Research Roundup: Ebola found in West African bat for the first time, global health R&D money reaches record high, and temperature-stable TB vaccine enters clinical testing

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.In what is being heralded as an “enormous breakthrough” in the fight against malaria, scientists for the first time have successfully sequenced DNA from a single mosquito. Previous DNA models have been comprised of a patchwork of dozens of mosquitoes due to the difficulty of sequencing an insect that small in size. This advancement will enable scientists to create a full, high-quality picture of a mosquito’s genetic sequence—enabling researchers to study how mosquitoes spread disease, adapt to insecticides, and reproduce. This could help inform approaches to vector and malaria control. The Drugs for Neglected Diseases initiative and Medicines for Malaria Venture (MMV) launched the Pandemic Response Box, which offers researchers free access to 400 diverse compounds to be used for screening against infectious and neglected diseases to accelerate development of new treatments for life-threatening pandemic diseases. In return for free access to these compounds, researchers are expected to publish their findings in an open access journal two years following data generation—encouraging transparency and collaboration in drug development research. Timothy Wells, Chief Scientific Officer at MMV noted, “The hope is that these efforts will contribute to the discovery and development of next generation therapies to manage a future pandemic as well as existing threats such as the Zika virus and Ebola.” An experimental Ebola treatment, mAb114, passed an early stage human clinical trial, according to a study in The Lancet. Developed by the National Institute of Allergy and Infectious Diseases Vaccine Research Center, mAb114 prevents Ebola from infecting human cells by “tying itself to the core receptor binding domain of its surface protein.” The experimental vaccine is currently being offered to Ebola patients in the Democratic Republic of Congo as part of a phase 2/3 clinical trial, with an additional phase 1 trial planned to take place in Africa. The vaccine has the potential to make combating Ebola outbreaks quicker and easier as it is not restricted to freezer storage—reducing the logistical burden of transport.

As the partial government shutdown stretches into a fifth week – the longest in United States history – news of its impact on agencies essential to global health broadly, and research and development in particular, is taking clearer shape. While less visible than long lines at Transportation Security Administration (TSA) airport check-points, the consequences of shuttering the US Agency for International Development and furloughing broad swaths of the State Department and Food and Drug Administration workforce for more than a month will only become more obvious as the dispute between Congress and the administration over funding for a border wall continues.Here’s what we know now, based on news reports, anecdotal evidence, and intel from agency contacts:Food and Drug AdministrationThe Food and Drug Administration (FDA) has managed to continue many activities in the midst of the shutdown by drawing down on prescription drug user fees, with reviews of submissions filed and paid for ahead of the partial shutdown on December 22, but drug reviews will stop completely as that funding dwindles in the coming weeks. A sign-on letter sent this week on behalf of “millions of American patients, caregivers, healthcare providers, and researchers” raised alarm that the shutdown “has begun to put future scientific discovery and innovation in jeopardy” by forcing the FDA to “make difficult choices regarding to which essential functions its greatly reduced resources are directed,” and urging that “the health and safety of Americans today should never be weighed against the prospect of new life-saving therapies for patients.”State Department/PEPFAROn January 17, the State Department announced it would be “taking steps to make additional funds available to pay employee salaries” to resume most personnel operations and fund most salaries beginning this week and continuing through at least February 14. The announcement from Bill Todd, Deputy Under Secretary for Management, specified that “although most personnel operations can resume, bureaus and posts are expected to adhere to strict budget constraints with regard to new spending for contracts, travel, and other needs.” For the remainder of this interim fix, it appears most of the President’s Emergency Plan for AIDS Relief (PEPFAR), funded through the State Department, should be operating as usual.  US Agency for International DevelopmentIn advance of the shutdown, the US Agency for International Development (USAID) released guidance noting that about half of its 3,100 person staff would be furloughed, with the remainder exempt and expected to continue working, including “those who are funded through mechanisms other than annual appropriations; employees whose jobs are considered necessary for the protection of life and property or necessary to carry out the president’s constitutional duties; or those who are authorized because of their connection to operations that will continue.” While this allows many contract employees across the agency to continue working, only a handful of full-time agency staff within the Global Health Bureau are reported to be in the office.The development and global health community is slowly beginning to feel and communicate the impact of USAID’s staffing and funding shortages. Last week, Devex detailed one example of a USAID funding commitment delayed by the shutdown, though most development leaders they contacted for comment suggested that the shutdown has had limited effect thus far as USAID-funded programs continue operating on prior year funds, but could soon slow funding approvals and dry up grant funds if protracted. This week, we began to hear anecdotes from implementing nongovernmental organization partners to that end, detailing agency guidance to slow spending and even cease activities on some USAID-funded projects.The Washington Post reported this week that White House Acting Chief of Staff Mick Mulvaney has asked agency leaders to provide him with a list of high-impact programs at risk if the shutdown continues into March and April, which increased concern that a compromise is not imminent. On Thursday, two bills with the potential to end the shutdown failed in the Senate, and no immediate path to resolve this impasse and reopen the government has emerged. Of note, a spending package released by House Democrats last week – based on compromise bills drafted last year by House and Senate negotiators – which is expected to shape final funding outcomes, increased global health programs by US$147 million over fiscal year 2018 enacted levels, including boosts to HIV and AIDS, nutrition, tuberculosis, maternal, newborn and child health, and neglected tropical diseases, as well as positive language about USAID’s role in product development.GHTC continues to track reports of how the shutdown may be affecting global health research and development (R&D) activities. Please email Emily Conron (econron@ghtcoalition.org) to share details of any impacts your organization or partners are experiencing as a result of agency closures.