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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 National Institutes of Health (NIH) began enrolling patients in a study to test hydroxychloroquine—a malaria drug also used to treat rheumatoid arthritis and lupus—as a potential therapy for patients hospitalized with symptomatic COVID-19. Although President Trump has repeatedly touted hydroxychloroquine as a “game-changer” treatment in combating the novel coronavirus, the drug has yet to be proven safe and effective as a COVID-19 therapy in a clinical trial. This NIH-funded trial is one of 18 trials in the United States seeking to determine if hydroxychloroquine can treat COVID-19. The US Food and Drug Administration issued an emergency authorization allowing doctors to prescribe hydroxychloroquine and chloroquine to treat COVID-19—leading to a spike in demand and causing shortages.US researchers began clinical trials of a second experimental COVID-19 vaccine that uses a skin-deep shot instead of the usual deeper injection. This study is evaluating if two doses of Inovio Pharmaceuticals’ vaccine candidate is safe enough for efficacy larger tests. The Inovio vaccine works by packaging a section of the virus’ code inside synthetic DNA which is then injected into the skin. The cells act a mini factory, producing harmless protein copies which prompt the immune system to make protective antibodies against them should the real virus ever come along. After the injection, researchers use a device to give the injection site an electrical zap to help the vaccine more easily penetrate and get to work. This vaccine—like the NIH and Moderna’s vaccine candidate—is not made using the actual virus, meaning there’s no chance of getting infected from the vaccine and that it is able to be produced more quickly than traditional vaccines.Australian researchers have published a study showing ivermectin, a drug commonly used to treat parasitic infections, can also kill coronavirus in a laboratory setting in under 48 hours. Research was carried out on cell cultures in the lab, which does not always translate to effectiveness in people who have contracted the infection. The exact manner in which the drug kills the virus is unknown, but researchers say it was likely done by "dampening down" the ability of host cells to clear the drug. Ivermectin has already been studied and approved to treat other conditions, offering an advantage over new drug development—a long process that typically involves many years of studying safety and efficacy before being able to reach human patients. Further research is needed to determine whether the drug could be used to treat 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. Last week, doctors in China reported that the malaria drug hydroxychloroquine helped to speed the recovery of a small number of patients who were mildly ill from COVID-19, the disease caused by the novel coronavirus. Symptoms such as cough, fever, and pneumonia went away faster, and the disease was less likely to become severe in people who received hydroxychloroquine than in a comparison control group that did not receive the drug. The study was small with just 62 individuals, limited to patients who were only mildly or moderately ill, and excluded patients with underlying conditions that could be made worse by hydroxychloroquine. The authors of the report noted hydroxychloroquine is a promising treatment for COVID-19 but that more research is required, including on how it works in treating the disease and how best to use it.The US government has made deals with Johnson & Johnson (J&J) and Moderna Inc—and is reportedly in talks with two other companies—to prepare them to mass produce coronavirus vaccines before one that is safe and effective has even become available. Last Monday, J&J announced a US$1 billion deal to create enough manufacturing capacity to produce more than one billion doses of a vaccine candidate that will not begin testing until September. This effort will be funded in part by the Biomedical Advanced Research and Development Authority (BARDA). Moderna, which has already begun human clinical trials of a vaccine candidate supported by the National Institutes of Health, also signed a deal with BARDA—an agency which ultimately plans to support five or six experimental vaccine candidates with the hopes of having two or three successful ones. There are currently no approved vaccines for COVID-19, and experts have estimated it could be 12 to 18 months before one receives regulatory approval.The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a new coronavirus test that takes only 15 minutes. The test from Abbott runs on its point-of-care ID NOW platform and weighs less than seven pounds, so it can be easily deployed to disease hotspots. This test is one of the fastest tests for COVID-19 available and comes just weeks after FDA EUA approval of a 45-minute rapid point-of-care test. Abbott plans to deliver 50,000 tests per day starting last week and plans to produce about five million tests per month. Public health experts say that a key factor in ending the spread of coronavirus is to dramatically increase testing. A lack of availability of COVID-19 test kits has been a point of contention in the United States, which now has the largest number of COVID-19 cases of any country in the world.

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 studying the genetic code of the novel coronavirus have determined it is not mutating quickly, suggesting the virus is less likely to become more dangerous as it spreads. Although all viruses evolve over time, accumulating mutations as they replicate inside a host’s cells and spread through a population, scientists say there is no evidence that some strains of the new coronavirus are deadlier than others. Researchers at Johns Hopkins University are now studying more than 1,000 samples of the virus and have noted only four to ten genetic differences between the strains that have infected people in the United States and the original virus that spread in Wuhan. This represents hope for researchers working to create a long-lasting vaccine against the pathogen. Several vaccines are currently in development, but experts posit it could be at least a year to 18 months before one becomes available. The US Food and Drug Administration (FDA) has announced it is making it easier for doctors to try an experimental treatment for seriously ill COVID-19 patients that uses plasma from people who have had the disease and recovered. Though there is currently little evidence this treatment works in people infected with the novel coronavirus, the approach has recently been used with some effectiveness to treat patients with SARS and Ebola. The idea is that so-called convalescent plasma taken from donors recovering from infection will contain antibodies to the virus that can be used to treat other patients. There are risks with this approach, the worst being it could make the patient sicker—a response known as antibody-dependent enhancement where the virus is actually helped to proliferate by a patient's own immune system. The FDA will still require doctors to seek approval to use the treatment for individual patients, but they can receive authorization in less than four hours via phone call. The FDA has granted emergency use authorization for a rapid COVID-19 test on the GeneXpert platform, a widely used tool for tuberculosis diagnostic, which could facilitate increased testing capacity in low- and middle-income countries (LMICs). There are more than 23,000 of the devices worldwide, which are produced by Cepheid, including an estimated 7,000–10,000 across Africa, Latin America, and South-East Asia. The tool can process nose swab samples in only 45 minutes and perform up to 96 tests in 24 hours. GeneXpert tests are automated, point-of-care devices which allow healthcare facilities to perform the test in-house without having to send samples off to a lab, allowing for real-time management of patients being evaluated for admission to facilities. Advocates are calling on Cepheid to reduce the price of test cartridges from US$20 to $5 to make them more affordable in LMICs.

GHTC joined civil society in urging G20 policymakers at today’s C20 meeting with the G20 Health Working Group to strengthen R&D to meet urgent health challenges, including achieving universal health coverage (UHC) and combating antimicrobial resistance (AMR) and other health threats.GHTC director Jamie Bay Nishi delivered remarks on advancing R&D for AMR at this face-to-face meeting with G20 officials, and the coalition provided input on broader civil society recommendations.During the meeting, the C20 called for leaders of the world’s largest economies to recognize the central role R&D plays in achieving the G20 health priorities and to take the following actions:Universal health coverageRecognize health and its enablers, including R&D, as a fundamental human right: The right to health guarantees the enjoyment of the highest attainable standard of physical and mental health, which includes the prevention, treatment, and control of disease. Strong and resilient health systems, robust R&D capacity, and equity and gender equality are vital to leaving no one behind.Health preparednessProvide sustainable financing to address urgent R&D gaps: G20 nations should commit new funding to address urgent gaps in the global response to COVID-19 and other emerging threats, including funding R&D for new diagnostics, treatments, vaccines, and other innovations. This should include support for multilateral institutions including the Coalition for Epidemic Preparedness Innovations [CEPI].Embrace access principles as central to these efforts: Any funding for R&D for new tools must attach public interest access principles to ensure that the end product is affordable, accessible, and available for everyone who needs it.Enhance coordination mechanisms for R&D: The creation of an R&D action package with the Global Health Security Agenda could ensure that country health system strengthening efforts include a focus on capacities to develop new drugs, vaccines, diagnostics, and other medical countermeasures.Antimicrobial resistanceDrive collective action on AMR: Successfully diagnosing and treating more people with tuberculosis (TB) will help prevent the development and spread of drug-resistant TB, a key driver of the global threat of AMR. While G20 commitments on paper represent significant progress in the fight against TB, action on these has been fairly limited as of yet. Increase funding for TB R&D: This should align with member state commitments made in the political declaration of the United Nations High Level Meeting on Tuberculosis (UNHLM) to “contribute appropriately” to TB R&D, which is in line with the new World Health Organization TB Research and Innovation Strategy. One way to do this is to benchmark funding against a target, such as 0.1 percent of gross domestic expenditure on R&D to be spent on TB R&D. Tackle market failure for AMR using drug-resistant TB as a pathfinder: The renewed global drive to tackle TB, following the UNHLM, will be incomplete without solving market failure for TB R&D. The G20 can drive this agenda by promoting a collaborative approach to TB R&D that includes push, pull, and pooling incentives, as well as principles of equity, access, affordability, and transparency. G20 countries should also engage with and provide ongoing support to the Global AMR R&D Collaboration Hub.