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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. FasterCures recently hosted a congressional briefing, during which more than 100 congressional staffers, patient advocates, academics, and drug developers came together to hear about the importance of federally supported translational research. PATH and Standard Diagnostics, Inc., have formed an agreement to bring to market a rapid test for the neglected tropical disease onchocerciasis, also known as river blindness. For the first time, an international team of researchers has estimated that after an initial dengue infection, a person is protected from infection with other strains for between one and three years. The results have implications for designing more effective dengue vaccine studies. Recent breakthroughs in HIV prevention research and development have confirmed the promise of new options to help end the AIDS epidemic and highlight the urgent need for ongoing research to develop additional prevention options, according to a new report from the HIV Vaccines and Microbicides Resource Tracking Working Group. Health advocates are saying that a free trade pact under negotiation between the United States and 11 Asia-Pacific nations will impose intellectual property rules that could restrict access to affordable medicines in developing countries.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The TB Alliance recently launched an online resource that allows users to follow the progress of the organization’s efforts to develop new drugs for tuberculosis (TB). The US Food and Drug Administration has announced a five-year, $7.5 million contract with the World Health Organization (WHO) to support regulatory science and enhance global regulatory capacity. The funding will support WHO’s efforts to provide substantial regulatory support to many of its 193 Member States. A new report from the Institute of Medicine finds that a National Institutes of Health program to spur the translation of science to clinical therapies is largely successful but could be more collaborative. WHO, the World Trade Organization, and the World Intellectual Property Organization are planning a discussion on the current model for researching and developing new medical and pharmaceutical products—as well as new incentives and collaborative innovation models. The University of Washington has received funding from the Department of Defense to continue a project aimed at developing a small, paper-based device that could test for infectious in areas where diagnostic capabilities are limited.

Congress is heading for its July 4 recess next week, having made a few incremental steps toward a fiscal year (FY) 2014 budget for the federal government—including releasing spending levels for several agencies and programs that support global health and research efforts. The Senate released its FY14 302(b) allocations last week (the House released its own allocations a few weeks back). 302(b) allocations set limits on congressional appropriations for key accounts. As expected, the Senate’s allocations are overall higher than their House counterparts. For example, the State and Foreign Operations budget, which includes global health research and development (R&D) programs under the State Department and US Agency for International Development, is funded at $50.6 billion—essentially flat compared with the FY 2013 enacted level. It is also somewhat lower than President Obama’s FY 2014 request for that account. In contrast, the House budget level for this account is $10 billion lower than the Senate version and would require significant cuts from current spending. The Senate’s budget for the Labor, Health and Human Services (HHS) account—another controversial account—is a whopping $42 billion higher than the House level of $121.8 billion. This account include key programs at the Centers for Disease Control and Prevention, as well as the National Institutes of Health. Congress recently released spending levels for several agencies and programs that support global health and research efforts. Credit: Richard Franco. This pattern should sound familiar, as recent appropriations cycles have seen similar cavernous differences between the House and Senate. And as we know very well, the threat of budget sequestration has not been enough to bridge the gap. These huge disparities will make it extremely difficult for policymakers to agree on a final budget level for the government, meaning that we are almost certainly headed for another continuing resolution to keep the government open past September. There are some positive signs on the policy side of the appropriations saga. Both the House and Senate included report language in recently passed appropriations bills that would improve the US Food and Drug Administration’s (FDA) engagement in global health by boosting its global partnerships and ensuring its ability to review and license new global health technologies for all neglected diseases. Language was also included in the House’s version of US Department of Defense legislation promoting the development of a malaria vaccine, although the full House has not passed this bill yet. Aside from the Defense and FDA bills, neither the House nor Senate has progressed on appropriations legislation that directly affects global health R&D. Neither chamber has taken up bills for State and Foreign Operations or Labor-HHS. If past years are any indication, it’s very unclear whether this will happen at all. On a more positive note, the House Foreign Affairs Committee Subcommittee on Africa and Global Health is holding a hearing today to examine the need for new treatments for neglected diseases. As Subcommittee Chair Rep. Chris Smith (R-NJ) stated, “A number of so-called ‘neglected diseases’ receive little attention from researchers in such critical areas as detection, strategies, vaccines, or drug therapies.” Although research into new tools to combat neglected diseases does rely on researcher interest, even more essential to this effort is a strong combination of US government and private-sector funding and support for programs and partnerships that conduct global health research. Still, this hearing is a welcome contrast to potential threats to global health research faced in ongoing budget sequestration and the stalled appropriations process. Whether through FY 2014 budget negotiations or other legislative mechanisms, Congress should help move this cause forward by protecting US research and product development funding and promoting a comprehensive, thoughtful, and coordinated strategy for global health R&D.

In this guest post, Dr. John Boslego, director of PATH’s Vaccine Development Global Program, writes about an innovative partnership between the United States and India to develop an oral vaccine against rotavirus diarrhea. I recently had the pleasure of attending an international symposium on rotavirus vaccines where the government of India’s Department of Biotechnology (DBT) and the Indian vaccine manufacturer Bharat Biotech announced positive results from a Phase III clinical trial of an oral rotavirus vaccine that was developed and manufactured in India. Data from the trial showed the vaccine, ROTAVAC®, to be safe and effective in protecting infants against severe rotavirus diarrhea, the most lethal cause of childhood diarrhea. ROTAVAC® represents an important scientific breakthrough against severe rotavirus diarrhea, responsible for approximately 100,000 deaths of small children in India each year. Credit: PATH. However, what’s most extraordinary about this announcement actually may not be the results themselves, but the long and unique road that ROTAVAC® traveled to reach this point. This vaccine is the product of an innovative partnership between the United States and India, involving renowned experts from a range of agencies and sectors across the two countries. The vaccine originated from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in the mid-1980s. Since then, partners in the vaccine’s development have included DBT, Bharat Biotech, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and PATH. Each group has provided its own contribution to the project, ranging from technical assistance on vaccine development and manufacturing the vaccine batches used in clinical trials, to guidance on designing and implementing clinical trials that meet international standards. With the development costs shared by several partners, Bharat Biotech was able to commit to a price of US$1.00 per dose for ROTAVAC®. As such, Bharat Biotech plans to register the vaccine for use in India first. If licensed by the Indian regulatory authority, the vaccine will be a more affordable alternative to the rotavirus vaccines already on the market. This represents an important scientific breakthrough against severe rotavirus diarrhea, responsible for approximately 100,000 deaths of small children in India each year. If licensed, this vaccine could save the lives of thousands of children each year in the country. Bharat Biotech also plans to submit ROTAVAC® for prequalification by the World Health Organization, so it may be procured for subsidized use in the developing world, giving it the potential to have an enormous impact on global public health by reducing rotavirus-related illness and deaths worldwide. I’m proud of the role that PATH has played in reaching this incredible milestone, and I am particularly impressed with how this truly innovative approach to a vaccine development partnership has resulted in the production of a safe and efficacious new rotavirus vaccine, ROTAVAC®.