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. A research team was able to induce broadly neutralizing antibodies targeting hepatitis C virus (HCV) in laboratory models for the first time, providing a promising approach for a vaccine targeting the virus, which an estimated 58 million people globally are chronically infected with and which causes 290,000 deaths annually. HCV is identified as a globally prioritized pathogen for vaccine research and development by the World Health Organization, but developing a vaccine has been a challenge due to the high genetic diversity of the virus. This new approach, if proven successful in further studies, could not only bring us closer to an effective HCV vaccine that could help limit the spread of the virus but could also lay the foundation for a new generation of vaccines against other priority viruses.Last week, the World Health Organization (WHO) announced that it had granted prequalification to Cepheid’s Xpert MTB/RIF Ultra rapid diagnostic test for tuberculosis (TB), the first TB diagnostic test to be prequalified by WHO. The designation will hopefully help ensure broader access to the product, allowing for accurate and early detection of TB, especially drug-resistant TB. Within hours, the test detects the genetic material of Mycobacterium tuberculosis in sputum samples and identifies mutations associated with rifampicin resistance, a key indicator of multidrug-resistant TB. A recent report found that 8.2 million people—the highest number of cases recorded by WHO since it began global TB monitoring—were diagnosed with TB in 2023, underscoring the need for greater access to new and improved tools.Last week, the World Health Organization (WHO) announced that it had granted prequalification to tafenoquine, the first single-dose medicine for the prevention of Plasmodium vivax malaria, and also included tafenoquine, co-administered with chloroquine, in the new WHO malaria guidelines for South America. P. vivax is the dominant malaria parasite in most countries outside of sub-Saharan Africa, with children under five and migrant populations at particular risk. The prequalification and inclusion of tafenoquine in the updated guidelines are aimed at improving access to the treatment, which is shorter and simpler than current treatment regimens.

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. A study published last week tested a promising new malaria vaccination strategy that aims to boost immunity through bites from mosquitoes carrying a genetically engineered version of the malaria parasite, which could pave the way for improved malaria vaccines. There are two approved vaccines for malaria, but they are only about 75 percent effective and require booster shots. In a trial, researchers exposed participants to bites from mosquitoes that had a version of the malaria parasite that was genetically modified to stop developing after delivery into a human, finding that nearly 90 percent of participants exposed to the modified parasites avoided contracting the disease after being bitten. The next step will be a larger trial to confirm this strategy as a viable candidate to advance malaria control efforts.A new study found that vaccines for diarrhea could reduce bacteria-associated diarrhea and antibiotic use among young children in low- and middle-income countries, which could also help reduce the emergence of antimicrobial resistance due to antibiotic overuse in low-resource settings where cases of diarrheal disease are most common. The research team used data from a previously published study exploring enteric infections and diarrheal illness in children in low- and middle-income countries and generated simulations to estimate the hypothetical impact of nine vaccine scenarios, including six single-pathogen vaccines and three combination vaccines. They found that, compared to the other single-pathogen vaccines, a vaccine against Shigella could cause the greatest reduction in antibiotic courses, and an adenovirus-norovirus-rotavirus vaccine could cause the greatest reductions in antibiotic use compared to the other combination vaccines.Last week, the Coalition for Epidemic Preparedness Innovations (CEPI) announced $1.46 million in funding for PATH to develop antibody reagents for developing vaccines against Severe Acute Respiratory Syndrome, or SARS. Antibody reagents are critical for measuring and analyzing a vaccine’s potency and ability to induce an immune response. PATH will lead efforts to develop and test reagents, as well as collaborate with the Texas Children’s Center for Vaccine Development to select and scale up a SARS-CoV-1-specific antibody to ensure these reagents are available globally, particularly in low and middle-income countries. The project aims to strengthen global health security by allowing researchers and manufacturers the tools to develop and scale up vaccines quickly in the face of an outbreak or new variant.

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. Recently published research found that a new, noninvasive test for malaria could provide a more reliable, safer, quicker, and more sensitive diagnostic option in low- and middle-income countries. The Cytophone, a tabletop printer-sized device, uses targeted lasers and ultrasound to detect malaria-infected cells in the bloodstream via a small, noninvasive probe placed on the back of a person’s hand. Malaria-infected red blood cells accumulate a by-product with unique properties that can be distinguished from normal red blood cells when they pass through a laser. The test, which provides results within minutes, was found to be as good or better at detecting symptomatic Plasmodium falciparum malaria infections than the current gold standard point-of-care methods for malaria testing, which require blood samples and special laboratory equipment. The next phase of testing the device will also investigate whether the device can detect and distinguish between other species.Last Tuesday, Bavarian Nordic announced the start of a clinical study of the MVA-BN® mpox/smallpox vaccine in children between 2 and 11 years old, who are highly vulnerable to infection during the ongoing mpox emergency. The study, which currently has sites in the Democratic Republic of Congo and plans to include sites in Uganda as well, is investigating the safety and immunogenicity of the vaccine in children compared to adults. Last month, the World Health Organization prequalified the vaccine for adolescents between 12 and 17 years old, following the European Medicines Agency’s approval for this age group. Results from the new trial could support an extension of the current approval.Researchers have identified a novel class of antimicrobial agents known as encrypted peptides that play a key role in the immune system’s response to bacterial infections, opening up new possibilities for combating drug-resistant infections as antimicrobial resistance continues to grow as a global health threat. The immune system is traditionally thought to rely primarily on proteins explicitly linked to immune functions, but this new research reveals that other structural proteins contribute to antimicrobial defenses. Leveraging the immune system’s natural defenses through these non-immune proteins could allow researchers to develop effective antibiotic therapies less prone to resistance.

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.