Hannah Sachs-Wetstone

While we know that vaccines, drugs, diagnostics, devices, and vector control innovations are all vital tools in our global health toolbox, in this year of the World Health Assembly resolution on strengthening diagnostics capacity, GHTC wanted to shine a special spotlight on diagnostics as an often underrecognized driver of global health progress. Diagnostics play a critical role for patients, health care providers, and decision-makers, and innovating and improving access to diagnostics are necessary to achieving universal health coverage. The below presentation, which was shared during GHTC's Innovating for Impact Awards reception on December 12, features an explainer of types of diagnostics tests and a glossary of terms, as well as key quotes and facts that demonstrate the critical role of diagnostics.

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 Thursday, Gavi, the Vaccine Alliance, announced the African Vaccine Manufacturing Accelerator, which will invest up to $1 billion in boosting African manufacturing to address the inequality in vaccine access faced by Africans during the COVID-19 pandemic, as well as to produce vaccines to tackle diseases with a high burden on the continent, including cholera and malaria. The funding for the new scheme comes from leftover money from the COVAX initiative, which aimed to help the world’s poorest countries access COVID-19 vaccines during the pandemic. The accelerator is expected to launch in June of next year and hopes to ensure African manufacturers can offer competitive prices, even for new technologies like viral vector and mRNA vaccines.The startup NanoPin Technologies has developed an ultra-sensitive, blood-based test for difficult-to-detect tuberculosis (TB) cases now on the market, which is also the foundation for a multiplex TB and HIV test the company is developing. Both the NanoDetect-TB blood test, which is supposed to ease and speed up the detection of active TB, and the NanoDetect-TB/HIV multiplex assay, which uses quantitation of viral and bacterial loads to simultaneously detect HIV and TB, offer potential advantages over existing tools. Currently available tests, including the gold standard sputum-based methods for TB detection, can have low sensitivity to samples from patients with HIV and TB coinfection. Further research will be necessary to demonstrate that the multiplex test maintains efficacy in the field and that it can continue to be sensitive while reducing cost, complexity, and instrument requirements as much as possible.Last week at the International Conference on AIDS and STIs in Africa, researchers from the PrEPVacc trial that was testing two different vaccine regimens in Africa announced that the study has been shut down, leaving no HIV efficacy trials underway globally. The trial was halted after an independent data monitoring committee concluded there was little or no chance the study would demonstrate efficacy. The study had previously been dubbed the last chance for an HIV vaccine until the 2030s. PrEPVacc was a pioneering study as one of the first large, African-led HIV vaccine trials and one of the first trials to incorporate PrEP. However, the trial did use older vaccine designs that some scientists doubted would demonstrate adequate efficacy. The hope is that data from the halted trial can eventually inform future trials for new and innovative HIV tools.

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. This month, with support from the local government, German biotechnology company BioNtech is opening an mRNA vaccine factory in Rwanda, which is expected to become the first of what the company says will be a decentralized and robust end-to-end mRNA vaccine manufacturing network in Africa that will manufacture novel vaccines for Africans across the continent. The plant is expected to start by producing 50 million vaccines and will increase production based on demand. BioNTech is currently advancing vaccine candidates to address malaria and tuberculosis based on its mRNA vaccine platform.Last week, Population Council announced that South African company Kiara Health will start producing vaginal rings for HIV prevention in the next few years, which could make the innovative tool cheaper and more readily available to women in Africa. The dapivirine ring, which has been authorized by nearly a dozen countries and the World Health Organization, offers women an alternative HIV prevention method that can be taken without anyone else’s knowledge or consent. Population Council owns the rights to the ring, which is currently produced by a Swedish company. About a half million rings have been made available freely in Africa through donor support. Population Council and Kiara estimate that the company will be able to produce double the currently available supply annually.The Coalition for Epidemic Preparedness Innovations (CEPI), the International Vaccine Institute (IVI), and Medical Research Council Unit The Gambia last week announced the launch of the Research Preparedness Program West Africa, which will support a consortium of regional stakeholders to bolster the growing clinical research sector across the region. Specifically, the partners will work toward building up clinical trial capacity to conduct the first-ever large-scale phase 2b and 3 clinical trials of Lassa fever vaccines in the region. The program also aims to improve general preparedness to ensure the capacity to generate high-quality clinical trial data during future outbreaks of other diseases in the region in as little as 100 days.

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 new phase IV observational study will test whether a novel approach to managing severe malaria, involving interim treatment with rectal artesunate, could address the challenge of treating those with severe cases in isolated rural settings far from a health facility. In the study, patients will be treated with artesunate rectal capsules at the community level and evaluated for clinical outcomes and then will receive follow up treatment with oral artemisinin-based combination therapies once they are well enough to swallow the medicine. The study, led by the newly created Severe Malaria treatment with Rectal artesunate and Arteminisin-based Combination Therapy [in remote settings] (SEMA ReACT) consortium, is intended to generate evidence to inform gaps in guidance on how to approach treatment when it is not feasible to transfer severely ill patients in timely manner to high-level health facilities as current guidance recommends.The results from a new study coordinated by the Drugs for Neglected Diseases initiative (DNDi), the Japanese pharmaceutical company Eisai, and the Mycetoma Research Center in Khartoum found that the oral drug fosravuconazole is up to 85 percent effective in treating the neglected tropical disease mycetoma and has no side effects. Currently, mycetoma is treated with itraconazole, a drug which needs to be taken with food four times a day for a year, has a myriad of side effects, is expensive, and is not available in all endemic countries. In contrast, fosravuconazole, only needs to be taken once a day without food, is inexpensive, and already widely used to treat fungal nail infections—factors that enhance its suitability for widespread use in low-resource settings.The Global Antibiotic Research & Development Partnership (GARDP) has been awarded around $3.07 million from the Research Investment for Global Health Technology Foundation to support an international clinical trial to evaluate three novel antibiotic regimens for neonatal sepsis. This infection affects over 3 million newborns every year, most of whom live in low- and middle-income countries. The trial, run by GARP and partners, is underway in Kenya and South Africa and will expand to more countries next year. The funding will also enable GARDP to collaborate with South Korean Jeil Pharma to explore options to optimize the manufacturing and approval of the novel antibiotics included in the regimens under study to ensure affordable prices and stable supplies of the drugs.

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. TB Alliance has launched a new pan-phase 2 clinical trial to evaluate the safety and efficacy of replacing bedaquiline with a new experimental compound, TBAJ-876, in the organization’s three-drug BPaL regimen. The new regimen, composed of novel compounds with minimal pre-existing resistance, could provide a method to treat all patients with active tuberculosis (TB), including drug-sensitive and drug-resistant TB, with a universal treatment that is shorter, simpler, and more people-friendly than current regimens. Results from the preclinical and phase 2 studies showed that TBAJ-876, compared to bedaquiline, eliminated TB bacteria faster and was potentially safer. The study aims to enroll 300 participants with drug-sensitive TB at 21 trial sites in Georgia, the Philippines, South Africa, Tanzania, and Uganda.  Last week, the Bill & Melinda Gates Foundation announced a $23.6 million grant to US-based life science company Micron Biomedical to fund the first-ever mass production of needle-free vaccine technology. The technology, which uses dissolvable microneedles attached to the skin via a patch-like device, has the potential to boost the uptake of a variety of injectables, particularly in low-income countries, because it is simpler to transport and easier to administer. Specifically, the funding will support the development of a manufacturing facility that can make around 10 million doses annually for large clinical trials and hopefully wider use, subject to approval from regulatory authorities.A phase 3 clinical trial in South Africa found that a widely available oral antibiotic, levofloxacin, was safe and substantially reduced the risk of children and adults developing multidrug-resistant tuberculosis (MDR-TB). The trial is the first high-quality study to look at a preventive treatment for MDR-TB in children—there are currently no preventive MDR-TB treatments for adults or children. The researchers hope the new results will lead to updated guidelines from the World Health Organization that will lead to the rapid scale-up of levofloxacin because the drug is already widely available and relatively affordable, with child-friendly formulations already available through procurement agencies.  

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 Thursday, the US Food and Drug Administration (FDA) announced its approval of the first vaccine to prevent the disease caused by the chikungunya virus. The Ixchiq vaccine, developed by Valenva, is approved for adults at increased risk of exposure to the virus. It was previously granted fast-track and breakthrough therapy designations from FDA. Chikungunya is a chronic and debilitating disease that has no specific treatment, which has become an increasing global threat due to climate change. FDA is requiring that Valneva perform a post-market study to continue to monitor the vaccine’s safety and side effects.With support from Medicines for Malaria Venture (MMV), Kenyan manufacturer Universal Corporation Ltd has received prequalification from the World Health Organization (WHO) for sulfadoxine-pyrimethamine plus amodiaquine (SPAQ), an antimalarial drug used to prevent seasonal malaria in children during peak transmission periods. This approval, which makes UCL only the sixth African pharmaceutical company to have a product WHO-prequalified, will allow Africa to reduce reliance on imported generic versions of the drug from India and China. In the face of a myriad of barriers to quality local drug production and a persistently high burden of malaria cases and deaths, the approval will also make it easier for other African companies to enter the market and attract major buyers, as well as ensure the accessibility and availability of the drug where it is most needed and free up national resources to dedicate to other aspects of the malaria response.A new study found that more than half of tuberculosis (TB) patients in South Africa receiving treatment with a bedaquiline-containing regimen had isolates resistant to the drug, which was introduced in South Africa in 2012 and has recently become part of all standard drug-resistant TB regimens globally. The study is one of the first to report individual-level bedaquiline resistance gain over time among patients in a setting with a bedaquiline-containing regimen as the standard treatment. The results highlight the need for drug-susceptibility testing capacity to accompany the scale-up of new drugs like bedaquiline to monitor the emergence of drug resistance.