Research Roundup: New treatment for sleeping sickness, innovations to combat AMR, and Merck Ebola vaccine update

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. According to a report released last week by the Access to Medicines Foundation, just five companies are carrying out 63 percent of the urgently needed research and development projects for priority health areas such as HIV and AIDS, tuberculosis, Chagas disease, and leishmaniasis. This reliance on a small group of companies contributes to a fragile ecosystem, according to the report authors. A change in strategy for any of the companies could put access to medicines in low- and middle-income countries (LMICs) at risk. The Access to Medicines index, an independent report released every two years, ranks the world’s 20 largest pharmaceutical companies based on their efforts to make their medicines available in LMICs. This year, GlaxoSmithKline—the developer of a single-dose drug to prevent malaria relapse—tops the list of companies in the overall ranking.  Recruitment of women in Uganda has begun for a phase 3 clinical trial, which will assess if a long-acting injectable antiretroviral called Cabotegravir, administered every two months, is safe and effective as a form of Pre-Exposure Prophylaxis (PrEP) to reduce an individual’s risk of contracting HIV when exposed to the virus. This recruitment is part of a large-scale, five-year trial that will be conducted in six additional countries—including Kenya, Malawi, Botswana, Zimbabwe, South Africa, and Swaziland—among approximately 3,200 HIV-negative individuals who are at a high risk of contracting the virus. If Cabotegravir proves to be safe and efficacious, it would offer a new alternative for individuals on PrEP other than taking daily oral pills. A vaccine to prevent Zika virus infection was found to be safe and induce an immune response in an early stage trial, according to an announcement released on November 19 from developer Emergent BioSolutions Inc. and partner Valneva SE. The vaccine, VLA1601, was tested in two doses in 67 adult trial participants. The initial results contained analyses up to day 56, after the first vaccination. Final analysis will take place up to day 208 and is expected to be released in the first quarter of 2019. Emergent BioSolutions Inc. announced an exclusive worldwide licensing deal for Valneva SE’s Zika vaccine in July of last year.

While the dust is still settling from the US midterm elections on November 6—with a handful of key races yet to be decided and others headed for run-offs—the major takeaways are set. Democrats have decisively retaken control of the House of Representatives with at least 228 of 435 seats declared in their favor (a 34-seat pickup likely to grow as the remaining races are called). Meanwhile, Republicans have solidified and likely expanded their hold on the Senate, with at least 51 of 100 seats called for Republicans and the still-too-close-to-call remaining races leaning in their favor. With Washington poised for at least two years of divided government, one commentator has predicted that “We may be looking at two years in which a Congress we already regard as pretty dysfunctional doesn’t really function much in the legislative sense.” He foresees a Congress that “functions as an investigative body in the House”—intent on investigating the Trump Administration and flexing oversight muscle— “and a judge-making machine in the Senate”—fulfilling Republicans’ promise to their voters to confirm conservative federal judges. What does all of this mean for US support of global health research and development (R&D)? Of top interest are potential changes to the leadership and makeup of key congressional committees. While these rosters will not be set until early 2019, one broad takeaway is that only a few members currently serving on such committees lost their races. No Senators on committees of interest lost, though Cindy Hyde-Smith (R-MS), currently serving on the Senate Appropriations Committee and its Labor, Health and Human Services and State and Foreign Operations Subcommittees, faces a run-off election on November 27. However, some already-announced retirements will still mean shake-ups for global health leadership in the Senate. Senator Bob Corker (R-TN), who currently chairs the Senate Foreign Relations Committee (SFRC), and fellow committee member Senator Jeff Flake (R-AZ), who chairs the Africa and Global Health Policy Subcommittee, announced their retirements earlier this year. This means we will see at least two new Republican faces on SFRC come 2019, with the potential for more to be added after the top Senate Republicans and Democrats negotiate committee ratios to account for Republicans adding seats to their majority in the chamber. While the House of Representatives overall will look quite different in the 116th Congress due to the change in party control, retirements, and flipped seats, only a few current members on key committees of interest to global health R&D will not be returning. In the House, John Culberson (R-TX), Kevin Yoder (R-KS), David Young (R-IA), and Scott Taylor (R-VA) of the House Appropriations Committee; Leonard Lance (R-NJ) on the Energy and Commerce Committee and its Subcommittee on Health; and Dana Rohrabacher (R-CA) and Dan Donovan (R-NY) on the House Foreign Affairs Committee lost their races. House Foreign Affairs Committee Chairman Ed Royce (R-CA) had already announced his retirement, and it is not yet clear who will succeed him. Donovan’s departure, in particular, will leave a leadership gap on global health among House Republicans. He served on the House Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights and International Organizations; several global health-related caucuses; and frequently led or signed Dear Colleague letters on global health appropriations. He is one of several moderate Republicans who have been frequently called upon by the global health community to serve on caucuses or sign Dear Colleague letters who will not be returning to Washington for the 116th Congress. Notably, two-thirds of House Republicans who signed a Dear Colleague letter on fiscal year 2019 maternal and child health funding lost their races or are retiring come January. Of course, a “glass half full” perspective also accounts for some exciting new members set to join the ranks of the 116th Congress who could be cultivated as champions for global health R&D. Of particular interest to global health R&D advocates, at least nine new “science-credentialed candidates” were elected on November 6—eight to the House and one to the Senate. These science-engaged members include a pediatrician (Kim Schrier, a Democrat elected to Washington’s 8th District), a dermatologist who began his career as a naval physician (John Joyce, a Republican elected to Pennsylvania’s 13th District), and a registered nurse with a Master of Public Health degree (Lauren Underwood, a Democrat elected to Illinois' 14th District who served in the Obama Administration as a senior adviser at the Department of Health and Human Services focused on bioterrorism threats and public health emergencies). On both sides of the aisle, many candidates with military or national security backgrounds won their races, which should expand the audience for advocacy on issues of international concern. A quick snapshot of some other freshmen with interesting backgrounds coming to town include: A son of Eritrean refugees (Joseph Neguse, D-CO-2) and a Somali refugee who has previously worked as a community nutrition educator (Ilhan Omar, D-MN-5). A former associate vice president of Florida International University’s Herbert Wertheim College of Medicine (Debbie Mucarsel-Powell, D-FL-26). A former Washington director of Human Rights Watch and Assistant Secretary of State for Democracy, Human Rights, and Labor with experience on the National Security Council (Tom Malinowski, D-NJ-7). A former Secretary of Health and Human Services, who was the longest-serving in history (Donna Shalala, D-FL-27).  There are real challenges to come in the new year. With Democrats taking the House having campaigned on big promises squarely focused on domestic priorities, getting the attention necessary to advance global health R&D will continue to require creative approaches. This is compounded by growing fiscal constraints, including looming budget caps and additional demands on non-defense discretionary funding across the board, which will make maintaining and growing the resources we need even more difficult. One thing is certain: between wins, losses, and retirements, Congress will look very different come January. Educating new members and continuing to cultivate the support of their returning colleagues on the value of US investments in global health R&D will be an exciting challenge.