Breakthroughs Blog: WHO

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 in four African nations found no substantial difference in HIV risk among women using three different methods of contraception—an injectable, progestin-only contraceptive, a nonhormonal intrauterine device, or IUD, and a progestin-based implant. However, the study—conducted by a consortium led by FHI 360—revealed high rates of HIV contracted among each group of women studied, prompting calls for deeper integration of HIV prevention and family planning services. The World Health Organization (WHO) will begin synthesizing and sharing findings from the Evidence for Contraceptive Options and HIV Outcomes, or ECHO trial, with WHO’s Guideline Development Group, which will convene at the end of July 2019. This group will consider the trial’s results, along with other research, to determine whether changes are needed to the global guidance on contraceptive use and issue recommendations at the end of August. A study performed by researchers at the University of Oxford, along with partners at five other institutions, has identified the human antibodies that prevent the malaria parasite from entering blood cells—potentially key to creating a highly effective malaria vaccine. The study was done as part of a clinical trial in Oxford of the first vaccine candidate that targets the RH5 malaria protein, a protein contained in the parasite which must bind to a human protein on red blood cells in order to infect them. This study demonstrated which human antibodies effectively block RH5 from binding, thus preventing the parasite from spreading through the blood. Another key finding of the study is the discovery of a new antibody which slows down the speed with which RH5 binds to red blood cells, giving antibodies that do block RH5 from binding more time to act. Researchers aim to use these findings to develop an improved RH5 vaccine that induces more of the effective antibodies. A new civil society group, the Drug Transparency Observatory, has formed in France to monitor the French government’s implementation of a resolution on the transparency of medicines markets adopted at the World Health Assembly last month. A statement released by the new group calls on the French government and all countries to not only implement the adopted resolution, but also the transparency measures included in the initial resolution draft, which go beyond just medicines pricing to include disclosure of research and development costs. The statement noted that the Drug Transparency Observatory will monitor “the advancement on the implementation of the transparency resolution in pricing, clinical trials, research and development, marketing and patenting.”

An estimated 125 million pregnancies around the world are at risk from malaria annually.[1] For both mother and baby, the disease is potentially life-threatening and babies that do survive are often born with low birth weight, which is associated with negative impact on development.[2] These mothers-to-be need medicines to both protect them from getting infected with malaria and to treat them should they fall ill. Yet, these needs remain inadequately addressed.Medicines for Malaria Venture (MMV) is working with partners to improve the quality of global supplies of the World Health Organization (WHO)-recommended medicine sulphadoxine-pyrimethamine (SP) for use as intermittent preventive treatment in pregnancy (IPTp). As a partner in the Unitaid-funded Jhpiego-led consortium TIPTOP, MMV is supporting improved coverage of SP for IPTp in Africa through community health workers by strengthening the supply side for WHO-prequalified SP. For women who become infected with malaria during pregnancy, WHO currently recommends artemisinin combination therapies (ACTs) for the treatment of malaria in the second or third trimesters, and quinine with the antibiotic clindamycin in the first trimester. Angela Kangulumais is a primary school teacher in Zambia. She is 6 months pregnant with her second child.  Angela is no stranger to malaria—she fell ill just before her first pregnancy and was treated with an ACT. Pregnant women at risk of malaria like Angela benefit from IPTp to protect themselves and their unborn babies from malaria. Photo: Medicines for Malaria VentureBased on meta-analyses comparing treatment outcomes using the ACT artemether-lumefantrine (AL) versus quinine in first trimester pregnancies and following a recommendation for policy change from an Expert Review Group, WHO is considering whether to recommend the use of all ACTs in all trimesters of pregnancy. That said, the data set regarding the use ACTs other than AL in the first trimester is comparatively small. MMV is working with the Liverpool School of Tropical Medicine’s Timika Research Facility in Indonesia to analyse historical data and to capture new evidence regarding the use of the ACT dihydroartemisinin-piperaquine (DHA-PQP) in the first trimester of pregnancy. These new analyses will contribute to the evidence base regarding safety and tolerability of this ACT during pregnancy.In addition to expanded use of ACTs for treatment in pregnancy, the malaria research community is also focused on exploring the use of DHA-PQP as a potential substitute for SP for IPTp in the future, should SP’s preventive efficacy decline. MMV is working with the London School of Hygiene and Tropical Medicine in Tanzania on a study to evaluate the cardiac safety of a single course of IPTp with DHA-PQP in pregnant women with and without asymptomatic infection.For the future, we are also looking at the medicines we have in development and how they might be used for pregnant women. Traditionally, most drugs are tested for safety in pregnancy quite late in development (if at all), since in many therapeutic areas, a product that cannot be used in pregnancy can still have enormous therapeutic value. However, in the case of malaria, the needs of pregnant women are clear and compelling. MMV thus focuses early on in its drug development process to identify molecules that may have an acceptable safety profile in pregnancy. This focus includes conducting standard embryo-foetal development studies in parallel with other non-clinical safety assessment or phase I studies. A favorable safety report early on means that these molecules could be prioritized for development. In addition, with MMV’s support, a review was carried out and published to help guide the prioritization of antimalarial drugs for development. It detailed the non-clinical safety of all non-artemisinin antimalarial drugs. [3] The article summarized data that was previously not easily accessible to health experts and is helping to guide the development of next-generation antimalarial medicines that could have an appropriate safety profile in pregnant women. With our partners, MMV is committed to investigating all the avenues to improve pregnancy outcomes for women at risk of malaria. By focusing on protecting and treating pregnant women at risk, we safeguard two lives, not just one.[1] Dellicour S et al. “Quantifying the Number of Pregnancies at Risk of Malaria in 2007: A Demographic Study”. PLos Med; 7(1): e1000221 (2010).[2] Schantz-Dunn J & Nour NM. “Malaria and Pregnancy: a global health perspective”. Rev Obstet Gynecol; 2(3):186–192 (2009).[3] Clark RL. “Animal Embryotoxicity Studies of Key Non-Artemisinin Antimalarials and Use in Women in the First Trimester.” Birth Defects Res. 109(14):1075-1126 (2017). 

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. World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus announced at the 72nd World Health Assembly that a WHO Foundation would be set up later this year. The foundation, which was first mentioned at the 144th Executive Board Meeting in January, aims to broaden the organization’s donor base and “enable us to generate funding from previously untapped sources,” said Dr. Tedros. Details about the proposed foundation’s structure, governance, operating model, and legal status are still being hashed out. According to WHO officials, the foundation would be totally independent of WHO—no longer requiring the approval of the World Health Assembly—but could potentially be linked by contract to WHO to help fundraise for the organization from the general public and high net worth individuals. WHO aims to raise US$14.1 billion between 2019-2023 to deliver on its triple-billion targets. On Wednesday, WHO officially declared Algeria and Argentina free of malaria. Algeria, the country where malaria was first discovered, is now the third African country—following Mauritius in 1973 and Morocco in 2010—to eliminate the disease, which kills more than 400,000 people annually. Argentina is the second country in the Americas, after Paraguay, in 45 years to eliminate the disease. Despite WHO declaring 38 countries malaria-free since 1955, progress against the disease has stalled as malaria-carrying mosquitoes have become resistant to certain drugs used to treat the disease and insecticides used in bednets that protect people from being bitten while sleeping. Researchers at McMaster University have developed an affordable, durable method of transporting temperature-sensitive vaccines to low-resource settings that is inspired by breath strips. The solution: mixing dried vaccines with two sugar powders used to create the dissolvable film structure of breath strips. By using this technique, vaccines can stay stable at temperatures up to 40 degrees Celsius for up to three months. This approach circumvents the need to maintain a “cold chain” during transport from supplier to patient—a task which poses logistical and financial challenges in the hot climates of developing countries where infectious disease threats are endemic. Water or saline can be added to dissolve the sugary combination, and the same reconstituted liquid can be used for injections or nasal sprays. The researchers have tested the approach in lab experiments, but not people, and are pursuing funding to refine and deploy the technology.

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, the World Health Organization’s (WHO) new Science Division unveiled a Health Product Profile Directory—an online resource to guide the research and development of new technologies to combat neglected diseases and other health threats, including antimicrobial resistance and diseases that pose a pandemic threat. The Health Product Profile Directory is a free, searchable database of target product profiles for needed health products to tackle the world’s most pressing global health issues. Each product profile outlines eight to ten key characteristics for development of various health products, including vaccines, medicines, and diagnostics. The directory currently contains 196 product profiles developed by 24 agencies, 91 of which are focused on infectious diseases. In this editorial piece, Dr. Madhukar Pai also discusses whether the product profiles should address affordability, the opportunity to leverage the directory to tap into the potential of emerging innovators in the Global South, and ways to improve the new WHO resource. Every year, 5.4 million people are bitten by snakes. Between 81,000 and 138,000 die as a result, and of those who survive, 400,000 suffer lifechanging injuries. Two years ago, WHO formally classified snakebite as a neglected tropical disease and later this month it will launch a global strategy aimed at halving the number of deaths and cases of disability caused by snakebite by 2030. Last week, two major funding announcements for snakebite research were made public. Wellcome Trust announced a new £80 million program to transform the way snakebite is managed globally, and the UK Department for International Development (DFID) released £9 million to fund the development of a universal snake antivenom. The DFID-funded consortium—which includes the International AIDS Vaccine Initiative, the Liverpool School of Tropical Medicine, and snakebite specialists from Kenya, Nigeria, the United States, and India—will leverage the technology and processes that led to the discovery of drugs to combat HIV to develop new antivenom therapies. It will run through 2021, when a pre-clinical prototype of antivenom is expected. TB Alliance was awarded a Center of Excellence in Translational Research grant by the National Institute of Allergy and Infectious Diseases to support the development of two new clinical stage tuberculosis (TB) drug candidates. The grant, spaced out over five years, will provide US$5.5 million in the first year and reach a total of $28.4 million by 2024. With this grant, TB Alliance and its research partners will focus on the development of compounds that address drug-sensitive and multidrug-resistant strains of TB. “Expanding the global portfolio of new TB drug candidates, from which we can assemble tomorrow’s shorter and simpler cures, is crucial in the fight against TB,” said Dr. Mel Spigelman, president and CEO of TB Alliance.