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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. 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.

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. Since 2015, scientists from the Fiocruz Institute in Brazil have been infecting mosquitoes with Wolbachia bacteria in a lab and then releasing them into the wild in trial tests in the hopes of slowing the spread of mosquito-borne diseases like dengue. Wolbachia bacteria—common among insects except the Aedes aegypti mosquito, which transmits dengue, Zika, and chikungunya—works by boosting a mosquito's immune system, making it less likely to contract disease. However, if a mosquito does contract dengue, Wolbachia makes it harder for the virus to grow inside the insect and be transmitted to humans. The hope is that the lab-infected mosquitoes will reproduce with wild mosquitoes, spreading the bacteria through the population. Scientists report “significant reductions” in cases of dengue and chikungunya in neighborhoods near where mosquitoes were released. Tests also show more than 90 percent of mosquitoes in areas where the first infected insects were released more than three years ago have the bacteria. Scientists see this technique as one in a suite of tools to control mosquito populations and halt the spread of disease. The Biomedical Advanced Research and Development Authority (BARDA) awarded the Sabin Vaccine Institute (Sabin) an initial US$20.5 million, with options for an additional $107.5 million, to support development of vaccines against Marburg virus and Sudan Ebola virus. With the initial award, Sabin will conduct development and non-clinical activities with the intent of continuing clinical research through phase 2 trials, which may be supported by the additional funding. The Sudan Ebola vaccine candidate is the first of this virus strain to receive BARDA support and the Marburg vaccine candidate is the second to receive BARDA support. BARDA is also supporting the development of vaccines, therapeutics, and diagnostics against the Ebola virus strain causing the current outbreak in the Democratic Republic of the Congo. For the first time, researchers have developed a rapid diagnostic test that uses a biomarker in saliva to detect the mosquito-borne parasite that causes malaria. The test, which will be marketed as SALVA!, is less invasive than traditional malaria diagnostics, which require a blood sample, and can even detect the disease before people carrying the parasite show symptoms or fall ill. Easy-to-administer at the community level, the test also delivers results in five to twenty minutes without samples being sent to a lab. Global Health Innovative Technology Fund has awarded the test’s developers more than £1 million for field trials and continued development. The World Health Organization has called for more new tools to detect malaria, a disease for which there are more than 200 million cases worldwide each year.

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 study has revealed that an antibody, known as IgM, is far more influential in combating malaria than previously thought—which may have important implications on the development of a malaria vaccine. It was previously thought that IgM played a supporting role in the body’s immune response to malaria, that it would initiate this response and then disappear when the primary antibody, IgG, took over. However, this new research shows IgM acting as a co-lead with IgG to block and clear malaria infection in the blood. As a next step, scientists are seeking to understand why the immune system generates both antibodies in response to malaria infection and determine whether vaccines that stimulate an immune system to produce IgM antibodies give better protection against malaria. Researchers hope this new insight brings them one step closer to developing a highly effective vaccine against malaria. The Biomedical Advanced Research and Development Authority (BARDA) announced that it will provide US$14 million and organizational expertise to support the continued development of the investigational Ebola treatment known as mAb114. BARDA will assist Ridgeback Biotherapeutics of Miami, the company manufacturing mAb114, with its application for licensure with the US Food and Drug Administration (FDA). mAb114, a monoclonal antibody that works by binding to virus proteins, thus reducing their ability to infect human cells, is currently being used in the Democratic Republic of the Congo to help combat the ongoing Ebola outbreak as part of a clinical trial. mAb114 has already obtained an FDA Breakthrough Therapy Designation, which allows participating companies to work more closely with FDA officials in pushing for approval. Last week, at the United Nations (UN) General Assembly High-Level Meeting on Universal Health Coverage (UHC), member states reached a comprehensive agreement which commits countries to advance UHC for their citizenry. UN Secretary-General António Guterres called the political declaration “the most comprehensive agreement ever reached on global health” and a “significant achievement” that will drive progress over the next decade on tackling diseases like HIV and AIDS, tuberculosis, and malaria, along with the growing burden of non-communicable diseases and antimicrobial resistance through primary health care systems. In adopting the declaration, member states have committed to investing in policies that expand access to health care while preventing financial hardship and developing and implementing high-impact health interventions to combat diseases and protect women’s and children’s health.