must be a permanent fixture of the G20 and G7 agendas. We must recognize that women and girls often are agents of change in society, and we need to leverage their role in program design and implementation to address specific healthcare system challenges that cover wellness, prevention, diagnosis, time to treatment, delivery pathways, and access to care across the life course. The G20&G7 Health and Development Partnership therefore calls on G20 and G7 countries to: 1. Recognize and address the disconnect between the excellent evidence-driven outputs of our health scientists and clinicians and our political leaders who shape the public policies that impact the social determinants of health. 2. Recognize that the threats of infectious diseases and non-communicable disease are heavily impacted by the social determinants of health. Therefore, this requires member states to invest in significantly improved dialogue and communication with local communities and citizens on the steps that must be taken to reduce and prevent the risks of infection, build trust, and promote behavioral change in addition to public health prevention, prioritizing sustainable investment in healthcare infrastructure and systems by driving domestic resource mobilization, implementing underutilized fiscal policies, and leveraging financing and intervention mechanisms that will help manage and prevent NCDs, including but not limited to cardiovascular disease, diabetes, and preventable cancers, including cervical cancers, as well as infectious diseases predominantly affecting LMICs such as AIDs, Tuberculosis, Malaria, and Neglected Tropical Diseases. 3. Take urgent action to build resilient and effective cross-government, cross-departmental One Health teams to ensure that national governments are equipped to comprehensively address the triple planetary challenges—climate change, pollution, and biodiversity loss—institutionalizing stronger cooperation between national ministries of health, finance, environment, and agriculture 4. Recognize that health burdens for women are systematically underestimated, with datasets that exclude or undervalue important conditions, we encourage the Presidencies to Systematically collect and analyze, ethnicity and gender-specific data to have a more accurate representation of women’s health burden and the impact of different interventions. 5. Recognize “women's health is wealth” and promote innovative financing mechanisms specifically focused on investing in women’s health at all stages of their lifecycle, including pregnancy & lactation, ensuring a wholeof-society approach. 6. Adopt the practice of an increasing number of G20+ countries of appointing global health ambassadors and AMR envoys to work with multilateral organizations such as the WHO, and the UN on promoting deeper international cooperation and sharing of practical best practices in addressing the global disease burden. 7. Recognize the central role of the WHO in global health, and in keeping with the recommendations of the Member States Working Group on Sustainable Financing adopted by the World Health Assembly, support the resource replenishment approach and the successful implementation of the WHO formal Investment Round to ensure increased, sustainable and predictable funding for the critical work of the WHO. 8. Convene a meeting of MDBs to establish a joint roadmap to fund initiatives on health - starting with new funding, incentive and lending structures to address the growing threat of AMR - developing a common taxonomy on sustainable financing for health that will help attract further investments. 9. Urge all green financing initiatives to contain a clear and meaningful public health dimension and utilize lessons learned and best practices on impact investments in global health. 10. Welcome the structured dialogue that has been created by the G20&G7HDP between the Francophone and Commonwealth Parliamentary Associations together with the European Parliament to strengthen parliamentary engagement and oversight of the outcomes of the G20 and G7 health track and the implementation of conclusions at a country level. 11. Support the establishment of the UN Independent Panel on Evidence for Action on AMR to gather and analyze data on AMR so that key decision-makers can make informed decisions based on common metrics and evidence. 12. Support the establishment of an ongoing AMR Ministerial Meeting, of which will be held in Jeddah in 2024, as a biannual meeting of ministers of Health, Agriculture, Environment and Finance to assess progress on tackling AMR and promoting the sustainable finance required to ensure access, equity, innovation, and improving antibiotic stewardship 13. Ensure that the declarations drawn up for the health track of the G20, G7, and the UN High-Level meetings are practical and actionable, joined up. Signatories Further Signatories Prof Agnes BUZYN (former French minister of Solidarity and Health) Hon. Laurent Wehrli, Chair of the Parliamentary Network to Fight HIV/AIDS, Tuberculosis and Malaria, Chair of the Education, Culture and Education Commission, Parliamentary Assembly of the Francophonie (APF), Member of the National Council of Switzerland Hon. Dr Christopher Kalila, Member of Parliament Zambia, Former Executive Committee member of the Commonwealth Parliamentary Association. Roberto Duran-Fernandez Professor at the School of Government and Public Transformation, Tecnologico de Monterrey Brian Li Han Wong- Independent Consultant Dr Kate Isoken Obayagbona (MD, MPH) Dr Emma Berntman, Senior Engagement Specialist, FAIR David Holland Senior Business Development Manager (Global) Solidsoft Mae Peri Kass, University of Virginia, Stanford University, Morgan Stanley Investment Bank

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 recently published study found that a malaria vaccine candidate given to women who planned on becoming pregnant was safe and effective for both the women and their babies. This exciting research could lead to a vaccine to protect pregnant individuals— who are often excluded from clinical trials—and their babies from malaria in the face of an estimated 50,000 maternal deaths and 200,000 stillbirths every year caused by malaria infections in pregnancy. The investigational attenuated vaccine, PfSPZ, will next be tested for use during pregnancy and in a larger study on preconception use. Just as the World Health Organization and the Africa Centres for Disease Control and Prevention declared the current mpox outbreak a public health emergency last week, SIGA Technologies and the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health reported mixed results from a preliminary analysis of a study testing the smallpox antiviral treatment Tpoxx against mpox. While the study, which took place in the Democratic Republic of Congo and began during the 2022 global outbreak, did not meet the trial’s primary endpoint of reducing the time to lesion resolution within a 28-day treatment period, the company says these results are not entirely unexpected and is highly encouraged that Tpoxx did elicit a “meaningful improvement” in some participants with severe cases, supporting a potential use case as post-exposure treatment for patients with severe mpox. The company also pointed to four other ongoing studies that significantly differ from the Congo trial and will provide additional data on the treatment.The NxTAG Respiratory Pathogen Panel, which detects and differentiates between common respiratory viruses, recently received 510(k) clearance from the US Food and Drug Administration. The combination test, which was developed with support from the Biomedical Advanced Research and Development Authority (BARDA) can, from a single swab, detect and differentiate 19 common respiratory viruses, including the virus that causes COVID-19, influenza A and B, and RSV, allowing health care workers to test patients and provide appropriate treatment rapidly. BARDA’s support is part of a broader effort to advance diagnostic testing platforms that can be rapidly adapted to emerging threats.

GHTC responded to a request for information (RFI) on House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA)'s recently published framework that lays out the current challenges facing the National Institutes of Health (NIH) and makes recommendations for reform with the letter below, raising concerns that some of the recommendations could limit important and lifesaving work and urging that any reforms included in legislation to be thoroughly vetted to protect that work.Dear Chair McMorris Rodgers, As members of the global health advocacy community, thank you for your interest in optimizing the National Institutes of Health (NIH) and for the opportunity to provide input on the  Reforming the National Institutes of Health Framework for Discussion.We are pleased to share thoughts below on several specific proposals. However, given the significance of NIH to the health, security, and well-being of the American people and populations across the globe, it is critical to engage in a process that permits interactive discussion with and between different parties who can shed light on the day-to-day implications of these potential changes. Through this process, we can work together to identify opportunities to strengthen NIH in support of the goals and objectives of members of Congress from both sides of the aisle.    For this reason, we are deeply concerned that changes outlined in the framework have been incorporated into the Fiscal Year 2025 House Labor, Health and Human Services, Education, and Related Agencies (LHHS) appropriations bill even before the deadline for comments on the proposal. Our concern is not that the calls for reform and increased transparency are without merit but rather that any reform included in legislation be thoroughly vetted to ensure that the important and lifesaving work of NIH is allowed to thrive.In the spirit of such a process, the following text provides specific input from the global health research community and advocates on several proposals included in the framework. The community’s apprehension centers on bifurcating the National Institute of Allergy and Infectious Diseases (NIAID); collapsing several institutes and centers, including the Fogarty International Center, into a single institute; and incorporating the Advanced Research Projects Agency for Health (ARPA-H) into an NIH institute. These actions will impose barriers, both administrative and scientific, for global health research and development that will affect NIH’s reputation as the global leader in biomedical sciences, a legacy that enhances the United States’ image on the international stage as a champion of global health innovation and a steward of global health diplomacy. NIAID is the world leader in global health research and development because its basic research expands our fundamental knowledge of antimicrobial resistance, HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases. As COVID-19 variants continue to arise, the complex interactions between immunity and infectious threats have reached the public’s attention as never before. Antimicrobial resistance is another example of how the intertwined nature of infectious diseases and immunity requires constant collaboration between professionals from these fields. We are concerned that NIAID will not cleanly split in two as the LHHS report and House Committee on Energy & Commerce’s proposed framework posit. Rather, the split will disrupt the research helping us defeat the most deadly infectious disease threats—past, present, and future—at home and abroad. We are also concerned that grouping the Fogarty International Center (FIC) with topically unrelated and domestic-facing institutes into the Institute on Health Sciences Research would minimize the key role FIC plays in maintaining the United States’ global health security leadership role and advancing medical progress that benefits the American people and populations across the globe. FIC is a lesser-known but hugely consequential branch of NIH responsible for training a vast network of approximately 8,500 professionals from 132 countries in public health threat response. These trainees have gone on to hold high-ranking academic and government positions and have moved the needle on neglected and emerging infectious diseases, such as HIV/AIDS, COVID-19, Zika, and Ebola.  Rather than embedding FIC in another institute, we believe an important opportunity exists to strengthen this center to play an even more impactful role in advancing the health and security of Americans. We would welcome the opportunity to discuss options such as expanding FIC’s role to encompass strengthening clinical trial capacity and strategic partnerships in countries where capacity gaps pose risks and create tragic missed opportunities for faster medical progress. Finally, we believe that maintaining ARPA-H’s independent status is important for preserving its unique approach to high-risk, high-reward innovation as initially envisioned by Congress, which does not duplicate NIH’s critical role in basic and translational research.  The agency, authorized in 2022, has not been in place long enough to evaluate federal investment in this new model. Its efforts to reverse blindness, dramatically increase the precision of tumor removal, and overcome challenges with broad significance should be given the time they need to succeed or fail. Had Congress abandoned the Defense Advanced Research Projects Agency in its first years of operation, GPS could be a matter of science fiction, not everyday use. ARPA-H has the potential to bring new scientific thought and processes to a field marked by tradition—minimizing its role risks the United States falling behind our geopolitical rivals in health innovation during an age of rapidly evolving technologies. We believe it is in the nation’s interests to put ARPA-H’s muscle toward addressing health threats within and (currently) outside our borders. Again, Chair McMorris Rodgers, we share your commitment to strengthening NIH and believe that thoughtful, bipartisan reforms, supported by thorough discussion and vetting, are key to achieving this goal. We write to advocate for robust funding and a structural, operational, and policy infrastructure that best supports fast-paced scientific, medical, and public health progress. NIH is an asset that serves US interests and contributes in profoundly important ways to the health and well-being of all around the world. We urge that congressional efforts to optimize NIH take place on a bipartisan and bicameral basis and that only changes that have been carefully vetted through a thorough, interactive, and cross-sector process are considered. Thank you for your consideration,Alex LongUS Policy & Advocacy OfficerGlobal Health Technologies Coalition (GHTC)E: along@ghtcoalition.org