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. IAVI and Moderna are preparing to launch the first in-Africa trial for an mRNA HIV vaccine candidate, the organizations announced last week. The phase 1 vaccine trial will take place at the Center for Family Health Research in Kigali, Rwanda, and The Aurum Institute in Tembisa, South Africa. The vaccine candidate, mRNA-1644, uses Moderna’s mRNA technology to deliver a specific class of B cells needed to develop broadly neutralizing antibodies to fight HIV infection. mRNA technology could accelerate the development of a safe, effective, affordable, and durable HIV vaccine, according to IAVI, and the trial will build on progress in HIV vaccine research using the combination of Moderna's proven mRNA vaccine technology and a novel HIV vaccine approach developed by IAVI and Scripps Research, and draw on more than two decades of collaboration with scientific centers of excellence in sub-Saharan Africa, supported by the US Agency for International Development.A US Centers for Disease Control and Prevention (CDC) advisory panel on Thursday voted to recommend children between the age of 5 and 11 should be offered a third dose of the Pfizer-BioNTech COVID-19 vaccine at least five months after receiving their second dose. CDC Director Dr. Rochelle Walensky then endorsed the panel’s recommendation, which followed authorization by the Food and Drug Administration earlier that week. In making their decision, the CDC advisors reviewed data indicating a third dose increases the antibody response from the vaccine, which should protect recipients better, at least temporarily. CDC also now recommends those who are 12 and older and immunocompromised and all people over the age of 50 should receive a second booster, at least four months after their first dose.Clinical research in the United States faces a “critical shortcoming” when it comes to diversity, a new report from the National Academies of Science, Engineering, and Medicine stresses. While diversity has become an increasingly important priority, racial and ethnic minority populations continue to be left behind in research, leaving a large portion of the US population—and those that often face the greatest health challenges—less able to benefit from discoveries, because they are not adequately represented in clinical studies. Members of the LGBTQIA+ community, older adults, pregnant and lactating individuals, and people with disabilities are also among the populations frequently left out. The report offers recommendations to increase the inclusion of these groups in order to advance equitable research—described as a clinical trial population that matches the demographics of the disease being studied.

On May 16, with negotiations over fiscal year 2023 (FY23) appropriations underway on Capitol Hill, the Global Health Technologies Coalition (GHTC) hosted congressional staff and coalition members for a virtual briefing on the Supporting Innovative Global Health Technologies (SIGHT) Fund—a proposal for a new $250 million appropriations line in the FY23 State, Foreign Operations, and Related Programs bill dedicated to global health research and development (R&D) at the US Agency for International Development (USAID).Emily Conron, senior US policy and advocacy officer for GHTC, kicked things off with a presentation on the basics of the SIGHT Fund and the challenges it is designed to solve. She noted how 15 years ago, USAID spent about 8 percent of its global health funding on innovation, but that while USAID’s global health budget has doubled in that time, spending on innovation has not kept pace, dropping to less than 5 percent as a share of global health investment. She also emphasized that the pace of global health progress in the future will depend on the reversal of these investment trends today, with more resources urgently needed for R&D: “Today's global health tools like antiretrovirals for HIV/AIDS, oral rehydration therapy to save lives from diarrheal diseases, vaccines that have dramatically reduced child mortality globally—these tools are the product of robust R&D investments begun decades ago….We need to invest proactively today to ensure continued progress in global health in the years to come, and establishing the SIGHT Fund with an initial investment of $250 million dollars—which I should note is a level of investment representing less than 3 percent of all current US spending on global health—could really catalyze the development of tools that accelerate progress against emerging and enduring global health challenges. This would save US taxpayer dollars, maximize the impact of our programs, and ultimately improve and save lives around the world.” Rachel Cohen, regional executive director of the Drugs for Neglected Diseases initiative (DNDi), North America, followed with the perspective of a leading global health product development partnership on why the SIGHT Fund could be transformative for global health innovation. She described previous R&D partnerships DNDi has had with USAID, but how budget limitations cut this promising work short—work that a new source of dedicated innovation funding could be tapped to continue. USAID’s disease-focused programs, with their limited funding, “shouldn't have to make these kinds of trade-offs—between critical funding for service delivery and funding for the next generation of lifesaving tools,” Rachel noted. “That's why DNDi is supporting the SIGHT Fund and why we need a mechanism that perhaps could be more crosscutting and catalytic.” She noted how the fund could complement work advanced by other US agencies, ensuring that promising innovations do not languish in the dreaded R&D “valley of death” when early-stage R&D funding often drops off: “One important example of this would be, for example, to take some of the funding that NIH, the National Institute of Allergy and Infectious Diseases, is funding for broad-spectrum antiviral drug discovery,” she shared. “Once those tools are perhaps ready for clinical trials, USAID could fund the development of broad-spectrum and spectrum antivirals for a range of viral pathogens of pandemic potential.” She also noted new R&D areas the fund could support, such as funding “in a more transformative way the R&D needs of infants and young children, ensuring gender-responsive R&D, or addressing the health consequences of the climate crisis.” Another innovator perspective was shared by Dr. Anand Anandkumar, co-founder and chief executive officer of Bugworks Research Inc. Anand shared background on the growing crisis of antimicrobial resistance (AMR), a global threat Bugworks is combatting through the development of novel broad-spectrum antibiotics designed to be affordable and accessible globally. “We all know from the experience of COVID that none of us is safe until everyone is safe—these are global problems requiring global solutions,” he reflected. “This [SIGHT Fund] could actually fill in a lot of key global gaps and make the United States a leader in connecting and finding solutions that are important globally.” He shared a helpful image of a triangle to describe three interconnected gaps in the current global innovation ecosystem he believes the SIGHT Fund could help address. “One axis of the triangle is support funding of clinical development for phase 2 and 3 with an eye on LMICs [low- and middle-income countries],” he said. “There are already fascinating programs like CARB-X that have created a good pipeline to phase 1, fascinating programs like GARDP out of DNDi that are trying to support phase 2 and phase 3, and AMR Action Fund, that are trying to support phase 2 and phase 3—but that valley is a complex valley. It needs more support.”“Number two, USAID, through the SIGHT Fund, can build clinical trial capacities on the ground in LMICs,” he noted. “You have patient population that have multidrug resistance, a very rich patient population—that’s the right place to do clinical trials, to find out how your drugs are going to work on the worst, difficult patients, but they [LMICs] don’t have capacities.” “And third and last point: a fund like SIGHT could actually bring regulators together, take lessons from COVID, and accelerate these highly needed treatments for unmet population,” he concluded. “So one vertex of the triangle is supporting clinical development to plug the phase 2, phase 3 gap, one vertex is creating clinical trial capacities where it matters the most in LMICs, and the third is regulatory harmonization.” The final intervention was made by Dave Milestone, former acting director of the USAID Center for Innovation and Impact, who shared what he experienced leading innovation activities during his tenure at USAID and why that has made him a supporter of the SIGHT Fund proposal today. “We know that there's a need for innovation,” Dave shared. “We're slowing our progress toward the achievement of our health SDGs [Sustainable Development Goals]. If we just go with sort of the status quo today, even if we deploy all the existing solutions that we have, there's a number of studies that say that we would still fall short. We need innovation. We need new local solutions. We need new partners, and we need to start with local problem solvers to make sure that we're identifying those right problems and then engaging the global R&D community to address those needs.” Dave described several successful innovation partnerships from his time at USAID, including Grand Challenges, which crowded in new thinkers and problem solvers to address leading challenges such maternal and child health, Ebola, and Zika. But he noted that many of these partnerships, while very successful, were short term and ad hoc. “USAID funding for R&D and innovation isn't institutionalized. It's not consistent. It's not long term,” he emphasized. “We should think about a more strategic, holistic approach,” which he noted includes, but is not limited to, the level of funding: “It's also about crowding in the right skill sets and mindsets to how we work with innovation…bringing in the sort of people who understand the practice of innovation, who have portfolio management expertise. These are new skill sets and mindsets that should come with the [establishment of the] SIGHT Fund at USAID.” He concluded with a strong call to action: “If our goal is to end the need for foreign aid, then we need to do this. The status quo isn't cutting it, and we need to be prepared to solve tomorrow's problems with tomorrow's solutions—and the SIGHT Fund is an important step in that right direction.”Jamie Bay Nishi, executive director of GHTC, finished the event by leading a question and answer session with the speakers, in which they emphasized the far-reaching impact that $250 million in new annual funding could have, how the fund could improve USAID’s responsiveness during health emergencies like COVID-19, and how it could advance not only discrete global health innovations, but also innovate the practice of R&D, strengthening the capacity of global partners to lead this work. On this last topic, Rachel offered an inspiring closing point: “If COVID has taught us nothing, it's that …this whole concept that ‘trickle-down innovation’ is going to work—I think we have all been disavowed of that myth. By that, I mean [the belief that] all the innovation happening in high-income countries…[will, with enough good will] eventually make their way to low- and middle-income countries.” She emphasized that “the model of the future needs to be—especially for diseases that are highly prevalent in low- and middle-income countries—driven by the incredible innovation capacity that exists in those countries. But that cannot happen if all the money is flowing only to organizations and academic institutions that are based in high-income countries. We just have to break that cycle…[and] make sure that the experts, the scientists, the clinicians, and the policymakers from low- and middle-income countries are helping to set the priorities, to make the decisions, to allocate the resources, and ultimately to drive the innovation agenda of the future.” You can watch the recording of the full session below, and learn more about the SIGHT Fund here. 

The 75th World Health Assembly (WHA) will kick off Sunday with delegates and limited civil society gathering in person in Geneva, Switzerland, for the first time since the pandemic was declared more than two years ago. While immediate COVID-19 response needs still remain a high priority, the conversation has also shifted to how to reform the global health architecture to better prepare for future health threats and how to reinvigorate the fight against other health challenges. Here are the top five issues GHTC will be tracking:1. Will WHO get a budget boost?Many experts have pointed to the World Health Organization’s (WHO) financial health as a key obstacle hindering the agency’s ability to plan strategically and respond effectively during crises. Over the past two decades, assessed member state contributions—or countries’ mandatory dues to WHO—have stagnated, today accounting for just 16 percent of the WHO budget. This has left the agency increasingly reliant on unpredictable, often earmarked voluntary contributions from wealthy countries and philanthropic donors. In January 2021, the WHO Executive Board (EB) tasked a new WHO Working Group on Sustainable Financing with remedying this problem. In late April, the group announced it had reached a consensus agreement to raise assessed contributions to cover 50 percent of WHO’s base budget by 2030, which would be linked to progress on WHO governance reforms. While this agreement is a positive signal of broad member state support, it still needs to be adopted at WHA, which is not a certainty. If approved, the first increases will take place next year and will hopefully usher in a more solid, sustainable financial future for WHO.2. What changes are ahead for WHO and the global preparedness architecture?Heading into WHA, several processes have begun unfolding that could fundamentally alter how WHO—and the world—prepares for and responds to health emergencies. At the 74th WHA and the November Special Session, member states established a new Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) and an Intergovernmental Negotiating Body (INB) to advance a potential new pandemic treaty or instrument. While the INB is not expected to meet again until June, after holding a historic public hearing in April, the WGPR has released its draft report of recommendations for WHA consideration. Among other actions, the WGPR proposes independent evaluations to determine the future and evolution of new initiatives like the Access to COVID-19 Tools Accelerator, COVID-19 Technology Access Pool, mRNA vaccine hub, and BioHub pathogen sharing system and calls for member states to grow national and regional manufacturing capacity. Notably, the report also calls for a process to amend the International Health Regulations (IHR), the current legal framework that dictates member state responsibilities to prevent and combat disease outbreaks, urging this year’s assembly to adopt any amendments that are ready. The US government has already submitted its amendments for IHR reform for WHA consideration, but other resolutions from member states could still be forthcoming. It remains to be seen whether the assembly takes forward any amendments this year or pushes the process into 2023.Alongside IHR reform, we’ll also be watching whether WHA takes action to expand the Global Influenza Surveillance and Response System (GISRS), following a report presented at January’s EB that suggested GISRS be broadened to cover other respiratory viruses with epidemic and pandemic potential, building on the success of leveraging the system for the COVID-19 response. In the interim months between, the WHO Secretariat has engaged with stakeholders for feedback on this proposal, but it’s unclear whether WHA will vote on this proposal, and key questions remain as to how this expansion would align with other related initiatives like the WHO BioHub pathogen sharing system and requirements of the Nagoya Protocol, which governs the access and benefit-sharing provisions of biological sample sharing.3. How’s the progress report on TB innovation, NTDs, and immunization?While COVID-19 and health preparedness are consuming much of the political energy going into the 75th WHA, they are certainly not the only global health challenges the world is facing. This year’s assembly will also take up agenda items on the global strategy for tuberculosis (TB) research and innovation, the road map for neglected tropical diseases (NTDs), and Immunization Agenda 2030, which are all WHO-led health-area strategies that run through 2030. While the assembly is just expected to hear progress reports on these matters and interventions from member states and civil society, given the significant impact of COVID-19-related disruptions on many of these issues, it will be important to hear whether targets are on track, gauge the level of political will to reinvigorate efforts against these critical challenges, and see what concrete steps member states highlight as priority areas for WHO. In addition, the assembly is also expected to vote to extend the global strategy and plan of action on public health, innovation and intellectual property, which now runs through 2022, until 2030.4. Will a resolution drive changes in the way clinical trials are approached?While this matter has largely flown under the radar, the assembly is anticipated to consider a resolution introduced by the United Kingdom aimed at improving the quality of clinical trials. The intent of the resolution is to build on lessons learned from the COVID-19 pandemic, which drove a surge in funding for clinical research on COVID-19 tools, but also saw many trials that weren’t large enough or employed inconsistent protocols and outcome measurements across geographies, making it difficult to pool and compare data to turn conclusions into medical practice. Among other matters, the resolution urges countries to better coordinate research, standardize protocols, improve reporting on trial registration and results, and work to increase clinical trial capacity globally, particularly in low- and middle-income countries—though none of these actions are binding. It also requests WHO develop a global action plan to strengthen clinical trial practices to be presented for consideration at next year’s assembly.5. Will civil society engagement be satisfactory this year?During these past pandemic years, civil society has unfortunately experienced diminished opportunity to meaningfully engage in WHA and other WHO meetings as forums have turned virtual and agendas have become increasingly jam-packed. Last year and this year, WHO experimented with separate pre-WHA consultations for non-state actors (NSAs), which have left many participants dissatisfied as actual member state participation has been low and the mechanism is unclear for how feedback is transmitted to member states. This year, NSAs have been invited back to the Palais in person for the first time since the pandemic began, with passes limited for safety, and they are expected to be able to deliver interventions live before the assembly. Yet continued scheduling constraints often result in limited time for NSA interventions at best, or being excluded from speaking on certain agenda items altogether at worst. In addition, with few technical public consultations and little transparency around the status of negotiations on specific agenda items, NSAs are left with fewer vehicles to influence proceedings than in the past. We’ll be watching closely if this semi-return to normal engenders better opportunity for NSAs to have their voices heard and will continue to push for robust civil society involvement this year and beyond.

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. World leaders convened virtually Thursday for a second Global COVID-19 Summit to accelerate collective efforts in the global pandemic response, pledging about $3.1 billion in new 2022 funding along with commitments to bolster availability of COVID-19 tools. The funding commitments, though falling short of the goal of $10 billion for vaccinations and $3 billion for therapeutics and oxygen, included more than $2 billion in funding for the immediate COVID-19 response and $962 million for a new pandemic preparedness and global health security fund to be established at the World Bank. The United States, which cohosted the summit alongside Belize, Germany, Indonesia, and Senegal, also announced a new National Institutes of Health licensing agreement to share technologies with the World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool to support the development of therapeutics, early-stage vaccines, and diagnostic tools.The Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $19.3 million to support development of a “variant-proof” COVID-19 vaccine by an international consortium consisting of Bharat Biotech, the University of Sydney, and ExcellGene SA. The funding will support preclinical and clinical proof of concept for an adjuvanted subunit vaccine candidate—including immunogen design, preclinical studies, manufacturing process development, and a phase 1 clinical trial—with the goal of providing broad protection against all known SARS-CoV-2 variants of concern as well as future variants of the virus. The project could contribute to long-term control of COVID-19, according to CEPI, and the partnership has committed to achieving equitable access to any outputs of the project.A World Trade Organization (WTO) proposal to temporarily waive patent protections on COVID-19 vaccines is receiving tepid reactions from members ahead of a long-delayed ministerial conference set for June. The current compromise proposal would ease some existing barriers to issuing compulsory licenses for patents on COVID-19 vaccines, but also introduces new impediments, including a condition requiring countries to list each patent they intend to waive. The deal is a result of discussions between the European Union, United States, South Africa, and India, following the original proposal by South Africa and India presented in 2020, which sought to not only waive intellectual property protections on patents, but also trade secrets, copyrights, and industrial designs, for treatments, tests, and vaccines. WTO member states expressed mixed views at a recent meeting of the Council on Trade-Related Aspects of Intellectual Property, or TRIPS, ultimately leaving the fate of the proposal uncertain.