Harnessing health innovation to achieve the global goals

Last week, an oral cholera vaccine receivedWorld Health Organization (WHO) prequalification, a process of regulatory review which paves the way for procurement by United Nations agencies and international organizations. Up to 4.3 million cases and 142,000 deaths from cholera are reported annually, primarily in low- and middle-income countries, and the vaccine—Euvichol®—is 65 percent effective against the bacteria. Euvichol® was developed by GHTC member the International Vaccine Institute (IVI), and has been licensed to the Korean company Eubiologics, which plans to produce 6 million doses in 2016. The vaccine is a reformulated version of Shanchol™, which is licensed to Shantha Biotechnics in India, and was prequalified in 2011. According to the WHO, prequalification of Euvichol® could double the global supply of cholera vaccines. Euvichol® produced by EuBiologics. Photo: IVI Scientists have identified three compounds that could serve as the basis for a vaccine against onchocerciasis (river blindness). More than 17 million people globally are affected by river blindness, 70 percent of whom experience skin conditions, including itching and lesions, and 10 percent of whom develop eye conditions, leading to visual impairment. Without a vaccine, river blindness control programs use the antiparasitic drug ivermectin to treat the disease, however, ivermectin is not recommended for use in children under five. Additionally, in Central and Western Africa, where coinfection with Loa loa worms is common, use of ivermectin can lead to fatal brain inflammation. The team hopes to initiate safety and efficacy trials for a potential vaccine candidate by 2020 and 2025, respectively. The Global Fund to Fight AIDS, Tuberculosis and Malaria is launching an “e-marketplace” through which global health product procurers (i.e., governments and nongovernmental organizations) can purchase everything from drugs and diagnostics to condoms and cars. The e-marketplace will be an online platform utilizing the Global Fund’s pooled procurement mechanisms. Through this mechanism, the Global Fund negotiates with manufacturers and purchases large quantities of global health commodities; governments and other organizations are then able to purchase products directly from the Global Fund, reducing product and transaction costs. This approach also improves demand forecasting and ensures a sustainable supply of products. The launch of the e-marketplace will be phased: while in the first quarter of 2016, only bednets will be available, artemisinin combination malaria medicines, malaria and HIV and AIDS diagnostics, and antiretrovirals will be available by the end of the year. The e-marketplace will initially be limited to Global Fund grant recipients, and 10 to 20 countries are expected to utilize the platform in 2016. The Global Fund hopes to open the e-marketplace to more buyers in the future and eventually offer products that are not part of Global Fund agreements, enabling procurers to independently compare quotes from different manufacturers.

In this guest post, Dara Erck, vice president of external affairs at Aeras, discusses the new White House National Action Plan for Combating Multidrug-Resistant Tuberculosis and how it could accelerate research and development (R&D) of new technologies to combat multidrug-resistant TB (MDR-TB). When the World Health Organization (WHO) unveiled its Global Tuberculosis Report 2015 last October, the most striking revelation was that tuberculosis (TB) is now the world’s leading single infectious disease killer, accounting for 9.6 million illnesses and 1.5 million deaths in 2014. And the report’s findings about MDR-TB were also alarming, noting 480,000 cases of MDR-TB globally in 2014, with nearly 10 percent of these being extensively drug resistant (XDR-TB). Considering this high human toll in context of the estimated annual US$1.3 billion funding gap for TB R&D, it is clear we must achieve a sea change in the global approach to TB R&D funding. This is why there was much hopeful anticipation for the release of the White House’s recent plan to address MDR-TB, as a follow up to its 2014 National Action Plan for Combating Antibiotic Resistant Bacteria. Released in late December 2015, the National Action Plan for Combating Multidrug-Resistant Tuberculosis is a product of countless hours of collaboration between the Obama Administration and its partners in government, including the White House Office of Science and Technology Policy which convened an interagency working group including the US Agency for International Development, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the State Department, and others. During the course of the plan’s development, TB advocates vigorously urged the Administration to broaden the goals related to MDR-TB. And the White House listened. The goals of the action plan are to strengthen domestic capacity, improve international capacity and collaboration, and accelerate basic and applied research to combat MDR-TB. I am especially pleased to see this acknowledgment of the critical role of TB R&D. Accelerating basic and applied research to combat MDR-TB is absolutely necessary if we are to conquer the TB epidemic. The plan recognizes that “ultimately, an effective vaccine to prevent all forms of TB will be required to eliminate TB globally.” This acknowledgment is an important step, indeed. But we must not ignore that funding this critical work is a necessary next step. We simply cannot discover and develop the new tools required to end this deadly epidemic without urgently needed additional resources. I urge President Obama to include robust funding for implementing agencies in his fiscal year 2017 budget. TB vaccine research. Photo: Aeras The plan outlines a significant focus on R&D. In the coming year, NIH is directed to expand its TB dialogue among basic scientists, funders, and vaccine developers to identify novel strategies for vaccine development, encourage research related to vaccine design, and educate partners about resources available to contribute to vaccine development, as well as continue to support studies to map the diversity of immune responses required for vaccine efficacy. Within three to five years, NIH is tasked with continuing its support for TB research, preclinical studies, and clinical trials and studies for the evaluation of new vaccines, adjuvants, and preventive drugs. NIH and CDC will also intensify collaborations with domestic and international vaccine developers to leverage preclinical and clinical resources for vaccine development. These directives are an important move in the right direction—but without significant new strategies and resources, the scientific community will struggle to advance new vaccine candidates that can prove effective in providing protection against TB. I am particularly encouraged to see the call for collaboration with private-sector organizations including nonprofit product developers. At Aeras, we partner with a wide range of academic and pharmaceutical organizations dedicated to TB vaccine research. And we aren’t alone—other nonprofit product developers such as TB Alliance and FIND lead their fields in new drug and diagnostic development, respectively. The release of this plan was an exciting moment for all TB advocates and researchers, as it attracts new and much needed attention to the threat of MDR-TB. It provides the opportunity to create renewed accountability for ending this deadly epidemic. It also validates and supports other initiatives, including the WHO’s aim to end the TB epidemic by 2035, and the United Nations’ new Sustainable Development Goals which target ending the TB epidemic by 2030. But for the plan to be successful, Congress will need to dedicate the resources necessary to achieve its ambitious treatment, diagnostic, and vaccine development targets. The US government is a key partner in this critical work. I deeply appreciate the Administration’s efforts to create this plan and hope that the US Congress will provide the funding that is so urgently needed to realize a TB-free world.