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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.  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.

GHTC director Jamie Bay Nishi delivered in-person testimony on March 12, 2020 before the House Appropriations Subcommittee on State, Foreign Operations, and Related Programs on the fiscal year 2021 (FY21) budget for Global Health Programs at the US Agency for International Development (USAID) and State Department. View her testimony below as prepared:Chairwoman Lowey, Ranking Member Rogers, and members of the Committee, thank you for the opportunity to provide testimony on FY21 appropriations for global health programs at USAID and the State Department. We appreciate your committed leadership in global health, and we hope that your support will continue. I am sharing this testimony on behalf of the Global Health Technologies Coalition, a group of 30 organizations advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. To this end, we strongly urge the Committee to continue its established support for global health research and development by:First: Sustaining and supporting US investment in global health research and product development by rejecting cuts to global health programs called for by the Administration for FY21 and supporting at minimum sustained funding at FY20 levels for each disease or population-specific program under the USAID and State Department global health accounts. Second: Instructing USAID to prioritize R&D within each of the disease and condition areas under their Global Health Programs account and requiring leaders at State and USAID to work together with other US agencies to develop a whole-of-government global health R&D strategy to ensure that US investments are efficient, coordinated, and streamlined.Third: Calling for the expansion of the annual report on USAID’s health-related research and development strategy, which is vital for transparency and oversight, and for the public release of the annual report required by the Global Health Innovation Act, which details the development and use of global health innovations by the Agency.The recent outbreak of COVID-19 has demonstrated once again that we do not have all the tools needed to prevent, diagnose, and treat many neglected and emerging infectious diseases—a reality we also saw during the Zika epidemic and West Africa Ebola epidemic just a few years ago. Yet, the impact of the ERVEBO Ebola vaccine on the now-waning epidemic in the Democratic Republic of the Congo demonstrates the power of having the right tool at the right time to respond to a health emergency. This new vaccine, developed with critical US government funding, is 97.5% effective – a game-changer for this and future outbreaks.As the only US agency with a mandate to focus on global health and development, USAID is uniquely positioned to support the end-to-end development of new global health technologies in a way that is not replicated elsewhere in the US government. USAID’s global presence and unique understanding of the needs of patients in different settings and contexts is key to developing health innovations that are transformative on the ground. However, for the vast majority of USAID’s global health programming, there are no dedicated funding streams expressly supporting R&D. This means that decisions on USAID’s R&D investments are made at the program level, based on overall funding allocations for each disease or population-specific health area. Funding cuts would put significant strain on USAID’s global health programs and jeopardize the agency’s ability to balance current programming needs with needs for new drugs, vaccines, diagnostics, and other tools to accelerate global health gains.In addition, while there are areas of USAID’s global health portfolio that are leading the way in R&D, there are areas where a lack of resources and prioritization are acute. For example:USAID does not currently incorporate research for new vaccines for tuberculosis into its programming despite TB becoming the world’s largest infectious disease killer, andNew tools are needed to reach the end game for neglected tropical diseases, including more sensitive diagnostics to ensure that elimination goals have been met. Diseases know no borders. As we’ve seen with COVID-19, health crises abroad can become health crises at home. It is imperative that we sustainably invest in R&D for a broad range of neglected infectious diseases so that we have tools ready to go when we need them. On behalf of the members of GHTC, I would like to extend my gratitude to the Committee for the opportunity to testify, and for your continued support of these life-saving investments. View video of testimony here (1:30:00).

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 new all-oral drug combination of bedaquiline, pretomanid, and linezolid cures 90 percent of people with deadly drug-resistant tuberculosis (TB) if given for six months, according to clinical trial results reported in the New England Journal of Medicine (NEJM).Typically, this high of a success rate is only seen when TB responds to conventional therapy. When TB is resistant, the success rate falls to well below 50 percent and averages just 14 percent in South Africa, where the trial was conducted by TB Alliance. Current therapy for drug-resistant TB requires taking up to seven drugs, which cause many side effects, for at least 18 months. The new regimen takes just six months, has fewer side effects, and is less costly. TB kills an estimated 1.5 million people annually and of the 10 million new cases each year, roughly 500,000 are drug resistant. The Bill and Melinda Gates Foundation have paid for 15,000 drug molecules to be shipped to the Rega Institute for Medical Research, outside of Brussels, to be tested as a potential cure to the novel coronavirus. The samples are all active ingredients in current antiviral treatments which will be rapidly screened to determine whether they have an inhibiting effect on a sample from the first Belgian patient to be diagnosed. They expect to complete the screening in a week or two. The Gates Foundation has said it will provide up to US$100 million to improve detection, isolation, and treatment efforts in response to the coronavirus outbreak. Though there are currently no proven treatments for coronavirus, a few drug trials are already underway. As of last Wednesday, more than 93,000 people had been infected in more than 80 countries and the global death toll was 3,190. Results from two phase 3 clinical trials reported in the NEJM suggest that a monthly shot of the antiretroviral (ART) drugs cabotegravir and rilpivirine work just as well as daily pills to suppress the viral load of HIV in the bloodstream. ART therapy can effectively halt the replication of the virus and nearly eliminate it from the bloodstream, prolonging life expectancy. If approved by regulators, this long-acting combination therapy could be a more convenient treatment for people living with HIV than the conventional treatment regimen of two or more pills per day, which experts say can pose adherence challenges for many. There is currently no cure for HIV, the virus that causes AIDS.

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 Thursday, the World Health Organization (WHO) launched the first digital version of its latest Model list of Essential Medicines (EML), which provides countries with guidance on the most crucial medicines to have in supply. The EML list has been revised every two years by a group of WHO experts since 1977 but has previously only been published in print or PDF format. The new electronic format makes the EML list more accessible and easily searchable, as users can filter results and export customized lists to Microsoft Excel or Word. More than 150 countries currently use the EML list to determine which medicines best meet their national health needs to compile their own national essential medicines list. US biotech firm Moderna has shipped its first batch of an experimental coronavirus vaccine to US government researchers at the National Institute of Allergy and Infectious Diseases for initial trials that could begin as soon as April. The experimental vaccine candidate will be used in a phase 1 study in the United States, which will test two doses of the vaccine on 45 healthy people. Even if this initial clinical trial is successful, further testing and regulatory approvals would be required before the vaccine could be deployed for widespread use—a process that could take at least one year or 18 months. Moderna is among a slew of companies around the world rapidly trying to identify treatments or develop vaccines against the novel coronavirus that emerged in Wuhan, China late last year, which has infected more than 80,000 people worldwide. The first clinical trial in the United States of a potential treatment for the novel coronavirus is now underway at the University of Nebraska Medical Center. In a draft research plan published last month, WHO said this antiviral medicine remdesivir was considered “the most promising candidate” to treat the novel coronavirus, citing laboratory studies suggesting it might be able to target Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS)—cousins of the novel coronavirus. Remdesivir, which is made by Gilead Sciences, is part of a study already underway in China to test its efficacy against the novel coronavirus and was previously tested in some Ebola patients in the Democratic Republic of Congo before the study was stopped. Currently, there are no proven treatments or vaccines for the novel coronavirus.