Breakthroughs Blog: United Nations

  2018 is shaping up to be another important year for US policy related to global health and medical research. As Congress returns for a busy work session and the White House continues to roll out policy reforms, here are the top five issues GHTC will be following in 2018: 1. US funding for global health R&D President Trump’s fiscal year 2018 (FY18) budget proposal called for dramatic cuts to global health, medical research, and public health accounts across the National Institutes of Health, US Centers for Disease Control and Prevention, US Agency for International Development (USAID), and the Department of State. While legislators pushed back sharply on these proposed cuts, Congress has not yet passed final FY18 spending bills. This means that we still do not have a final picture of what US government funding for global health and medical research will look like for this year. As Congress tries to navigate budget caps and other pressures that may constrain overall government spending, GHTC will continue to advocate for strong, stable public funding for critical global health and medical research programs. We’re also looking ahead to the fiscal year 2019 (FY19) budget and appropriations process, and bracing for a proposal from President Trump that may include even more significant spending cuts than those proposed in FY18. Despite verbal acknowledgement from the Trump Administration that US global health and medical research programs remain critically important, as the Administration continues plans to streamline government activities and reign-in spending, we do not expect to see prioritization of these issues reflected in Administration-driven spending proposals. GHTC will closely monitor FY19 proposals in the coming months and continue to engage with Congress, who ultimately sets government spending levels. 2. USAID and State Department reorganization As part of the Trump Administration’s plans to streamline and reshape the federal government, it has announced plans to reorganize the State Department and USAID. USAID plays an important role in global health research and development (R&D), supporting late-stage clinical research and implementation research as well as operating Grand Challenges to identify and advance promising health innovations from around the world. USAID and the State Department submitted reorganization plans to the White House Office of Management and Budget on September 15, 2017, but details of those plans have not yet been made public and further information remains scarce. GHTC will continue to monitor evolving plans and policy and strongly advocate for continued leadership of USAID in global health innovation. 3. BARDA reauthorization The Pandemic and All-Hazards Preparedness Act (PAHPA), which authorizes the Biomedical Advanced Research and Development Authority (BARDA), is due for reauthorization this year by Congress. In recent years, BARDA has played an increasingly important role in the advanced development of medical countermeasures for emerging infectious diseases, like Ebola and Zika, and antimicrobial resistance. Reauthorization presents a potential opportunity to bolster BARDA’s role in the global health R&D space. GHTC will monitor the PAHPA reauthorization process and work with Congress to support a strengthened role for BARDA in the emerging infectious disease space. 4. Global health security GHTC is also watching US efforts to promote global health security, including continued support for the Global Health Security Agenda (GHSA)—an international partnership launched in 2014 to help countries strengthen their ability to respond to health threats. The United States is now funding GHSA through the one-time emergency Ebola supplemental funding, which expires in FY19, so future financing for the program remains uncertain. Without renewed commitment and financial support for global health security activities, the United States will have to pull back critical disease detection, prevention, and response operations around the world. GHTC will also work to include R&D in global health security policy decision-making. During the two most recent global disease epidemics, Ebola and Zika, a lack of proactive, sustainable funding for R&D meant that United States and the world did not have the drugs, diagnostics, and other tools needed to contain these diseases. Despite this, GHSA in its current form lacks any prioritization or commitment to R&D to detect, prevent, and respond to global epidemics. As domestic and global discussions on global health security continue, GHTC will advocate for R&D as a critical component of epidemic preparedness and response. 5. US engagement with key multilateral bodies Multilateral organizations and partnerships are vital mechanisms to help advance a healthier and more secure world. In our modern and increasingly globalized world, new, emerging, or long-standing health challenges, which do not respect borders, cannot be tackled by individual countries alone. Strong US leadership and funding for organizations like the United Nations (UN), the World Health Organization, and the Global Fund to Fight AIDS, Tuberculosis and Malaria are key to advancing global health and ensuring that these organizations function effectively in support of US priorities. Despite several senior Trump Administration officials expressing support for strong multilateral engagement, the United States’ role in pushing for a recent $285 million cut to the UN’s overall budget appears more indicative of how the United States can be expected to engage in the near future. While it is currently unclear exactly how these cuts will be implemented across the various UN health-related programs, GHTC anticipates significant impact on the various UN technical agencies’ ability to support global health, including R&D. GHTC is committed to leading strong, coordinated action to advance US leadership in global health R&D in 2018 and beyond. The United States has long been a leader in global health, development, and medical research, and we look forward to sustaining and bolstering this legacy in the years ahead.  

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The release of antibiotics into the environment is a significant environmental threat, according to a new United Nations Environment Programme report. The presence of antibiotics have been found in soil deposits, lake and river sediment, and wastewater facilities around the world, suggesting industrial, human, and pharmaceutical disposal leads to traceable amounts of antibiotic compounds in the environment. This issue alarms experts because even minimal traces of antibiotics may lead to the continued evolution of antimicrobial resistant bacteria. While more research is needed on the consequences of antibiotics in the environment, experts suggest various strategies to help mitigate the problem including deploying improved methods to treat wastewater, treating animal waste before using it as fertilizer, and improving antimicrobial stewardship. An Army-developed Zika vaccine candidate (ZPIV) performed well across three Phase 1 clinical trials, according to new findings published in The Lancet. The three studies were designed to elicit information on background immunity, vaccine dosage, and vaccine schedule in adult populations. A total of 67 participants received two injections four weeks apart, and researchers found more than 90 percent of participants who received the ZPIV vaccine had an immune response to the virus. The Army developed the vaccine candidate in response to the 2015 outbreak, noting the need for a Zika vaccine not only to advance global health, but also to protect US service members and their families. Countries are restricting use of the world’s only dengue vaccine—Dengvaxia— following an announcement by developer Sanofi Pasteur raising safety concerns. The company discovered, from data analysis, that the vaccine could raise the risk of a deadly form of dengue for people who had not been exposed to the virus prior to vaccination. In response, the Philippines ceased an ongoing, mass immunization campaign, and Brazil tightened restrictions on the vaccine. While Sanofi stressed there were no reported deaths related to the dengue vaccine, they believe more severe cases of dengue may occur if an immunized individual, who was not previously infected before receiving the vaccine, is then subsequently infected with dengue. This rare complication leaves children at a higher risk of contracting the severe form of dengue, as they are less likely to have been exposed to infection before receiving the vaccine. Dengue sickens hundreds of millions of people and kills more than 20,000 every year, underscoring the need for a safe, effective, vaccine.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The US Centers for Disease Control and Prevention (CDC) reported that they expect rates of multidrug resistant tuberculosis (MDR-TB) in Russia, India, South Africa, and the Philippines to rise significantly in the next 25 years. These four countries carry the heaviest burdens of resistant (both drug-resistant and MDR) TB, accounting for 230,000 cases in 2015—nearly 40 percent of cases worldwide. It is predicted that one third of all TB cases in Russia will be drug resistant by the 25-year mark. The CDC suggests that efforts should be taken to prevent the airborne transmission of TB. In addition, CDC notes the need to expand diagnostic capabilities in low- and middle-income countries and access to rapid diagnostics and effective treatments. Zoonotic diseases, or diseases passed from animal to humans, such as Ebola, HIV and AIDS, swine flu, Spanish Influenza, malaria, and the bubonic plague, have been around for hundreds of years. With increased disease surveillance efforts globally, PREDICT, a global surveillance network financed by the US Agency for International Development and other partners, has recognized something important: healthy ecosystems and wildlife leads to less disease, which lowers disease burdens and makes humans safer. In tracking outbreaks like Ebola and swine flu, PREDICT has taken samples from over 55,000 wild animals and have tracked down 815 novel viruses. When ecosystems are damaged and the animals living in those systems are displaced, disease rates are higher. This research suggests that climate conservation can also help prevent pandemics. The United Nations Environment Agency and partners launched a new surveillance platform called the Global Mosquito Alert designed to survey mosquito patterns. Leveraging a global network of scientists and volunteers, the platform will track mosquito populations and disease patterns around the world. The global alert will provide real-time open access data via cloud computing networks, allowing the general population to engage and contribute to documenting and observing the patterns of mosquitoes.  

2016 was a year that ushered in significant shifts in the global health landscape. We witnessed the waning of the Ebola epidemic and the waxing of the Zika outbreak; important leadership changes among the biggest institutional players in global health; and the development and introduction of new innovations that could turn the tide against leading infectious disease killers. As the year comes to an end, GHTC is reflecting on the top stories in global health innovation that made news in 2016. Here are seven of those top moments: 1. Scientists mobilize against Zika A vial of the National Institute of Allergy and Infectious Diseases (NIAID) Zika Virus Investigational DNA Vaccine (Photo: NIAID).Once considered an obscure virus responsible for a mild illness, Zika took the world by storm in 2016. As the virus gained a foothold in more than 60 countries, its association with devastating birth defects and neurological conditions was firmly established. Prior to Zika’s emergence in the Americas, only 25 research papers had been published on the virus. As the epidemic grew, scientists around the world joined the fight against Zika, often sharing their data and research in real time to speed progress. Thanks to the efforts of these researchers, over the past year our scientific understanding of Zika has grown exponentially, and we have advanced a robust pipeline of new tools to prevent, detect, and treat Zika. Today, there are more than 35 Zika vaccine candidates under development; 13 Zika diagnostics have been authorized for use by the US Food and Drug Administration; and researchers are screening novel compounds and evaluating existing drugs to advance treatments for the disease. 2. The world commits to the fight against antimicrobial resistance United Nations General Assembly (Photo: GHTC/Matthew Robinson). 2016 marked the year the world finally got serious about tackling antimicrobial resistance. On the heels of several major analyses examining the potentially devastating health and economic impact of antimicrobial resistance, the United Nations (UN) General Assembly convened global leaders for a high-level summit on antimicrobial resistance—the fourth time such a meeting has been held on a health-related topic during the UN’s 71-year history. At the close of the summit, UN member states unanimously endorsed and adopted a political declaration committing to developing action plans and policies; mobilizing resources; and supporting public awareness, surveillance, and R&D efforts to combat antimicrobial resistance. It is our hope that 2017 will mark the year political commitment translates to concrete action to advance the development of new antibiotics. 3. New strategies deployed to stymie mosquito-borne diseases Mosquito-borne diseases remain an age-old scourge, but 2016 saw the advancement of several novel strategies to combat these tiny foes. Efforts to combat mosquito-borne diseases with the transmission blocking–bacteria Wolbachia took an important leap forward this year. Past studies have shown that when the Wolbachia bacteria is introduced to Aedes aegypti mosquitos—which carry viruses like Zika and yellow fever—it prevents the viruses from replicating and blocks further transmission. Because the bacteria can be passed from one generation of mosquitoes to the next, the bacteria offers hope for eliminating a virus’s presence within a local mosquito population. After several years of conducting small-scale tests of this method, the Eliminate Dengue Program announced in 2016 it would begin conducting two large-scale trials in South America to determine whether this approach is effective in halting the spread of mosquito-borne diseases in large urban settings. This year the biotech company Oxitec also advanced efforts to test the use of genetically modified mosquitoes to reduce mosquito populations and disease transmission. The company has engineered mosquitoes that mate with A. aegypti mosquitoes, producing offspring that are unable to mature to adulthood. Early last year, Oxitec introduced the mosquitoes into the Brazilian city of Piracicaba, resulting in an 82 percent decrease in the population of A. aegypti mosquitoes in just nine months. Now, Oxitec has expanded the trial to a larger geographical area and is also initiating trials in the Florida Keys and the Cayman Islands. 4. World’s first kid-friendly TB medicine launches Children who receive tuberculosis (TB) medicines require a different dose than adults, yet until this year, there were no TB medicines designed specifically for children, so parents were forced to split or crush adult pills in an attempt to administer the right dose to their child. This year, that all changed with the launch of the world’s first kid-friendly TB medication. Developed by TB Alliance, the medicine is designed with the unique needs of children in mind: It is fruit-flavored, dissolvable in water, easy to administer, and appropriately-dosed. Already, more than 30 countries have adopted the new medicines, and enough orders have been placed to treat half of childhood TB cases worldwide. 5. Unique HIV prevention option for women reaches important development milestone Image captionMonthly vaginal dapivirine ring helps protect women against HIV (Photo: International Partnership for Microbicides). Women may soon have a powerful new tool at their disposal to prevent HIV infection. Earlier this year, the International Partnership for Microbicides (IPM) announced the results of two large phase 3 clinical trials demonstrating that a monthly vaginal ring containing the antiretroviral drug dapivirine can help protect women from HIV. While initial results indicated that the dapivirine ring reduced HIV risk by approximately 30 percent, further analysis revealed that the ring reduced infection rates by 75 percent in women who used the ring consistently. Now, IPM is seeking regulatory approval for the dapivirine ring and is conducting open-label studies, enabling trial participants to continue using the ring as IPM collects additional data. The dapivirine ring is the only long-acting, female-initiated HIV prevention tool to have proven successful in phase 3 clinical trials. Young women in sub-Saharan Africa are more than twice as likely to be infected with HIV than their male counterparts, and thus female-centered prevention tools are needed stem the epidemic. 6. Roll out begins of world’s first malaria vaccine candidate After decades of development and testing, the world’s first malaria vaccine candidate will soon be introduced in several communities in sub-Saharan Africa. The vaccine—RTS,S—was developed by PATH and GlaxoSmithKline and received a positive opinion from the European Medicines Agency last year following completion of phase 3 clinical trials. In November, the World Health Organization (WHO) announced it would pilot and evaluate the vaccine in real-life settings, thanks to funding from The Global Fund; UNITAID; and Gavi, the Vaccine Alliance. Pending results of these pilot tests, WHO will determine whether to deploy the vaccine on a wider scale. 7. New global health technologies advance through the pipeline PATH launches an easy-to-use, rapid diagnostic for onchocerciasis (Photo: PATH/Dunia Faulx) Over the past year, several other promising new health innovations have moved through the development pipeline and one step closer to reaching the hands of patients: Two important health tools—a novel, affordable oral cholera vaccine developed by the International Vaccine Institute, and the Woman’s Condom developed by PATH and partners—received WHO prequalification this year, paving the way for their procurement by UN agencies and other international procurement organizations. Two new rapid diagnostic tests for the neglected tropical diseases onchocerciasis (river blindness) and lymphatic filariasis were launched this year. Developed by PATH, these tests provide results in just 30 minutes and can be stored at a wide range of temperatures. Development has begun for an affordable therapy for hepatitis C. In 2013, the world’s first cures for hepatitis C hit the US market, however, treatment remains out of reach for many patients due to the high price tag. This year, the Drugs for Neglected Diseases initiative announced it would begin testing an alternative therapy in phase 2 and 3 clinical trials, with a guarantee from the manufacturer that, if successful, the entire regimen will be sold for no more than US$294.  As 2016 draws to a close and 2017 begins, it is time for the global health community to redouble our efforts to make sure this vital progress in global health innovation continues to ensure that people around the world will have access to lifesaving and life-improving health technologies.