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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. The Combating Antibiotic Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced that it will award up to $1 million to the company Scout to develop a rapid, inexpensive, and easy-to-use point-of-care diagnostic test for gonorrhea, which could expand access to testing and proper treatment in the face of a rise in gonorrhea cases and drug-resistant gonorrhea cases globally, especially in low- and middle-income countries. The test, STI-Scout, is designed to detect and differentiate between Neisseria gonorrhoeae and Chlamydia trachomitis and can provide results in only 30 minutes using urine samples or vaginal swabs at less than half the cost of other available tests. The test uses a proven isothermal technology that was validated for SARS-CoV-2 detection. Last week, EuBiologics and the International Vaccine Institute (IVI) announced that the World Health Organization (WHO) had prequalified Euvichol-S, an improved oral cholera vaccine produced with a simplified method that will hopefully help to address the rise of cholera outbreaks globally and a dire vaccine supply shortage. The vaccine, whose development was supported by the Bill & Melinda Gates Foundation, is produced in a way that can improve formulation and manufacturing productivity by 40 percent compared to the company’s prior oral cholera vaccine and demonstrated efficacy in a Phase 3 trial in Nepal last year. The prequalification paves the way for United Nations agencies and Gavi, the Vaccine Alliance, to buy the vaccine for countries experiencing outbreaks.The New Nets Project, funded by Unitaid and The Global Fund to Fight AIDS, Tuberculosis and Malaria, recently reported results from several pilot studies showing that a pair of second-generation bed nets tested in malaria-endemic areas helped to prevent up to 13 million additional cases of malaria, saving close to 25,000 lives—exciting news that comes as malaria cases, as well as resistance to the standard insecticide used to treat nets, rise globally. The studies found that the new nets, the Interceptor G2 and Royal Guard—which both use dual insecticides to address resistance—were between 20 and 50 percent more effective than traditional nets, which only use pyrethroid insecticide, in reducing mosquito exposure and reduced the risk of infection by up to 55 percent. Although the new nets are more expensive, the additional cost seems to be offset by the public health savings of malaria prevention. Researchers expect malaria parasites to eventually become resistant to the new nets, highlighting the need for continued research into other methods of vector control, as well as ensuring population-scale protection through vaccination.

GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on April 18 ahead of the G20 Health Ministers' Meeting in Rio de Janeiro.Thank you for the opportunity to share our coalition’s priorities for the upcoming G20 Health Ministers’ meeting in Rio de Janeiro. As the United States and others consider reforms to realize a more fit-for-purpose global health architecture, the Global Health Technologies Coalition urges them to prioritize the following actions to strengthen research and development (R&D): 1. We urge the G20 countries to invest $80 million in FIND's 100 Days Mission for diagnostic and $1.5 billion to fulfill the Coalition for Epidemic Preparedness Innovations' 100 Days Mission strategy for vaccines, as well as to support Unitaid and others for therapeutics. Additionally, we appreciate US leadership in catalyzing investment in the Pandemic Fund, and we urge the US government to work with G20 countries to fully finance the institution annually at $10.5 billion, focusing on low- and middle-income countries, and to develop a global pandemic response financing playbook for flexible access to medical countermeasures. 2. We urge the United States to support national and regional regulatory bodies ensuring safe product distribution in low- and middle-income countries, invest in tailored health technologies for vulnerable populations, provide technical support for equitable distribution through organizations like the World Health Organization, and engage local communities in designing and delivering health technologies. 3. We advocate for the establishment of an inclusive medical countermeasures platform guided by human rights principles, prioritizing low- and middle-income countries through sustainable financing and equitable access.  4. To strengthen local capacity, we urge the United States to support R&D hubs, endorse regionally led manufacturing plans, and secure commitments from private sector and government for technology transfer and regulatory support.  5. To tackle climate and antimicrobial resistance (AMR), we urge the United States to invest in interdisciplinary R&D for novel antimicrobials, increase funding for push and pull incentives like the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator and the Global Antibiotic Research and Development Partnership, and facilitate global discussions on R&D priorities through the Global AMR R&D Hub. 

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. As the dengue outbreak in Latin America has continued to grow and the threat of dengue continues to rise globally due to climate change, better and cheaper vaccines are on the horizon but are unlikely to be available soon enough to address the current crises. Currently approved vaccines for dengue include one expensive two-shot regimen and one that can only be given to people who have already been infected. A new, single-dose vaccine designed to target all four strains of the dengue virus, which was created by the US National Institutes of Health and licensed for development by the Brazilian Instituto Butantan, provided strong protection in a Phase 3 trial. The institute plans to submit the vaccine to Brazil’s regulatory agency for approval within the next few months, and if approved, the institute could start producing tens of million doses next year. Merck also licensed the vaccine technology and is developing a related vaccine for the rest of the world but has yet to test it in a clinical trial. In the meantime, the Brazilian government bought global supply of Takeda’s Qdenga vaccine, which, at a steep per-dose price, will provide some protection during the current outbreak. Takeda’s vaccine has also been licensed to an Indian generic drugmaker, but a slow start-up process means that is unlikely to be available before 2030.Pfizer recently announced that its RSV vaccine demonstrated the potential to protect adults between 18 and 50 at high risk of severe illness in a late-stage clinical trial, offering the promise of a tool to protect a far broader population against the virus that not only causes thousands of hospitalizations and deaths among older Americans and hundreds among infants every year but also can also cause severe illness in younger adults with weakened immune systems or underlying chronic conditions. Abrysvo is currently approved in the United States and elsewhere for adults 60 and older and expectant mothers. Pfizer announced plans to submit the final results from the trial for expanded approval of Abrysvo, although a timeline for submission has not yet been disclosed. Last fall, GSK released late-stage trial data demonstrating that its RSV vaccine could protect adults between 50 and 59 years old, and the US Food and Drug Administration is expected to make its decision on that vaccine in June.A research team from the Centre for Clinical Microbiology at University College London has developed a new method for testing tuberculosis (TB) that would allow lower-resourced laboratories in low- and middle-income countries (LMICs) to process samples safely, with the method primarily aimed at use for monitoring drug treatment response and clinical trials. The World Health Organization recommends monthly treatment monitoring with sputum culture to ensure patients are adhering to treatment to reduce the emergence of multidrug- or rifampicin-resistant TB, but monitoring with culture is often unavailable or incredibly slow in LMICs. The new method cuts out the need for a culture; uses common instrumentation available in most laboratories, even in LMICS; does not have high energy requirements; and takes only three or four hours to return a result. The method is already being used in clinical studies.

GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on April 11 on the Intergovernmental Negotiating Body's pandemic accord process.Thank you for the opportunity to provide feedback on the pandemic accord process. I represent the Global Health Technologies Coalition, an R&D-focused advocacy coalition of more than 45 members. Given the late stage of negotiations, we want to highlight potential areas that can be enhanced in the current draft and offer small tweaks and some specific changes that we would like to see reflected in the final agreement.  Firstly, we call on the United States to consider explicit language underscoring the importance of gender equity and broader inclusion across all stages of research and development (R&D) to ensure effective pandemic prevention, preparedness, and response. While there is a strong focus on gender equity in certain parts of the current draft, we believe that this language should be reflected consistently and explicitly across all sections of the text, not just those specifically focused on equity and inclusion.  We note that in Article 9, language on equitable representation in clinical trials has been removed; GHTC recommends reinstating this language, as well as reinstating detailed language on enhancing clinical trials capacity, including for health research workforce. There should also be an explicit reference to the inclusion of underserved populations in all their diversity in clinical trials, including children and people who are pregnant or of childbearing age.  In Article 10, we urge the United States to push to expand provisions to incentivize continuous research for epidemic-prone diseases. Furthermore, we call on the United States to continue to stress the importance of equitable access to medical countermeasures and call for transparency provisions that focus on compelling the publication of license agreements to be included, particularly in Article 11.  Finally, we call on the United States to support provisions that underscore the importance of regulatory capacity, not just harmonization. Text should be added that establishes regional protocols for the regulation of products during health emergencies. The current draft only focuses on licensing of pandemic products without considering broader elements of the regulatory ecosystem. In addition, we emphasize the need for greater coordination between regulatory authorities and ethics committees for clinical trials and highlight the pivotal role of the World Health Organization in coordinating research efforts and defining research priorities.  Thank you for your consideration, and good luck in the final stretch of negotiations!