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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. 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.

GHTC contributed to Global Health Council's statement below entered into the official record at the 77th World Health Assembly in response to Agenda Item 11.8: Antimicrobial resistance: accelerating national and global responses.AMR is a growing existential threat that requires sustained action and urgent attention. The UN High Level meeting on AMR must prompt Member States to promote infection prevention and control measures, including WASH, and invest in priority, new and improved antimicrobials, novel compounds, diagnostics, vaccines, and other technologies to fight AMR. Innovations should be developed with access in mind, especially for gender minorities, underserved populations, and those in low-resource settings.We also call on countries to accelerate the implementation of national AMR action plans and prioritize a comprehensive, collaborative One Health approach that integrates gender perspectives. Member States should support the resolution on this agenda item and call for the creation of a global AMR laboratory network to strengthen diagnostic capacity.

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 study, researchers from the Baylor College of Medicine and partner institutions found that a novel, nonhormonal sperm-specific approach showed promise in mice as a reversible male contraception option. The researchers identified a small molecule that would inhibit a key protein, STK33, required for fertility in both mice and human males and generated modified versions of STK33 inhibitors to make them more stable, potent, and selective, eventually testing the most effective compound they generated in mice. The researchers hope to further evaluate the inhibitor and similar compounds to determine effectiveness as a potential contraception option. There has been research into a variety of different strategies for male contraception, but there are currently no approved options for men beyond male condoms.Tens of thousands of genetically modified mosquitoes have been released in Djibouti to stop the spread of Anopheles stephensi mosquitoes that transmit malaria as part of the pilot phase of a partnership between Oxitec, the government of Djibouti, and Association Mutualis. The modified mosquitoes carry a gene that kills female offspring, the only mosquitoes that bite and transmit malaria, before they can reach maturity. If successful, the modified mosquitoes will be tested in larger field trials, and operational deployment will continue through next year, hopefully boosting malaria control efforts. This partnership is the first time that modified mosquitoes have been released in East Africa and the second time on the African continent, although similar technology has been successfully used in Brazil, the Cayman Islands, Panama, and India, with more than one million modified mosquitoes released around the world since 2019.The Administration for Strategic Preparedness and Response at the US Department of Health and Human Services is moving forward with a plan to produce 4.8 million doses of H5N1 avian flu vaccine, as the current outbreak's second human case in the United States was identified this week. The two vaccine candidates are currently in bulk form, with one of the two candidate vaccine viruses reportedly well-matched to the currently circulating strain. Health officials have identified a manufacturing line at one of its manufacturing partners for fill-and-finish, which will take a couple of months to complete. Agency officials are also coordinating with mRNA vaccine makers Pfizer and Moderna about their potential involvement in vaccine development. There are additional ongoing interagency discussions about what would trigger vaccine deployment, including a change in transmission propensity, like human-to-human or animal-to-human spread; any sign of increased illness severity; a change in the complexion of the cases, like a human infection with no tie to the affected dairy farms; or the identification of a mutation in the virus.

GHTC submitted the below response to a request for information (RFI) to inform the new five-year strategic plan of the US National Institutes of Health's National Institute for Allergy and Infectious Diseases (NIAID).To Whom It May Concern: We write to you today representing the Global Health Technologies Coalition (GHTC), a group of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people. It is with this perspective that we intend to contribute input to the National Institute of Allergy and Infectious Diseases’ (NIAID’s) strategic plan, which will guide NIAID’s priorities over the next five years. The National Institutes of Health (NIH) has long been a cornerstone of basic and early-stage biomedical research, playing a pivotal role in driving scientific discoveries that pave the way for the creation of lifesaving global health technologies by the private sector, nonprofits, and other US agencies. In its new five-year strategic plan, GHTC advises that NIAID further integrate its global impact into its core mission and stated priorities. Within the five priority areas highlighted in the request for information, several jump out as opportunities to incorporate global health research and development (R&D) in both policy and practice. It is our opinion that these opportunities to include global health R&D should be seized, especially considering new economic data. A recent study by GHTC and Policy Cures Research revealed that between 2007 and 2022, the US government invested $46 billion in global health R&D, yielding $104 billion in direct returns and creating more than 600,000 jobs. Additionally, these investments are projected to generate $255 billion in future economic gains. Notably, NIH, predominantly through NIAID, accounted for three-quarters of this funding, solidifying NIAID's position as the world’s largest funder of global health R&D. Priority 1 highlights the need to better understand the immune system and its limitations. On this priority, our membership is interested in research aimed at improving our understanding of genetic mutations that play a role in drug resistance. This research would allow for the scale-up and development of drug susceptibility tests that can help inform patients with drug-resistant infections of their treatment options. Drug resistance is an issue for tuberculosis (TB) treatment as well as the treatment of other neglected diseases worldwide. The R&D undertaken for this priority should pay close attention to how new technologies and protocols can be used in low-resource settings for historically underserved populations like women and children.  Priority 3 is a core priority of GHTC in pursuit of the development of effective treatment strategies for neglected diseases like HIV/AIDS. We urge NIAID to acknowledge underserved populations like women and children, including lactating women, who are an especially underrepresented community in clinical trials, at the outset of the R&D process. We also urge NIAID to prioritize establishing plans for access early in the R&D process to avoid barriers to uptake often seen in low- and middle-income countries, especially for products for diseases like HIV/AIDS that can carry stigma. NIAID received an award from GHTC for its work on cabotegravir long acting for HIV prevention because, among other reasons, it is fit for use in low-resource settings and simpler for patients because it can be taken bimonthly rather than daily. Moving forward, we hope that all HIV and non-HIV research is conducted with low-resource communities in mind, which is important for domestic and foreign settings alike. GHTC is pleased to see Priority 5 as a key topic for NIAID since it will bolster the critical work NIAID has done in the past to take basic science research and apply it to the most pressing health challenges of the day. We saw in the global responses to SARS, Zika, Ebola, and, of course, COVID-19 that NIAID-led research provided a vital cornerstone. Within this priority, GHTC hopes to see a specific mention of how this work is globally relevant and will position US-funded global health R&D as the front line against future threats, both known and unknown. Affirming NIAID’s work on neglected diseases, as well as new and emerging infectious diseases is core to GHTC’s goals for the institute. Like the other issue areas, it is important to incorporate equity and access into the R&D process for Priority 5, since in the case of a pandemic, it is in our best interests that technologies made to test, treat, and heal US citizens can also be applied globally to effectively mitigate the spread of a pathogen with pandemic potential. GHTC was also happy to see the inclusion of many new themes NIAID is considering incorporating into its strategic plan. Of course, the theme of global health should be central to the work of NIAID since infectious diseases are not and have never been a one-country issue. Additionally, the interconnectedness of the world we currently live in, coupled with shifts in the environment because of climate change, have contributed to a modified disease landscape in the United States, forcing us to grapple with diseases once labeled as “tropical” or not of consequence to US citizens. For example, just last summer, we saw local malaria transmission in the United States for the first time in decades, and this summer, we are already seeing the rise of fungal infections in the United States and dengue in Central America, South America and, more recently, Miami. These developments should inspire action within the R&D community, especially since we need more and better tools and treatments to address these threats. We also see room to grow in these themes through the lens of clinical trials. The themes of Diversity, Equity, Inclusion, and Accessibility; Women’s Health; Research Inclusivity; and Health Disparities should be considered in ensuring diversity in clinical trial participants, which will help lead to new global health technologies that are applicable and accessible in low-resource settings, suitable for racially diverse groups, and that address the needs of underserved populations like lactating woman and children—to name a few key issue areas. Increasing NIAID’s global health mandate will serve the institution well in the fight against emerging infectious diseases and neglected diseases at home and abroad. By learning from past successes at NIAID, the world grows to be stronger and healthier. The global health R&D community has consistently advocated for NIAID’s mission and prominence in a crowded field of global health champions. It is our hope that NIAID consistently maintains interagency coordination with other government agencies and partners, not just in times of crisis. We hope our advisement is considered when the new strategic plan is forged, and we are happy to provide consultation on the strategy throughout the strategy development process.  Sincerely,  Alex Long  US Policy & Advocacy Officer  Global Health Technologies Coalition (GHTC)