Breakthroughs Blog: Access

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 Africa Centres for Disease Control and Prevention (Africa CDC) is expected to declare its first-ever “public health emergency of continental security” as the mpox outbreak in sub-Saharan Africa continues to grow—with 14,000 cases and 511 deaths reported so far—and spread to countries that had never previously identified cases. The decision, a direct response to the global inequity faced by Africa during the COVID-19 pandemic, aims to mobilize international support and vaccine donations. Africa CDC has said that the need for vaccines greatly exceeds what is available and what many African countries can afford, with a costly price tag for the currently available vaccine. The United States has pledged almost $424 million to the Democratic Republic of Congo, where the outbreak started, as well as $10 million for the mpox response and 5,000 mpox vaccine doses. Japan, the European Union, and vaccine manufacturers are also preparing vaccine donations. World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus announced last week that he will convene an emergency panel of experts to advise him on whether to declare the outbreak a global health emergency, which would garner even more attention and international support.Phylex Biosciences recently published the preliminary findings from an immunogenicity study conducted in collaboration with scientists from the US Centers for Disease Control and Prevention that showed promising results for a new mRNA nanoparticle vaccine against Nipah virus, a serious zoonotic disease that has an estimated case fatality rate between 40 and 75 percent. There is no preventive vaccine available for Nipah. The study found that the vaccine elicited a robust neutralizing response and confirmed the advantages of using mRNA and a nanoparticle, which allow, respectively, for quicker manufacturing and development timelines and efficacy after one dose. The company will next pursue clinical development for the vaccine candidate.Last week, WHO called for greater coordination on policies to strengthen the antibacterial pipeline as the global challenge of drug resistance, which disproportionately impacts low- and middle-income countries (LMICs), continues to rise. WHO highlighted the insufficient number of antibiotic candidates and limited innovative products in the fragile R&D antibacterial pipeline, as well as the lack of products in clinical development that address the evolving mechanisms of drug resistance, use oral formulations, and are formulated for infants and newborns, pointing to persistent R&D challenges like the dominance of small, resource-limited biotechnology companies in the sector. At the highest level, WHO called for greater global coordination and cooperation to improve data collection and sharing and ensure that efforts to boost R&D address the needs of underserved populations and LMICs. Specifically, WHO called on governments to provide adequate resources and incentives to boost the antibiotic R&D pipeline by addressing the needs of the small companies that dominate the sector and strengthening the capacity of the scientific communities and drug developers in LMICs.

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. On Friday, the World Health Organization (WHO) published a new report detailing the antibacterial agents, including antibiotics, in clinical and preclinical development worldwide, finding that despite improvements, the pipeline remains inadequate to confront the urgent need for new, innovative technologies to address serious infections and replace those becoming ineffective due to rising antimicrobial resistance. According to the report, new products are not being developed at the pace and scale needed to ensure new antibiotics are delivered, given the time required for products to move through the pipeline and the likelihood of failure. Specifically, the report identified gaps in agents for children, agents with more convenient oral formulations, and agents that can address drug-resistant pathogens. The report also stressed that efforts to boost innovation must accompany parallel efforts to ensure equitable access to existing and new products, particularly in low- and middle-income countries, where access gaps can hasten the rise of drug resistance.  Last week, the Global Antibiotic Research & Development Partnership (GARDP) announced an agreement with Bugworks Research to support the further development of a new broad-spectrum antibiotic that targets some of the most difficult-to-treat bacterial pathogens, aiming to enable access simultaneously in Western countries and low- and middle-income countries with a high burden of antimicrobial resistance. GARDP will provide Bugworks up to $20 million in financial and technical support through the approval and commercialization of BWC0977, a compound that has demonstrated in-vitro activity against WHO critical priority pathogens, in return for the manufacturing and commercialization rights to it in 146 primarily low- and middle-income countries. Bugworks previously received more than $12 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, for the preclinical development and Phase 1 study of the compound. Moderna recently announced positive late-stage trial results for mRNA-1083, its COVID-flu combination vaccine. The company is the first of several testing a combined COVID-flu vaccine to announce positive late-stage trial results, as experts raise calls for new tools to ensure more people have better protection against both viruses. Trial participants who received the vaccine showed an improved immune response compared with those who got the standalone flu and COVID vaccines that are currently available, even for people 65 years and older, who generally do not mount as robust immune responses to vaccines compared to younger people. The company hopes to have the vaccine approved for the fall of 2025.

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.

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 International Vaccine Institute (IVI) has initiated a technology transfer, first announced last year, of the simplified Oral Cholera Vaccine (OCV-S) to Indian company Biological E. Limited. In the face of an unprecedented rise in cholera outbreaks around the world in recent years, the technology transfer aims to increase the volume of affordable cholera vaccines in the Indian and international markets. IVI is providing technical information, know-how, and materials to support clinical development and regulatory approvals of the vaccine. OCV-s is a simplified formulation of the Oral Cholera Vaccine that can lower production costs while increasing capacity for manufacturers.The Bill & Melinda Gates Medical Research Institute last week announced the launch of a Phase 3 trial evaluating a vaccine for tuberculosis (TB), which researchers hope could become the second licensed vaccine for TB in more than 100 years. The adjuvanted subunit vaccine M72/AS01E was originally developed by GSK, Aeras, and IAVI. The trial, funded by the Bill & Melinda Gates Foundation and the Wellcome Trust, is testing the vaccine’s ability to prevent latent TB from progressing to active pulmonary TB in adults and adolescents. If successful, the pivotal trial could lead to a new tool with the potential to transform TB control globally.A research team from the University of Pittsburgh School of Medicine has identified drug candidates that demonstrate the potential to eliminate the HIV viral reservoir that cannot be expelled completely by existing antiretroviral drugs, preventing people who have undetectable viral load from being completely cured of HIV. The drug candidates, which are called proteolysis targeting chimeras, or PROTACs, can trigger the degradation of the viral protein that prevents the immune system from destroying infected cells by hiding signs of the virus on the surface of the cell. Through this method, the drugs show promise in reversing the ability of HIV to evade detection by the immune system. The PROTAC approach still has significant hurdles to go before it can be used in humans, including preclinical testing in animal models and medical chemistry optimization.