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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 US Food and Drug Administration (FDA) has approved an Ebola vaccine developed by Merck, making it the first Ebola vaccine to be approved in the United States. Merck’s vaccine, Ervebo, protects against the Zaire strain of the virus, which has been the most common cause of Ebola outbreaks and is responsible for the current outbreak in the Democratic Republic of the Congo (DRC). The decision by FDA to approve Ervebo follows the European Commission’s decision to license the vaccine last month. In securing approval by FDA, Merck also qualifies for a tropical disease priority review voucher. Merck announced it has also submitted Ervebo for approval to regulatory authorities in a number of African countries at risk of having Ebola outbreaks. The vaccine has also been prequalified by the World Health Organization, which could speed up regulatory approval in African countries.Scientists at the Massachusetts Institute of Technology have developed a microneedle patch that, when applied to a person’s skin, can simultaneously deliver a vaccine and embed a record of the vaccine using a pattern of fluorescent nanocrystals. The vaccine record, written in quantum dots that emit near-infrared light that is invisible to the naked eye but readable by a modified smartphone, does not require a link to a database and is not tied to any personal information. This device could help fill a gap in medical record keeping, especially in developing countries where resources to properly document immunizations may be lacking. Still in the prototype stage, the technology has been tested in the skin of human cadavers exposed to a simulated five years of sunlight, and its efficacy at delivering polio vaccine has been confirmed in rats. Further feasibility and human trials will be needed.Researchers at the University of Queensland and QIMR Berghofer Medical Research Institute have discovered that a virus can be “masqueraded” to resemble other viruses to help develop new, more effective vaccines against mosquito-borne diseases. The Binjari virus, which affects mosquitoes but is harmless to humans, can have its surface manipulated, so that it resembles other viruses. When these “chimera” Binjari virus cells are then used in vaccines, they prompt an immune response for the virus they are imitating without causing harm from that virus. This chimera virus is also much safer to work with compared to live viruses, which risk breaking biocontainment protocols during research and vaccine production. Researchers also noted that the Binjari virus is easy to re-dress, meaning scientists could quickly develop chimera viruses, reducing the time it takes to respond to an outbreak. Developing safe and effective vaccines for mosquito-borne viruses would be a major scientific breakthrough as vaccine coverage for this disease group is currently very limited.

This week, months of tense negotiation between leaders in the Democratically-controlled US House of Representatives, the Republican-held Senate, and the White House concluded with the congressional passage of two massive spending packages encompassing all federal government spending for fiscal year (FY) 2020 —nearly three months behind schedule. Two continuing resolutions, passed by Congress to allow additional time for the process to play out after the start of the new fiscal year on October 1, have kept the government operating at FY19 levels, while from week to week, it was anyone’s guess whether the stalemate over funding levels and contentious items like border wall funding could be broken to avoid another government shutdown.A long process to produce two very long billsIn November, the appropriations “cardinals”—chairs and ranking members of both chambers’ Appropriation Committees—announced they had reached a deal on overall spending for each of the 12 appropriations bills, figures known as 302(b)s. This marked a critical step in the negotiations, given that at the time the House and Senate passed a two-year budget deal over the summer, each chamber had been working off of different overall blueprint funding envelopes: The House had already passed its appropriations bills assuming much higher funding levels than were ultimately included in the deal, while the Senate was developing its bills under the more modest final caps.Once the gulf was bridged and the 302(b)s were set, the leaders and their staff worked quickly to develop final compromise appropriations bills, which they grouped into two “minibus” funding packages released on December 16: a “national security appropriations” minibus and a “domestic priorities and international assistance appropriations” minibus, which included the bills for Labor, Health and Human Services, and Education (LHHS) and State and Foreign Operations (SFOPS).Funding increases included for several key accounts The later minibus encompassing LHHS and SFOPS was a mixed bag for accounts that support global health research and development (R&D). In the LHHS division of the minibus, overall funding for the National Institutes of Health (NIH) was boosted 6.7 percent from FY19 enacted levels—including increases of 6.7 percent for the National Institute of Allergy and Infectious Diseases, 3.3 percent for the National Center for Advancing Translational Sciences, 3.4 percent for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and 3.4 percent for the Fogarty International Center. The joint explanatory statement accompanying the division also notes “an increase of no less than $25,000,000 over the fiscal year 2019 level for HIV and AIDS research” at NIH.The Centers for Disease Control (CDC) saw even greater overall growth than NIH, with an increase of 8.7 percent; however, GHTC-priority accounts that finance global health R&D were mostly flat-funded. While the Center for Global Health (CGH) received a 16.8 percent bump, the entirety of the increase went to Global Public Health Protection—which funds global health security activities—and a new Global Tuberculosis line—which represents level funding of an amount previously transferred annually from a domestic tuberculosis (TB) line to support global TB activities. All other CGH lines were flat-funded. The National Center for Emerging and Zoonotic Infectious Diseases got a modest 1.6 percent bump. The final GHTC priority account in the LHHS bill, the Biomedical Advanced Research and Development Authority (BARDA), was flat-funded.The SFOPS division of the minibus increased overall funding for Global Health Programs at the State Department and US Agency for International Development (USAID) by 2.9 percent. This is slightly lower than what had been proposed in the Senate SFOPS bill earlier this fall and significantly lower than the House proposal to increase by 5.2 percent, but overall still a positive trend reflecting strong support for global health among appropriators, who were working under the constraints of a modest overall SFOPS allocation in the final agreement. At USAID, most health area-specific allocations were flat-funded or increased by about two to four percent—the big exception being the Global Fund for AIDS, Tuberculosis, and Malaria, which was increased by 15.6 percent to reflect the higher pledge made by the US government at the Global Fund’s international pledging conference in October.Report language signals policy support for global health R&DGHTC successfully advocated for the inclusion of several sections of report language, included in the original House and Senate SFOPS bill reports, that will hold under the final agreement. Report language serves as guidance from Congress to US agencies on how it would like to see funding implemented. Language that will hold for FY20 includes GHTC-supported language on USAID’s important role in and reporting on health-related R&D and inter-agency collaboration and coordination on global health product development, as well as support for “CDC’s continued and enhanced work in research and development aimed at creating new tools to respond to health threats at home and abroad” and BARDA’s contributions to emerging infectious disease outbreaks and other naturally occurring threats.The “domestic priorities and international assistance minibus” not only included some positive funding increases and report language, but also advanced a bill supported by GHTC—the End Neglected Tropical Diseases (NTD) Act, which supports R&D activities by USAID to control and eliminate NTDs.The House passed both packages Tuesday afternoon, with the Senate following suit Thursday and now the bills are awaiting signature by the President. GHTC applauds Congress for their strong continued support for global health R&D evidenced by the final deal and looks forward to building on this foundation for our advocacy as we enter a new decade full of opportunities for global health innovation.

The passage of the End Neglected Tropical Diseases Act—included in a federal spending package passed by both chambers of Congress this week—will strengthen US efforts to combat neglected tropical diseases (NTDs). We applaud Congress for recognizing that putting an end to these devastating diseases, which impact the world’s poorest people, will require the discovery of new drugs, vaccines, and other health technologies to prevent and treat these threats.One in seven people worldwide is affected by at least one NTD, including vulnerable people here in the United States. Yet of the 17 priority NTDs identified by the legislation, only five are considered “tool-ready” by health authorities—meaning we have low-cost, effective interventions to control them. Likewise, no preventive vaccines exist for 16 of the 17 diseases—underscoring the urgent need for new innovations and deepening the US Agency for International Development’s (USAID) nascent support for NTD research and development (R&D). The legislation directs USAID, through its NTD Program, to continue investments in R&D of new tools and approaches to control and eliminate NTDs, as well as to ensure that research breakthroughs are incorporated into existing programming to reach individuals in need. Given the program’s tremendous global footprint in supporting mass drug administration to prevent and treat many NTDs, USAID has a unique and vital charge to support the development and deployment of new and improved tools.We look forward to working with the supporters of this legislation to ensure the bill’s vision for NTD R&D is realized and adequately funded in the years ahead so we can end these horrible scourges.  # # #Background:The End Neglected Tropical Diseases Act addresses 17 diseases that collectively afflict more than 1 billion people, who often live in the most impoverished communities in tropical and subtropical countries. The 17 NTDs include:Buruli ulcer (Mycobacterium ulcerans infection)Chagas diseasedengue or severe dengue feverdracunculiasis (guinea-worm disease)echinococcosisfoodborne trematodiaseshuman African trypanosomiasis (sleeping sickness)leishmaniasisleprosylymphatic filariasis (elephantiasis)onchocerciasis (river blindness)scabiesschistosomiasissoil-transmitted helminthiases (STH) (roundworm, whipworm, and hookworm)taeniasis/cysticercosistrachomayaws (endemic treponematoses)CONTACT: Katy Lenard, klenard@burness.com, +1 301-280-5719