Ansley Kahn

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. Early data from two phase 3 clinical trials at the University of Chicago testing Gilead Sciences’ antiviral medicine remdesivir among COVID-19 patients is showing rapid recoveries in fever and respiratory symptoms among the patients. The university recruited 125 patients with COVID-19 to participate in these studies, of which 113 had severe cases of the disease. Researchers overseeing the trials reported nearly all patients were discharged from the hospital in less than one week after receiving daily infusions, noting only two patients have died. Although public health experts largely view these results as encouraging, clinical trials of remdesivir, including those with randomized control groups, are being run concurrently at other institutions to determine if this drug is safe and effective against COVID-19. Positive results from these trials could lead to fast approvals by the US Food and Drug Administration and other regulatory agencies in what could be the first approved treatment for the disease.Sanofi and GlaxoSmithKline (GSK) are joining forces to develop a vaccine for COVID-19. Sanofi will test its experimental coronavirus vaccine with GSK supplying some of the adjuvants—additional ingredients that improve efficacy and make it easier to produce vaccines in larger quantities. The companies plan to start human trials in the second half of this year, with the goal of having a vaccine available by the second half of 2021 if the studies are successful. If this partnership does produce a vaccine, GSK has also committed to reinvest any short-term profit from the vaccine into COVID-19 research and long-term pandemic preparedness. This partnership is one among many working to develop a COVID-19 vaccine. Earlier this year, Sanofi partnered with the Biomedical Advanced Research and Development Authority, a US agency focused on funding research and development for global health threats. In a statement, both companies pledged to make any vaccine that is developed affordable and accessible worldwide.Last week, President Trump announced he was halting US payments to the World Health Organization (WHO) pending a 60 to 90-day review. In his announcement, President Trump cited the organization’s failure to properly investigate early reports of the virus’ emergence and to stop its spread after it first appeared in China as reasons for halting payments. President Trump accused WHO of being China-centric and alleged the organization was critical of his administration’s travel ban from China as COVID-19 continued to spread globally. President Trump’s announcement has prompted international outcry with many noting now is not the time to end support for WHO. The US government contributed nearly US$900 million to WHO’s 2018–2019 budget, representing one-fifth of the agency’s operating budget for those years.

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.

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. Due to overwhelming demand, Gilead Sciences has paused granting patients access to remdesivir, an experimental drug which up until now has been used under a “compassionate use” policy against COVID-19—the disease caused by the novel coronavirus. In a statement, the company said it is focused on processing previously approved requests and establishing a new system that allows patients to get the drug in a similar time frame to what it would have taken to work through the requests it has already received. The company will make exceptions for pregnant women and children under the age of 18, as well as those with confirmed cases of COVID-19 who are experiencing “severe manifestations” of the disease. Gilead noted that, in recent weeks, there has been an “exponential increase” in requests for compassionate use of remdesivir due to the spread of COVID-19 in the United States and Europe, which has flooded the treatment access system which was never intended for use in response to a pandemic. Remdesivir is currently being studied in five large clinical trials, two of which could yield results in early April. The World Health Organization (WHO) has announced it will launch a multi-arm, multi-country clinical trial, known as the SOLIDARITY trial, for potential coronavirus therapies. The trial will test four drugs or drug combinations already licensed and used for other illnesses as part of a global effort to identify treatments for COVID-19. The four therapies include the antiviral drug remdesivir; a combination of two HIV drugs, lopinavir and ritonavir; lopinavir and ritonavir plus interferon beta; and the antimalarial drug chloroquine—all of which have shown some effectiveness against the novel coronavirus either in vitro and/or animal studies. These therapies will be compared to the standard of care—the regular support hospitals treating patients currently use, such as supplementary oxygen. Ten countries have already indicated they will take part in the trial. WHO launched a similar trial in the Democratic Republic of Congo in November 2018 to test four therapies against Ebola. Phase 2 and 3 clinical trials of Takeda’s tetravalent dengue vaccine candidate showed that it is safe, produces immunity in children, and protects against the disease—regardless of previous exposure to different strains of the virus—according to studies published in The Lancet. In the phase 3 trial, researchers found an overall vaccine effectiveness of 80.2 percent in the first 11 months and 73.3 percent in the first 17 months. Takeda’s dengue vaccine candidate is only the second dengue vaccine to enter clinical trials, following Sanofi Pasteur's Dengvaxia. Sanofi’s vaccine was 56–61 percent effective in preventing dengue in children, but it was tied to severe illness in some individuals vaccinated without having prior exposure to infection. Dengvaxia was approved by the US Food and Drug Administration last May, but with caveats due to potential adverse effects. Takeda is conducting clinical trials in dengue endemic countries before seeking regulatory approval.

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 clinical trial to test an experimental vaccine against the novel coronavirus is expected to kick off today. This initial trial will inject 45 healthy participants with different doses of the vaccine candidate co-developed by the National Institutes of Health and Moderna Inc. The goal for the initial trial is to check that the vaccine shows no worrisome safety side effects in order to set the stage for larger efficacy tests. Public health officials say it may take up to 18 months to fully validate the potential vaccine. Dozens of research groups and companies are racing to develop a vaccine against the novel coronavirus. A second vaccine candidates from Inovio Pharmaceuticals is expected to begin safety tests next month. A man initially known as the “London Patient” has become only the second person in the world to be cured of HIV. The man, Adam Castillejo, has decided to go public with his identity one year after being declared free of the virus and now 30 months after ceasing antiretroviral therapy. Mr. Castillejo was cured of HIV after receiving a stem cell treatment for cancer. The donors of these stem cells have an uncommon gene that gives them, and now Mr. Castillejo, protection against HIV by preventing the virus from replicating inside the body. In 2011, Timothy Brown, the "Berlin Patient" became the first person reported as cured of HIV, three and one-half years after having similar treatment. Although this high-risk therapy was primarily used to treat the patients’ cancer—and is not a feasible treatment for millions living with HIV worldwide—it offers hope to finding a cure for HIV using gene therapy. A new collaboration between Medicines for Malaria Venture and the Liverpool School of Tropical Medicine will establish pregnancy registries in malaria-endemic countries in Africa to fill the data gap on the use of antimalarials in one of the most vulnerable populations to malaria. The study will be conducted across three African countries and will capture data on the real-life use of artemisinin-based combination therapies (ACTs)—the standard care for malaria— during all stages of pregnancy, including the first trimester. The goal of the study is to collect enough safety and exposure data that, if positive, would allow for policy change on the use of ACTs in the first trimester of pregnancy. ACTs are currently not recommended in the first trimester of pregnancy owing to a historic lack of safety data.