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. Drug-resistant germs sicken about three million people every year in the United States and kill about 35,000, representing a much larger public health threat than previously understood, according to an updated report released last Wednesday from the Centers for Disease Control and Prevention (CDC). The CDC previously estimated in a 2013 report that about two million antibiotic resistant infections occur every year, causing 23,000 deaths. Using previously unavailable data and by applying new methods, the CDC calculated that the 2013 estimate missed about half of the yearly cases and deaths caused by antibiotic resistant infections. Infectious disease experts say that the new numbers, though still conservative, underscore the magnitude of the problem and establish a new national baseline of infections and deaths that will help prioritize resources to address the most pressing threats. Health authorities in eastern Democratic Republic of the Congo (DRC) have introduced a new Ebola vaccine produced by Johnson & Johnson (J&J) in an effort to combat the world’s second-worst outbreak of the virus on record. The new vaccine—which has completed phase 1 and 2 clinical trials and has been endorsed by the World Health Organization (WHO) —will be administered to 50,000 people in the city of Goma, on the Rwandan border. The experimental vaccine, which requires two injections eight weeks apart, will be rolled out alongside Merck’s single-dose Ebola vaccine. Merck’s vaccine has been administered to over 250,000 people since the start of the current outbreak in August 2018 through a strategy known as ring vaccination, offering the vaccine to contacts of those likely to be infected. The J&J vaccine will be provided to “targeted at-risk populations” in areas where the virus is not yet being actively transmitted, according to WHO. The European Commission granted marketing authorization to Merck’s Ebola vaccine, known as Ervebo, last Monday, making it the world’s first approved Ebola vaccine. This authorization comes less than one month after the European Medicines Agency recommended it to be licensed. A few days following this approval, Merck also received WHO prequalification, a process in which WHO assesses vaccines and other medical products in order to assure member countries that they are safe and effective. Merck said it will also continue to work with the US Food and Drug Administration and regulatory agencies in African countries to license the vaccine. Ervebo is currently being used in the DRC under a “compassionate use” or research protocol similar to a clinical trial. Merck expects the licensed doses will become available during the third quarter of 2020 and has made a commitment to make the vaccine available to countries eligible for purchasing assistance through Gavi, the Vaccine Alliance, at the lowest possible price.

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 have identified a new strain of HIV for the first time in 19 years. This strain is part of the Group M version of the HIV-1 virus—the same family of subtypes responsible for the global HIV pandemic—and is the first new Group M HIV strain to be identified since the guidelines for classifying subtypes were established in 2000. Knowing which virus strains are circulating ensures that diagnostic tests used to detect the disease are effective and provides scientists with a more complete picture of how HIV evolves. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, noted there was no need for panic as current treatments for HIV are effective against this strain and others. According to the World Health Organization, approximately 36.7 million people in the world are living with HIV, and UNAIDS estimates that in 2016 1.8 million people became newly infected with the virus. Takeda Pharmaceuticals reported preliminary results from a late-stage study evaluating the effectiveness of its dengue vaccine candidate, which showed promising but mixed results. In the study which tested two doses of the vaccine in more than 19,000 children in eight countries, the vaccine demonstrated an overall effectiveness rate of 80.2 percent against all four strains of dengue virus. In one strain, known as DENV-2, the effectiveness rate was 97.7 percent but the effectiveness rates in two other strains, DENV-1 and DENV-3, were much lower at 73.7 percent and 62.6 percent respectively. There was not enough data to assess the effectiveness of the vaccine against the fourth strain of the virus. Experts note that before final safety and efficacy determinations can be made about the vaccine, longer term safety data is required, especially among children who were not previously infected with dengue virus—an issue that has hampered rival pharmaceutical company Sanofi’s Dengvaxia vaccine. In a pilot program in Zanzibar, an island off the coast of Tanzania, drones are being tested to deploy a new tool to help fight malaria. The drones will spray rice paddies, which are typical breeding grounds for malaria-transmitting mosquitoes, with Aquatain, a non-toxic, silicon-based liquid gel that creates a thin film on top of the water that traps and kills mosquito larvae and pupae by preventing them from breathing at the water surface. After the trial in Zanzibar, researchers plan to publish their findings in peer-reviewed journals and hope to expand their approach across the African continent. According to the United Nations, malaria kills a young child every minute and causes 75 percent of all deaths under the age of five.

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 new blood test for Zika that can detect the virus within a few hours has been approved for production and use by the Brazilian Health Regulatory Agency. The test can detect the virus in infected patients in less than four hours, a dramatically shorter turnaround time than current methods which can take anywhere from 15 to 30 days. This test is also highly accurate in people who have contracted other diseases transmitted by the Aedes aegyptis mosquito, whereas existing lab tests have challenges in differentiating between infections. The test will be produced by a Brazilian company, AdvaGen Biotech, and sold at no more than US$10 per test so that it’s available to most labs, according to the lead scientist who developed the tool. An experimental tuberculosis (TB) vaccine has shown nearly 50 percent protection against progression of active TB in clinical trials, researchers reported last week at the 50th Union World Congress on Lung Health in Hyderabad, India. These final findings from a phase 2b trial confirm earlier results first reported in 2018 for the vaccine M72/AS01E, developed by GlaxoSmithKline and the International AIDS Vaccine Initiative, and put the world one step closer to developing a better vaccine against the disease. Currently, the only available TB vaccine is the bacilli Calmette-Guerin vaccine. Developed in 1921, it is fairly effective for infants and young children, but its protection varies widely in adults. Researchers concluded that trial results support further evaluation of the vaccine as a tool for global TB control, including confirming results in larger, longer studies and broader populations. A Lassa fever vaccine candidate that could offer protection in a single injection was selected by the Coalition for Epidemic Preparedness Innovations to be advanced into human clinical trials by the end of the year. This vaccine, which is based on the measles vaccine platform, was the most effective single-injection vaccine candidate against Lassa fever evaluated by scientists at the Institut Pasteur and offered protection two days after immunization. Lassa fever is a hemorrhagic fever endemic to West Africa and infects up to 300,000 people per year, killing between 5,000 and 6,000.

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. On World Polio Day last week, the World Health Organization officially declared that type three poliovirus has been eradicated—making it the second of the three strains of the virus to be wiped out. Naturally-occurring cases of the last remaining virus strain, type one, are now limited to Afghanistan and Pakistan with a total of just 33 new cases last year. Though much progress has been made toward eradicating this disease, the number of confirmed cases this year has risen to 88 in those two countries as violence and mistrust have hindered vaccination campaigns. Cases caused by the vaccine itself have also thwarted eradication efforts. The National Institutes of Health and the Bill and Melinda Gates Foundation will jointly invest US$200 million over the next four years to develop genetic-based cures for sickle cell disease and HIV. Both partners have vowed that the cures will be both affordable and available in low-resource countries hit hardest by the two diseases, particularly in Africa. This partnership reflects growing concerns that scientific advances such as gene therapies and genome-editing are prohibitively expensive and therefore out of reach to most patients. This collaboration aims to move gene-based therapies into clinical trials in the United States and countries in sub-Saharan Africa within the next seven to ten years and eventually make treatments for sickle cell disease and HIV available in the hardest hit areas. After a two-day meeting in Okayama, Japan, health ministers of the world’s twenty largest economies issued a declaration endorsing the rapid achievement of universal health coverage (UHC), more effective support of healthy ageing, increased attention to health emergencies and their causes, and more forceful action on antimicrobial resistance. The G20 Health Ministers Declaration goes well beyond the general commitments made by G20 leaders to advance global health goals after their two-day meeting back in June. As part of the commitment to UHC, the health ministers recognized the importance of access to medicines and vaccination and reaffirmed pledges to end HIV, tuberculosis, and malaria, among other measures.

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. An Ebola vaccine developed by Merck & Co was approved by European regulators on Friday in a move hailed as a “triumph for public health” by the World Health Organization (WHO). The vaccine, which protects against the Zaire strain of the Ebola virus—the one that most commonly causes outbreaks—, is being used on an emergency basis during the current outbreak in the Democratic Republic of the Congo. The regulators recommended conditional marketing authorization for the vaccine, which the European Commission is likely to affirm in the coming weeks, granting full marketing authorization to all member states under its purview. The vaccine is also under review by the US Food and Drug Administration using a fast-track pathway, with a decision expected in the first quarter of next year. Last week, WHO released its 2019 Global Tuberculosis Report which highlights several new technologies in the pipeline to diagnose and treat tuberculosis (TB), including a promising vaccine that could prevent people with latent TB from developing the disease. The report cites that the vaccine is one of 23 drugs, combination regimens, and vaccine candidates currently in clinical trials. Though funding for TB research and development reached US$772 million in 2017, it remains well below the target of $2 billion annually agreed to by United Nations member states at the High-Level Meeting on TB in 2018. Researchers in Brazil have identified a new parasitic disease that causes severe damage to the liver, spleen, and skin and is believed to have infected more than 150 people and caused two deaths in a northeast region of the country. The disease displays similar symptoms to two forms of leishmaniasis–a neglected tropical disease spread by infected female sandflies that attacks both the skin and internal organs. However, this new disease, which is caused by the Cridia sergipensis parasite, does not appear to respond to conventional treatments for leishmaniasis. A researcher involved in the journal article identifying this new disease emphasized the need for further research. “This is the first warning. We still need to diagnose where this parasite is located, what the vectors are, how it is transmitted, and develop an effective medicine,” he said.

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. At its sixth replenishment conference, the Global Fund to Fight AIDS, Tuberculosis and Malaria received commitments of more than US$14 billion for the next three years to wipe out three of the world’s deadliest diseases. The Global Fund is the world’s largest backer of programs to combat tuberculosis (TB) and malaria and the second largest funder of programs to fight HIV and AIDS. The $14 billion pledged, a 15 percent increase from its previous fundraising round in 2016, will cover the Global Fund’s work from 2020 to 2022 and is the largest amount of money ever raised by a health organization. Since the Global Fund’s establishment in 2002, it has helped save the lives of 32 million people and has cut deaths from TB, malaria, and AIDS by 40 percent in the countries in which it invests. For the first time, the US Food and Drug Administration (FDA) has granted marketing authorization for a rapid diagnostic test to identify the Ebola virus. The test, known as the OraQuick Ebola Rapid Antigen Test, detects Ebola virus antigens, or proteins, in certain body fluids from living and deceased individuals. The FDA reviewed the test under the De Novo premarket review pathway, a regulatory pathway for new types of devices considered low-to-moderate risk, following considerations of data from many clinical studies. The FDA also granted Breakthrough Device designation to the OraQuick Ebola Test and worked closely with OraSure Technologies, the device’s manufacturer, to improve device development and facilitate the generation of evidence, as well as expedite FDA's review of the device. The National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, will provide up to $51 million in funding to launch a network of research centers that will work to develop more broadly effective influenza vaccines, including a universal flu vaccine that offers long-lasting protection against multiple viral strains. The allocation for this initiative, dubbed the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program, is designed to support the program for more than seven years. The CIVICs program will consist of three vaccine centers: one vaccine manufacturing and toxicology center, two clinical centers, and one statistical, data management and coordination center.