Breakthroughs Blog: Devices

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 US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Moderna’s mRNA-based COVID-19 vaccine candidate, making it the second shot to receive a greenlight in the United States after Pfizer and BioNTech’s candidate obtained EUA one week prior. The authorization follows a recommendation from an independent advisory panel to FDA, which met last Thursday to review evidence and subsequently voted to endorse the vaccine for use in people 18 years of age and older. Data released in late November indicated that the Moderna vaccine showed 94 percent efficacy in its phase 3 clinical trial, leading the company to seek regulatory clearances in the United States and Europe. The Moderna vaccine does not require the same ultra-cold temperature storage as the Pfizer/BioNTech vaccine, allowing it to be delivered more widely in upcoming distribution efforts.The US National Institutes of Health (NIH) is sponsoring two phase 3 clinical trials investigating monoclonal antibodies as treatment for hospitalized COVID-19 patients with moderate illness. The trials are sub-studies of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-3 program, an adaptive trial designed to investigate new therapeutics as they become available. One of the treatments, developed by GlaxoSmithKline and Vir Biotechnology, is a fully human anti-SARS-CoV-2 investigational monoclonal antibody with potential to neutralize the virus and kill infected cells. The second treatment, developed by Brii Biosciences, is a combination of two neutralizing monoclonal antibodies. Both trials hope to show treatment efficacy in hospitalized patients, a subset of patients for which monoclonal antibody treatments have so far not shown an impact.The FDA granted EUA last week to the first-of-its-kind rapid COVID-19 test that can be conducted fully at home without need for a prescription. The diagnostic, which was developed by Ellume, detects SARS-CoV-2 virus fragments from a nasal swab sample using an analyzer that connects with a smartphone app, providing results in as little as 20 minutes. While less accurate than typical molecular diagnostics, the test has shown a sensitivity of 96 percent and specificity of 100 percent and, in asymptomatic individuals, a sensitivity of 91 percent and specificity of 96 percent. Ellume intends to produce around 3 million tests by next month and 20 million by the second half of 2021 to be accessible in drug stores for over-the-counter use.

On November 19, the Global Health Technologies Coalition (GHTC) convened its first virtual Hill event of the COVID-19 pandemic, connecting a group of congressional staff with representatives from four organizations advancing COVID-19 innovations to meet global needs. Twelve staffers representing members serving on key committees participated in the virtual dialogue. GHTC hosted the conversation to continue educating allies on the Hill about the need for COVID-19 innovations designed for use in low-resource settings, and how the US Agency for International Development (USAID) could support that effort—if Congress appropriates sufficient emergency funding in the next COVID-19 relief bill. The organizations who participated have strong records of advancing innovations for health emergencies with USAID support and are poised to play an important role in the global response to COVID-19. The event began with a presentation by Dr. Rebecca Richards-Kortum, director of the Rice 360° Institute for Global Health, on the institute’s COVID-19 diagnostic tool. The simple-to-use, rapid point-of-care diagnostic offers results in 30 minutes or less, using a platform that is expected to cost less than US$5,000 per instrument and less than $2 per test. With USAID support, Rice is validating the test and plans to pursue emergency use authorization from the US Food and Drug Administration (FDA). The team hopes to scale the test quickly to countries in sub-Saharan Africa where they have research partners and infrastructure in order to make an impact in communities where trained laboratory personnel, basic hardware, and reagents are not readily available to support widespread testing using currently available COVID-19 diagnostics. Shift Labs' DripAssist device. Photo: Shift Labs Next, Dr. Beth Kolko, co-founder and CEO of Shift Labs gave an overview of its DripAssist IV device. This ingenious device, designed to be durable, portable, easy to assemble, and operable with minimal training, can help a clinician anywhere in the world give IV medication safely and effectively without the use of costly infusion pumps. DripAssist, which was developed with support from USAID through the Fighting Ebola and Saving Lives at Birth Grand Challenges, was widely used during the recent Ebola outbreak in the Democratic Republic of the Congo—and even more recently was deployed in health care facilities in the United States facing a shortage of infusion pumps to address a surge in COVID-19 patients. “Designing for global needs gives engineers like our team a set of constraints that requires them to be more inventive,” Dr. Kolko noted, “And on the back end, you end up with a device that is more widely deployable,” including right here at home. Dr. Devin Sok, senior director of antibody discovery and development at GHTC member IAVI, followed with a presentation on IAVI’s COVID-19 antibody research efforts and how emerging antibody therapies could be a key tool to defeat COVID-19 globally. IAVI is focused on developing COVID-19 monoclonal antibodies both to treat individuals just exposed to the virus to stop progression to the severe form of the disease and also to prevent infection in individuals who might be at risk of exposure, like a temporary vaccine. While antibody therapies are typically expensive, Dr. Sok referenced the example of a low-cost monoclonal antibody product already on the market for rabies and noted that IAVI is proactively taking several steps in developing its product to drive down costs and ensure that it will be accessible and deployable in low-resource settings worldwide, even though this might delay product introduction. “We were aware from the beginning that we were not going to be first to market, but the priority was to be first to access,” he said. OraSure Technologies' rapid HIV self-test. Photo: World Health OrganizationFinally, Dr. Stephen Tang, president and CEO of OraSure Technologies, shared more about his company’s progress on developing a rapid antigen self-test for COVID-19, a tool with potential to dramatically simplify and expand access to COVID-19 testing in the United States and globally. Described by Dr. Tang as a “lab on a swab,” the test uses a self-collected nasal sample and delivers easy-to-read results at point of care without the need for additional instruments or laboratory analysis. OraSure’s history of designing diagnostics for global health needs has positioned the company well to support global access to COVID-19 diagnostic tools. It created the first rapid oral HIV self-test prequalified by the World Health Organization and the first FDA-approved rapid diagnostic test for Ebola, and it is now leveraging the same lateral flow platform these tests are built on for its COVID-19 diagnostic. Subject to receipt of an emergency use authorization by FDA, OraSure’s rapid self-test for COVID-19—developed with funding from the Biomedical Advanced Research and Development Authority—could be deployed worldwide.  Reflecting on the lessons OraSure has drawn from its experience developing HIV diagnostics and what’s required to ramp up COVID-19 diagnostic testing to the massive scale the world requires, Dr. Tang emphasized several interrelated factors: instrument-free self-tests are ideal for countries with limited laboratory infrastructure; ease of use is key, particularly in countries with low literacy rates; experience counts when it comes to working with regulators, particularly during health emergencies; and the ability to scale manufacturing to meet demand is paramount for impact.  After the presentations, the congressional staff participants posed a range of thoughtful questions about the innovations as well as the innovators’ perspectives on what the United States can do support the global response to COVID-19—from how US military research capabilities can be leveraged to design COVID-19 products suited for austere settings, to how members of Congress who represent researchers and research institutions can better advocate for resources needed to support science, to the specific measures that must be taken to scale up COVID-19 diagnostic capacity in the United States and around the world. As we consider the challenges of delivering certain COVID-19 products—including the leading vaccine candidates—everywhere they are needed worldwide, GHTC will continue to connect policymakers and their teams with innovators working to design tools with global access in mind. We hope this dialogue creates the foundation for an enduring partnership between congressional champions for global health innovation and the researchers whose work is fueling progress against COVID-19 and other global health threats.

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 week, Pfizer and BioNTech released preliminary data from their ongoing phase 3 COVID-19 vaccine trial, indicating up to 90 percent efficacy of their mRNA-based vaccine candidate. The companies hope to have enough data to file for emergency use authorization (EUA) within the next few weeks. If the vaccine candidate does receive approval, Pfizer and BioNTech will launch their extensive distribution plan—which requires the vaccine to be kept at -94°F, a strict cold chain that has led to feasibility concerns from many countries—to fulfil hundreds of millions of doses ordered through advanced purchase commitments. These commitments include a 300-million dose deal with the European Union, a 120-million dose deal with Japan, a 100-million dose deal with the United States, and a 30-million dose deal with the United Kingdom. Pfizer and BioNTech plan to roll out a total of 100 million doses of the vaccine by the end of 2020, followed by an additional 1.3 billion doses in 2021.The US Food and Drug Administration (FDA) last week granted EUA to Eli Lilly’s COVID-19 antibody treatment for use among people age 12 or older with mild or moderate COVID-19 infection. The drug, bamlanivimab, continues to be tested in a clinical trial to establish additional safety and efficacy data, after early results suggested it may help clear COVID-19 infection sooner and cut hospitalization rates in patients with mild or moderate cases. A study of the treatment in hospitalized patients was stopped in late October due to lack of efficacy, upon recommendation from independent monitors of the trial. The US government has signed an agreement with Eli Lilly to purchase 300,000 700-mg vials of the drug, though it is unclear how many doses that will provide, as early results indicated at least 2,800 mg is necessary to provide any effect. Eli Lilly’s therapeutic is the first antibody drug to receive EUA to treat COVID-19.The Senegal-based Pasteur Institute is developing an affordable, handheld COVID-19 diagnostic kit able to provide results in minutes. The rapid test kit contains a simple test strip housed in a plastic unit and requires a small blood sample, collected by finger prick. No electricity or laboratory analysis is required, and the center hopes the kits will cost as little as US$1. Developers plan to start manufacturing and distribution after regulatory checks are complete, making the kits first available to countries in Africa through governments and health organizations like the Africa Centers for Disease Control and Prevention, with a goal of issuing 10 to 15 million kits by February 2021.

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. Regeneron will need to place on hold enrollment of patients requiring high-flow oxygen or mechanical ventilation in its COVID-19 antibody cocktail clinical trial, based on recommendations from an independent data monitoring committee. The trial can continue to enroll hospitalized patients who need either no or low-flow oxygen, and the treatment’s outpatient trial will continue unaffected. Early data on the antibody cocktail, REGN-COV2, indicated it reduced COVID-19–related medical visits by 57 percent. The cocktail is currently under evaluation by the US Food and Drug Administration for emergency use authorization, specifically in mild to moderate outpatients at high risk for poor outcomes.Singapore-based startup firm Breathonix has developed a breathalyzer test able to diagnose COVID-19 infection in under a minute. The device, designed to avoid cross-contamination, uses disposable mouthpieces and assesses the chemical compounds of the breath to determine infection. Results are then generated by a computer within 60 seconds. The test achieved more than 90 percent accuracy in a pilot clinical trial of 180 people, according to Breathonix, and could act as a first-level screening device with a more sensitive polymerase chain reaction nasal swab test used to confirm the diagnosis. The company will be expanding its trial in Singapore with the intention of improving accuracy and receiving a green light for commercial use in the first quarter of next year.Sanofi and GlaxoSmithKline (GSK) announced an agreement to supply 200 million doses of their COVID-19 vaccine candidate, if approved by regulators, to the COVID-19 Vaccine Global Access (COVAX) Facility. The vaccine candidate began a phase 1/2 clinical trial in early September, and first results are anticipated in December 2020 to support a phase 3 trial before the end of the year. Sanofi and GSK, in statements on the COVAX partnership, emphasized a commitment to ensuring affordable and accessible COVID-19 vaccines around the world. The COVAX Facility—a global collaboration of governments, global health organizations, businesses, and philanthropic organizations focused on accelerating development and production of COVID-19 products—is designed to ensure people in all parts of the world get access to COVID-19 vaccines once available. More than 180 countries and economies are currently a part of the mechanism.