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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. On Friday, the World Health Organization (WHO) published a new report detailing the antibacterial agents, including antibiotics, in clinical and preclinical development worldwide, finding that despite improvements, the pipeline remains inadequate to confront the urgent need for new, innovative technologies to address serious infections and replace those becoming ineffective due to rising antimicrobial resistance. According to the report, new products are not being developed at the pace and scale needed to ensure new antibiotics are delivered, given the time required for products to move through the pipeline and the likelihood of failure. Specifically, the report identified gaps in agents for children, agents with more convenient oral formulations, and agents that can address drug-resistant pathogens. The report also stressed that efforts to boost innovation must accompany parallel efforts to ensure equitable access to existing and new products, particularly in low- and middle-income countries, where access gaps can hasten the rise of drug resistance.  Last week, the Global Antibiotic Research & Development Partnership (GARDP) announced an agreement with Bugworks Research to support the further development of a new broad-spectrum antibiotic that targets some of the most difficult-to-treat bacterial pathogens, aiming to enable access simultaneously in Western countries and low- and middle-income countries with a high burden of antimicrobial resistance. GARDP will provide Bugworks up to $20 million in financial and technical support through the approval and commercialization of BWC0977, a compound that has demonstrated in-vitro activity against WHO critical priority pathogens, in return for the manufacturing and commercialization rights to it in 146 primarily low- and middle-income countries. Bugworks previously received more than $12 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, for the preclinical development and Phase 1 study of the compound. Moderna recently announced positive late-stage trial results for mRNA-1083, its COVID-flu combination vaccine. The company is the first of several testing a combined COVID-flu vaccine to announce positive late-stage trial results, as experts raise calls for new tools to ensure more people have better protection against both viruses. Trial participants who received the vaccine showed an improved immune response compared with those who got the standalone flu and COVID vaccines that are currently available, even for people 65 years and older, who generally do not mount as robust immune responses to vaccines compared to younger people. The company hopes to have the vaccine approved for the fall of 2025.

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. Last Wednesday, US Food and Drug Administration advisers recommended that next fall’s updated COVID-19 vaccine target the lineage of the JN.1 variant, which became dominant in the United States last winter. There was some debate among experts on whether the vaccine should target the KP.2 subtype of the variant that is now most common in the United States or other offshoot subtypes that may become more dominant over the summer, ultimately deciding to target JN.1 itself, with the hope that the vaccine would offer some cross-protection against other subvariants that might emerge. Moderna, Pfizer, and Novavax say they could have JN.1.-specific shots ready by the fall.Two clinical trials have been launched to test a new, long-acting form of HIV pre-exposure prophylaxis, or PrEP, in cisgender women and people who inject drugs, two populations that have been largely underrepresented in HIV clinical trials. The mid-stage studies, sponsored and funded by Gilead and implemented through the HIV Prevention Trials Network, will test lenacapavir, an injectable antiretroviral drug administered every six months, which is already approved by the US Food and Drug Administration for HIV treatment in combination with other antiretroviral therapy for heavily treatment-experienced individuals and is the first in the capsid inhibitors class of drugs to be FDA approved for HIV treatment. The researchers hope these studies will provide critical data on the use of lenacapavir as HIV PrEP.Last week, the Sabin Vaccine Institute announced a new research project with the Kenya Medical Research Institute aimed at optimizing the use of the oral cholera vaccine in the face of a global resurgence in cholera and acute vaccine shortages, hopefully improving the impact of the vaccine and saving lives. The shortage of the oral cholera vaccine in 2022 led the World Health Organization (WHO) to temporarily modify the two-dose vaccine regimen and recommend a single dose during outbreaks, underscoring the urgent need for research to optimize vaccine use. WHO currently recommends two doses of oral cholera vaccine two weeks apart. The new research will test strategies to extend the time between doses to ensure that more people can receive protection.

Last week, rain clouds gathered over Geneva as delegates from all over the world completed their annual pilgrimage to the World Health Assembly (WHA), the World Health Organization’s (WHO’s) annual forum for the 194 member states. The somber background reflected the mood heading into the meeting, as many were expecting this year’s gathering to be a washout. A visibly weary WHO Director-General Dr. Tedros Adhanom Ghebreyesus expressed his disappointment on the opening day that negotiations on a pandemic accord had not been completed in time for a WHA vote. Representatives also expected contentious fights over sexual and reproductive health and geopolitical conflicts, such as the ones in Ukraine and Gaza, to spill over into the proceedings, freezing debate and derailing possible progress on agenda items ranging from climate and health to universal health coverage. Yet, despite some serious bumps in the road, WHA also showcased that any multilateral system obituary is premature and that multilateralism can still deliver the necessary change we need to advance the global health agenda.   WHA approves new IHR amendments, resets timeline for pandemic agreement negotiationsAll eyes were on whether member states could come together to finalize the negotiations around the pandemic accord, a proposed convention to address some of the shortcomings exposed during the COVID-19 pandemic, as well as amendments to the International Health Regulations (IHR), an existing framework that codifies member state and WHO responsibilities in preparing for and responding to a public health emergency.  Heading into WHA, many stakeholders waited with bated breath to see if member states could bring both these processes across the finish line. Unfortunately, despite two long years of grueling negotiations, countries were unable to forge sufficient consensus to approve the pandemic accord. Instead, countries agreed to extend the mandate of the intergovernmental negotiating body, which coordinates the deliberation process for another year, providing additional time to reach compromises around the most contentious issues (financing, technology transfer—the process by which knowledge is transferred from the originator of a technology to other manufacturers to support the diffusion of health technologies into additional markets—, and a proposed access- and benefit-sharing system, which would pair commitments by countries around the sharing of pathogen samples and sequencing data with commitments from manufacturers to set aside a dedicated portion of their products for equitable distribution during health emergencies).  Nonetheless, member states notched a desperately needed win in reaching consensus on amendments to the IHR, achieving an agreement in the final hours of WHA. The consensus takes on added significance given that country representatives were not only in a race against time but also against fast-eroding trust in multilateralism, which was deeply fractured by the pandemic and subsequent geopolitical conflicts. The amendments to these technical rules, last revised in 2005 following the SARS outbreak, represent the first significant change in international law in the aftermath of the COVID-19 pandemic. While there were many changes to the IHR, one that stands out the most is that the added provisions include a commitment to solidarity and equity on strengthening access to medical products and to financing, including specific text that directs countries to promote research and development (R&D) and strengthen local production of quality, safe, and effective relevant health products. The previous IHR did not include any mention of R&D or the need to ensure equitable access to new tools.   WHA reinvigorates maternal and child health agenda  Progress was also made on a couple of other fronts in Geneva. Alarmed by the stagnation of progress in reducing maternal and child mortality, member states passed a critical resolution committing to specific actions to prevent the deaths of women, babies, and children.The resolution, led by Somalia and other cosponsors, commits countries to tackle the leading causes of maternal and child deaths, particularly in the hardest-hit nations. In it, countries agreed to improve access to maternal health services, including sexual and reproductive services, and comprehensive child health services through stronger primary health care and expanded access to emergency services. It also urges countries to develop and invest in tools that enable access to essential quality medicines for pregnant women, lactating women, mothers, and newborns and calls on WHO to strengthen and expand collaborative efforts, such as those promoted by WHO technical departments and the Global Accelerator for Pediatric formulations, or GAP-f, network, for facilitating better access to medicines for children. The WHA resolution marks WHO’s first significant action on maternal mortality in nearly a decade, following the adoption of the Global Strategy for Women’s, Children’s and Adolescents’ Health in 2015. Antimicrobial resistance in the spotlight  Antimicrobial resistance (AMR) also was in the spotlight in Geneva. With the United Nations High-Level Meeting (UN HLM) on AMR taking place in New York in September and a high-level ministerial meeting in Saudi Arabia in November, this year has been supercharged with attention on the issue, with WHA featuring numerous AMR events, roundtables, and initiatives.  Delegates approved a resolution to accelerate national and global responses on AMR, with many of them highlighting it as a crucial building block for the meetings in the fall. The resolution welcomes WHO’s strategic and operational priorities to address drug-resistant bacterial infections in the human health sector, which include prevention of infections; universal access to affordable, quality diagnosis and appropriate treatment of infections; strategic information, science and innovation; and effective governance and financing of the human health sector response to AMR.  The resolution also calls on member states to support investments in R&D for new tools to combat AMR and replenish the shockingly waning pipeline, to strengthen the capacities and standards of laboratories, and to participate in the WHO’s Global Antimicrobial Resistance and Use Surveillance System, or GLASS.While WHA did ultimately feature some contentious moments, especially around the geopolitics of Ukraine and Gaza, and major pushback on sexual and reproductive health, the latter almost derailing the adoption of several key decisions, the wins on IHR, maternal and child health, and AMR will have reverberations beyond WHA. Delegates hope that these wins will provide the necessary momentum to continue to make progress on the pandemic accord and at the UN HLM on AMR in the fall.  

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A new study successfully stimulated animals’ immune systems to induce a rare, priority class of HIV broadly neutralizing antibodies (bNAbs), findings that the researchers hope could eventually lead to an HIV vaccine that generates multiple classes of bNAbs to prevent HIV. The researchers engineered immunogens, or molecules used in vaccines to elicit a specific immune response, and tested them in monkeys and mice to see if they induced antibodies that showed signs of maturing into the class of HIV bnABs that is a priority for HIV vaccine development because it neutralizes a broad range of HIV variants. bnAbs are seen as an especially promising strategy for HIV vaccine development because they bind to parts of the genetically diverse virus that stay constant even as it mutates. These findings support the potential of these immunogens as the first part of a multistep vaccine regimen for humans.The Coalition for Epidemic Preparedness Innovations (CEPI) has awarded $6.5 million to support phase 2 clinical trials of Bavarian Nordic’s MVA-BN mpox vaccine for children in Africa, as the disease has spread rapidly in recent years and has particularly affected children, who account for most of the infections and deaths in the current outbreaks in East and Central Africa. The study, which is expected to launch later this year in one or more African countries, will enroll 460 people in endemic regions who do not have a history of mpox illness or vaccination. This trial also complements a plan by African countries, announced in April, to coordinate mpox efforts.Last week, the Ministry of Health of Indonesia and the Medicines Patent Pool (MPP) announced that they have signed a Memorandum of Understanding to improve access to and uptake of vaccines and medicines in Indonesia, as well as to strengthen local production in the country. MPP will provide technical assistance on local manufacturing by identifying possible manufacturing partners, exploring opportunities for technology transfer, and working with manufacturers to strengthen their capacity to produce high-quality, affordable products and new technologies, including mRNA vaccines. The partnership will also support the introduction of innovative medicines that address current access gaps and needs, health workforce capacity-strengthening, and support for the licensing and uptake of products licensed by MPP.