Breakthroughs Blog: NIH

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.  GlaxoSmithKline has licensed a promising tuberculosis (TB) vaccine candidate to the Bill & Melinda Gates Medical Research Institute in an effort to advance this vaccine for use in low- and middle-income countries. The institute will lead further development of the vaccine candidate and sponsor future clinical tests. The vaccine candidate, developed in collaboration with IAVI, was shown in mid-stage testing to be effective in approximately half of the people who were vaccinated for as long as three years. The only licensed TB vaccine that currently exists—called Bacillus Calmette-Guerin—prevents severe disease in infants and young children but gives limited protection to adolescents and adults. TB infects about 10 million people annually, killing about 1.5 million.A new research group at the National Institutes for Health (NIH) tasked with conducting human trials for vaccines against emerging health threats will be testing the first of likely many experimental vaccine candidates against the novel coronavirus that emerged in Wuhan China late last year. They hope to have a vaccine ready to test in just three months’ time. Chinese scientists quickly identified the genetic sequence and posted it publicly, allowing scientists to begin vaccine development without waiting for a sample of the virus. NIH scientists are now working with US biotech Moderna Inc. to develop an RNA-based vaccine, while additional candidates are in development by other funders and companies. According to Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci, three months from gene sequence to initial human testing would be the fastest the agency has ever gotten such a vaccine off the ground. As of Friday, Reuters reports more than 800 people in China have been infected with the new coronavirus and 26 have been killed. Cases have also been confirmed in Thailand, Vietnam, Singapore, Japan, South Korea, Taiwan, Nepal, and the United States.According to a report by the Access to Medicine Foundation, the world is “precariously reliant” on a small number of pharmaceutical companies to develop new antibiotics, running the risk of a rise in superbugs. The biennial Antibiotic Resistance Benchmark report, which looks at pharmaceutical companies’ efforts to tackle antimicrobial resistance, found that only a core group of eight drug firms are developing antibiotics and that the pipeline of new products is very small. This report echoes a warning from the World Health Organization last week that a lack of private investment and innovation in the development of new antibiotics is undermining efforts to combat drug-resistant infections. Drug-resistant infections are predicted to kill 10 million people annually by 2050 if drug resistance continues to grow at its current rate—meaning that, increasingly, the treatments we rely on to kill infections are not working, and new ones are needed.

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.

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.  Indian generic drug manufacturer Cipla and the Drugs for Neglected Diseases initiative have developed a new, palatable pediatric formulation of HIV medicines priced at US$1 day, which experts say could save the lives of thousands of children each year. The drug, called Quadrimune, contains four HIV drugs—ritonavir, lopinavir, abacavir and lamivudine—and comes in strawberry-flavored granules the size of grains of sugar that can be mixed with milk or sprinkled on baby cereal. The granules are also coated with a polymer that doesn’t melt until it hits the stomach, eliminating the need for cold transport or storage of the drug, which can be inconsistently available in rural areas, especially in sub-Saharan Africa. Quadrimune is still under review by the US Food and Drug Administration and, if approved, will likely lead to rapid certification by the World Health Organization. Each year, approximately 80,000 babies and toddlers die of AIDS in part because their medicines come in hard pills or bitter syrups that are very difficult for small children to swallow or keep down.Final data from a landmark clinical trial of four Ebola therapies in the current outbreak in the Democratic Republic of the Congo show two of the drugs dramatically reduce the risk of dying from the disease, especially in those who started treatment quickly after the onset of their illness. Findings of the PALM trial show that a monoclonal antibody cocktail called REGN-EB3, made by Regeneron Pharmaceuticals, and a single monoclonal antibody developed by the US National Institute of Allergy and Infectious Diseases called mAb114 led to a survival rate of about 65 percent in treated patients compared to 33 percent in the overall outbreak. The other two products tested in the trial, an antibody product called ZMapp and the antiviral drug remdesivir made by Gilead Sciences, did not perform as well, saving only half the patients who were treated with one of those two therapies. The PALM trial began November of last year but ended early in August of this year because an interim analysis showed REGN-EB3 and mAb114 were statistically better than ZMapp and remdesivir.When babies are born with HIV, starting treatment within hours to days is better than waiting a few weeks or months, which is the norm in many countries. The findings from a small study in Botswana, funded by the US National Institutes of Health, show that very early treatment limits how HIV takes root in a newborn’s body, shrinking the “reservoir” of the virus that hides out waiting to rebound in case the children stop taking their medication. The study also demonstrated that the earliest-treated children had more normal functioning of some key parts of their immune system. These findings could influence care in regions hard hit by the epidemic and offer clues as scientists pursue a cure. Though it has become routine practice to give pregnant women a cocktail of anti-HIV drugs to prevent mother-to-child transmission of the virus, it is estimated that 300 to 500 infants are infected every day in sub-Saharan Africa.

Faces of Innovation—a new GHTC project that features scientists on the front lines of research and development on new global health tools and technologies—profiles Hannah Wu, who we met at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Conference, who is working to develop vaccines against the neglected tropical disease schistosomiasis at Brown University.My Name: Hannah WuWhere I work: Brown University Medical School in Providence, Rhode IslandI’m funded by: NIHMy research: We do research on neglected tropical diseases, for malaria and schistosomiasis…I’ve been working on schistosomiasis for a long time. I am lucky enough I can not only work in the lab, but also go to the field to see people. Even though schistosomiasis is more neglected than malaria, there are people in the world suffering from this disease. It’s caused by a trematoda—this is a worm. If we have a vaccine for it, that might be much better to cure the disease or to prevent the disease. So that’s what we are working at. We look at immune mechanisms from the population, and we are trying to find vaccine candidates. For the shistosomisis species, that I am specifically working on…it is also a one health strategy that we should use….We hope that we will have more funding to do other experiments and research on this vaccine, to be available in the livestock.For parasitic diseases, animals are a very important reservoir host. Some people are in touch with animals every day, in their daily life. So we are not only making vaccines for the humans, we can actually make vaccines for, in my case in schistosomiasis, for water buffalo which account for 70 to 90 percent of transmission. So that’s the concept of one health.Motivation: When I was in graduate school, I was not very clear what I wanted to do, but I think I was lucky enough, I got to see the people who had the disease…Because of their everyday life, they have to be in contact with the pathogen, so they cannot really avoid to have the disease, and they don’t have other means….Research has a curiosity I always like. And I was curious about finding new things…but if at the same time I can…contribute to this world by finding a vaccine to help people, that would be great. So that motivates me.Why federal support is critical: We are human beings. We’re not isolated…We care about other people, so that’s one basic reason we can do this research for the world, to improve human health. And I really believe that everyone deserves an opportunity to get health care and to live a more healthy life.When I’m not in the lab: I am involved with my church a lot. Through the church I work with young people. I tell them science is about curiosity. We have the privilege to do science, so we should do real science for real people. We’re not doing science just for the sake of science, we’re doing science for the betterment of human life.