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Last week, the Review on Antimicrobial Resistance, commissioned by United Kingdom Prime Minister David Cameron, released its final report, Tackling Drug-Resistant Infections Globally: final report and recommendations. The report details ten recommendations and calls for funding and incentive mechanisms to spur research and development (R&D) for new antibiotics, rapid diagnostic tests, and preventative vaccines. The research, development, and use of new and existing vaccines could limit the dependence on antimicrobials, while rapid diagnostic tests preclude unnecessary antibiotic prescriptions. To stimulate antimicrobial R&D, the report calls for the creation of a global innovation fund to support basic research and market-entry rewards to incentivize pharmaceutical companies to bring new antibiotics to market. The report calls for US$2 billion over five years for the fund, and the United Kingdom and Chinese governments have each pledged $72 million for these efforts. While new antibiotics are critical to combatting the spread of antimicrobial resistance, their use must be restricted and market limited to prevent new drug-resistant infections. Consequently, the report calls for market-entry rewards of $0.8 to $1.3 billion to incentivize the development of new antibiotics. While implementing the report’s recommendations would cost $40 billion over the next decade, current trends suggest that drug-resistant infections will cost the global economy $100 trillion between now and 2050. The White House announced last week the establishment of the National Microbiome Initiative to catalyze and fund research on microbiomes, develop new platforms for curating and sharing microbiome data, and to build the microbiome workforce through training and educational opportunities. The Initiative will be launched with an investment of $121 million from five federal agencies as well as funding from more than 100 private organizations including $100 million from the Bill & Melinda Gates Foundation. A microbiome is the makeup of microorganisms (i.e., bacteria) in a given ecosystem. While the human microbiome is the most well-known, the purview of the Initiative goes much farther, and will even support microbiome research in space.  Researchers in Ireland have created a coating that can be applied to surfaces such as smartphones, door knobs, or countertops which kills 99.99 percent of strains of Methicillin-resistant Staphylococcus aureus (MRSA), Escherichia coli (E. Coli), and Trichophyton rubrum. MRSA and E. Coli spread rapidly within hospitals (MRSA can survive on surfaces for up to five months) and T. rubrum—which causes athlete’s foot and other fungal infections—is primarily transmitted via surfaces or objects (i.e., damp floors, towels). The coating is comprised of titanium oxide, fluoride, and copper and is sprayed and baked onto a surface, after which it becomes indiscernible to the eye. The bacteria and fungi are not able to spread on the coating and die within 24 hours. The team, led by Dr. Suresh Pillai of the Institute of Technology, Sligo, believes the coating could be used in hospitals and laboratories but also on smartphones, ATMs, and even food packaging.

This coming week the “who’s who” of the global health community (as well as some much more modest global health advocates such as your humble author) will make the annual trek to Geneva, Switzerland, for the 69th World Health Assembly (WHA), where World Health Organization (WHO) member states will collectively decide WHO’s plans for the coming year. This year’s agenda is packed and includes many topics that could impact global health research and development (R&D). Below are the agenda items GHTC will be tracking in Geneva and topics we’ll dig into in more detail at a May 23 side event and webinar we are cohosting with the Geneva Centre for Security Policy, Global Health R&D: What’s at stake during the 69th WHA? Framework of engagement with non-State actors WHO routinely engages with a variety of non-State actors (NSAs)—any organization other than a member state. These collaborations support core components of WHO’s global health strategy. Some have argued, however, that WHO’s current ad-hoc approach to managing such engagements undermines its independence and impartiality. As I have written previously, the current draft framework runs the very real risk of excluding key WHO partners and actors in the global health R&D community. Given the significant member state pushback against the proposal, it will be fascinating to see how the tension is resolved.   Health in the 2030 Agenda for Sustainable Development With the approval of the Sustainable Development Goals (SDGs) in September 2015, the global development community has been trying to sort out how to implement and measure programming to achieve what are, by all admissions, extremely ambitious targets. WHO is no different, and has been hard at work laying out strategies to achieve the various components of goal 3, the “health SDG.” It is particularly heartening that target 3.b specifically commits member states to supporting health R&D. What shape this will take, and how WHO will engage are definitely hot topics to watch at this WHA.   Global Action Plan on Antimicrobial Resistance Following the 68th WHA’s adoption of the Global Action Plan on Antimicrobial Resistance (AMR), WHO has been working to develop strategic options to achieve the plan’s goals and will be presenting a progress update and an options paper to WHA this year for input. GHTC is closely monitoring plans for the R&D objective, which states: “… develop the economic case for sustainable investment that takes account of the needs of all countries, and increase investment in new medicines, diagnostic tools, vaccines and other interventions.” While the options paper is quite broad, in the R&D space the WHO Secretariat is specifically asking for input on methods to de-link R&D costs from sale price, how best to support access to innovative antimicrobials, and how to develop a prioritization mechanism to support appropriate R&D on AMR specifically. Given the danger that the global rise of AMR represents, the discussion is likely to be extensive and intense.   Follow-up to the report of the Consultative Expert Working Group (CEWG) on Research and Development: Financing and Coordination (Report of the open-ended meeting of Member States) GHTC has been following the CEWG process for some time as it winds its way forward after what has already been a decade-long process. The prototype R&D observatory is now online, and the demonstration projects are returning their progress reports. The WHO Special Program for Research and Training in Tropical Diseases (TDR) has prepared an analysis that outlines how a pooled fund and R&D observatory could work to identify unmet needs and channel funds to those R&D projects. While almost everyone agrees that additional funds and greater coordination are sorely needed, as we heard at GHTC’s webinar on CEWG, the jury is still split on the CEWG’s specific proposals. While it is unlikely that the CEWG process will come to an end at this WHA, the number of concerns that can be ironed out with all the decision-makers in the room will be telling in regards to future prospects.   For more analysis on these subjects, read GHTC’s fact sheet on Research and development at the 69th World Health Assembly.  

Last Wednesday, researchers from the Washington University School of Medicine, the University of São Paulo, and the Chinese Academy of Sciences offered new insights into the impact of the Zika virus on fetal brain development in mice, publishing their findings in Cell, Nature, and Cell Stem Cell, respectively. The first two studies sought to successfully infect pregnant mice with Zika—a feat in itself as mice don’t often fall ill after infection with the virus. Consequently, the team at Washington University used a genetically modified mouse with a weakened immune system as well as a mouse whose immune system was weakened by an antibody, while researchers at the University of São Paulo used a particularly high dose. The team at Washington University detected placental insufficiency in the infected mice—which limits blood flow to the fetus—and the team at University of São Paulo reported intrauterine growth restriction, a condition restricting the growth of the fetus. When the virus reached the fetal brains, both teams witnessed a thinning of brain tissue and cell death. The concentration of the virus in the brain was limited, which inhibited further research on how Zika behaves once in the brain. The team at the Chinese Academy of Sciences, however, injected the virus directly into the brains of fetal mice, and they determined that the virus targets neural progenitor cells and causes the fetal brain to shrink. Silk has been used in developing heat-stable vaccines and drugs, and now, researchers at Tufts University have demonstrated that silk can be used to maintain blood samples in low-resource settings. Blood-based diagnostics are only effective if certain proteins, which indicate either the presence of a pathogen or the immune system’s response to it, are preserved, however, heat and humidity can directly damage the proteins or cause enzymes in the blood to attack the proteins. Labs prefer that blood samples are refrigerated, although they can also be dried on special filter paper that can withstand heat but which often doesn’t hold enough blood for analysis. The team at Tufts created a silk-based powder and solution, combined it with blood samples, and allowed it to dry. The samples were then stored at high temperatures (72 to 113ºF) and remained viable for 84 days. GHTC member the International Vaccine Institute (IVI) announced last week that a single dose of the oral cholera vaccine Shanchol, currently administered in two-dose regimens, provides protection against the disease. The two-dose regimen provides 65 percent protection against cholera for at least five years, while the single dose demonstrated 40 percent protection against the disease for at least six months. While the two-dose regimen is preferred, the single dose could be appropriate for epidemics or in settings where the two-dose vaccine schedule is impractical. The study enrolled 204,700 individuals residing in the urban slums of Mirpur in Dhaka, Bangladesh, where cholera is endemic. In addition to reducing cases by 40 percent, the vaccine resulted in a 63 percent decrease in cases of severely dehydrating cholera.