Research Roundup: FDA approves Ebola vaccine, experimental vaccine patch leaves a mark, masquerading virus for vaccine R&D

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.  A team of Brazilian researchers are leading an international consortium to discover new drug candidates for malaria, visceral leishmaniasis, and Chagas disease. The organizations involved in the consortium include FAPESP (São Paulo Research Foundation), Medicines for Malaria Venture (MMV), Drugs for Neglected Diseases initiative (DNDi), Universidade Estadual de Campinas, and the University of São Paulo. The consortium has received US$10.7 million from the participating organizations for the next five years and will prioritize selecting and training researchers from São Paulo and investing inA new study has found that delivering the BCG (bacille Calmette-Guérin) tuberculosis (TB) vaccine intravenously better protected monkeys against infection than the standard administration method of injecting it into the skin. The BCG vaccine, which is the only licensed TB vaccine, is effective in preventing early-childhood forms of TB but provides limited protection against pulmonary TB, the dominant form in adults. Researchers have suspected that delivering the vaccine via other routes of administration, such as inhaled aerosolized vaccine or IV, could improve efficacy. In this study, researchers used rhesus macaque monkeys to compare the potency of intravenous needle injection to aerosolized and intradermal routes of vaccine delivery. Remarkably, nine of the ten monkeys that received the intravenous injection were highly protected from exposure to TB six months after vaccination—and six of the monkeys showed no signs of exposure. local institutions. DNDi and MMV will provide frameworks and resources for drug discovery, including MMV’s database of molecules.A new study has found that delivering the BCG (bacille Calmette-Guérin) tuberculosis (TB) vaccine intravenously better protected monkeys against infection than the standard administration method of injecting it into the skin. The BCG vaccine, which is the only licensed TB vaccine, is effective in preventing early-childhood forms of TB but provides limited protection against pulmonary TB, the dominant form in adults. Researchers have suspected that delivering the vaccine via other routes of administration, such as inhaled aerosolized vaccine or IV, could improve efficacy. In this study, researchers used rhesus macaque monkeys to compare the potency of intravenous needle injection to aerosolized and intradermal routes of vaccine delivery. Remarkably, nine of the ten monkeys that received the intravenous injection were highly protected from exposure to TB six months after vaccination—and six of the monkeys showed no signs of exposure.Researchers at the Institut Pasteur and the Centre national de la recherche scientifique have discovered a new route for developing antimalarial drugs. In studying the Plasmodium parasite and its ability to adapt between host environments in humans and mosquitoes throughout its life cycle, the researchers realized they could exploit this adaptability. The parasite uses a process called DNA methylation to modify which genes are expressed during different stages of its life cycle in humans and mosquitoes. The researchers tested 70 methylation-inhibiting molecules and found many that were effective, including some that killed the parasite within hours. The researchers also found that the most promising molecules were able to kill artemisinin-resistant malaria strains. This research could lead to new treatments in the future against treatment-resistant malaria strains.

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.