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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 Wednesday, The New England Journal of Medicine published the full results of the PURPOSE 2 trial testing Gilead Science’s twice-yearly lenacapavir shot for HIV prevention, finding that it was extremely effective in a broad and geographically diverse range of cisgender men and gender-diverse people. These results follow those of the first PURPOSE trial published earlier this year, which found that the drug was 100 percent effective as a prevention option in a study of women and adolescent girls. Lenacapavir is already approved and available in several countries, including the United States, as an HIV treatment option. With additional approvals as an HIV prevention option, the shot could be a game-changer for many marginalized communities that face the highest risk of HIV infection.A recent study found that the investigational drug quabodepistat in combination with delamanid and bedaquiline demonstrated safety and efficacy as a treatment for pulmonary tuberculosis (TB). TB treatment has historically been months long and difficult to tolerate, leading to discontinued treatment courses that raise the risk of the emergence of drug resistance. This combination treatment could potentially help fill the gap for safer, shorter regimens that cause fewer side effects. Further large-scale and long-term trials will be needed to validate these findings before this treatment combination can be available to the communities that face the highest burden of TB.Last week, the US Department of Health and Human Services announced nearly $27 million to support the rapid development and scale-up of manufacturing capacity for diagnostic tests to address future biologic threats through the Biomedical Advanced Research and Development Authority consortium. The COVID-19 pandemic exposed the gap in the United States' capacity to quickly develop, validate, produce, and roll out diagnostic tests to curb the spread of an infectious disease outbreak. While the funding will specifically support the development of tests to detect Burkholderia pseudomallei, the bacterium that causes melioidosis, and Marburg virus, the aim is to advance diagnostics platforms that can be leveraged to quickly produce tests for other threats as they emerge.

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 study published last week tested a promising new malaria vaccination strategy that aims to boost immunity through bites from mosquitoes carrying a genetically engineered version of the malaria parasite, which could pave the way for improved malaria vaccines. There are two approved vaccines for malaria, but they are only about 75 percent effective and require booster shots. In a trial, researchers exposed participants to bites from mosquitoes that had a version of the malaria parasite that was genetically modified to stop developing after delivery into a human, finding that nearly 90 percent of participants exposed to the modified parasites avoided contracting the disease after being bitten. The next step will be a larger trial to confirm this strategy as a viable candidate to advance malaria control efforts.A new study found that vaccines for diarrhea could reduce bacteria-associated diarrhea and antibiotic use among young children in low- and middle-income countries, which could also help reduce the emergence of antimicrobial resistance due to antibiotic overuse in low-resource settings where cases of diarrheal disease are most common. The research team used data from a previously published study exploring enteric infections and diarrheal illness in children in low- and middle-income countries and generated simulations to estimate the hypothetical impact of nine vaccine scenarios, including six single-pathogen vaccines and three combination vaccines. They found that, compared to the other single-pathogen vaccines, a vaccine against Shigella could cause the greatest reduction in antibiotic courses, and an adenovirus-norovirus-rotavirus vaccine could cause the greatest reductions in antibiotic use compared to the other combination vaccines.Last week, the Coalition for Epidemic Preparedness Innovations (CEPI) announced $1.46 million in funding for PATH to develop antibody reagents for developing vaccines against Severe Acute Respiratory Syndrome, or SARS. Antibody reagents are critical for measuring and analyzing a vaccine’s potency and ability to induce an immune response. PATH will lead efforts to develop and test reagents, as well as collaborate with the Texas Children’s Center for Vaccine Development to select and scale up a SARS-CoV-1-specific antibody to ensure these reagents are available globally, particularly in low and middle-income countries. The project aims to strengthen global health security by allowing researchers and manufacturers the tools to develop and scale up vaccines quickly in the face of an outbreak or new variant.

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 study published last week and presented at the American Society of Tropical Medicine & Hygiene’s (ASTMH’s) annual meeting found that the malaria parasite is acquiring partial resistance to artemisinin, a key drug used to treat children with severe malaria, meaning that infection takes longer to clear and is not always being completely cleared by the drug. The researchers found partial resistance to the drug in 11 of the 100 children treated in the study, with 10 patients “cured” of severe malaria having a resurgence of the same strain within a month of the original infection, implying that the first treatment did not fully eliminate the parasite. More studies are needed to determine how widespread artemisinin resistance is in Africa. Still, the findings underscore the need for novel or alternative drugs to be used in the treatment of severe malariaThe US Centers for Disease Control and Prevention (CDC) has awarded Alveo Technologies a contract to develop a molecular assay to detect and differentiate the H5 subtype of avian influenza A from seasonable influenza A and B viruses in humans, as the ongoing spread of H5N1 in animals across the United States raises concerns about a new pandemic as regular flu season looms. Currently, only CDC and US state and jurisdictional public health labs have access to CDC’s molecular test to detect the H5 strain of influenza A, which could lead to delays in diagnosis or treatment if we start to see transmission between humans. Decentralized testing capabilities at the point of care will be needed to ensure any spread between humans is detected and controlled quickly to avoid another pandemic, as well as to reduce the burden on centralized laboratories.  Last week, the endTB consortium announced the completion of the endTB-Q trial, the first Phase 3 randomized controlled trial to exclusively enroll people with pre-extensively drug-resistant tuberculosis (pre-XDR-TB), with preliminary results demonstrating that a shorter, less toxic treatment strategy of four drugs achieved high cure rates overall, especially in those with non-severe cases of TB disease. Pre-XDR-TB has historically been treated with toxic regimens that last up to two years, are hard to tolerate, and are not very effective. This study tested a personalized medicine strategy, with disease severity and early treatment response used to decide between a six- or nine-month treatment regimen. The study included participants from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam.

The Global Health Technologies Coalition, FIND, Medicines for Malaria Venture, IAVI, PATH, and TB Alliance welcome the establishment of the G20 Global Coalition for Local and Regional Production, Innovation and Equitable Access.We are particularly supportive of the focus on innovation to develop the missing health tools needed by some of the world’s most neglected communities—including those facing historically neglected diseases, such as leishmaniasis, Chagas disease, and dengue, as well as more common poverty-related diseases such as HIV, tuberculosis, and malaria.We are encouraged by the Coalition’s focus on strengthening local and regional production to promote more equitable access to safe, affordable, quality, and effective health products and technologies. Shifting the center of gravity of innovation, manufacturing, and production to countries and regions that carry the greatest burden of disease will help reduce disparities and build resilience into health systems. Current outbreaks like mpox highlight the need for manufacturing capacity in all regions. G20 countries are uniquely situated to mobilize the necessary scientific and financial resources to make this Coalition a success and build upon knowledge, as well as match capabilities and needs across G20 countries and other invited countries and partners.We commend Brazil for its leadership, and we urge leaders to ensure civil society and community voices have a seat at the table. Our organizations stand ready to support the Coalition.