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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. Rotasiil, a first-of-its-kind thermostable vaccine to prevent rotavirus—the most common cause of severe diarrheal disease in children worldwide—has achieved prequalification from the World Health Organization. This status will allow United Nations agencies and other organizations to procure the vaccine at low-cost for use in low- and middle- income countries. Developed by the Serum Institute of India with clinical trial and licensure support from PATH, Rotasiil is an oral vaccine administered to infants in a three-dose course, which does not require refrigeration—making it easily distributable in places where power shortages and failures can disrupt the cold chain necessary to keep traditional vaccines viable. Rotasiil is the fourth rotavirus vaccine on the market, and the second developed by an Indian organization. Japanese company Kansai Plascon has launched the world’s first mosquito repellent paint in Zambia. The paint technology, which has shown to be safe in humans, disrupts the nervous system of a mosquito upon contact, reducing its ability to remain on walls where the paint has been applied. “The knock-down effect lasts for up to two years, offering lasting protection from malaria infection and other mosquito-borne diseases,” Kansai said. Mosquito repellent paint offers a new tool in the arsenal to fight malaria—one of the world’s deadliest diseases—alongside other anti-malarial measures such as bednets, prophylactics, and insecticide spraying. The Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Defense Advanced Research Projects Agency (DARPA) has launched a new partnership to strengthen the health security of the United States by focusing on the research, development, and deployment of medical countermeasures and advanced technologies to combat these threats. ASPR and DARPA will focus on two initial areas of collaboration—bacterial pathogens to combat microbial threats and the discovery of molecular biomarkers. ASPR’s Biomedical Advanced Research and Development Authority (BARDA) and DARPA will conduct preclinical and clinical trials of a new type of therapeutic for antibiotic resistant bacteria with an aim to develop a product that mitigates the effects of multidrug-resistant infections. BARDA and DARPA will also focus on discovering and validating biomarkers—which define a person’s exposure to a virus before the person shows symptoms of infection—and developing tests that can identify infected patients quickly to help contain disease outbreaks. Through the partnership, ASPR and DARPA will increase collaboration and share data—maximizing the impact and investment of both agencies.

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 the first-ever United Nations (UN) High-Level Meeting (HLM) on Tuberculosis (TB), member states committed to finding and treating 40 million people suffering from TB and to preventing infection in 30 million people by 2022. The political outcome declaration resulting from the HLM includes a commitment to mobilize US $13 billion for universal access to quality treatments and prevention and $2 billion for research and development (R&D) of new drugs, diagnostics, vaccines, and other tools. In addition, it highlights the need to address drug-resistant forms of TB and commits to complying with global stewardship programs in line with the UN resolution on antimicrobial resistance. An experimental vaccine, developed by GlaxoSmithKline and Aeras, reduced by half the incidence of active TB among individuals with latent TB infection in clinical trials—making it potentially the first new shot to fight the disease in over a century. Results from the Phase IIb trial of the vaccine, known as M72/AS01, show a 54 percent efficacy rate in stopping latent TB from becoming active and causing sickness. This experimental vaccine has the potential to help the estimated 1.7 billion people who have latent TB infection and are at risk of developing the disease that killed 1.6 billion people last year. The experimental vaccine will go through larger trials in the future to test its dosing schedule and to potentially target different groups that are most likely to benefit from the vaccine. A team of scientists at the Imperial College of London has developed a method of manipulating mosquito genetics to drive populations of mosquitoes toward extinction. The manipulation involves a gene drive that alters a stretch of DNA that does not vary from one mosquito to another. The altered gene disrupts a mosquito’s sexual development, making female mosquitoes infertile while forcing males to pass on the debilitating gene to all of their offspring—resulting in the population crashing over multiple generations. Results from the study in Anophele gambiae mosquitoes showed that laboratory populations of mosquitoes can become extinct within 11 generations and, according to computer models, wild populations of mosquitoes could crash in approximately 4 years. This manipulation of mosquitoes may provide a potential method of ridding the world of malaria—a disease that infected 194 million people in Africa and killed 445,000 in 2016.

A “who’s who” of politicians, philanthropists, CEOs, and civil society leaders descended upon New York City this week for the annual United Nations General Assembly (UNGA)—a gathering renowned for its policymaking, pledging, and perennial traffic problems. GHTC was on the scene all week—attending side events, tuning into the official debates, and navigating police barriers—to be your eyes and ears on the ground. Here is what we heard and our top four takeaways on global health research and development (R&D): 1. We can’t end TB without new tools, so it’s vital for world leaders to marshal the political will and resources to close the TB R&D funding gap. Tuberculosis (TB) was a top topic at this year’s assembly with the convening of the first high-level meeting (HLM) on TB. Repeatedly, we heard—from advocates and policymakers, at side events and in in the official proceedings—how poor treatment options are a cornerstone of our failure to eradicate TB and of growing drug resistance, and that new vaccines and improved treatments and diagnostics will be key to turning the tide. While much attention focused on this lack of necessary tools, equal attention focused on the lack of political will and resources to end the epidemic. Many speakers lamented how shamefully slow progress has been since the World Health Organization (WHO) declared TB a global emergency 25 years ago and highlighted the urgent need to close the funding gap for TB, including the US $1.3 billion gap for TB R&D.   As the curtain closed on the HLM, world leaders, as expected, endorsed a carefully negotiated political declaration. GHTC was pleased to see it include a commitment to increasing investment in TB R&D by $2 billion and strong recognition of the importance of cross-border, cross-sector collaboration in driving product development. However, we also share concerns raised by other advocates on accountability. For this meeting to catalyze true change, rhetoric must now translate to action, and commitments must be matched with mechanisms that track investments and hold nations accountable. 2. There are many roads on the path to universal health coverage, but innovation can be an accelerator. Universal health coverage (UHC) was another topic that took the spotlight at UNGA 73, championed by the issue’s top “cheerleader in chief” WHO Director-General Dr. Tedros Adhanon Ghebreyus, who has made achieving UHC a centerpiece of his directorship. Given the focus of the world’s doctor on UHC, many advocates at UNGA framed their specific issues through the lens of UHC, highlighting the myriad of steps needed to achieve this ambitious goal‒from building a stronger health workforce, to expanding access to medicines, to tackling leading killers like malaria, HIV and AIDS, and TB. Yet, a common theme heard across these conversations is that along each of these roads, innovation can be an accelerator.   Throughout the week, speakers highlighted how innovations and new technologies can help deliver care more efficiently and effectively, improve access and drive down costs, and accelerate countries along the path to achieving UHC. TB advocates highlighted how shorter treatment regimens can improve care, decrease costs, and free up resources, while digital health advocates argued that better use of data can empower health workers to track and treat patients and allocate precious health resources most effectively. Others highlighted how innovative new tools like point-of-care diagnostics can bring improved care to the community level and to people in the most remote corners of the globe. 3. We need additional resources for R&D, and that requires countries to step up in an equitable way. Domestic resource mobilization and equitable financing were words repeated throughout the week, particularly in conversations around the TB HLM and closing the TB R&D funding gap. Advocates, think tanks, and even government officials, argued that high-burden TB countries need to increase domestic investment in TB R&D and treatment. Some advocates have called for a “fair share” or equitable financing approach to TB R&D financing, with each country committing to spend .1 percent of their GDP on R&D. Others spoke to the potential of the BRICS nations—Brazil, Russia, India, China, and South Africa—to play a greater role in financing R&D.   While much of the TB financing dialogue focused on increasing public sector contributions, conversations also highlighted the impact and further potential of financing models like the airline-tax-funded work of UNITAID or public-private partnership approaches—like product development partnerships and the work of the Global Health Innovative Technology Fund—which have married multisector contributions to bring novel, affordable, accessible tools to market. Other speakers highlighted the opportunity for industry to increase its TB R&D investment, though many lamented that although industry has brought new TB drugs and diagnostics to market in recent years, uptake has been slow due to high product costs. 4. There is reason for optimism and reason for concern. The mood seemed mercurial in midtown Manhattan, as UNGA orators vacillated between optimism and concern about the future of global health and development. In the drumbeat to UNGA, the always-impatient optimists Bill and Melinda Gates unveiled their foundation’s Goalkeepers report. The report’s stylish line graphs, which show a downward trajectory on health issues like child mortality, are uplifting and inspiring—a great reminder of the staggering progress we’ve achieved in global health and what’s possible for the future.   The basis of our optimism about the world has always been our belief in the power of innovation to redefine what’s possible – Bill and Melinda Gates   Yet, three years in, it has also become clear the world is not on track to meet the Global Goals. And even the optimistic Gates are reminding us that though we hold the blueprint for a healthier world, continued progress is not inevitable. The choices our policymakers implement today will determine whether progress continues or stalls. Throughout the week, many speakers gave voice to fears, highlighting concerns that foreign aid spending is under increased attack in leading donors countries like the United States—a notion echoed in President Trump’s speech to the Assembly—and that political changes like Brexit and an “America First” doctrine signal a movement toward isolationism over collective action. Given significant global health R&D funding comes through foreign aid budgets and the necessity of collaborative global action to deliver the cures of tomorrow, these developments are worrisome. Will these trends threaten progress, or will momentum continue? That’s a question we’ll surely continue to reflect on for many UNGAs to come.

This afternoon, President Trump signed into law a spending bill that pairs full-year fiscal year (FY) 2019 funding for Labor, Health and Human Services (LHHS) and Defense with a stopgap measure to keep other agencies funded through December—staving off a partial government shutdown on the eve of the end of the fiscal year. The “minibus”-plus-continuing resolution (CR) legislation boosts funding for medical research across the Department of Health and Human Services (HHS) for FY19, while maintaining funding for global health at the US Agency for International Development and the Department of State through December 7 via the CR measure. Given Trump already signed into law a spending package covering Energy, Veterans Affairs, and the Legislative Branch, now 75 percent of the government is funded for the full fiscal year; while the remaining agencies will remain funded through the CR as lawmakers work to finish full-year funding bills for them. While this year’s appropriations approach may be unusual, by recent historical standards, it was also remarkably efficient: Today marks the first time in 22 years that the government has succeeded in getting at least five of the twelve annual spending bills signed into law before the new fiscal year begins. Here’s a breakdown of how global health and medical research funding fared in the spending package: National Institutes of Health The National Institutes of Health received an impressive US $2 billion boost overall (a 5 percent increase over FY18), including increases of 3-9 percent to each center involved in global health research and development (R&D). In increasing order, the package provided a boost of 3.4 percent for the Fogarty International Center, 3.75 percent for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, 5 percent for the National Institute of Allergy and Infectious Diseases, and 8.62 percent for the National Center for Advancing Translational Sciences. Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) also saw an overall increase from FY18 – depending on how you do the math. In the FY18 omnibus appropriations bill passed in March, CDC received a one-time $480 million funding infusion to support the construction of a replacement Prevention Biosafety Level 4 high containment laboratory to enable continued research on dangerous pathogens like Ebola. Less the cost of that lab, CDC’s overall year-on-year budget rose 1.63 percent. The Center for Global Health was level-funded, while the National Center for Emerging and Zoonotic Infectious Diseases received a 1 percent bump. The bill also established a new CDC-wide Infectious Disease Rapid Response Reserve Fund with an initial infusion of $50 million, a key win for global health security advocates. Biomedical Advanced Research and Development Authority The Biomedical Advanced Research and Development Authority (BARDA) saw a $25 million budget increase in the bill (a 4.66 percent boost). This—coupled with the House passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018—earlier this week, which reauthorized BARDA and authorized $250 million annually for five years for a new emerging infectious diseases program—is welcome news for those looking to BARDA to play an increasingly robust role in global health R&D. However, given the Senate still needs to pass their own version of a bill and continues to pursue a general all-hazards approach in their bill, a call out for emerging infectious diseases may not come to fruition in the final reauthorization. US Agency for International Development & State Department Global health accounts at the US Agency for International Development and the Department of State will be level funded through December 7 since the funding package signed into law today includes a CR for the State and Foreign Operations appropriations bill.   The bottom line: Yet again, strong congressional support has protected global health R&D from deep cuts to key agencies proposed in the President’s budget request and even won significant increases to some accounts. As we get closer to the midterm elections, we will keep a close eye on political developments that could affect our funding prospects for FY20.