Breakthroughs Blog: G20

In many ways, 2024 has been a year marked by change—the first new year since the official end of the COVID-19 pandemic and a record number of elections ushering in political transitions around the world. With the global spotlight shifting to antimicrobial resistance (AMR) and tuberculosis (TB) reclaiming the designation as the top infectious disease killer from COVID-19, it may seem, at first glance, that the world has moved on from the pandemic that dominated every aspect of life for the better part of four years. However, with a deeper look, it’s clear that the global community is still reacting to and learning from the pandemic—for better or worse.As the year comes to an end, GHTC is reflecting on the global health innovation news and policies that shaped 2024.1. New disease outbreaks arise around the world, spurring need for and progress in R&D.In 2024, disease outbreaks continued to dominate the headlines—from the first reports of avian flu in the United States in March to the rapid global spread of the clade 1b mpox strain over the summer to the outbreak of the deadly Marburg virus in Rwanda beginning in September. Each of these incidents exposed devastating gaps in our prevention and response toolkit and spurred important steps forward on research and development (R&D) and access.For example, in response to the worrisome spread of avian flu, both the World Health Organization (WHO) and the US government launched efforts to accelerate the development of mRNA vaccines that could be deployed in case of human-to-human transmission of the currently spreading strain of avian flu or redirected to target another form of pandemic influenza if needed. Additionally, following declarations from the Africa Centres for Disease Control and Prevention and WHO designating mpox a public health emergency this past August, WHO prequalified the first vaccine against mpox and approved the first mpox test for emergency use, with the goal of accelerating global access to these critically needed tools. The outbreak also provoked new research to develop improved vaccines against mpox and the broader range of orthopox viruses, with early studies of mRNA mpox vaccines in macaques and mice demonstrating promising results.This fall, as cases of Marburg were on the rise in Rwanda, and with no currently approved vaccines or treatments available, researchers fast-tracked efforts to evaluate tools to stem the current outbreak and curb future ones. Rwandan health authorities initiated an open label vaccine trial in health workers and others at heightened risk, and there has since been a randomized clinical trial arm launched, which will offer critical efficacy data. Additionally, scientists launched the first-ever clinical trial for a Marburg treatment this year.Beyond accelerating innovation against these outbreaks, 2024 also brought exciting research advancements targeting other pathogens scientists believe are most likely to cause the next pandemic, including trials that could lead to the first-ever approved vaccines for Sudan ebolavirus and Lassa fever, as well as further efforts to improve coronavirus vaccines and simplify and speed up vaccine development and manufacturing.2. Pandemic preparedness policy reforms march forward while post-COVID political backlash in United States grows.Multilateral efforts to strengthen the world’s pandemic preparedness and response architecture moved incrementally forward this year. At the World Health Assembly (WHA) in May, member states adopted several amendments to the International Health Regulations—an existing framework codifying international responsibilities during a pandemic—, including new commitments to solidarity and equity on financing and ensuring access to medical products. The World Bank-hosted Pandemic Fund, a financing mechanism launched in 2022 to help low- and middle-income countries strengthen their preparedness and response capacities, also raised $982 million in new contributions and an additional $1.8 billion in co-financing this year, as well as awarded $500 million in grants to countries to strengthen surveillance, laboratory, and workforce capacities and fast-tracked an additional $129 million for the mpox response. Under the Brazilian presidency, G20 nations established a voluntary coalition to strengthen local and regional production of health products, which, while focused foremost on neglected diseases, could also strengthen capacities critical for pandemic preparedness and response. Unfortunately, despite some progress on negotiations toward a new pandemic accord, countries failed to reach sufficient consensus before the end of this year, and negotiators are now pushing to wrap up by the next WHA in May of 2025.At the same time as some progress was achieved on the international front, in the United States, post-COVID political backlash has deepened and become more entrenched through congressional scrutiny and reform agendas targeting the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). Though the fiscal year 2025 budget is not expected to be finalized until next year, the health-related spending bill introduced by the House proposes spending cuts to CDC and a reorganization of NIH, which mirrors that put forward by House Republicans over the summer and could have serious implications for the agency’s core global health R&D capacities. Beyond appropriations, we also continued to see a plethora of congressional hearings targeting NIH and CDC on the origins of COVID-19, gain-of-function research, China’s influence, and the perception that these agencies are overstepping their mandates. The scrutiny and reform efforts we saw this year are expected to intensify in 2025, as Republicans gain control of both chambers of Congress and the White House.3. AMR captures the world’s attention as the global threat continues to grow.2024 was informally dubbed “the year of AMR,” with AMR elevated on the global agenda at several key moments. In May, a WHA resolution was adopted to accelerate national and global responses to AMR by advancing R&D, strengthening surveillance systems, and forging international partnerships. Later in September, a landmark report found that without further policy interventions, the death toll from AMR is expected to reach 39 million between 2025 and 2050—the equivalent of three deaths per minute.This shocking report set the scene for the United Nations High-Level Meeting on AMR in September, which led to the adoption of a political declaration that set the goal to reduce AMR deaths by 10 percent by 2030 and committed countries to promote the R&D of and equitable access to antimicrobials, vaccines, diagnostics, and other products. Global leaders also adopted an action plan in November, built off of the declaration, to provide actionable objectives and additional check-ins to monitor progress.This political momentum on AMR was also matched by exciting research breakthroughs that made the news this year. Researchers discovered a new compound that could potentially treat a resistant bacterial pathogen that can cause lethal hospital infections. Additionally, Phase 3 trials yielded promising results for both a therapeutic option for patients with serious bacterial infections and limited treatment options, as well as a new antibiotic that could cure uncomplicated gonorrhea infections, which could be approved sometime next year.4. TB reclaims title of deadliest infectious disease, but promising trials offer hope. This past year, TB surpassed COVID-19 to reclaim the spot as the world’s leading infectious disease killer, according to WHO’s Global Tuberculosis Report 2024. While this sobering news underscored major gaps in the tools needed to prevent, diagnose, and treat TB, especially drug-resistant TB, 2024 also brought exciting news on the research front that will hopefully help fill them.In March, a Phase 3 trial launched in South Africa, which is testing a TB vaccine candidate that could eventually become the first vaccine to prevent pulmonary TB in adolescents and adults. The only approved TB vaccine on the market, which was developed more than 100 years ago, is effective at preventing some types of TB in infants, but it offers inconsistent protection in adults against pulmonary TB. Additionally in November, the endTB consortium announced the completion of the first Phase 3 randomized controlled trial to exclusively enroll people with pre-extensively drug-resistant TB, a very hard-to-treat form of TB. Preliminary results demonstrated that a shorter, less toxic treatment strategy achieved high cure rates. Earlier in the year, WHO also recommended three new regimens for multidrug- or rifampicin-resistant TB, offering a much-needed variety of therapeutic alternatives for those with multidrug-resistant TB. 5. A major HIV breakthrough, but work remains on access. In what has been hailed as a breakthrough in HIV prevention, in 2024, exciting results were reported from a series of clinical trials for Gilead’s long-acting HIV prevention drug, lenacapavir, which found that the drug was 100 percent effective in preventing HIV in cisgender women and adolescent girls and 96 percent effective among cisgender men, transgender men and women, and gender nonbinary individuals who have sex with men. Both trials were so successful that they were unblinded early to offer the drug to all participants. Lenacapavir, which is administered via a twice-yearly injection, is currently approved as a treatment for multidrug-resistant HIV, but, if approved as a preventative regimen, the drug could be a game-changer for the HIV pandemic.Advocates applauded Gilead for its historic commitment to inclusion in these trials, while also urging that lenacapavir be made accessible and affordable as soon as possible to those that most need it. In October, Gilead announced a plan to allow generic versions of the drug to be sold in 120 countries, including all those with the highest HIV rates. However, the plan faced criticism for excluding most middle- and high-income countries that account for around 20 percent of new HIV infections. In these countries, the originator drug will only be available at higher prices, making it potentially inaccessible to at-risk populations.In other welcome HIV prevention news, in October, Population Council announced the results of a Phase 1 trial, which suggest that a three-month dapivirine vaginal ring for HIV prevention will be as effective as the currently approved one-month ring. The ring, which is self-inserted into the vagina and slowly releases an antiretroviral drug to prevent infection over three months, was found to deliver the drug at higher levels than the one-month ring. If the longer-acting ring continues to demonstrate success, it could offer a more cost-effective and convenient option for at-risk women. 6. Trump presidency and Republican trifecta portend changes to US leadership in global health.In the November election in the United States, former President Donald Trump won the presidency and Republicans gained control of both the US House of Representatives and the Senate. It was an across-the-board victory that will portend changes to US leadership on global health and medical research. If past is prologue, we’re likely to see President-elect Trump once again propose significant funding cuts to US global health programs and public health agencies like NIH and CDC, as well as withdraw the United States from WHO and other multilateral initiatives, the latter of which could derail efforts to finalize a pandemic accord. Given that the United States is the largest funder of global health programs and global health R&D efforts, these political changes could have a reverberating impact on health around the world.Since winning the presidency, President-elect Trump has also nominated several controversial picks to lead America’s public health agencies. These include Robert F. Kennedy Jr, a noted vaccine skeptic who has expressed a desire to cut the NIH workforce and refocus the agency on chronic diseases over infectious diseases, to lead the Department of Health and Human Services; Dr. Jay Bhattacharya, a health economist who criticized public health measures during the COVID-19 response and a vocal critic of NIH, to lead NIH; and Dr. Dave Weldon, a former Congressman who has questioned vaccine safety, to lead CDC.On the congressional front, with Republicans now in control of both chambers of the US Congress, as discussed, we’ll likely see continued scrutiny and reform efforts targeting NIH and CDC, as well as potential spending cuts to health and foreign assistance programs.7. New policies and innovative research approaches help reach underserved populations.Every person, everywhere, deserves to benefit from the fruits of science, and in this otherwise tumultuous year, there were several successful efforts to advance more inclusive clinical studies. In September, WHO released new guidance on clinical trial best practices outlining practical considerations for trials to include children and pregnant and lactating individuals, populations currently underrepresented in trials, leading to a lack of approved technologies for these groups. This guidance aligned with WHO’s living toolkit to facilitate the inclusion of pregnant and breastfeeding populations in clinical trials that was published earlier in the year. 2024 also brought the launch of two historic trials that aim to diversify research and thereby ensure that future technologies will serve the needs of underserved populations. This summer, a global consortium launched the first-ever Phase 3 clinical trial testing the efficacy and safety of antimalarials in women in their first trimester of pregnancy, which will hopefully not only lead to an urgently needed new treatment option for these women but also set a precedent for the inclusion of pregnant women in future clinical trials. Earlier this year, the US Administration for Strategic Preparedness and Response also announced funding to Walgreens to support a decentralized clinical trial testing COVID-19 vaccines. This unique approach will allow for a more diverse pool of study participants by bringing the study closer to where they live, ultimately ensuring that the resulting data reflects real-world use among a broader swath of the population. In the end, 2024 proved to be a complicated year, marked by both scientific and political steps forward and back. As new innovations and policies emerge in 2025 and beyond, GHTC will continue to work to ensure support for global health R&D remains a political priority and that the gains we have already made on neglected and emerging health challenges are not only sustained but also strengthened to combat an evolving health landscape.For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2025 and beyond, sign up now to receive GHTC’s R&D News Roundup newsletter.

The health ministers of G20 nations concluded their annual meeting last weekend with the adoption of an “outcome document” that includes welcome commitments to advance the research and development (R&D) of health products. While normally such a ministerial-level meeting would end with the release of a formal consensus communique, broader geopolitics derailed this process, with Russia and China opposing the inclusion of language condemning the Russian war of aggression against Ukraine. Below we break down what R&D commitments are included in the outcome document, why it matters, and where conversations are expected to go from here. What’s in the declaration? At the highest level, G20 nations made commitments to strengthen the global health architecture and “build more resilient, equitable, sustainable and inclusive health systems equipped to address ongoing global health challenges and future public health emergencies with equitable access to safe, effective, quality-assured and affordable vaccines, therapeutics, diagnostics, and other medical countermeasures.” They also reaffirmed their commitment to ending the epidemics of AIDS, tuberculosis, and malaria; achieving polio eradication; advancing universal health coverage (UHC) and the Sustainable Development Goals (SDGs); and tackling antimicrobial resistance (AMR). On the latter issue of AMR, the ministers vowed to strengthen R&D for AMR and further the development of novel antimicrobials. They welcomed the work of various international initiatives and GHTC members including the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Global Antibiotic Research and Development Partnership (GARDP) and voiced continued support for the Global AMR R&D Hub, which was established under the German G20 presidency to promote AMR R&D coordination. On the broader issue of R&D for pandemic prevention, preparedness, and response (PPPR), G20 leaders agreed to support a World Health Organization (WHO)-led consultative process to develop an interim (and potentially later permanent) medical countermeasures (MCMs) mechanism to coordinate the end-to-end R&D, manufacturing, procurement, and equitable delivery of MCMs during health emergencies. They advised that such a mechanism should consider a “network of networks” approach, building off existing international and regional partnerships, and should be coherent with the outcomes of ongoing efforts to amend the International Health Regulations (IHR) and advance a binding pandemic instrument. Additionally, the ministers underscored the need to strengthen local and regional R&D networks and manufacturing capabilities, especially in low- and middle-income countries, as well as voiced support for what many call the “100 Days Mission” to develop and make available safe and effective vaccines, therapeutics, and diagnostics within 100 days of the identification of a pandemic or epidemic threat. They also noted the importance of public-private R&D partnerships—calling out the contributions of GHTC members the Coalition for Epidemic Preparedness Innovations (CEPI), Medicines Patent Pool (MPP), and FIND—and technology transfer and knowledge sharing “on voluntary and mutually agreed terms.”Why it matters?  G20 nations currently conduct and fund the majority of the world’s health R&D. Thus, it is great to see G20 leaders reaffirm the importance of R&D to achieving UHC, SDGs, and PPPR and demonstrate political will to accelerate R&D efforts. However, the outcome document is short on specifics as to how G20 countries intend to operationalize their many promises, and it disappointingly includes no new funding targets or commitments.  Additionally, going into this year’s G20 cycle, many observers and health advocates also expected that the G20 under the Indian presidency would play a more active role in envisioning and detailing a specific proposal for the creation of an end-to-end MCMs mechanism or platform to succeed and build upon the Access to COVID-19 Tools Accelerator. Instead, the G20 simply promised to support a WHO-led consultative process to design an interim mechanism and punted it to the International Negotiating Body (INB) process for a pandemic instrument to determine the prospects for a permanent MCMs platform. What’s next? With G20 nations offering few specifics on a vision to reimagine the global health architecture and advance an MCMs platform, the focal point for change is now squarely within the separate but interrelated processes now underway to amend the IHR, advance a pandemic accord that will create a more comprehensive framework for how countries will prevent and respond to outbreaks, and design an interim MCMs platform. While these processes have been ongoing, the deliberations have been stymied as countries struggle to reach consensus around thorny R&D topics like access and benefit sharing, with some pushing for more aggressive legally binding commitments for transparency, conditions on public R&D funding, patent waivers, and new supply chain mechanisms for ensuring low- and middle-income countries access to medical countermeasures. Questions remain on the full scope of some of the processes, and how they will delineate which issues will be tackled where and with the target date of May 2024 for the adoption of an instrument rapidly approaching and the INB and IHR processes largely behind schedule, it remains to be seen what tangible changes for R&D can be realized. While it is impossible to know what exactly what the future of these negotiations hold, GHTC promises to continue to watch, weigh in, and report back in the months ahead as these interrelated processes unfold. Stay tuned! 

With the world still reeling from the pandemic and global inequities more exposed than ever when it comes to access to medical countermeasures and response capabilities, all eyes were glued on G20 leaders in Rome last week. This G20 heads of state meeting was supposed to be a key global moment for shaping effective, innovative, and equitable responses toward a new post-pandemic global health architecture, but world leaders failed to come together and deliver the necessary action to end the historic crisis still unfolding or create the structures to prepare for the next one. The meeting did offer a small glimmer of hope: research and innovation was firmly anchored as a core tenet of leaders’ strategies to address a myriad of global health challenges, whether COVID-19-related or focused on enduring health threats. While this very much feels like the G20 missed its opportunity, hope remains that the international community can utilize other upcoming forums to take up the torch.  Missing the mark As G20 leaders got together to hammer out agreements to address both current and future health challenges, expectations were high, as many global health advocates hoped the group would start taking concrete steps to act on the numerous initiatives and recommendations from the various review processes this past year. Unfortunately, the global health community was left disappointed, as G20 leaders failed to step up to the plate, providing little by way of concrete pledges, funding, or specific road maps on how to turn their words into action. While countries agreed to a target to vaccinate 40 percent of the world by the end of the year and 70 percent by the middle of 2022, they offered no concrete plans to achieve that goal and failed to make good on their earlier dose promises to COVAX by confirming actual delivery dates. Under current projections, close to 80 countries won’t hit that 40 percent mark by year’s end and would struggle to hit the target in the first quarter of 2022.  Funding also remains a concern, as G20 nations made no new commitments to help address the US$15.9 billion shortfall in monies needed by the Access to COVID-19 Tools Accelerator to accelerate the rollout of tests, treatments, and vaccines, as well as the continued investment needed in innovation to address variants as well as second-generation medical countermeasures that can be more easily deployed. There were also expectations that the G20 would agree to some framework for the creation of a financial intermediary fund for pandemic preparedness, a mechanism that would provide countries with financing to address their long-term preparedness capacity strengthening needs, including potential investments in surveillance, laboratory, clinical trial, and manufacturing infrastructure. However, the G20 didn’t jump at the opportunity to move this initiative forward at the summit, choosing instead to set up a finance-health task force to consider a potential financing facility, creating yet another process.  Silver lining on research and development Despite not spelling out major commitments, the G20 leaders did include several high-level pledges related to research and development (R&D) and broadly acknowledged that research and innovation are important cornerstones of pandemic preparedness and response capacity writ large. It is rare that the G20 leaders’ communique makes direct mention of R&D, so seeing that language included in the final document is remarkable in and of itself. What stands out in the declaration is a pledge by G20 countries to support science to shorten the cycle for the development of safe and effective vaccines, therapeutics, and diagnostics from 300 to 100 days following their identification. While this ambitious target was not supported directly by specific commitments, it does provide a principles framework for future discussions on R&D coordination and capacity strengthening. G20 leaders also had strong rhetoric on strengthening supply chains and manufacturing capacity in the long term, highlighting the need to support mRNA hubs in low- and middle-income countries in particular. Finally, it was also good to see explicit callouts underscoring the need to sustain investments in malaria, tuberculosis, and HIV/AIDS and tackle the growing threat of antimicrobial resistance.  Who will pick up the torch? While this year’s G7 and G20 processes did not lead to the kind of concrete commitments advocates were hoping for, there are still a few summits and milestones in the coming months that could help cement follow-through action to meet global vaccination targets, fully resource the global COVID-19 response including ongoing R&D needs, and enhance transparency around the global supply and delivery of COVID-19-related medical countermeasures. Today, US Secretary of State Antony Blinken will host a meeting with foreign ministers from several countries to discuss commitments to the global COVID-19 response in follow-up to the Global COVID-19 Summit in September. There are also the ongoing discussions being held by member states in the lead-up to the upcoming special session of the World Health Organization on how to strengthen the agency’s health preparedness capabilities, including a potential new framework convention or pandemic treaty. These deliberations have considered a number of changes to the global health security architecture, including developing and reforming governance and coordination mechanisms for R&D. The pressure is now on these forums to deliver solutions to the broad set of challenges that the G20 Ministerial didn’t deliver and to build on the strong rhetoric on R&D to create a fit-for-purpose global health system that provides true equitable access to the health tools the world needs. 

Last month, G20 health ministers convened for their annual summit to address today’s greatest challenges to global health. As usual, they concluded with a new health declaration, which this year included language in support of multilateral cooperation to end the COVID-19 pandemic and improve access to COVID-19 medical countermeasures. It also recommits to health priorities like combating antimicrobial resistance (AMR), preparing for health emergencies, and achieving universal health coverage (UHC), and provides a framework to prioritize these global health challenges through the lens of equitable access and research and development (R&D) coordination. These seem to be powerful commitments, but where do they fit in context? In this Breakthroughs Blog, we look back on commitments from previous years to reflect on how the declarations have evolved and what they have been missing.Reflecting on five years of ministerial commitments Since the first G20 health ministers’ meeting in 2017, the health declarations have been a powerful platform for confronting long-standing global health challenges and adapting to new ones. While some topics such as AMR, health emergencies, and UHC have been featured repeatedly over the past five years in hopes of achieving equitable quality of and access to care, the declarations have also been used to react in real time to urgent crises such as COVID-19. Here are some key takeaways that help us understand where we’ve been:  Antimicrobial resistance Since 2017, the G20 health ministers have remained consistently committed to combating AMR through international collaboration. R&D has been a critical component of AMR commitments since the establishment of the Global AMR R&D Hub, an independent initiative to identify research gaps and align funders that was launched in 2018 following a call from G20 health ministers the prior year. Health ministers continue to recognize the urgent need for sustained R&D to accelerate the development of safe, effective, and affordable antimicrobials and partnerships to maintain the global supply of existing antimicrobials. Additionally, these health commitments also focus on surveillance and data sharing. Specifically, the World Health Organization (WHO) Global Antimicrobial Resistance Surveillance System (GLASS) Report was a step toward increasing the systematic collection of quality data on antimicrobial sales, consumption, and resistance to understand and mitigate the risks posed by AMR. Though AMR continues to be a focal point and some important initiatives have been launched, it is crucial that health ministers follow through on their agreed-upon proposals.Health emergencies While pledges to combat health emergencies and improve global health security were made prior to COVID-19, this issue has now taken center stage for G20 health ministers. Many of the pledges made in the 2020 health declaration focused on COVID-19 and discussed the adverse effects the pandemic is having on other health areas. Health ministers also recognize the importance of R&D to address infectious diseases with epidemic and pandemic potential. This past month, they put R&D at the core of the G20 agenda with a focus on the Access to COVID-19 Tools Accelerator, new pandemic preparedness initiatives, and reinvestment in existing programs. In 2019, much of the messaging and commitments were similarly focused on containing the Ebola outbreak in the Democratic Republic of the Congo. Along with pledges focused on specific health emergencies, the G20 health ministers have maintained yearly commitments to international cooperation and health systems strengthening under WHO guidance and in accordance with the International Health Regulations (IHR), both critical components of global health security. Despite reaffirming the need for strong health systems and compliance with the IHR as essential for health preparedness, health ministers have fallen short or been unable to secure commitments to the sustainable financing necessary for prevention and response. The lack of sustainable financing has translated into a lack of capacity, particularly in low- and middle-income countries, and left WHO and other multilateral institutions without adequate resources to mitigate pandemic threats. Recognizing these limitations, in January 2021, the G20 established a High-Level Independent Panel (HLIP) that worked at breakneck speed to propose actionable solutions for reliable and sustainable financing of the global commons for pandemic prevention, preparedness, and response by June 2021.Universal health coverage G20 health ministers have consistently recognized that UHC will be best achieved through strengthening health systems and promoting international collaboration, especially through sharing data, exchanging best practices, and sustainable financing. Their commitments reflect the multifaceted elements foundational to achieving UHC including primary care; health care workforce capacity; nutrition; immunization; and water, sanitation, and hygiene, as well as R&D and equitable access to medicines and health services. Health ministers have recognized and articulated the continued need for global investment in those areas, while also emphasizing that countries need to develop their own pathways toward the achievement of UHC by accounting for national contexts and priorities through engagement with civil society and the private sector. Despite consistently reaffirming their commitment to UHC, G20 countries have made few pledges shaping tangible action.The missing wheel for the road aheadFor the past five years, G20 health ministers have agreed on powerful language in their declarations—and yet each year, with a few notable exceptions, progress has rarely been made beyond a stamped paper. Unsurprisingly, the most recent declaration includes strong language on COVID-19, AMR, UHC, and health emergencies, but outside of pandemic financing, it is not connected to a plan to meet those pledges. It is unfortunate that the standard has become all talk and no action. But this month, G20 leaders can set a new course. Following the G20 health ministers’ meeting last month, the G20 heads of state will convene for their annual summit later this month. Together, the heads of state have an opportunity to fulfill the vision set forth by their health ministers; follow through with specific HLIP recommendations on how to fill gaps in pandemic preparedness, prevention, and response; and ultimately set a new standard of combining commitments with tangible action for future G20 health-related meetings.