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. Scientists at the Icahn School of Medicine at Mount Sinai and research partners have developed an innovative antibody platform to tackle viruses like SARS-CoV-2 (the virus that causes COVID-19) that can rapidly evolve and render vaccines and treatments ineffective. The platform uses engineered nanobodies to simultaneously target multiple stable regions of the virus that are less likely to mutate, making it harder for resistance to develop. While most therapeutic antibodies target only a single viral site and can lose effectiveness within a year as viruses evolve, this platform has the potential to offer a more durable, resilient defense against these tricky viruses. It could also be potentially adapted to target other pathogens. In lab tests and experiments in mice, the platform was able to effectively target a range of variants of the SARS-CoV-2 virus and even the closely related SARS-CoV virus. A new research project led by researchers at the Barcelona Institute for Global Health and Columbia University aims to develop a lateral flow test for diagnosing malaria at the point of care that would also enable health care workers to determine the severity of the disease and decide whether a course of treatment is necessary. While some patients with uncomplicated malaria can be treated at home, malaria can also rapidly progress and require more complicated treatment in a health care setting. Lateral flow tests for malaria diagnosis exist, but parasite counting using microscopy is needed to determine severity and that cannot be done at the point of care. The researchers, who hope to have a validated prototype by the fall of 2026, are looking to develop a portable, paper-based assay that uses a smartphone and can deliver results within minutes.   Last Monday, Roche announced that its mpox assay, Cobas MPXV, has been listed under the World Health Organization’s (WHO’s) Emergency Use Listing procedure, a designation that aims to accelerate the availability of and access to the test during the current global mpox emergency. The automated real-time PCR-based test detects DNA from the virus that causes mpox using a dual-target approach and previously received Emergency Use Authorization from the US Food and Drug Administration in 2022. Earlier this month, Abbot’s mpox test was also listed on the Emergency Use Listing procedure following a call by WHO for manufacturers to submit expressions of interest back in August.

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. On Friday, the World Health Organization (WHO) announced the prequalification of Bavarian Nordic’s MVA-BN vaccine for mpox, the first-ever vaccine for the virus on the prequalification list. Prequalification status is anticipated to facilitate timely and increased access to the vaccine, helping to contain the current outbreak on the African continent by accelerating procurement by governments and international agencies and enabling national regulatory authorities to fast-track additional approvals. The vaccine has been licensed for use in people 18 years and older with a two-dose schedule given a month apart. However, the WHO Strategic Advisory Group of Experts has specifically recommended the use of the vaccine for people at a high risk of exposure in the context of an outbreak; thus, the vaccine has been used in infants, children, adolescents, and pregnant and immunocompromised people. It has also recommended single-dose use to stretch limited supplies while also urging the need to collect additional data about the vaccine’s safety and efficacy in these circumstances.Last week, Gilead published new results from the highly anticipated PURPOSE 2 trial, the second Phase 3 study of its twice-yearly, long-acting drug for HIV pre-exposure prophylaxis (PrEP), lenacapavir. The trial showed that the drug was able to reduce HIV infections by 96 percent compared with background HIV incidence and was 89 percent more effective than Gilead’s already available PrEP drug, Truvada. The study, which included more than 3,000 cisgender men, transgender men and women, and gender non-binary individuals aged 16 and older across seven countries, was unblinded early to offer lenacapavir to all patients in the study. This news follows the exciting results from the PURPOSE 1 trial of the drug in cisgender women and adolescent girls, which demonstrated 100 percent efficacy and was also unblinded early. Lenacapavir is currently available for use alongside other agents in patients with multidrug-resistant HIV, which make up only 2 percent of adults living with HIV, but, if approved for additional populations, the drug could be available as soon as 2025 and could be a game-changer for the HIV epidemic. Emergent BioSolutions last week announced that the Biomedical Advanced Research and Development Authority (BARDA) awarded the company a $41.9 million research and development option to its existing ten-year contract to further the development, validation, commercialization, and scale-up of the company’s monoclonal antibody treatment for Ebola virus infection. The treatment, Ebanga, was initially developed by Ridgeback Biotherapeutics with support from BARDA and was approved by the US Food and Drug Administration as a single infusion for the treatment of Ebola Zaire virus infection in 2022. The award is part of BARDA’s broader strategy to support treatments that can be deployed during virus outbreaks.

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.