Breakthroughs Blog: Devices

With support from the US Agency for International Development’s (USAID) global health Grand Challenges for Development program led by the Center for Innovation and Impact, innovators from across the globe have been designing and scaling up affordable solutions to the world’s most significant global health challenges, from saving lives at birth to fighting Ebola, Zika, and other threats. These brilliant minds have transformed a trick to remove a cork from a bottle into a product to safely deliver babies and created an app to identify disease-carrying mosquitoes by the sound of their buzz.With the toll of COVID-19 now intensifying in low- and middle-income countries (LMICs), many of these innovators are turning their attention to this grandest of global health challenges we face—drawing on their unique expertise to leverage or adapt existing technologies to help fight COVID-19 in the world’s poorest places. This work is essential given many of the COVID-19 interventions deployed in high-income countries, like the United States, are ill-suited for use in low-resource settings, which often lack electricity, clean water, or adequate health infrastructure. Yet thus far, Congress has largely overlooked the importance of supporting LMICs in responding to this crisis, something policymakers should remedy as the pass this next round of COVID-19 appropriations.Examples of impact-ready innovations already being advanced by previous USAID Grand Challenge winners which could be mobilized to fight COVID-19 globally include:DripAssist, a low-cost tool—developed by Ebola Grand Challenge winner Shift Labs—that manages the flow rate of IV treatments with a simple gravity system, replacing the need for expensive, difficult-to-use infusion pumps. Costing less than one-tenth of the price of a traditional IV pump, DripAssist requires no maintenance and runs on a single AA battery, making it particularly suitable for use in resource-limited settings. With many of the first potential COVID-19 treatments like remdesivir requiring IV administration, this is an important tool to improve patient care in LMICs.Highlight, an ingenious powder—developed by Ebola Grand Challenge winner Kinnos—that temporarily turns disinfectant blue, so it is visible during application before fading back to clear once a surface has been decontaminated. This helps health care workers ensure they have fully covered and decontaminated areas, important for stopping the spread of highly infectious diseases like COVID-19. In response to the pandemic, Highlight’s developers are working to scale up production to provide the product at a discount in LMICs.A biometric patient ID system—developed by Saving Lives at Birth Grand Challenge (SL@B) innovator Simprints—to help health care systems reliably identify patients to improve disease surveillance, contract tracing, and care management. Simprints’ main flagship product uses a fingerprint scanner for patient identification, but the team is now testing a contactless system for COVID-19 that uses mobile phone cameras and palm/facial recognition. More than 1 billion people worldwide lack access to reliable identification, complicating health care treatment and tracking efforts.A simple-to-use, rapid point-of-care COVID-19 test designed for low-resource settings—developed by SL@B innovator Rice University—that offers results in 30 minutes or less, using a platform that is expected to cost less than $5,000 per instrument and less than $2 per test. With USAID support, Rice is validating the test and pursuing emergency use authorization from the US Food and Drug Administration.While clearly there is no shortage of high-impact ideas to bolster the fight against COVID-19 in LMICs, to identify the best solutions and advance them from proof of concept to widespread availability, additional funding is urgently needed.That’s why GHTC, leading global health and development organizations, and Members of Congress on both sides of the aisle are urging Congress to provide additional emergency funding to support the international COVID-19 response—including support for USAID to advance innovations for low-resource settings through models such as a Grand Challenge for COVID-19.USAID and its network of innovators have a long and storied track record of delivering tools that are as effective in low-income countries as they are in high-income countries, uniquely equipping the agency and its partners to take on this grandest global health challenge yet.A lot is at stake in getting this international response right. After all, we will not defeat this disease anywhere until we defeat it everywhere.This piece was originally published to the Global Health Council's blog and has been crossposted with permission.

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 European Medicines Agency (EMA) issued a positive opinion on the monthly dapivirine vaginal ring, developed by GHTC member the International Partnership for Microbicides (IPM), for use by cisgender women 18 and older in developing countries to reduce HIV risk. The ring—designed to help address women’s unmet need for HIV prevention methods—is the first long-acting HIV prevention product. The EMA opinion recommended the ring’s use in combination with safer sex practices when daily oral pre-exposure prophylaxis (PrEP) is not used or cannot be used. Efficacy data indicated the dapivirine ring reduced women’s HIV risk by 35 percent and showed no safety concerns with long-term use. This EMA decision paves the way for review by the World Health Organization (WHO) and regulatory bodies in each country where it is intended for use. IPM is continuing market and implementation research and working on rollout plans, with a hope for making the ring available in some communities with urgent need sometime in 2021.Three laboratories working on COVID-19 vaccines released promising results last week, reporting their findings from early human trials. The three vaccine candidates—developed by Oxford University/AstraZeneca, CanSino Biologics, and Pfizer/BioNTech—all produced strong immune responses with antibody levels similar to those seen in patients who have recovered from COVID-19. The developers also indicated that immunity is likely to require a second vaccine dose. Scientists have cautioned that lab results from these early vaccine trials do not guarantee COVID-19 disease prevention. Among outstanding questions is the long-term efficacy and effects of these candidates, as the trials have only measured results over a few weeks. The three developers that released results last week—along with Moderna, which reported its vaccine candidate’s positive immune response the week prior—will continue further human trials in the upcoming months.A study conducted by the UK-based company Synairgen reported positive results for a potential new COVID-19 treatment method: an inhaled form of interferon beta, a naturally occurring antiviral protein more commonly used in its injectable form to treat diseases like multiple sclerosis. Results from the study of 101 patients, not yet published in a peer-reviewed journal, showed that hospitalized patients who received the treatment had a 79 percent lower risk of developing more debilitating symptoms and were twice as likely to recover without limitations compared to those receiving a placebo. The preliminary double-blind placebo-controlled study will be followed up with larger clinical trials.

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 US Department of Defense is providing US$71 million for increased production of Inovio Pharmaceutical’s Cellectra devices—small, hand-held tools that are used to deliver Inovio’s vaccine candidate, INO-4800, directly to the skin without the use of needles. The device works by using a small electrical pulse that enables the DNA-based virus to pass into the recipient’s skin. Cellectra operates on AA batteries, and it is designed to "function reliably in challenging environments and can be stockpiled in large quantities without maintenance.” The vaccine, INO-4800, is expected to remain effective for up to one year in room-temperature storage. These durable qualities could make this vaccine system effective for low-resource settings. Inovio expects to begin a phase 2/3 trial in July. On Wednesday, the University of Oxford launched the first clinical trial in Africa of a COVID-19 vaccine. The vaccine being evaluated, AZD1222, was invented at the University of Oxford and is being developed in partnership with AstraZeneca. The trial is being conducted in South Africa, which has 120,000 of the continent’s 340,000 total cases. It represents a key moment for a continent that has so far been elbowed out of the global competition for medical supplies during the pandemic. Africa Centers for Disease Control and Prevention Chief John Nkengasong said, “unless we act now, Africa is at risk of being left behind on the global vaccine.” Others noted that several African countries have clinical trial capacities to contribute to global research and development. The University of Oxford is also running trials of AZD1222 in Brazil and Britain.Remdesivir, the first drug to demonstrate a benefit for treating COVID-19, has so far been delivered intravenously but will now be evaluated in an inhalable form in clinical trials. The inhalable version will be delivered via a nebulizer, a tool commonly available in the United States. Scientists at Gilead, remdesivir’s sponsor, hope that the availability of nebulizers will make it easier to use remdesivir at earlier stages of infection, such as when a patient tests positive but is presymptomatic. While delivering remdesivir as an inhalant may help overcome some of the limitations of intravenous delivery, it may also present other issues. Some physicians are worried that using a nebulizer could enable the spread of viral particles, and at improper doses, remdesivir can be toxic.

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 Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the Biomedical Advanced Research and Development Authority (BARDA) will partner with SiO2, an advanced materials science company, to introduce a novel technology for packaging COVID-19 vaccines and other pharmaceuticals. JPEO-CBRND and BARDA will provide US$143 million in funding to scale production of the company’s new technology that includes a plastic container with a microscopic glass coating. The product is thermal stable (range of -196 C to 121 C), highly durable (able to withstand 1,500 pounds of direct force), and precision molded, making it more dimensionally consistent than glass vials.The vaccine candidate, mRNA-1273, developed by the National Institute of Allergy and Infectious Diseases in partnership with Moderna, will begin phase 3 clinical testing by July, followed in August by Oxford University/AstraZeneca’s vaccine, and in September by Johnson & Johnson’s vaccine. All three companies are backed by the US government as part of Operation Warp Speed, and each is testing new technology.On Monday, an official from the World Health Organization (WHO) suggested that spread of COVID-19 by people who are asymptomatic is “very rare,” but clarified on Tuesday that scientists are actually unsure how frequently asymptomatic spread occurs. The initial comments caused a stir among public health experts, some labelling the comment as miscommunication. Underlying the confusion is that the term “asymptomatic” can mean either people who are presymptomatic or people who develop a full infection without showing symptoms. There is some evidence that fully asymptomatic cases may not be very contagious, while other studies show that patients may be most contagious when they are presymptomatic. Either way, experts note, individuals without symptoms should still be taking precautions.