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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. Scientists have discovered the Ebola virus in a Miniopterus inflatus bat in Liberia—marking the first time the virus has been found in a bat in West Africa. Though no human cases of Ebola are linked to this discovery, it is nonetheless a step forward in understanding where human Ebola cases come from—an unanswered question surrounding outbreaks of the virus. Though bats have long been a suspected reservoir for Ebola—meaning the virus can live and grow inside them without harming them—researchers still don’t know what animal or animals carry the virus or how it spreads to people. Notably, the Miniopterus inflatus is an insect-eating bat, whereas most experts say that the natural animal host for Ebola is some type of fruit bat, not one that eats insects. Experts claim more study is required to determine which, if any, bat species are a natural host for the Ebola virus. Researchers are also working to determine whether the virus found in the bat in Liberia is the same exact virus that caused the West Africa Ebola epidemic and the current Ebola outbreak in the Democratic Republic of Congo. Global investment in research and development (R&D) for neglected diseases reached an all-time recorded high in 2017 of US$3.5 billion, a seven percent increase from the previous year, according to the G-FINDER report by Policy Cures Research, which has tracked annual global investment for 11 years. Though the United States remained the largest funder, G-FINDER reported significant increases in funding contributions from other governments—including the United Kingdom, the European Commission, Germany, and India. Notably, despite a record high in funding for neglected disease R&D globally, no country reached the World Health Organization target for member states to spend 0.01 percent of their Gross Domestic Product on research for the health needs of developing countries. A phase 1 human clinical trial has begun for a freeze-dried, temperature stable formulation of a tuberculosis (TB) vaccine candidate. A freeze-dried powder vaccine—which does not require a temperature-controlled transportation system—can be distributed at a lower cost and with reduced logistical burdens, especially in low-resource settings. In this trial, researchers are examining if the vaccine candidate, ID93, and the adjuvant GLA-SE, an immune response-stimulating protein, can be combined into a single vial and remain as effective at inducing an immune response as the previously tested two-vial combination. This recombinant vaccine candidate is being developed as a vaccine that could be administered to people who have already been exposed to TB or those who have received the TB vaccine Bacillus Calmette-Guérin—which is commonly given to babies in TB-endemic regions but does not adequately prevent TB in adolescents or adults. Early stage clinical trials in South Africa and the United States have shown the recombinant vaccine candidate to be immunogenic and safe.

As the partial government shutdown stretches into a fifth week – the longest in United States history – news of its impact on agencies essential to global health broadly, and research and development in particular, is taking clearer shape. While less visible than long lines at Transportation Security Administration (TSA) airport check-points, the consequences of shuttering the US Agency for International Development and furloughing broad swaths of the State Department and Food and Drug Administration workforce for more than a month will only become more obvious as the dispute between Congress and the administration over funding for a border wall continues.Here’s what we know now, based on news reports, anecdotal evidence, and intel from agency contacts:Food and Drug AdministrationThe Food and Drug Administration (FDA) has managed to continue many activities in the midst of the shutdown by drawing down on prescription drug user fees, with reviews of submissions filed and paid for ahead of the partial shutdown on December 22, but drug reviews will stop completely as that funding dwindles in the coming weeks. A sign-on letter sent this week on behalf of “millions of American patients, caregivers, healthcare providers, and researchers” raised alarm that the shutdown “has begun to put future scientific discovery and innovation in jeopardy” by forcing the FDA to “make difficult choices regarding to which essential functions its greatly reduced resources are directed,” and urging that “the health and safety of Americans today should never be weighed against the prospect of new life-saving therapies for patients.”State Department/PEPFAROn January 17, the State Department announced it would be “taking steps to make additional funds available to pay employee salaries” to resume most personnel operations and fund most salaries beginning this week and continuing through at least February 14. The announcement from Bill Todd, Deputy Under Secretary for Management, specified that “although most personnel operations can resume, bureaus and posts are expected to adhere to strict budget constraints with regard to new spending for contracts, travel, and other needs.” For the remainder of this interim fix, it appears most of the President’s Emergency Plan for AIDS Relief (PEPFAR), funded through the State Department, should be operating as usual.  US Agency for International DevelopmentIn advance of the shutdown, the US Agency for International Development (USAID) released guidance noting that about half of its 3,100 person staff would be furloughed, with the remainder exempt and expected to continue working, including “those who are funded through mechanisms other than annual appropriations; employees whose jobs are considered necessary for the protection of life and property or necessary to carry out the president’s constitutional duties; or those who are authorized because of their connection to operations that will continue.” While this allows many contract employees across the agency to continue working, only a handful of full-time agency staff within the Global Health Bureau are reported to be in the office.The development and global health community is slowly beginning to feel and communicate the impact of USAID’s staffing and funding shortages. Last week, Devex detailed one example of a USAID funding commitment delayed by the shutdown, though most development leaders they contacted for comment suggested that the shutdown has had limited effect thus far as USAID-funded programs continue operating on prior year funds, but could soon slow funding approvals and dry up grant funds if protracted. This week, we began to hear anecdotes from implementing nongovernmental organization partners to that end, detailing agency guidance to slow spending and even cease activities on some USAID-funded projects.The Washington Post reported this week that White House Acting Chief of Staff Mick Mulvaney has asked agency leaders to provide him with a list of high-impact programs at risk if the shutdown continues into March and April, which increased concern that a compromise is not imminent. On Thursday, two bills with the potential to end the shutdown failed in the Senate, and no immediate path to resolve this impasse and reopen the government has emerged. Of note, a spending package released by House Democrats last week – based on compromise bills drafted last year by House and Senate negotiators – which is expected to shape final funding outcomes, increased global health programs by US$147 million over fiscal year 2018 enacted levels, including boosts to HIV and AIDS, nutrition, tuberculosis, maternal, newborn and child health, and neglected tropical diseases, as well as positive language about USAID’s role in product development.GHTC continues to track reports of how the shutdown may be affecting global health research and development (R&D) activities. Please email Emily Conron (econron@ghtcoalition.org) to share details of any impacts your organization or partners are experiencing as a result of agency closures.

Senator Hillary Clinton famously wrote that “it takes a village.” Meanwhile, President Donald Trump has increasingly called for other nations to pay “their fair share” in global affairs. While these statements may be rooted in differing worldviews, at their heart they share a common truth: It does take the contributions of many to tackle the world’s greatest challenges—including ending diseases that affect the world’s poorest people like HIV and AIDS, tuberculosis, and malaria.The US government has long played an indispensable role in driving global health progress as the world’s leading funder of research and development (R&D) for new vaccines, treatments, and other tools to fight neglected diseases. It is a blue ribbon honor America should wear proudly. It is a show of both our scientific might and our compassionate hearts; it is making a difference—US support has helped advance 42 new lifesaving global health products approved since 2000, including child-friendly malaria medicines and a vaccine to eliminate meningitis A—and it’s greatly needed. Because neglected diseases strike the world’s poorest places, there is little commercial incentive to develop urgently-needed vaccines or medicines, making government R&D investment vital to drive progress.Yet, new research shows that other countries are increasingly stepping up to the plate to fund neglected disease R&D, narrowing the United States’ significant global lead, and that is news that should be welcomed by all Americans, no matter on which side of the political aisle you sit.According to the latest G-FINDER survey by Policy Cures Research, which tracks annual global investment in R&D for neglected diseases, global funding in 2017 reached the highest level ever recorded by the survey—US$3.56 billion, up 7 percent from the previous year and the highest year-over-year percentage increase documented in ten years. Importantly, while the US government did increase its investment by $23 million, countries other than the United States were the primary drivers of this overall global funding growth. Several larger government funders, including the United Kingdom, the European Commission, India, and Germany significantly increased their funding, while smaller donors like South Africa, Brazil, and Japan also increased investment—leading to the most diversified funding pool for neglected disease R&D ever recorded by the G-FINDER.Rarely do Americans like to cede part of our lead in any arena, but in this case, we should feel pride and encouragement that the gap is beginning to narrow between the United States and other funders. The US government’s historical leadership in neglected disease R&D has both built a foundation and set a bar. Now, other nations are striving to follow our lead and meet our example. Millions of people worldwide, including Americans, will benefit.A patients with sleeping sickness in the DRC. Photo: PATH/Georgina Goodwin We are already seeing the incredible gains from past investment in neglected disease R&D. Last year alone we saw the emergence of game-changing new tools like fexinidazole, the first all-oral treatment for sleeping sickness; tafenoquine, the first new treatment for plasmodium vivax malaria in 60 years; and moxidectin, the first new treatment for river blindness in 20 years.However, despite the tremendous progress in global health achieved through innovation, there is still a long way to go. We still don’t have the tools we need to combat many diseases that continue to impoverish communities and threaten health security. New next-generation vector control products, new vaccines and treatments, and improved point-of-care diagnostics are urgently needed.While this year’s global funding increase is cause for celebration and will bring us closer to meeting the world’s R&D health challenges, as a global community we are still falling short of the funding levels needed to deliver health for all and quell emerging epidemic threats. Not a single country in 2017, including the United States, met the World Health Organization recommendation that member states dedicate at least .01 percent of their Gross Domestic Product to research into the health needs of developing countries. Continuing the current positive funding trajectory and ultimately closing the resource gap for neglected disease R&D will take both sustained funding from the US government and increased investment from other nations and stakeholders. The United States can help deliver a safer, healthier world for all. We can’t do it alone, but we can continue to lead the way.

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. According to clinical trial results recently published in the New England Journal of Medicine, tafenoquine—a new single-dose oral antimalarial drug developed by Medicines for Malaria Venture and GlaxoSmithKline—significantly lowered the risk of the recurrence of malaria caused by the Plasmodium vivax (P. vivax) species of the parasite. P. vivax malaria affects approximately 7.5 million people annually and often lies dormant in the liver even after initial treatment, causing debilitating recurring malaria episodes. This single-dose treatment could significantly boost cure rates, as adherence to the standard two-week drug course is difficult in low-resource regions in Southeast Asia, Latin America, and parts of North Africa where this form of malaria is endemic. Based on the results of this clinical trial, the US Food and Drug Administration has already approved tafenoquine for use in July 2018, followed by the Australian Therapeutic Goods Administration in September 2018. A new, long-acting contraceptive designed to be self-administered by women using microneedle skin patch technology could provide a valuable new family planning option, particularly for women in low-resource settings where access to healthcare can be limited. When the patch is applied to the skin, microscopic needles break off and remain under the surface of the skin where biodegradable polymers slowly release the contraceptive drug, levonorgestrel. In animal testing, an experimental microneedle patch provided a therapeutic level of contraceptive hormone for more than a month with a single application. Experimental patches designed for humans have been developed but not yet tested. If the microneedle contraceptive patch does eventually reach the market, it could become the first self-administered, long-acting contraceptive that does not require a conventional needle injection.A new rapid DNA and RNA sequencing device could offer potential to instantly diagnose viruses such as Ebola or Zika at the point of care during an outbreak. Researchers at the French agricultural research institute CIRAD have found a way to use a device known as the Oxford Nanopore MinION device, which can sequence DNA and RNA in real time, to identify plant viruses—and potentially animal and human viruses too. The CIRAD team was able to test and validate the use of this portable device to identify plant viruses quickly and early in the infection process—avoiding the time-consuming and potentially dangerous task of transferring contaminated samples to a lab. The device’s ability to rapidly and accurately detect a virus in plants is a step forward in providing real-time detection of viruses with a mobile device, which would be especially useful in low-resource settings and remote areas. This device has the potential to help public health officials manage outbreaks by reducing the time between taking a sample and diagnosing it as carrying a particular virus—enabling the detection of potential outbreaks at an earlier stage than was previously possible.