Breakthroughs Blog: COVID-19

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 Food and Drug Administration (FDA) authorized last week its first COVID-19 antibody tests that estimate the level of antibodies in a person’s bloodstream, indicating the strength of their immune response. Since April, FDA has greenlit 33 antibody tests, all of which provide a basic positive or negative result. The two recently approved tests, developed by Siemens Healthineers, are new versions of previous yes-or-no antibody tests that provide “semi-quantitative” readings of a patient’s antibody levels. Both tests are chemiluminescent immunoassays, tagging antibodies with reagent markers and producing more light when more antibodies are present. The new tests will provide an additional tool in evaluating COVID-19 immune response, but FDA also warned that results from these tests do not provide reason to stop following COVID-19 prevention guidelines and emphasized the remaining unknowns about antibodies and protective immunity.Research on monoclonal antibodies—lab-made imitations of natural antibodies—to treat COVID-19 is accelerating as two National Institutes of Health (NIH) clinical trials were launched last week. The trials, one focusing on patients early in disease progression and one on sicker, hospitalized patients, are intended to determine whether a monoclonal antibody developed by Eli Lilly has an effect on symptom duration and recovery time. Success as a COVID-19 treatment could also lead to exploration of monoclonal antibodies as an infection prevention measure. Scientists hope monoclonal antibody treatment can provide a “bridge” of immunity before a vaccine is available.The Serum Institute of India announced it will be receiving US$150 million in funding from the Bill & Melinda Gates Foundation in partnership with Gavi, the Vaccine Alliance, to produce 100 million COVID-19 vaccine doses for low- and middle-income countries. The Serum Institute will manufacture vaccines from developers AstraZeneca and Novavax once approved and make them available for procurement, priced at $3 per dose, in 92 countries via a Gavi advance purchase commitment as part of the COVID-19 Global Vaccine Access (COVAX) Facility initiative, co-led by Gavi, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization. COVAX aims to deliver 2 billion doses of approved, effective vaccines against COVID-19 by the end of 2021.

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. Moderna and Pfizer announced last week the launch of phase 3 clinical trials for their COVID-19 vaccine candidates, the first late-stage studies supported by Operation Warp Speed in the United States. Both vaccine candidates are mRNA-based, meant to induce an immune response by mimicking the virus. The 30,000-subject phase 3 trials—to be conducted in locations across the United States—will evaluate the safety and efficacy of the vaccines. Moderna, in partnership with the National Institute for Allergy and Infectious Diseases (NIAID), and Pfizer, in partnership with BioNTech, have said they hope to seek regulatory approval and start supplying vaccines by the end of the year.Sorrento Therapeutics has licensed a saliva-based rapid COVID-19 diagnostic test developed by a fertility lab at Columbia University. The test, COVI-TRACE, is single-step and contained within a small tube, requiring no laboratory equipment. It works by applying heat to saliva in the tube, inducing a reaction from enzymes and reagents to provide a result within 30 minutes. If positive, the enzymes and reagents will react to the presence of the virus’ RNA and turn the liquid from red to yellow. A preliminary, preprinted study produced a sensitivity level of 97 percent and a specificity level of 100 percent, indicating low rates of false negatives and false positives. Sorrento intends to pursue emergency use authorization from the US Food and Drug Administration (FDA) and scale up production of the test.As COVID-19 vaccine trials increasingly scale up, some advocate groups and individuals are pushing to ensure diverse representation in clinical research. Clinical diversity—the inclusion of diverse populations including racial and ethnic minorities, elderly people, and those with underlying medical conditions in clinical trials—helps ensure that research covers the different ways individuals might respond to drugs and therapies. When it comes to COVID-19, populations that have historically been underrepresented in clinical research are among the highest risk for infection and death. Data has shown that Black and Latino populations are three times more likely to be infected with COVID-19 than white people and twice as likely to die. Chronic kidney disease has been identified as one of the top risk factors for serious infection. Eight out of ten COVID-19 deaths reported in the United States have been of people ages 65 and older. Several vaccine developers have acknowledged the importance of representing high-risk communities in clinical trials, and recent FDA guidance “strongly encourages” the inclusion of diverse populations in clinical trials but does not mandate representation.

COVID-19 is an unprecedented global health crisis. Just as every sector is grappling with unforeseen challenges, global health advocacy has been continuously adapting to a policy environment in flux. As part of this community, the Global Health Technologies Coalition (GHTC) has been responding by:Reporting on the latest developments in COVID-19 research and development (R&D).Tracking COVID-19’s impacts on the R&D ecosystem.Sharing key US and multilateral policy updates with our members and partners.Developing and advancing specific policies that would drive creation of new tools for countering COVID-19 in low-resource settings, especially in low- and middle-income countries (LMICs).GHTC applauds many of the actions taken by lead US policymakers over the last several months. Congress has appropriated more than $10 billion for research to respond to COVID-19 through four emergency supplemental bills, and this funding is driving high-impact innovation at record speed. Yet many of the new products that result from this innovation will be ill-suited for low-resource settings, which often lack electricity, adequate hygiene, highly trained health care workers, laboratory networks, robust supply chains, and other attributes often taken for granted in well-resourced systems. For these settings, we need different innovations:Drugs that are easily transported and administered without the need for highly trained health workers.Rapid diagnostic tests that can deliver results at point of care without using complex laboratory equipment.Vaccines that are single dose, can be stored at room temperature, can be rapidly produced and distributed, and are easily administered (ideally through ingestion, a patch on the skin, or an electrical pulse rather than an injection). Medical devices, such as specially designed non-invasive ventilators, IV infusion monitors, and oxygen delivery devices, that require minimal technical expertise, have fewer and more easily replaceable parts, are quickly manufactured, and are battery operated.Personal protective equipment that is durable, reusable, open-source, and can be quickly manufactured and adapted in a variety of settings.Through our US and multilateral policy efforts, GHTC has been advocating for policies that would foster these needed products. In our US advocacy, we are pushing Congress for three funding lines that would drive innovation at the US Agency for International Development (USAID), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Centers for Disease Control and Prevention (CDC):$200 million for Global Health Programs at USAID to advance and deliver innovations to help LMICs prevent, prepare for, and respond to COVID-19 and other pandemic threats. These innovations should be specifically designed for low-resource settings and should include vaccines and vaccine delivery systems; diagnostics; therapeutics; medical devices; personal protective equipment for frontline health workers; health facility innovations; and the financing, manufacturing, and delivery systems these essential resources require.At least $200 million to CEPI to advance vaccine candidates for SARS-CoV-2. CEPI is advancing nine vaccine candidates and has put forward a $5 billion global ask to advance this portfolio. US support for CEPI will help ensure that vaccines developed will be deployed effectively and affordably worldwide.Robust funding for the CDC Center for Global Health and National Center for Emerging and Zoonotic Infectious Diseases to support the development and deployment of essential tools to combat COVID-19 globally.In our multilateral advocacy, GHTC has been pushing back against the United States’ retreat from international leadership on COVID-19 R&D, including the decision to withdraw from the World Health Organization (WHO) in the middle of the pandemic. GHTC advocates that the United States should work with other global leaders to proactively invest in global product development, manufacturing capacity, and product delivery mechanisms, including the Access to COVID-19 Tools (ACT) Accelerator, which could be instrumental in helping LMICs finance the purchase and administration of COVID-19 vaccines, treatments, diagnostics, and other tools. GHTC has also been pushing other G7 and G20 leaders to fill the funding gaps for the ACT Accelerator and to support other financing mechanisms such as a World Bank global health security challenge fund and health systems strengthening investments by regional development banks.GHTC is also engaging with the Global Health Security Agenda (GHSA) and pushing for the explicit inclusion within GHSA of R&D for diagnostics and medical countermeasures to respond to emerging health threats.Finally, GHTC has been working with other global stakeholders to assess how new COVID-19 product development and deployment mechanisms could be used to reshape the global R&D ecosystem and benefit other critical global health priorities.To support our US and multilateral policy asks, GHTC is tracking US government and multilateral-supported COVID-19 R&D, publishing materials to help policymakers and the public better understand these research efforts, and leading and supporting our partners with aligned messaging:GHTC COVID-19 R&D Tracker [Editor note: This was discontinued in 2021]COVID-19 Vaccine 101: The Facts that MatterGHTC maps the US agencies involved in Global Health Security R&DGHTC-led Congressional letter to support R&D for the international responseGHTC featured in Global Citizen: “To Defeat COVID-19, the United States Must Invest in Innovations for All”GHTC defends WHO’s role in global R&D response to COVID-19GHTC condemns US withdrawal from WHOGHTC endorses FIND’s Call to Action on COVID-19 testingThis is the first global health crisis in this century to significantly affect every person living in the United States and around the world—a catastrophe that could raise awareness and support for global health R&D. GHTC will continue to leverage this moment and emphasize the narrative that links all the issues we work on, that global health and global health security can never be assured until we have a robust, coordinated, and global R&D ecosystem that includes the populations, diseases, and conditions too often overlooked.