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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. The World Health Organization (WHO) has announced a clinical trial of one or possibly two experimental vaccines designed to protect against the rare Sudan strain of the Ebola virus that has been identified in the recent, rapid outbreak in Uganda. The trial could begin within weeks depending on the Ugandan government’s permission, which is expected soon, as well as regulatory and ethics review approvals. The trial was announced by the WHO’s Health Emergencies Program, which has been conferring to identify vaccines that are far enough along in their development to undergo clinical testing. There are six vaccine candidates in development that are designed to target the Sudan strain, only half of which have advanced to the stage of human clinical trials. Of those, a candidate developed by the Sabin Vaccine Institute and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases is the furthest along in its development. Dengue resurged across Asia following a period of lower transmission due to reduced mobility because of COVID-19 restrictions, but an exciting vaccine has the potential to make huge strides in reducing the burden of the disease not only in the region but around the world. In August, Indonesia became the first country in the world to approve Takeda’s Qdenga, or TAK-003, vaccine for use against dengue in 6- to 45-year-olds. Qdenga showed incredibly promising results in clinical trials and is under review by the European Medicines Agency and other regulatory agencies in dengue-endemic countries, although it is yet to receive WHO prequalification. The vaccine addresses the complexity of dengue’s four strains by using a weakened version of the DENV 2 strain as its base and including genes from the other three strains.In 2020, a clinical trial in South Africa testing PrEP as a shot delivered every few months found incredible success with results showing high efficacy compared to the daily pill. The drug used in the trial (long-acting cabotegravir or Cab-LA) made by ViiV Healthcare has only been awarded regulatory approval in the United States to date. Access to the shot in low- and middle-income countries has been hampered by the company’s decision to not grant licenses for generic makers to produce the drug at a lower cost. The company has made an agreement with the Medicines Patent Pool that permits three or fewer companies to make generic versions of the drug in 90 low- and middle-income countries, but it could take at least three years for regulatory approval. Viiv Healthcare has submitted its drug for WHO prequalification, which could speed up this approval process. 

The annual opening of the United Nations General Assembly (UNGA) is always a key moment on the diplomatic calendar. For the first time since the COVID-19 pandemic began, UNGA was held in person. This provided opportunities to renew relationships, forge new partnerships, and debate in-depth in ways that are difficult in the Zoom world. And while many want to say that the pandemic is behind us, as President Joe Biden pronounced on his recent 60 Minutes appearance, COVID-19 and the possibility of future health threats still loomed large during the first half of UNGA discussions.Concurrently, leaders gathered for the replenishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria and to contend with the erosion of progress in other global health areas as a result of resources being diverted to COVID-19. Chief among the backslides are three of the world’s leading infectious killers: HIV, tuberculosis, and malaria, which all suffered setbacks during the pandemic with a reduction in access to testing and treatment coupled with a troubling rise in cases. If that were not enough, the rising threat of antimicrobial resistance was also top of mind for many leaders.Below are some of the key highlights from the first half of UNGA.Major focus on pandemic preparedness and global health architectureWhile some major speeches at UNGA, such as those by German Chancellor Olaf Scholz or US President Joe Biden, barely acknowledged the pandemic, plenty of events and meetings throughout the the first half of UNGA highlighted a sustained and strong focus on current and future health crises.Underscoring the need for a robust discussion on reforms to global political structures and recommendations put forth over the last two years by the Independent Panel for Pandemic Preparedness and Response and the Global Preparedness Monitoring Board, the UNGA overwhelmingly adopted a resolution to hold a high-level meeting at the heads-of-state- and government-level on pandemic preparedness and response no later than the 78th session of UNGA in September 2023. The agreement—co-sponsored by more than 100 countries—instructs the next General Assembly's president to organize the meeting in collaboration with the World Health Organization (WHO) and to “adopt a succinct political declaration aimed at, inter alia, mobilizing political will at the national, regional and international levels for pandemic prevention, preparedness and response.”Discussions were also centered on the future of the Access to COVID-19 Tools Accelerator. Civil society and other global health stakeholders questioned whether Accelerator is winding down, but stakeholders like WHO Special Envoy Dr. Ayoade Alakija assured the community that the framework is simply moving into a new phase. Questions remain on what the initiative will look like post-COVID-19, yet it is clear that there is a desire to retain some of the coordination functions of the framework, even as advocates continue to highlight the stark inequities and the sometimes-mismatched priorities that the framework created, highlighted by the lack of focus and resources for testing in LMICs.Bolstering local manufacturing capacity The COVID-19 pandemic laid bare what stakeholders across the Global South have long known: severe shortages in lifesaving medical products result when low-income countries are left to rely on the Global North and Asia as primary suppliers. The lack of local manufacturing capacity has been a driver of extreme global disparities in access to lifesaving COVID-19 vaccines, diagnostics, drugs, and devices. More than two years into the pandemic, it has become increasingly clear that strengthening health security in low- and middle-income countries (LMICs) will require long-term investments to fortify local capacity.This realization was echoed throughout discussions. Multiple stakeholders and events focused on the need to bolster manufacturing capacity in LMICs. PATH, in partnership with Foreign Policy, explored the investments, partnerships, and models that can inform a strategy for fostering a sustainable African manufacturing industry and distribution networks across the continent, addressing chronic inequities, and strengthening regional health security. At the Clinton Global Initiative, PATH committed to partnering with the African Union to develop principles for drug, vaccine, and diagnostic manufacturing on the African continent. We also witnessed firsthand commitments being made to strengthen this capacity, including by the Distributed Vaccine Manufacturing Collaborative. The Collaborative is co-chaired by Dr. Richard Hatchett from the Coalition for Epidemic Preparedness Innovations and Dr. Victor Dzau from the US National Academy of Medicine in partnership with the World Trade Organization; Gavi; WHO; the Wellcome Trust; Africa Centres for Disease Control and Prevention; the Oswaldo Cruz Foundation, or Fiocruz; and various governments and industry partners. The goal of the Collaborative is to increase vaccine access in LMICs through the establishment of a versatile global vaccine manufacturing network capable of producing vaccines during pandemic and non-pandemic times. Sustainable financing for pandemic preparedness Another focal point of the first half of UNGA was the need for incremental and sustained financing. While the elephant in the room was clearly the Global Fund replenishment, which raised a record-breaking US$14.25 billion, despite falling short of the ultimate target of $18 billion, broader conversations on financing for pandemic preparedness also attracted plenty of attention. COVID-19 has highlighted that the world has consistently underinvested in preparedness and specifically in the frontline health workforce, resilient supply chains, and research and development for new countermeasures including novel vaccines, therapeutics, and other platforms and technologies that can be deployed during a pandemic.Many dialogues prioritized equity, and the idea that regardless of location or income level, all people must be able to access the science, tools, and resources they need to both better prepare for and respond to health crises. Cross-sector leaders, including the World Trade Organization Director-General Ngozi Okonjo-Iweala, came together for a frank conversation about pandemic preparedness, prevention, and response financing needs, and how we can sustainably mobilize resources for the full range of needs.Much of the attention and debate zeroed in on the newly created financial intermediary fund. This fund is meant to provide a dedicated stream of additional, long-term financing to strengthen pandemic prevention, preparedness, and response capabilities and address critical gaps in LMICs through investments and technical support at the national, regional, and global levels. Yet at UNGA, with the backdrop of the recent disparities in the COVID-19 response still fresh, conversations swirled around how the Fund would ensure a broad set of voices were represented, its ability to achieve its full scope given limited catalytic funding, and how it connects to the broader health security architecture.  This year’s formal UNGA agenda did not feature health as prominently as in the past, perhaps a signal that the outsized attention our community has received due to COVID-19 is waning, as concerns about climate change, a global food crisis, and ongoing global conflicts rise on the list of the world’s most pressing challenges. In the coming months, advocates must pivot to ensure that pandemic needs are not forgotten, and that we start to build the fit-for-purpose architecture of the future, while also recommitting to non-COVID-19 health priorities and addressing the backslides we have seen since the onset of the pandemic.

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. In a new report, the US Department of Health and Human Services’ (HHS’) Office of the Inspector General (OIG) analyzed the US Food and Drug Administration’s (FDA’s) policies during the COVID-19 pandemic response and made recommendations for improving responses to future health emergencies. The report recognized several strong practices including the creation of templates for emergency use authorization (EUA) submissions and communication forums for the agency and developers. However, continual policy shifts and the decision to ease EUA requirements, possibly leading to the authorization of substandard assays, to increase the availability of COVID-19 tests were among the challenges identified. The report’s six recommendations include a revised device-tracking platform to facilitate the EUA submission process, formal communication channels with the lab community, and a national testing strategy.The messenger RNA (mRNA) hub, established last year in South Africa with support from the World Health Organization (WHO), began development of an mRNA vaccine for tuberculosis. The hub’s objective is to develop inoculations to address high-burden diseases in low- and middle-income countries. It is also working on developing a local mRNA vaccine candidate for COVID-19 (which will enter human trials in the coming months) after low- and middle-income countries faced major challenges accessing COVID-19 vaccines during the pandemic. The first approved mRNA vaccines were developed for the COVID-19 pandemic, but the technology has potential to accelerate vaccine development for other diseases as well, including tuberculosis.Last week, the government of Uganda declared an outbreak of a relatively rare strain of Ebola. The Sudan strain has not been reported globally in a decade and there is no approved vaccine to use against it. The rVSV-ZEBOV vaccine, or Ervebo, is currently used across Africa to limit the spread of Ebola outbreaks but it is only approved for the Zaire strain, which is responsible for the majority of outbreaks. However, WHO has pointed to a different Johnson & Johnson vaccine that has potential in targeting the Sudan strain, which could be confirmed through testing.