Breakthroughs Blog: Antimicrobial resistance

Universal health coverage (UHC)—the idea that everyone, everywhere, should be able to access quality health services—will take center stage at the World Health Assembly (WHA) later this month. World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus has made UHC a top priority, as his institution estimates that at least half of the world’s population still does not have full coverage of essential health services.While there are many building blocks to achieve UHC—from galvanizing political will and investment to strengthening health systems and training health personnel—one integral pillar that is too often overlooked is innovation—the creation of new and improved drugs, vaccines, and diagnostic tools. Global health research and development (R&D) is indispensable in delivering on the vision of quality health for all. R&D a vital component to achieve UHCHealth systems cannot meet the fundamental needs of their populations without high-quality and accessible drugs, vaccines, and diagnostics with which to treat, prevent, and detect disease. Today, we still lack many of the tools needed to combat diseases and conditions that exact a tremendous health burden in the world’s poorest places. No preventative vaccines exist for many neglected diseases, including Chagas, leishmaniasis, and chikungunya, and treatments available are often inadequate or toxic. Tuberculosis (TB) sufferers today face six to twenty months of treatment, involving thousands of pills and painful injections. We still don’t have the right tests to diagnose many infectious diseases at point of care, leaving patients wondering and waiting for care. The goal of ending AIDS will remain out of reach without a vaccine or cure. Meanwhile, growing antimicrobial resistance (AMR) against malaria, TB, and other infectious diseases threatens to roll back progress and is adding even greater urgency to the need to develop new innovations to prevent emerging resistance. Neglected diseases affect hundreds of millions of people worldwide and jeopardize achieving UHC for the most vulnerable among us.As the global community invests in policies and programs that support UHC, it must also prioritize R&D for new health technologies, especially where markets don’t catalyze these investments on their own. It will be impossible to truly deliver quality care for all without new innovations. Delivering the next generation of lifesaving health technologies will require strong political commitment and increased investment from all nations. To make that happen, it’s critical that the world explicitly acknowledge the importance of global health R&D to attaining UHC.WHO’s role WHO has a crucial role to play in strengthening R&D and access to achieve UHC. Through its global convening power, WHO sets the agenda and is often the institution policymakers rely upon to frame their countries’ health priorities and lead the implementation of important programs vital to improving access to quality treatment and services. For example, WHO’s essential medicines and diagnostic lists are highly vetted, evidence-based recommendations that provide member states with a robust framework to determine key investment, health service, and policy priorities. WHO also provides technical expertise and capacity-building programs to build regulatory frameworks that accelerate access to medicines and create stronger enabling environments for global health R&D. This includes supporting the development of laboratory systems and infrastructure, as well as clinical trial capacity. For everything ranging from establishing safety standards, to producing treatment guidelines for infectious diseases, to designating good clinical research practices, WHO sets the normative technical standards and provides clear targets for low- and middle-income countries for health system strengthening. WHO must continue to use its global convening power to facilitate coordination and alignment of priorities in order to advance the UHC agenda. This is why the 72nd WHA meeting presents the global health community with an opportunity to ensure that WHO continues to play a significant role in supporting R&D by stepping up its efforts to catalyze additional investment, build capacity, and provide resources to stakeholders to facilitate the development and effective deployment of tools to patients globally. While governments can, and should, play a leading role in the global UHC movement, WHO will also play an important part in making the vision of quality health for all a reality. As the world gets ready to descend on Geneva for WHA week, global health advocates should remember that there is no UHC without R&D.

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. Tuberculosis (TB) could be eliminated by 2045 if investments against the disease are increased to US$10 billion a year, according to a panel of experts from the Lancet Commission on TB. The commission has laid out a roadmap for ending TB by investing in a range of actions including research and development (R&D), targeted prevention, and improved diagnostics. It calls for TB R&D investments to be increased from the current amount of $772 million a year to at least $2 billion a year over the next four years and estimates that for every dollar spent on TB R&D there will be an estimated $16-82 return on investment. The commission launched its report six months after the United Nations High-Level Meeting on TB to provide guidance on translating member state commitments into action and investments to eliminate the disease. The Global AMR [antimicrobial resistance] Research and Development Hub, announced during Germany’s G20 presidency in 2017 and launched at last year’s World Health Assembly, is now taking shape in Berlin. Fully financed by the German government for an initial three years as part of a $556 million 10-year pledge to address AMR, the hub was conceived as a way to help align national and international initiatives on AMR and use data to inform the research agenda. The secretariat’s initial focus is creating a dashboard to map existing R&D activities worldwide to produce information and point to gaps to guide policymakers in making investment decisions. Given the influence this mapping could have on research priorities, external advocates are pushing to ensure the hub’s activities reflect the needs of low- and middle-income countries who are not often at the forefront of setting the global AMR agenda. The US Biomedical Advanced Research and Development Authority (BARDA) has awarded a two-year, $10 million contract to a US biotech firm to support the development of a vaccine against Marburg, a hemorrhagic virus that has caused a number of deadly outbreaks in Africa and is considered a potential bioterror threat by the US government. The contract with Public Health Vaccines will support advancement of a promising vaccine candidate now in pre-clinical development. If the research shows the vaccine to be feasible, BARDA has the option to provide up to $72 million in additional funding to support the vaccine candidate through a phase 2 clinical trial and begin development of an additional vaccine candidate against the Sudan Ebola virus, a closely-related virus.

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. The first all-oral drug for sleeping sickness received a positive scientific opinion Friday from the European Medicines Agency, paving the way for the treatment to be rolled out in endemic countries in 2019. Developed by the Drugs for Neglected Diseases initiative (DNDi) and Sanofi, fexinidazole is a tablet taken once daily for ten days that treats the most common form of sleeping sickness, a neglected tropical disease spread by tsetse flies that causes neuropsychiatric symptoms and can be deadly if left untreated. Current treatments for sleeping sickness require a complicated series of infusions and pills, are costly, and involve long hospital stays, which pose a huge burden on health systems to treat the disease. Fexinidazole is a simple once-a-day pill that could reduce this logistical burden. About 65 million people in sub-Saharan Africa are at risk of sleeping sickness. A novel device colloquially known as a “wiggle- ometer” may one day help physicians and health workers fight the growth of antimicrobial resistance (AMR). The device, which is a sub-cellular fluctuation imaging machine, detects minute movements in bacteria to determine whether they’ve been affected by an antibiotic, signaling to doctors whether a specific antibiotic works against a specific infection. Today, many physicians prescribe a broad-spectrum antibiotic to patients because of the lack of access to rapid diagnostic tests to determine the nature of an infection and what antibiotics will be effective against it. This overuse and misuse of antibiotics drives the growth of AMR. The “wiggle-ometer” is one of more than 70 projects from around the world competing for the £8 million Longitude Prize, launched by the United Kingdom government to fight AMR. The prize will be awarded to a team that develops an affordable, accurate, easy-to-use test for bacterial infections. Merck has begun the process of submitting the evidence required for regulatory approval of its experimental Ebola vaccine with the US Food and Drug Administration (FDA). The FDA gave the vaccine a “breakthrough therapy designation” in 2016—a form of regulatory fast track which allows a manufacturer to meet more frequently with the FDA to discuss filing and to submit material on a rolling basis, all with the aim of speeding the item through licensure. Merck’s experimental Ebola vaccine is currently being used in the Ebola outbreak in the Democratic Republic of Congo under compassionate use protocol, after having shown to be protective in a clinical trial in Guinea at the end of the West African Ebola outbreak of 2014-2016. Though there are a few experimental Ebola vaccines in development, Merck’s is furthest along in development. Merck initially planned to file with the FDA in 2017 but missed that goal due to “unexpected engineering and construction delays” at the manufacturing plant built to produce the vaccine. Merck now says it hopes to complete the filing process sometime next year.

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. Major funders are betting that a new online platform for genetic sequencing will help health workers worldwide more easily identify mysterious infections and track disease outbreaks. The platform, IDseq, seeks to make metagenomics sequencing—the analysis of genetic material and the matching of those readouts to databases of known microbes—, which can be expensive and technically demanding, more accessible and affordable, particularly in low-resource settings. Free and based in the cloud, IDseq allows researchers to upload patient data, which is then “crunched” against existing databases, to determine what infection a patient has. The Chan Zuckerberg Initiative is supporting the platform’s development, and the Bill & Melinda Gates Foundation announced last week a new training program to support clinicians around the world in using the platform. In an early stage trial, a combination of two broadly neutralizing antibodies (bNAbs)—proteins that can bind to different strains of HIV and prevent the virus from entering human cells—suppressed blood levels of HIV for months after treatment in some people. Participants received up to three infusions of bNAbs over a six-week period with their viral load monitored every one to two weeks. Though further testing and refinement is required, long-acting bNAbs combinations may eventually become an alternative to daily anti-HIV drugs. Researchers hope to test whether engineering the antibodies to last longer in the blood can improve viral suppression and explore new combinations with additional antibodies or other drugs. The Global Antibiotic Research & Development Partnership (GARDP) and Novartis are joining forces to reduce child deaths from antimicrobial resistance (AMR) by accelerating the development of generic antibiotic treatments for children. The strategic partnership will focus on: 1) enhancing the availability of generic antibiotics and increasing access for children in low- and middle-income countries, 2) developing heat-stable pediatric formulations, and 3) leveraging the knowledge and shared expertise of both partners. The partnership between GARDP and Novartis is a response to the World Health Organization’s call for affordable, improved, and adapted antibiotics for this vulnerable population, for which treatment options are limited.