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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 first all-oral drug for sleeping sickness received a positive scientific opinion Friday from the European Medicines Agency, paving the way for the treatment to be rolled out in endemic countries in 2019. Developed by the Drugs for Neglected Diseases initiative (DNDi) and Sanofi, fexinidazole is a tablet taken once daily for ten days that treats the most common form of sleeping sickness, a neglected tropical disease spread by tsetse flies that causes neuropsychiatric symptoms and can be deadly if left untreated. Current treatments for sleeping sickness require a complicated series of infusions and pills, are costly, and involve long hospital stays, which pose a huge burden on health systems to treat the disease. Fexinidazole is a simple once-a-day pill that could reduce this logistical burden. About 65 million people in sub-Saharan Africa are at risk of sleeping sickness. A novel device colloquially known as a “wiggle- ometer” may one day help physicians and health workers fight the growth of antimicrobial resistance (AMR). The device, which is a sub-cellular fluctuation imaging machine, detects minute movements in bacteria to determine whether they’ve been affected by an antibiotic, signaling to doctors whether a specific antibiotic works against a specific infection. Today, many physicians prescribe a broad-spectrum antibiotic to patients because of the lack of access to rapid diagnostic tests to determine the nature of an infection and what antibiotics will be effective against it. This overuse and misuse of antibiotics drives the growth of AMR. The “wiggle-ometer” is one of more than 70 projects from around the world competing for the £8 million Longitude Prize, launched by the United Kingdom government to fight AMR. The prize will be awarded to a team that develops an affordable, accurate, easy-to-use test for bacterial infections. Merck has begun the process of submitting the evidence required for regulatory approval of its experimental Ebola vaccine with the US Food and Drug Administration (FDA). The FDA gave the vaccine a “breakthrough therapy designation” in 2016—a form of regulatory fast track which allows a manufacturer to meet more frequently with the FDA to discuss filing and to submit material on a rolling basis, all with the aim of speeding the item through licensure. Merck’s experimental Ebola vaccine is currently being used in the Ebola outbreak in the Democratic Republic of Congo under compassionate use protocol, after having shown to be protective in a clinical trial in Guinea at the end of the West African Ebola outbreak of 2014-2016. Though there are a few experimental Ebola vaccines in development, Merck’s is furthest along in development. Merck initially planned to file with the FDA in 2017 but missed that goal due to “unexpected engineering and construction delays” at the manufacturing plant built to produce the vaccine. Merck now says it hopes to complete the filing process sometime next 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.

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. After hitting its primary goal in a phase 2 trial, Themis may be one step closer to developing a vaccine to protect against chikungunya—a disease which causes debilitating joint pain and for which there is currently no treatments or vaccines. MV-CHIK, Themis’ chikungunya vaccine candidate, was tested at two dose levels in a total of 263 participants and was found to induce neutralizing antibodies against the disease in all groups after two injections. Themis reported seroconversion rates ranging from 86 to 100 percent, touting the vaccine candidate as “promising and potentially effective” against the disease. Themis is looking to move the vaccine candidate into a phase 3 study “in the near term” and will likely pursue a priority review voucher, as the US Food and Drug Administration recently added chikungunya to its list of eligible diseases.  A new study suggests that frontline health workers in the Democratic Republic of Congo who received experimental Ebola vaccines could be protected against the virus for longer than a year. The study, which tracked healthy volunteers in the United Kingdom who received vaccines against Ebola between 2014-2016—including Merck’s rVSV-ZEBOV, GlaxoSmithKline’s ChAd3 EBOV, and Janssen’s AdHu26—found that after two-and-a-half years, those vaccinated still have a strong antibody response to the virus. These findings provide insight into how the vaccines can be used in future outbreaks in the region and how health care workers could be vaccinated before the disease becomes widespread during an outbreak. Researchers now plan to give a booster dose to the study participants to determine how it adds to their immunity. By utilizing the same technology used to develop the Ebola vaccine—a technology known as viral vectors—researchers also believe they can speed the development of vaccines for other infectious diseases. Researchers at the University of Southern California believe they have identified a panel of biomarkers specifically associated with symptomatic Zika infection during pregnancy—a discovery which could lead to the development of new prenatal screening tests to detect fetal abnormalities caused by the virus, as well as a better understanding of how Zika causes these abnormalities. During the study, researchers examined the immune systems of pregnant women through blood samples—comparing the samples of 30 Zika-infected pregnant women in Brazil to 30 healthy pregnant women in Brazil and 14 in Los Angeles. The researchers specifically examined cytokines, messenger chemicals released by the body in response to an infection, and identified 16 cytokines associated with abnormal births from Zika. However, it is unclear if the cytokines cause the birth abnormalities or are released in response to another cause.