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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. 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.

GHTC submitted written testimony to the House appropriations subcommittees with jurisdiction over the US Agency for International Development and Department of State and the Department of Health and Human Services and its sub-agencies urging these subcommittees to sustain and protect global health R&D funding in the fiscal year 2021 (FY21) budget.

GHTC sent letters to House and Senate appropriations subcommittees with jurisdiction over the US Agency for International Development and Department of State, Department of Health and Human Services, and Department of Defense, urging these subcommittees to sustain and protect global health R&D funding in the fiscal year 2021 (FY21) budget.

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.