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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. Amid the ongoing outbreak in Rwanda of the deadly Marburg virus, Rwandan health authorities announced Sunday that they will begin a clinical trial of a vaccine against the virus, for which there are no approved therapies or vaccines. The trial, which will deploy an investigational vaccine from the Sabin Vaccine Institute, will target health workers, emergency responders, and individuals who have been in contact with confirmed cases, according to the Health Ministry. The Rwanda Biomedical Centre will serve as the trial sponsor.Last Wednesday, Gilead Sciences announced a plan to allow six generic pharmaceutical companies in India, Pakistan, and Egypt to produce and sell the twice-yearly HIV prevention injectable drug lenacapavir in 120 countries, including all those with the highest HIV rates globally. This news comes after results published earlier this year from two clinical trials showed that the drug was extremely effective at preventing HIV across key populations—cisgender women, gay men, and trans and nonbinary people, who were all represented in the trials. While the new plan aims to enable rapid and broad access to the drug in many countries, the deal excludes most middle- and high-income countries, which account for around 20 percent of new infections. In those countries, the originator drug will only be available at higher prices, making it potentially unaffordable and inaccessible to at-risk populations, particularly those in middle-income countries.Last week, the World Health Organization (WHO) issued new recommendations encouraging vaccination of pregnant women and administration of antibody shots to newborn babies to protect against respiratory syncytial virus (RSV), which is a leading cause of severe infection and death in babies, with a majority of RSV-related deaths occurring in low- and middle-income countries. There is only one vaccine, Abrysvo, for pregnant women and one antibody shot, Beyfortus, for infants and toddlers available in the United States and a handful of other countries. Supply of these products is limited and the cost, specifically of Beyfortus, is high, which could limit global access and affordability until lower-cost, more widely available existing products and new, innovative products enter the market.

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. Two recent studies found that the virus that causes COVID-19 is developing resistance to two antiviral drugs commonly used for treatment in patients with compromised immune systems: remdesivir and nirmatrelvir. The first study from Cornell University and US National Institutes of Health researchers, which specifically looked at immunocompromised patients, found that the virus developed a reduced sensitivity to the drugs, while the second study from University of Pittsburgh, Brigham and Women’s Hospital, Stanford University, and Harvard University researchers also found resistant mutations, with the effect more evident in the immunocompromised and those who had received nirmatrelvir. These results raise concerns as the threat of antimicrobial resistance globally grows.Researchers from the University of California, Riverside; the University of California, Irvine; and the Yale School of Medicine have designed a new synthetic compound, MED6-189, which is effective against drug-sensitive and drug-resistant Plasmodium falciparum malaria strains in vitro and in mice engineered to have human blood. MED6-189, inspired by a compound extracted from marine sponges, works by targeting and disrupting a specialized part of P. falciparum cells, as well as the pathways used to transport materials within the cells, thereby preventing the pathogen from developing resistance. The next steps include continued optimization of the MED6-189 and further confirmation of its mechanisms of action, but, if the compound continues to demonstrate success, this research could lead to the development of an important tool to address the rising challenge of antimalarial drug resistance.Last week, the US Department of Health and Human Services through the Advanced Research Projects Agency for Health announced funding for the Transforming Antibiotic R&D with Generative AI to stop Emerging Threats project that will use artificial intelligence (AI) to speed up the discovery and development of new classes of antibiotics to meet the urgent need for new drugs amid the growing threat of antibiotic resistance. While conventional antibiotic discovery methods require time-consuming manual screening and testing of potential molecular compounds, most of which do not advance into further development, this project will employ deep learning to develop new methods to identify biomolecules with potential and use generative AI to expand the number of potential antibiotic candidates.

WASHINGTON, DC – Senator Cory Booker (D-NJ) introduced the Supporting Innovative Global Health Technologies (SIGHT) Act of 2024. The bill would empower the US Agency for International Development (USAID) to boost its research and development (R&D) capabilities for health care technologies in low- and middle-income countries abroad. This bill, S.5278, is a companion bill to H.R.6424, which was introduced in the House of Representatives last November by Representatives Brian Fitzpatrick (PA-01), María Elvira Salazar (FL-27), and Chrissy Houlahan (PA-06)."We applaud Senator Booker for his leadership in advancing next-generation health innovations that are critical for tackling both known and emerging global health challenges by expanding the global health R&D ecosystem within the US government," said Dr. Kristie Mikus, Executive Director of the Global Health Technologies Coalition (GHTC), which represents 49 nonprofit organizations, academic institutions, and aligned businesses dedicated to advancing life-saving innovations globally. "With its extensive presence in low- and middle-income countries and its strong track record of fostering public-private partnerships, USAID is uniquely positioned to drive groundbreaking health innovation. It is encouraging to see congressional leaders in both the House and Senate recognize USAID's potential to embrace new disease-agnostic program areas that will complement the ongoing USAID R&D partnerships that have already been instrumental in saving millions of lives around the world."

The Global Health Technologies Coalitions (GHTC) welcomes the political declaration approved today by the United Nations (UN) High-Level Meeting on Antimicrobial Resistance (AMR) and applauds its commitments to promote the research and development (R&D) of and equitable access to antimicrobials, vaccines, diagnostics, and other products. GHTC especially appreciates the inclusion of concrete targets, such as the goal to reduce AMR deaths by 10 percent by 2030, the commitment to raise $100 million to support the implementation of national action plans against AMR, and support for important new mechanisms like the independent panel for evidence for action against AMR, which will help guide country action and provide both technical support and accountability. GHTC also commends the text’s robust R&D language, which includes many provisions for which GHTC has advocated, such as recognition of the need for stronger local and regional manufacturing capacities and the importance of public-private partnerships (including explicit mentions of our members the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator and the Global Antibiotic Research & Development Partnership), and calls for stronger regional coordination of the licensing and registration of medical products and the use of push and pull incentives.   While GHTC welcomes the strong R&D focus in the political declaration, we believe that there should have been measurable research targets included as well, which would have facilitated better progress tracking and accountability among national governments. We also note with some concern the lack of follow-up outlined in the text, with the next High-Level Meeting on AMR to be held in 2029, providing insufficient time to course correct if inadequate progress has been made.   This political declaration is a laudable step forward, but the true test will be in the implementation of these commitments, as the next few months now become about setting up the right systems and structures to turn principles into action and ensure that this agenda is advanced in other multilateral forums like the G20.   “Antimicrobial resistance poses one of the most pressing threats to global health, and the High-Level Meeting on AMR and its political declaration represent a pivotal moment in our collective response,” said GHTC Executive Director Dr. Kristie Mikus. “We applaud the political declaration’s commitment to promote and invest in R&D in the AMR space, especially in low- and middle-income countries, and to push for a stronger innovation ecosystem for new technologies. As we continue to experience the rising tide of drug-resistant infections and emerging infectious threats, innovation will be more essential than ever before to promote the production of effective, affordable, and accessible health technologies on a global scale.”