Research Roundup: US launches biodefense strategy, TB remains world's top infectious killer, and human trials begin for antimalarial drug

This afternoon, President Trump signed into law a spending bill that pairs full-year fiscal year (FY) 2019 funding for Labor, Health and Human Services (LHHS) and Defense with a stopgap measure to keep other agencies funded through December—staving off a partial government shutdown on the eve of the end of the fiscal year. The “minibus”-plus-continuing resolution (CR) legislation boosts funding for medical research across the Department of Health and Human Services (HHS) for FY19, while maintaining funding for global health at the US Agency for International Development and the Department of State through December 7 via the CR measure. Given Trump already signed into law a spending package covering Energy, Veterans Affairs, and the Legislative Branch, now 75 percent of the government is funded for the full fiscal year; while the remaining agencies will remain funded through the CR as lawmakers work to finish full-year funding bills for them. While this year’s appropriations approach may be unusual, by recent historical standards, it was also remarkably efficient: Today marks the first time in 22 years that the government has succeeded in getting at least five of the twelve annual spending bills signed into law before the new fiscal year begins. Here’s a breakdown of how global health and medical research funding fared in the spending package: National Institutes of Health The National Institutes of Health received an impressive US $2 billion boost overall (a 5 percent increase over FY18), including increases of 3-9 percent to each center involved in global health research and development (R&D). In increasing order, the package provided a boost of 3.4 percent for the Fogarty International Center, 3.75 percent for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, 5 percent for the National Institute of Allergy and Infectious Diseases, and 8.62 percent for the National Center for Advancing Translational Sciences. Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) also saw an overall increase from FY18 – depending on how you do the math. In the FY18 omnibus appropriations bill passed in March, CDC received a one-time $480 million funding infusion to support the construction of a replacement Prevention Biosafety Level 4 high containment laboratory to enable continued research on dangerous pathogens like Ebola. Less the cost of that lab, CDC’s overall year-on-year budget rose 1.63 percent. The Center for Global Health was level-funded, while the National Center for Emerging and Zoonotic Infectious Diseases received a 1 percent bump. The bill also established a new CDC-wide Infectious Disease Rapid Response Reserve Fund with an initial infusion of $50 million, a key win for global health security advocates. Biomedical Advanced Research and Development Authority The Biomedical Advanced Research and Development Authority (BARDA) saw a $25 million budget increase in the bill (a 4.66 percent boost). This—coupled with the House passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018—earlier this week, which reauthorized BARDA and authorized $250 million annually for five years for a new emerging infectious diseases program—is welcome news for those looking to BARDA to play an increasingly robust role in global health R&D. However, given the Senate still needs to pass their own version of a bill and continues to pursue a general all-hazards approach in their bill, a call out for emerging infectious diseases may not come to fruition in the final reauthorization. US Agency for International Development & State Department Global health accounts at the US Agency for International Development and the Department of State will be level funded through December 7 since the funding package signed into law today includes a CR for the State and Foreign Operations appropriations bill.   The bottom line: Yet again, strong congressional support has protected global health R&D from deep cuts to key agencies proposed in the President’s budget request and even won significant increases to some accounts. As we get closer to the midterm elections, we will keep a close eye on political developments that could affect our funding prospects for FY20.

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. Two new studies at Scripps Research have shown how human and mice antibodies can bind to and stop the infection of all five types of Ebolavirus—a key step in developing therapeutics capable of neutralizing all variants of the virus. During the studies, scientists observed the ability of a human antibody called ADI-15878 to bind directly to the viral “fusion loop,” which the virus uses to fuse with human cells to initiate infection, making it impossible for the virus to enter into human cells. Discovered in a human Ebola survivor, ADI-15878 is the only known antibody ever found to neutralize all five strains of the Ebola virus. A new study shows the potential of a novel microneedle platform to be used to administer vaccines during a pandemic. Researchers created a unique prototype vaccine that combined different technologies including: tiny microneedles that penetrate only the upper of the skin, a version of the H5N1 vaccine made from noninfectious “virus-like” particles that can be rapidly produced in tobacco plants, and an ingredient called an adjuvant that speeds up and strengthens the body’s response to the vaccine and has demonstrated protection against related viruses. While the study showed the product was effective in ferrets and appeared safe in humans, large-scale human trials are still needed. As vaccine researchers search for new approaches to combat pandemics, this prototype could lead to vaccine patches that could be distributed rapidly and administered without a nurse. Scientists plan to test the efficacy of a Zika vaccine candidate by intentionally infecting people with the virus, a strategy known as a human challenge trial. Researchers first launched the vaccine trial in March 2017 following an outbreak of the virus in the Americas in 2016 and had planned to open new trial sites in infection hot spots, but the effort is currently in limbo given the significant drop off in Zika cases. A major concern of researchers is that those participating in the trial may never be exposed to the virus, making it impossible to determine if the vaccine works. Plans to conduct a human challenge trial for this Zika vaccine candidate were halted by an ethics committee in 2017, which worried that people intentionally infected with the virus might transmit it to their sexual partners. Now, this method is being considered again as cases drop and industry loses interest in bringing a vaccine to market.