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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. Last week at the Conference on Retroviruses and Opportunistic Infections, researchers presented exciting results from two different HIV vaccine studies that they hope will lead to an effective vaccine that can provide long-term immunity against the virus and greatly reduce the almost million new HIV infections yearly. One study found that a modification to the simian version of HIV drove monkeys to produce broadly neutralizing antibodies against HIV, and the other showed promising results in encouraging the immune system’s B cells to produce broadly neutralizing antibodies. Over the past four decades of HIV vaccine research, there have many failed and halted trials, thus, all current research into HIV vaccines in now in preclinical development, animal studies, or very early human trials. Nonetheless, HIV vaccine science has consistently driven innovation and science that benefits other infectious disease efforts and global health in general, such as mRNA vaccine technology. With maintained funding and global collaboration, researchers hope to see human trials for an HIV vaccine candidate resume as soon as the 2030s.The Coalition for Epidemic Preparedness Innovations (CEPI) is providing up to $1 million in funding to Amplitude Therapeutics to test a new vaccine approach that could address some of the challenges associated with current mRNA vaccine designs and cut down vaccine development times in future pandemics to as little 100 days. The trans-amplifying mRNA vaccine approach could serve as an advantageous alternative to the currently used self-amplifying method and works by separating the RNA fragment that contains the genetic instructions for the body’s cells to make the antigen that induces the body's immune response and the fragment that teaches the body how to replicate more mRNA. The trans-amplifying approach simplifies production and saves time and resources by extending antigen supply and allowing for key components of the vaccine to be developed ahead of time, underlining its ability to speed vaccine development in future pandemics.The results from a large clinical study presented last week at the Conference on Retroviruses and Opportunistic Infections demonstrated that the monthly dapivirine vaginal ring and daily oral pre-exposure prophylaxis with tenofovir disoproxil fumarate and emtricitabine were safe HIV prevention methods among pregnant people, who are an estimated three times more likely to acquire HIV through sexual intercourse than similarly aged non-pregnant people. The study, which was carried out in Malawi, South Africa, Uganda, and Zimbabwe by the Microbicide Trials Network, found that both methods were safe among cisgender women who started using one of them in their second trimester of pregnancy. These results fill data gaps for these two technologies, offering additional prevention options for this population.

With G7 and G20 nations set to convene later this year under the respective presidencies of Italy and Brazil, GHTC is calling upon policymakers to robustly fund R&D partnerships for pandemic preparedness, establish a global medical countermeasures platform, support investments to strengthen local R&D capacity globally, advance R&D for key priorities like antimicrobial resistance and climate resiliency, and improve equitable access through regulatory strengthening and prioritizing the R&D needs of underserved populations. G7/G20 2024 Priorities This year’s G7 Italian and Brazilian G20 presidencies will largely continue to focus on priorities that have emerged post-COVID, including pandemic preparedness, prevention, and response and building a more fit for purpose global health architecture; strengthening local capacity, especially manufacturing; and placing a bigger emphasis on climate and health. Although the initial response to the pandemic ignited a surge in political will across all spectrums to accelerate R&D and to do so in more geographically diverse areas, challenges persist in achieving equity and access. The momentum and investment in the necessary global architecture reform and capacity building efforts are already starting to wane. At the same time, antimicrobial resistance (AMR) has been dubbed as the “silent pandemic,” creating an urgent need for R&D and the deployment of safe and innovative new antibiotics. The following are Global Health Technologies’ (GHTC) recommendations to the G7 and G20 to address these concerns.  1. Financing pandemic prevention, preparedness, and response (PPPR)Fully and sustainably finance public-private R&D and access partnerships for strategic health products crucial during a future health emergency or pandemic, including committing $80 million to FIND’s 100 Day Mission (100 DM) framework for diagnostics and $1.5 billion to fulfill the remaining financing needs for Coalition for Epidemic Preparedness’s (CEPI) 100DM strategy for vaccines, and supporting Unitaid, and others for therapeutics including oxygen therapy.Agree on a plan to fully and sustainably finance the Pandemic Fund to enable it to reach its financing target of $10.5 billion per year in response to the high need and demand for support of pandemic preparedness and prevention efforts in low- and middle-income countries (LMICs), beginning with increased support for a robust resource mobilization effort for the Pandemic Fund, to be concluded in Q4 of 2024.Develop and endorse a global pandemic response financing playbook for medical countermeasures (MCMs) access that is rapid, flexible and reflects a network of partnerships.2. Equity in healthInvest and support national and regional regulatory bodies, ensuring that quality-assured and safe products are able to reach those who need them most, especially in LMICs. Ensure that the specific end-to-end R&D needs of women, children, and other vulnerable populations are addressed, including through: Specifying target product profiles for health technologies that address the needs of vulnerable populations and investing in therapeutic formulations for children and pregnant people.Providing technical support to countries to facilitate equitable distribution and uptake of new tools through institutions such as the World Health Organization (WHO). Engaging with primary healthcare providers, communities, and civil society in the design and delivery of health technologies to ensure the interventions meet the needs and priorities of local populations 3. Increase access to medical countermeasuresEstablish and adopt an equitable end-to-end MCM platform guided by human rights principles, focusing on the needs of all, particularly those in LMICs, through sustainable financing, addressing R&D needs, and implementing mechanisms for equitable access. Facilitate collaboration with stakeholders, including the Medicines Patent Pool, to expedite licensing and technology transfer. Prioritize a patient- and human-centered approach with meaningful LMIC and regional body representation in governance. Commit to the development of a shared access framework for public R&D spending during inter-pandemic periods, in consultation with LMICs, industry, and relevant stakeholders, to include consistent clauses within funding agreements to ensure equitable, affordable access to products for LMICs at every stage of R&D. Support the coordination of vaccine manufacturing networks to service clinical trials and routine supplies in inter-pandemic and pandemic periods.Facilitate agreement between key stakeholders, countries and funders on how sustainable stockpiles of (experimental) vaccines, therapeutics, and diagnostics can be created to enable a rapid response to new outbreaks. 4. Strengthen local capacityStrengthen local capacity through support for R&D hubs, distributed manufacturing, and clinical trial infrastructure in LMICs. Support regionally-led plans for economically viable vaccine, diagnostics, therapeutics manufacturing.Manufacturing investments must be coupled with commitments by private-sector companies and governments to step up support for technology transfer, technical assistance to local manufacturers for quality systems, regulatory authorization, market entry, and workforce development so that new manufacturing capacities have the equipment, expertise, know-how, and power to produce and deliver new innovations safely and rapidly at scale.Support preferential procurement policies for regionally manufactured products from global procurers such as Gavi, Global Fund, UNICEF, and Unitaid. Promote knowledge sharing with collaborative tracking and monitoring, and enhance accountability through transparency and robust enforcement mechanisms for traceability of countermeasures.Commit to develop globally accessible online prototype libraries of diagnostics, therapeutics, and vaccines for priority viral and bacterial families, and for disease X, in coordination with the WHO’s updated priority viral family list.Accelerate clinical trials for determining product safety and effectiveness and systematically include community engagement plans in clinical study protocols.  Establish reference standards for diagnostics early in disease outbreaks and clinical trials.5. Climate and antimicrobial resistanceJoin up efforts to strengthen climate and pandemic resilience and improve health outcomes in an agenda for action and investment. Support the adoption of data-driven strategies to prevent and treat climate-sensitive (e.g. vector-borne) disease as part of measures aimed to adapt to climate change, and ensure that health tools are always available to all populations affected by climate change. Invest in R&D that integrates scientific disciplines to enhance the development of intelligently designed, quality-assured, novel and improved antimicrobials, alternative biologics, diagnostics, vaccines, and other health technologies to address drug-resistant bacterial, viral, parasitic, and fungal microorganisms. There are few new antimicrobials in clinical development and declining private investment, and we must take urgent action to support the limited pipeline for antimicrobials and new therapeutics.Increase investment into push and pull incentives with public health–driven selection criteria and strong stewardship and access requirements, in particular contributing to existing global efforts such as the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, and the Global Antibiotic Research & Development Partnership, or GARDP, at the earliest opportunity and within reasonable and feasible timelines.Provide ongoing support to the Global AMR R&D Hub in its work providing countries and investors with the latest AMR R&D landscape that helps address market gaps. The Hub should also pave the way for efficient deployment of tailor-made incentives for R&D and facilitate global discussion on priorities and opportunities for increasing investments in R&D. 

A new report launched at Davos, from the World Economic Forum and the McKinsey Health Institute, refocused the spotlight on women’s health back in January. The report found a stark gap in health between women and men, adding up to 75 million years of life lost annually due to poor health or early death. This health gap is incredibly costly—closing it would benefit 3.9 billion women and would boost the global economy by $1 trillion by 2040 due to reductions in early deaths and health conditions, as well as the greater capacity for women to make socioeconomic contributions.In recognition of International Women’s Day, GHTC is spotlighting technologies, both available and still in development, that could help close the gender health gap and move us toward gender equity by both addressing the leading causes of morbidity and mortality for women and girls and empowering them to take control of their health and future. 1. CAB-LA and the dapivirine ring for HIV preventionHIV remains a major global challenge, especially for women and girls, who account for more than half of the 37.7 million people living with HIV and 46 percent of new infections in 2022. While the introduction of oral pre-exposure prophylaxis (PrEP) has helped drive significant declines in HIV infections globally, challenges adhering to the regimen of daily pills, as well as issues of stigma, have limited its impact in certain populations, including adolescent girls and young women. Long-acting cabotegravir (CAB-LA), developed by ViiV Healthcare, is a HIV prevention option administered by injection once every two months. CAB-LA offers an option that for many is easier to consistently use and also more discreet to receive than daily oral PrEP, which can reduce a barrier to use for those who fear stigmatization if their HIV status is exposed.The dapivirine ring, developed by the nonprofit International Partnership for Microbicides, is a flexible silicone ring inserted in the vagina that slowly releases the antiretroviral medication dapivirine over one month to reduce the risk of HIV infection. The ring offers an alternative discreet, user-controlled prevention option for women at high risk of HIV who are unable or prefer not to use other prevention methods.2. HPV vaccine and self-sampling for cervical cancer prevention and treatmentCervical cancer is the fourth most common cancer in women globally, but 90 percent of deaths from cervical cancer and more than 80 percent of cases occur in low- and middle-income countries (LMICs). This is mostly due to lack of access to human papillomavirus (HPV) vaccination (nine out of every ten cases of cervical cancer are caused by persistent HPV infection) and cervical screening and treatment services. Ensuring girls and women have access to HPV vaccines and testing can help to address the persistently high burden of preventable HPV cases and cervical cancer deaths.As of 2023, there are six vaccines for HPV available globally, which all protect against the highest-risk types of HPV that cause the most cervical cancers. While there have been many studies demonstrating the safety and efficacy of HPV vaccines, a new study published in January of 2024, which was the first to monitor a national cohort of women over a significantly long period of time (the study looks at women born between 1988 and 1996), found zero cases of cervical cancer—reinforcing HPV vaccines as a lifesaving tool that has and will continue to be a game changer for women’s health. Regular screenings for cervical cancer are globally recommended and are crucial because cervical cancer can be cured if diagnosed and treated early on. Yet 67 percent of women between 20 and 70 have never been screened for cervical cancer (by HPV or other tests). HPV self-sampling, an approach recommended by the World Health Organization (WHO) for women 30 to 60, has been shown to be about as reliable as sampling by health care providers. Additionally, it has also been shown to nearly double use of cervical cancer screening services because it offers privacy and convenience, requires little time and effort, and reduces any embarrassment, pain, or anxiety that may be associated with sampling done by health workers. 3. Next-generation contraceptivesAn estimated 257 million people globally who want to avoid pregnancy are not using safe, modern methods of contraception, leading to unintended pregnancies and then unsafe abortions, which cause up to 13 percent of all maternal deaths. Unacceptable or unsuitable contraception options are one of the leading causes of unintended pregnancy. An estimated 40 percent of women in LMICs who use a contraceptive stop within a year because of challenges, including side effects, the burden of sticking to a daily regimen, and the time and monetary cost of having to travel, sometimes far distances, to get new prescriptions. Introduction of the daily oral birth control pill helped contribute to a major increase in contraceptive use globally over the past 50 years, but contraception technology has not seen major innovations in generations, and the field is deeply underfunded, highlighting the need for new, less burdensome contraceptive options.Lyndra Therapeutics is developing a once-monthly contraceptive pill, currently in preclinical development, that could serve as one such alternative. Researchers are also developing longer-acting injectable contraceptive products, including a six-month injectable contraceptive being advanced by FHI 360. Microarray patches are another novel contraceptive option in early-stage development—they work by releasing hormones over several months and are discreet and easy to use at home. Contraception, and specifically access to a variety of contraceptive options that fit varying needs, allows women and girls to have autonomy over their bodies and lives. There remains a gap in further research into nonhormonal contraceptive options that cause fewer uncomfortable side effects or contraceptives for men that take the burden off of women.4. AI-enabled ultrasoundsAlmost 800 women died from preventable causes related to pregnancy and childbirth every day in 2020. While there are many contributing factors, one significant challenge is lack of access to diagnostic tools like ultrasounds. Fifty percent of women in LMICs received no ultrasound scans during the course of their pregnancy. Even where ultrasounds are available, they are usually bulky, expensive, and require specializing training or knowledge to operate, forcing patients to travel to specific health care facilities to access them. New technologies like Philip’s Lumify Handheld Ultrasound, which can be connected to a mobile device, offer a more compact, portable option in emergency situations or in low-resource settings when traditional ultrasounds are not available or are not feasible. The Bill & Melinda Gates Foundation is funding Philips to accelerate the adoption of artificial intelligence (AI) algorithms that can be used with the scanner to simplify the identification of key pregnancy abnormalities, with results already showing that the AI-enabled technology helped to improve informed decision-making in the care of pregnant women in rural, underserved communities. Nimble, compact technologies like this ensure that more women have access to basic, lifesaving technologies and that women, along with their health care providers, can make informed decisions about their health and pregnancy, reducing the likelihood of death from preventable causes.5. Postpartum bleeding solutionsPostpartum hemorrhage (PPH), or excessive bleeding after childbirth, is the world’s leading cause of maternal death and can lead to lasting disability and psychological trauma, despite being preventable and treatable. Adolescent pregnancies carry a higher risk of postpartum hemorrhage because adolescent uteruses are not fully developed enough to sustain a healthy pregnancy—pregnancy complications, as well as unsafe abortions, are the leading cause of death among 15- to 19-year-old girls globally.PATH and Sinapi developed a technology, called the Ellavi uterine balloon tamponade, which builds on a low-cost solution some health care providers had been using to combat PPH called a “condom catheter,” which uses items commonly found and self-assembled in a clinic to insert a condom into the uterus and then fill it with water to exert pressure on the uterine walls and stop the flow of blood. The Ellavi device was optimized to be a high-quality, simple-to-manufacture and -use, and affordable version of the “condom catheter” that could be deployed globally to save even more lives. Another simple, inexpensive solution to PPH comes in the form of a plastic sheet with a pouch to collect and measure the volume of blood loss. This tool helps health care providers better recognize when women are in danger and take action. In one large-scale study in Africa, this sheet, when used in combination with other WHO-recommended treatment options for PPH, reduced the number of women experiencing severe bleeding by 60 percent and also reduced the number of deaths from PPH.These innovative but simple and low-cost technologies are not moneymakers, but they can greatly reduce preventable maternal deaths, particularly among adolescents, illustrating a paradox in women’s health—the gap persists because many technologies that could have a tremendous impact, particularly in LMICs, do not necessarily yield the greatest profit.While these five solutions highlighted have the potential to save lives and empower women, it is clear that closing the cavernous gender gap in health will require many more new tools and improved access to existing ones. Greater investment in R&D for conditions that specifically affect women and girls and expanded roles for women and girls to engage and lead across the R&D sector can help ensure more breakthroughs are realized in our lifetimes and that resulting tools are designed with the diverse needs of women and girls in mind.

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 Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced $467,000 in funding to GlyProVac to develop a maternal vaccine that targets Escherichia coli, the bacteria mainly responsible for neonatal sepsis, which is the leading cause of death among infants and a particular challenge in low- and middle-income countries. The funding will specifically support the development of the vaccine candidate GPV02, which offers protection to newborns through the antibodies passed on by vaccinated expectant mothers in utero and through breast milk after birth. GPV02 uses a unique approach compared to other attempted protein-based bacterial vaccines because it involves previously undiscovered natural sugar modifications and uses BEMAP technology to allow the vaccine to imitate E. coli, preparing the immune system to recognize the bacterium in the case of future infection.Last week, the Advisory Group on Immunization Practices at the US Centers for Disease Control and Prevention (CDC) recommended Valneva’s Ixchiq chikungunya vaccine for some travelers and laboratory researchers at risk of contracting the mosquito-borne virus. The United States records about 100 to 200 chikungunya cases a year in people infected abroad by the virus, which is mainly found in parts of Central and South America, Africa, and Asia. The vaccine was licensed by the Food and Drug Administration last fall for adults—the first vaccine approved for chikungunya. CDC has indicated that it may later expand the recommendation for people living in US territories where the virus may spread.A new extensive, long-term analysis from the Icahn School of Medicine at Mount Sinai found that COVID-19 vaccines induce long-lasting antibody responses, debunking previous claims that mRNA-based vaccine immunity wanes quickly. The researchers examined in over 8,000 samples collected over three years in New York City how antibody responses changed after infections, during the first series of vaccinations, during booster vaccinations, and during breakthrough infections. They concluded that the major reason for breakthrough infections is the virus evolving to evade immunity rather than waning immunity. The results will, hopefully, not only encourage people to continue to get vaccine boosters but also to continue research into new vaccines and viral variants.