Breakthroughs Blog: WHO

This fall, the global health community gathered against a backdrop of change. Shifts in global funding, visible pullbacks from multilateralism, and an evolving global development architecture are reshaping how actors engage and advocate on the world stage.For the Global Health Technologies Coalition (GHTC)—and for many others—this moment has prompted reflection on how we show up in global forums and what it means to engage meaningfully amid transition. Following a busy season of high-level gatherings, we’ve taken time to reflect on what these moments revealed—both in the lead-up and in the conversations that followed—and how they are shaping our thinking about GHTC’s role and path forward in these spaces. Reconnecting at UNGA80 In the run-up to this year’s 80th United Nations General Assembly (UNGA80), there was an unusual air of hesitation across the global health community. Typically, mid-August brings a flurry of coordination calls and side event planning, but this year, the energy felt uncertain. For GHTC, our initial hesitation to participate stemmed from UNGA’s focus on noncommunicable diseases (NCDs), an area outside our traditional advocacy repertoire. However, we also had questions about which of our partners would be in New York City this year and what our role could or should be in the tumultuous year we have all had. Yet, as it goes, we and other organizations confirmed our plans to attend UNGA, and soon, the familiar rhythm of civil society’s presence in New York began to take shape.  In New York, GHTC and the Global Health Council (GHC), with STUF United Fund, cohosted an event on innovation, security, and equity in a changing global landscape, which brought together policymakers, funders, and implementers to examine how global health can stay resilient amid geopolitical uncertainty. The discussion was lively and focused on the technical aspects of innovation, security, and equity, but afterwards participants commented not on those technical matters, but on our authentic and pragmatic approach and tone with which we addressed these topics. Audience members remarked that the discussion was one of the most genuine moments of the week. For GHTC, moderating this dialogue reinforced the need for global health advocates to bridge communities and connect innovators, funders, and policymakers around a shared vision for equitable access. It also reminded us that the credibility of civil society depends on showing up authentically, especially in moments of uncertainty or disagreement.  One striking development at UNGA this year came during the High-Level Meeting on NCDs, where the United States laid out objections to the political declaration and voted against it, taking consensus for the resolution off the table. While this move was not unexpected given the US government’s posture toward multilateralism this year, it was still a sobering moment. Secretary of Health and Human Services Robert F. Kennedy has made NCD prevention a national priority under his leadership at the department, yet his sharp criticism of the declaration underscored the United States’ continued reluctance to advance these goals through global cooperation. Women’s health as a catalyst for R&D transformation  As the global health community’s focus shifted from New York to Berlin, Germany for the World Health Summit (WHS), many of the same themes carried forward—innovation, equity, and the importance of collaboration amid shifting global priorities. After UNGA80, we saw how essential it was for civil society's voices to remain present and aligned in global conversations, and we viewed WHS as an opportunity to do just that. For us, a standout moment in Berlin was our participation in the Gates Foundation’s Women’s Health Innovation Equity Forum—a convening of global leaders, innovators, and funders dedicated to advancing accountability and progress in women’s health research and development (R&D).  What stood out the most at this forum was the shared understanding that women’s health R&D can be a testing ground for how we build a more equitable and collaborative innovation system overall. Conversations at the forum went beyond individual products or technologies to look at the broader ecosystem: how research can better reflect women’s lived experiences, how artificial intelligence and digital tools can be designed to avoid bias, and how we can create inclusive pathways from discovery to delivery. The call was not just to innovate for women but to innovate with women, by centering their voices, co-designing solutions that fit their realities, and ensuring that they are represented as leaders, scientists, and decision-makers throughout the R&D process. These ideas align with GHTC’s work to strengthen the global health innovation ecosystem. Our goal is to help make equitable, inclusive, and well-resourced innovation systems the rule, rather than the exception.  Reimagining the global health architectureOver the past several months, we've participated in a number of conversations, meetings, and working sessions aimed at reimagining how the global health architecture can be rebuilt stronger and more resiliently in the years ahead. One gathering, hosted by the Wellcome Trust just after WHS, brought a new focus and sense of shared purpose to this discussion, convening partners from across North America and Europe to explore the future of global health amid ongoing change and reform. This initial session focused on North American and European partners, with additional regional discussions planned to ensure perspectives from low- and middle-income countries and other stakeholders are fully represented as the series continues. The gathering brought together an extraordinary mix of leaders—funders, policymakers, researchers, and advocates—who are committed to reimagining how the global health ecosystem advances innovation and equity. Our discussions explored how the next generation of global health architecture could deliver faster, more inclusive, and stronger regional capabilities for research and manufacturing and more sustainable financing that bridges discovery and delivery. It was both humbling and energizing to be part of such a thoughtful, solutions-oriented dialogue at a moment when the global community is being called to reexamine what collective action really looks like.  For GHTC, these reflections really brought home why our coalition’s work matters. The conversations highlighted how innovation, access, and financing are all part of the same continuum, which is exactly what GHTC has been advocating for as we work to strengthen R&D systems, regulatory pathways, and product access. What struck us the most was the shared understanding that reforming global health innovation is not only a technical or financial issue but also a matter of trust, shared power, and accountability. We left the meeting encouraged and inspired, knowing that voices like ours, grounded in evidence, partnership, and advocacy, have an important role to play in shaping a more connected, inclusive, and resilient global health ecosystem. In Berlin, we also had the chance to join our partners, including the Medicines for Malaria Venture (MMV), Impact Global Health, and others, at events highlighting innovation and equitable access on the margins of the WHS. Finally, to close out our continued engagement with the civil society arm of the G20, we supported our partners—including the South African Health Technologies Advocacy Coalition, Resilience Action Network Africa, MMV, Better Health Solutions, and others—in hosting a side event on science, research, and innovation on the sidelines of the G20 Social Summit. This event highlighted the value of meaningful partnerships and global collaboration, reinforcing the importance of civil society's voices in shaping health innovation and research agendas worldwide. Looking aheadAs this season of global convenings draws to a close, GHTC is taking stock. We are reexamining our multilateral priorities and exploring how to continue showing up—strategically, collaboratively, and boldly—in spaces that are themselves evolving. We extend deep thanks to our partners—GHC, MMV, Impact Global Health, the South African Health Technologies Advocacy Coalition, Resilience Action Network Africa, Better Health Solutions, and many others—for the coordination and collaboration that made this season so meaningful. Even during a period of change, these gatherings reaffirmed that innovation, solidarity, and shared purpose remain at the heart of progress in global health. 

The World Health Organization's (WHO's) TB Vaccine Accelerator Council recently published a new report calling for action to ensure equitable access to future tuberculosis (TB) vaccines currently in the pipeline. While the only licensed vaccine for TB is 100 years old and has limited effectiveness in adolescents and adults, as of September, there are 16 candidate vaccines in clinical development, six of which are in Phase 3 trials. WHO estimates that a vaccine for adolescents and adults that is at least 50 percent effective could avert up to 76 million TB cases and 8.5 million deaths over 25 years. However, as the report claims, global demand could far exceed supply in the initial years after a vaccine is approved because there is no designated funding for such a rollout in low- and middle-income countries most affected by TB, which are already facing significant funding shortfalls. In anticipation of these potential bottlenecks and barriers to access, the report identifies six solutions to encourage countries with a high burden of TB, manufacturers, and other funders and stakeholders to start preparing now for the rollout to ensure future vaccines can reach people who need them faster. In a Phase 1 randomized controlled trial, an experimental intranasal vaccine against multiple H5N1 avian flu strains generated a broad immune response, demonstrating the potential of such a vaccine to play a major role in preparing for outbreaks of emerging viruses with evolving strains, as H5N1 continues its worrying spread. The University of Maryland research team tested the vaccine against a placebo in 40 adults between 18 and 45, finding that the vaccine was safe, well-tolerated, and stimulated immunity at various doses. One group received a vaccine dose combined with an adjuvant, an ingredient used to trigger a stronger immune response, and their immune systems were better able to neutralize infected cells for longer, suggesting that the use of an adjuvant could be a promising approach that might allow for lower doses, which could stretch limited vaccine supplies in the event of an outbreak. Last week, IAVI published new findings from the first-in-human Phase 1 clinical trial of its Lassa virus vaccine candidate, which show that one dose of the vaccine triggers robust and long-lasting immunity and is safe. There are no vaccines or treatments currently licensed against the dangerous illness, which causes thousands of deaths in endemic West Africa and has been designated as a priority pathogen with pandemic potential. The trial enrolled 114 volunteers in Liberia and the United States. The candidate, now undergoing a Phase 2a trial in West Africa, is currently the most advanced Lassa fever vaccine candidate in the pipeline and uses the same platform as Merck’s single-dose Ebolavirus vaccine, which is approved in more than a dozen countries. 

A team of chemists from the University of Warwick and Monash University has identified a promising, potent new antibiotic that seems to be much more effective than existing drugs against deadly superbugs like MRSA and shows no signs of resistance so far, encouraging news as the global threat of antimicrobial resistance continues to grow and the pipeline of new antibiotics continues to fall short. The molecule had been overlooked for decades as an intermediate chemical in the natural process to produce another known antibiotic, methylenomycin A, which was discovered 50 years ago, and despite having been synthesized multiple times, the synthetic intermediates have seemingly not been tested before for antimicrobial activity. The new antibiotic is much more potent than methylenomycin A itself—100 times more active against a range of serious bacteria. It could not only be a powerful new tool against rising drug resistance, but this work could also pave the way for new approaches to antibiotic discovery. A team of researchers has developed an antivenom using antibodies from a llama and an alpaca that can neutralize venom from some of the world’s most venomous snakes. Snakebites are a neglected public health issue that kill around 20,000 people in sub-Saharan Africa yearly. Current antivenom treatments are usually specific to a single snake species, and it can be difficult to identify which of the many types of venomous snakes is behind a bite, making timely, effective treatment difficult to achieve. The researchers exposed an alpaca and a llama to venoms from 18 of the most dangerous snake species in sub-Saharan Africa, isolated the antibodies that the animals produced against the venom, and then combined some of those antibodies in a single cocktail. In mice, the treatment protected against toxins from 17 African snake species and reduced skin damage. Many scientists previously thought that developing a broad-spectrum antivenom would require too many antibodies to be practical because some venom can contain up to 100 toxins, but this study shows that a combination of just a handful of antibodies can neutralize the venom of many snake species, paving the way for the development of similar broad-spectrum antivenoms for other areas where snakebites are a common public health challenge. Last week, Cepheid announced that its Xpert MTB/XDR test for tuberculosis (TB) drug resistance has been prequalified by the World Health Organization (WHO), enabling procurement through international agencies and greater access in areas with a high TB burden. The test is designed to detect resistance to multiple first- and second-line TB drugs from patient samples. It also delivers results quickly, within 90 minutes, allowing health care providers to make quicker, more reliable treatment decisions and have a better understanding of drug resistance, especially in regions with a high TB burden where timing and accuracy are critically important. 

GHTC’s PQ Pulse interview series explores challenges in navigating the World Health Organization’s (WHO’s) prequalification (PQ) program with various stakeholders engaged in the regulatory ecosystem.  In our third installment, we spoke with Dr. Benjamin Djoudalbaye, head of the African Medicines Agency (AMA) interim secretariat, to discuss the agency's role in advancing regulatory harmonization across the continent and its intersection with WHO's PQ program.   In our interview, which has been lightly edited and condensed below, Dr. Djoudalbaye discusses his vision for a harmonious regulatory system across the African continent.   GHTC: To begin our conversation today, it would be helpful for you to outline AMA’s scope and highlight its current status.  Dr. Djoudalbaye: Yes, thank you for the question, and thank you for the opportunity for AMA to tell its story.  AMA is a specialized agency of the African Union, established to regulate and harmonize oversight of medicines, vaccines, medical devices, and veterinary and traditional medicines across the continent. The overarching goal of the agency is to ensure that all Africans have access to high-quality, safe, and effective medical technologies.   This is a quite broad definition of AMA, as it also has some specific key functions. These include regulatory harmonization across African regulatory bodies, assessing and listing medical products, pharmaceutical manufacturing, market surveillance, and supporting growth of local manufacturing in alignment with the African Pharmaceutical Manufacturing Plan. Oversight of clinical trials and good manufacturing practices also fall under the purview of the agency. I named just a few functions of AMA, but there are many more.In terms of governance, AMA is established by a treaty that is undergoing ratification and is currently endorsed by 31 countries. A Conference of State Parties has been established to oversee it, in addition to a governing board and secretariat. Dr. Delese Mimi Darko was appointed as AMA’s Director-General and will assume her role very soon at the agency’s headquarters in Kigali, Rwanda. My role consists of laying the foundation for Dr. Darko to take over and lead the institution. GHTC: That’s helpful context to gain an overview of AMA. It’s also exciting to see how much progress has been made to operationalize the agency in such a short among of time. GHTC: How do you see AMA’s role evolving as it relates to PQ, potentially as a partner and/or taking ownership of certain functionalities?Dr. Djoudalbaye: That’s an interesting question and one that I do not have all the answers to. AMA has not given an official position on its relationship with WHO PQ, but I can provide a few ideas on how that might play out.  To me, PQ has long served as a global benchmark for ensuring the quality, safety, and efficacy of medical products, particularly for [low- and middle-income countries] that lack robust regulatory systems. Africa has gotten support from this program’s rigorous assessment of medicines, diagnostics, and vaccines for products procured by [UNICEF] or by Gavi, the Vaccine Alliance, as those products must be prequalified by WHO before they are procured and then delivered. So that’s one way PQ and AMA will continue to engage with one another. We also need collaboration for quality control of health technologies, which is WHO PQ’s guaranteed service. Providing technical support and training to national regulatory authorities, specifically guidance for local manufacturers seeking to achieve international quality standards, is another area of expected engagement with WHO.  AMA is positioned to harmonize and coordinate Africa's network of quality control laboratories and build on platforms developed through PQ. So, in this regard, PQ is extremely important, and AMA needs to build on that. Despite the progress we see with AMA, we need to recognize the continent’s reliance on national and regional regulators. On the continent today, we have three layers. Layer one is the continental level, of what AMA will do and implement; the second is the African Medicine Regulatory Harmonization program, working alongside regional economic initiatives; and the third layer is the national level. It is important that these layers communicate with one another as they transition from reliance to recognition. Further down the line, we can think about leveraging the WHO Foundation to develop an Africa-specific or fast-tracking product assessment system that focuses on regional health priorities and locally manufactured products as a possible idea. Long-term, my goal is for AMA to decrease Africa’s dependence on external prequalification.GHTC: Yes, I agree. It’s hard in this environment to make any sort of clear determinations with all that is moving around us, especially with WHO’s reform, as well as changes in the US landscape.  GHTC: What challenges are you facing day-to-day? How do you ensure that you continue the forward momentum, as AMA is undergoing ratification?  Dr. Djoudalbaye: One challenge is the fragmented regulatory frameworks across the African continent, and it will be AMA’s role to coordinate and bring those stakeholders together. The diverse—and sometimes conflicting—regulations across countries and regions make it difficult for manufacturers to comply effectively, especially for those working across jurisdictions. We have countries with different national languages, which can also make alignment difficult. One united framework will help address bottlenecks, reduce approval times, reduce markets to entry, and bring down administrative costs.  Another challenge is bureaucratic inefficiencies. Complex, opaque regulatory procedures increase operational costs, discourage investments, and create barriers to scaling innovation. The issue may be—and I am choosing my words carefully here—perceived corruption and inconsistent regulatory enforcement in some countries that can erode trust in the system.Inadequate regulatory oversight is another pain point. Many regulatory authorities lack resources and capacity, and that is a contributing reason to why we only have eight African countries that have achieved maturity level three [Editor note: WHO has a four-level system for assessing the strength and functionality of national regulatory authorities]. We are striving to have at least half of Africa’s member states reach maturity level three, others to reach four, and even potentially have regional bodies added as WHO-listed authorities [Editor note: WHO-listed authority is a designation for countries with stable, well-functioning regulatory systems]. Policy integration and public-private collaboration are other areas to improve. In terms of integrated policy development, we need to encourage cross-sectional policymaking alignments, bringing the industrial, science, and trade sectors closer to create a coherent investment in the regulatory environment. Engaging private-sector voices in shaping regulatory reforms is important to innovating technology, developing skills, and modernizing regulatory technologies. For instance, we can fast-track product entry into the market by leveraging blockchain technology in regulatory affairs to expand training, technical education, and international partnerships like WHO PQ. Inconsistent adoption of international standards is another issue. There are disparities between local regulators and international standards that complicate compliance and block access to global markets, especially in high-growth sectors, such as pharmaceuticals and food processing.  Finally, trade barriers have emerged as another bottleneck. Persistent non-tariff barriers and the slow implementation of agreements like the African Continental Free Trade Area restrict intra-African trade and regulatory harmonization efforts.  So how do we overcome these challenges? We need regulatory reforms and harmonization to streamline bureaucratic processes from regional regulators to continental ones, like AMA. This will make it easier for businesses to expand across borders and tap into larger markets.  GHTC: This is a great transition to our last question: what do you envision for AMA as an agency for the next five to ten years?  Dr. Djoudalbaye: In the next five to ten years, I want to see AMA poised to become a cornerstone of Africa’s health regulatory landscape and shape the continent’s access to safe, effective, and high-quality medical products. We must also eliminate substandard and falsified products, and I see that as an avenue for a quick win for the agency. Overall, AMA’s emergence will signify a unified and collaborative regulatory framework that is vital for the continent.  Decentralization and harmonization are important to continental regulatory leadership. This will also strengthen national agencies, so we need to build capacity at the continental, regional, and country levels. However, AMA cannot solve everything. Integration of these levels will be essential for the scientific capabilities of the agency. I want to see AMA as a high-quality and independent organization, so its regulatory decisions are evidence-based and preserve scientific integrity.  GHTC: Thank you for your time, your insights, and your proposed solutions.