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In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Independent examined what’s known about the effectiveness of an experimental Ebola treatment involving blood transfusions from survivors of the virus to current patients. The treatment—known as passive immunotherapy—was first tested by doctors in 1995 during an outbreak in what is now the Democratic Republic of Congo. Of the eight patients who received blood transfusions, only one died, while the rest recovered completely, a 12.5 percent mortality rate during an epidemic with an 80 percent mortality rate. While some researchers argue these results make a case for wider use of passive immunotherapy, others note that very little is known about the efficacy and safety of the treatment, particularly in the current epidemic. The race to develop an Ebola vaccine is gaining momentum. The results from the first African trials of an Ebola vaccine—which ended in 2010—were published last week. The US National Institutes of Health had used knowledge gained from these trials to develop a more potent vaccine candidate, which recently completed Phase 1 trials and will begin Phase 2 trials in West Africa early this year. Another vaccine candidate, developed by NewLinks Genetics Corp and Merck & Co., is undergoing trials in Geneva and has been granted US$30 million from the US Biomedical Advanced Research and Development Authority for further testing. Mitchell Warren, executive director of AVAC, highlights some of the advancements in HIV prevention research that will be forthcoming this year. In the first quarter of the year, results from the FACTS001 study—which is looking at the effectiveness of tenofovir antiviral gel in preventing HIV transmission before and after sex—will be announced. Results from two other microbicides trials are also expected to be released in late 2015 or early 2016. This year, an AIDS vaccine trial will begin in South Africa which will follow up on 2009 vaccine trial in Thailand which demonstrated some level of protection against HIV. It was a strong year from drug approvals at the US Food and Drug Administration. The agency approved 41 new drugs in 2014, a 52 percent increase from the 27 approved in 2013, and the highest count since 1996. Approximately 40 percent of the new medicines approved were for rare diseases, which highlights the industry’s focus on this research area for which the competition is limited and the cost per patient is high. Kat Kelley is GHTC's Senior Program Assistant.

Congress passed an omnibus spending bill which largely flat funds global health R&D programs. Photo: Tim Evanson Working over a rare weekend session and racing against the clock to keep the government open, Congress finally came to an agreement on a year-long spending plan to fund the government through September 30, 2015 (with the exception of the Department of Homeland Security, which only goes through February 27). The package sustains budgets for global health research and development (R&D) and includes policies which we hope will improve coordination across the government to ultimately strengthen the impact of US investments. State, foreign operations, and related programs (SFOPS) For the most part, global health programs funded through the State Department and the US Agency for International Development (USAID) were essentially flat funded. Total fiscal year (FY) 2015 funding for USAID and State was US$8.44 billion, slightly above FY2014’s $8.454 billion. While most programs remained the same, Gavi, the vaccine alliance received a boost of $25 million, and malaria was increased by $4.5 million. While there was a $300 million decline in US contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria, bilateral funding for HIV and AIDS received a $300 million increase. One thing we were watching closely was how the bill would handle the White House’s proposed cut to tuberculosis funding—thankfully appropriators rejected the proposed cut and went with the higher House number of $236 million—which was the same as last year. In addition to tracking final funding levels, we were anxiously watching to see how appropriators would handle report language. The SFOPS explanatory statement noted that unless specifically stated, all report language put in the FY2015 House and Senate report still stands. As noted in our previous blog on report language, we are thrilled to see the Committee direct USAID to coordinate across the government with other agencies involved with global health R&D to ensure efforts are efficient and coordinated. Health and human services (HHS) The FDA received a 2 percent increase in FY 2015 funding over FY 2014 funding. Photo: FDA/Michael J. Ermarth At just over $30 billion, funding for the US National Institutes of Health (NIH) increased by $150 million in base funding from 2014, but still came in below both the White House and Senate request. Within the NIH, the National Institute of Allergy and Infectious Diseases, the Fogarty International Center, and the National Center for Accelerating Translational Science (NCATS) were essentially flat funded with NCATS receiving a slight increase of $2 million. Overall funding for global health at the US Centers for Disease Control and Prevention (CDC) remained the same. Within the CDC’s global health programs, the global immunization program overall, and specifically polio, saw slight increases of 3.8 percent and 5.8 percent respectively. Finally, the US Food and Drug Administration (FDA) was funded at $4.43 billion, which reflected the higher Senate request and was just over a 2 percent increase from FY2014 (note this number includes user fees). We were pleased to see appropriators include strong HHS report language around the need for coordination among agencies. Included in the joint explanatory statement was a request for a global health strategy that would direct the CDC, FDA, and NIH to “jointly develop, coordinate, plan, and prioritize global health research activities.” Defense The peer reviewed medical research program at the US Department of Defense (DoD)received funding at $247.5 million—$47.5 million more than FY 14 levels. This program funds important research for dengue and malaria. We were pleased to see that the final omnibus also includes language submitted by the GHTC affirming the DoD contributions to global health R&D, and asking the agency to improve upon current reporting on its work in infectious disease research. The report language also noted the importance of DoD’s research around malaria, dengue and Chikungunya and encouraged continued research and partnerships with other federal agencies and non-profit organizations. Ebola emergency funding Congress provided $5.4 billion in additional funding for US agencies to tackle Ebola. Photo: CDC/Sally Ezra Included in the $1.1 trillion omnibus agreement was $5.4 billion in additional funding for Ebola response at home and abroad (as a reminder, the president requested $6.2 billion). Out of that $5.4 billion, $2.5 billion is for the Department of State, $2.7 billion for HHS, which includes $1.78 billion for the CDC’s work in the US and around the world (including $597 million for the CDC to set up and strengthen National Public Health Institutes), $238 million for NIAID’s research (including its work on Ebola vaccines), and $157 million for research through the Biomedical Advanced Research and Development Authority (BARDA) at HHS. This funding for Ebola is on top of previously noted funding levels. We’re glad to see that appropriators heard our call that funds to meet the Ebola crisis must be made in addition to other global health funds and not at the expense of other spending. While we would have liked to see higher increases overall, we’re glad funding for global health R&D has been sustained and that important policy shifts are taking place to ensure increased efficiency and coordination, and ultimately making sure that we are seeing maximum bang for our buck.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last week, Policy Cures released its annual G-FINDER report, which analyzes global investment in neglected disease research and development (R&D). The report revealed a US$193 million (6.2 percent) decrease in global funding from 2012 to 2013 primarily due to the US budget sequester, which led to a $188 million (13 percent) decline in funding for the US National Institutes of Health (NIH), the largest funder of neglected disease R&D worldwide. The United Kingdom’s Review on Antimicrobial Resistance released its first report, which warned that, by 2050, up to 10 million people could die each year from drug-resistant infections, costing the global economy US$100 trillion annually. Economist Jim O’Neill, chief author of the report, believes that this crisis can be mitigated through increased R&D into new antimicrobial drugs and changes in drug-use practices. Two announcements were recently made that could benefit pharmaceutical companies working to develop Ebola vaccines. Last Tuesday, Secretary of the Department of Health and Human Services Sylvia Burwell announced that drug makers developing Ebola vaccines would be offered legal and financial immunity through the Public Readiness and Emergency Preparedness Act, and she urged other nations to follow suit to ensure that “legitimate concerns about liability do not hold back the possibility of developing an Ebola vaccine.” Last Thursday, Gavi, the Vaccine Alliance announced that it would commit $300 million to purchase Ebola vaccines once the World Health Organization approved a product. Gavi hopes this move will incentivize pharmaceutical investment and development. The Atlantic takes an in-depth look at the slow and often frustrating work of developing new drugs and treatments. The article explores the careers of leading scientists—including NIH Director Dr. Francis Collins and Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at NIH—illustrating how their work requires patience, resilience, and the ability to constantly live with and learn from failure.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. According to a recent study out of Oxford University, rapid evolution of the HIV virus is slowing the virus’s ability to cause AIDS. In this study of 2,000 women in South Africa and Botswana, researchers found that the HIV virus had evolved to adapt to a specific gene known as HLA-B*57, which provides some protective effect against HIV, slowing the progress to AIDS. As the virus has adapted to reduce this protective effect in individuals, the virus has also reduced its ability to replicate, making it less virulent over all. Last Thursday, the UN Secretary-General launched his synthesis report for the sustainable development goals. In this report, Secretary General Ban Ki-moon reaffirmed his support for the 17 goals and 160 targets proposed by the United Nations Open Working Group, despite concerns from some member states that the current list is too long. Of the 17 proposed goals, two contain targets related to the research and development of new technologies. Researchers are developing a powdered form of the measles vaccine which could make it easier and safer to deliver the vaccine to people in developing nations. The current FDA-approved measles vaccine is a live virus that has been freeze-dried into a powder, which requires reconstitution with water before being administered via syringe. The new vaccine under development is a powder that can be inhaled. This new formulation would eliminate the need for sterile water and needles, as well as cold-chain storage. A modified regimen of the HIV vaccine candidate RV144 was shown to be safe and capable of inducing a robust immune response in safety trials in South Africa. RV144—which was developed by the US and Thai military—showed early promise in clinical trials, but it was found to lose efficacy over time. This new regime is the same earlier RV144 vaccine regime with an added booster shot one year later. Further clinical trials of this new regime are set to begin in South Africa in early 2015.