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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.

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. Experimental treatments for Ebola administered during the most recent outbreak in the Democratic Republic of Congo (DRC) appear to be working, according to preliminary data presented at the annual meeting of the American Society of Tropical Medicine and Hygiene. Four treatments are in use, including remdesivir, an antiviral drug; mAb114, a human antibody cloned from a survivor of an outbreak years ago in Zaire; REGN-EB3, a cocktail of cloned human antibodies; and ZMapp, a cocktail of antibodies made from a blend of human and mouse proteins. The death rate among patients in the DRC who received one or more of the experimental treatments was 43 percent—32 percent if the count excluded patients who were within hours of death when they arrived at the hospital. Experimental treatments for Ebola administered during the most recent outbreak in the Democratic Republic of Congo (DRC) appear to be working, according to preliminary data presented at the annual meeting of the American Society of Tropical Medicine and Hygiene. Four treatments are in use, including remdesivir, an antiviral drug; mAb114, a human antibody cloned from a survivor of an outbreak years ago in Zaire; REGN-EB3, a cocktail of cloned human antibodies; and ZMapp, a cocktail of antibodies made from a blend of human and mouse proteins. The death rate among patients in the DRC who received one or more of the experimental treatments was 43 percent—32 percent if the count excluded patients who were within hours of death when they arrived at the hospital. This compares to a death rate of 68 percent for Ebola patients in hospitals before the new treatments were approved for emergency use. A once-monthly injection proved as effective in suppressing HIV as daily pills in a second study by GlaxoSmithKline—potentially paving the way for a new treatment regimen that could be simpler for some people living with and seeking to suppress HIV. In the study, HIV-positive adults—who had not been on a long-established, daily three-drug oral regimen—were put on a 20-week, three-drug program of daily pills to suppress the virus before being switched to a monthly two-drug injection of cabotegravir and rilpivirine. After 48 weeks, the injection maintained a similar rate of suppression as the pills, supporting the results of an earlier study which involved adults who were on a daily, three-drug oral regimen to control the virus. The trial provides further evidence that a long-acting injection could offer an alternative to a daily, oral treatment regimen for people who previously achieved viral suppression. Dogs could offer a noninvasive way to detect malaria, according to a recent study presented at the annual meeting of the American Society of Tropical Medicine and Hygiene. In the study, a trio of dogs correctly “sniffed out” socks worn by malaria-infected children 70 percent of the time and those worn by non-infected children 90 percent of the time. The study focused on asymptomatic malaria carriers because of their key role in malaria’s persistence, since they act as hidden reservoirs of the disease. In the study, nylon socks were given to nearly 600 Gambian children to wear overnight and then frozen for 15 months while the dogs were trained to sniff out the disease, as previous research has shown that malaria alters the compounds that make up a person’s odor. While it may not be economically feasible to train and deploy dogs to all malaria-endemic countries, malaria-detection dogs could work at ports of entry in countries that have eliminated the disease and want to keep it out. This research also provides further evidence of the capabilities of dogs and their ability to help detect deadly diseases.

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 12-month pilot research study conducted in rural Zambia found that administering a suppository form of a malaria-fighting drug to children without immediate access to a health facility drastically cut the number of child deaths caused by the disease. During the pilot, child deaths related to severe malaria were cut from eight percent to 0.25 percent. There were only three child deaths during the study period—94 fewer than would be expected in the same time frame, according to Medicines for Malaria Venture, one of the study’s research partners. During the pilot, all children suspected of having severe malaria were given the suppositories as a pre-referral treatment. This form of drug offers advantages as it can be administered even if a child is unconscious or vomiting. Children who received the suppository were then transferred to a health facility where they were given injectable artesunate malaria medication, followed by a three-day oral antimalarial treatment course. Researchers hope this model can be replicated in other rural settings where there is a high prevalence of malaria and limited access to health workers. Johnson & Johnson (J&J) unveiled promising early-stage results for a tetravalent mosaic-based HIV preventative vaccine regimen. This announcement follows a large-scale efficacy study J&J launched last November to test the tetravalent vaccine regimen in five sub-Saharan African countries. In this early-stage study, known as TRAVERSE, a vaccine regimen including the tetravalent vaccine candidate—which targets four strains of the HIV virus—was found to broaden immune responses to different HIV-1 strains when compared to the trivalent, or three-strain, version. J&J is conducting the TRAVERSE study in 200 patients in the United States and Rwanda. Study participants will receive two prime doses of either vaccine, followed by two boosters at weeks 24 and 48. These initial results are from after week 28, or after the first boost. J&J said findings from the TRAVERSE study were critical to the company’s decision to start the large-scale efficacy testing. In a clinical trial conducted in Belarus, a new treatment for a drug-resistant strain of tuberculosis (TB)—bedaquiline—administered alongside other antibiotics, was found to cure 80 percent of individuals. Of the 181 trial participants given the drug regimen, 168 completed the course and 144 were cured. The Belarus cure rate was largely replicated in bedaquiline trials in other nations in eastern Europe, Africa, and Southeast Asia. According to the World Health Organization, cases of multidrug-resistant TB have been reported in at least 117 countries around the world with only 55 percent of people treated successfully.