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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. 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! 

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 first participants have been vaccinated in a Phase 2 clinical trial of a vaccine candidate for Lassa fever virus, which is being led by an international collaboration between IAVI, the Coalition for Epidemic Preparedness Innovations (CEPI), and in-country partners in Nigeria. Lassa fever is recognized by the World Health Organization (WHO) as a priority pathogen requiring accelerated research and causes an estimated 5,000 deaths each year, with the disease primarily affecting West Africa. There are no approved vaccines for Lassa currently. The hope is that this trial, which is the most advanced Lassa vaccine trial to date, will lead to the availability of a vaccine candidate for evaluation and use in future Lassa outbreaks and eventually an approved vaccine for routine immunization, as well as foster sustainable in-country research capacity and partnerships through engagement with Nigerian partners.Last week, FIND and LifeArc announced a new project in Kenya aimed at improving the detection and treatment of visceral leishmaniasis, a neglected tropical disease that mainly affects children and is fatal in more than 95 percent of cases if untreated. The project, which will run from 2024 to 2027, aims to increase early diagnosis and treatment to prevent disability and death from the disease in part by accelerating the development of new and improved diagnostic tests that are more sensitive than those currently available. The project will also build on ongoing efforts to improve community awareness, boost local and national testing capacity, and strengthen overall health system capacity.Last week, Cepheid announced that its point-of-care HIV test has received prequalification status from WHO. The decision will lead to the inclusion of the company’s HIV-1 PCR assay with extended coverage on a list of tests that meet WHO’s standards for global use, boosting access in low- and middle-income countries without designated or stringent regulatory authorities. The test can be used to detect HIV infection in infants and people who were recently infected and provides rapid results, enabling improved linkage to further care and treatment initiation.

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 Tuesday, Valneva announced the launch of a Phase 1 clinical trial to investigate the safety and immunogenicity of a vaccine against the Zika virus, for which there are currently no available preventable vaccines or treatments. The second-generation adjuvanted inactivated vaccine candidate, VLA1601, will be tested in 150 adult participants in the United States, with the first topline data from the trial expected as soon as early next year.  Numerous outbreaks of Zika have occurred around the world, but the virus is currently circulating in Mexico, Central and South America, the Caribbean region, and some areas of the continental United States.Moderna’s next-generation mRNA vaccine for COVID-19 elicited a higher immune response against most strains of omicron BA.4/BA.5 and the original virus than the company’s currently licensed vaccine and has a similar safety profile in Phase 3 trial. The vaccine candidate, mRNA-1283, demonstrated the highest benefits in patients over 65, who are at risk of more severe disease. The trial included over 11,000 patients from across the United States, the United Kingdom, and Canada. These results also point to the future promise of the company’s combination mRNA vaccines for COVID-19 and influenza, which are also currently in development and previously demonstrated a similar immune response to the company’s vaccines for COVID-19.The US Food and Drug Administration (FDA) recently announced the approval of Roche’s Cobas malaria test for screening blood, organ, and tissue donors, which could help reduce the risk of transfusion-transmitted malaria. The test is designed to qualitatively detect in whole-blood samples Plasmodium DNA and RNA from the five main species of Plasmodium parasite species known to cause human infection: P. falciparum, P. malariae, P. vivax, P. ovale, and P. knowlesi. Roche’s technology is now the first FDA-licensed test for screening blood donors for malaria.