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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.A clinical trial is underway to evaluate experimental HIV vaccines using the mRNA technology also employed for highly effective COVID-19 vaccines. The phase 1 trial, sponsored by the National Institute for Allergy and Infectious Diseases and conducted by the HIV Vaccine Trials Network at the Fred Hutchinson Cancer Research Center, will enroll up to 108 HIV-negative adults at 11 sites across the United States. The three vaccine candidates—which use mRNA sequences designed by researchers at the Scripps Consortium for HIV/AIDS Vaccine Development and the IAVI Neutralizing Antibody Center at Scripps in collaboration with Moderna—will be assessed for safety and ability to induce an immune response. Knowledge gained from the study will help guide future development of a protective HIV vaccine regimen and expand on knowledge of mRNA vaccines, according to researchers.New studies are enlisting survivors of Nipah virus, a disease with known pandemic potential and a fatality rate as high as 75 percent, to evaluate how the body responds to infection and guide the development of tests, treatments, and vaccines. More than 50 people who have recovered from Nipah in Bangladesh will participate in the effort to research the immune response to the virus, which will be led by the International Centre for Diarrheal Disease Research, Bangladesh and funded by the Coalition for Epidemic Preparedness Innovations. There are currently no vaccines or drugs to fight Nipah infection, though several groups are working to develop vaccines, including a team at the University of Texas that unveiled data last week showing their candidate provided rapid, strong protection in animal studies. Australian regulators last week approved a simple drug combination as an effective cure for children ages 2 to 16 with Plasmodium vivax malaria, adding a new tool in the battle against the disease and opening the door to approval in other countries. The drug—tafenoquine, developed by GlaxoSmithKline and the Medicines for Malaria Venture—is a single-dose treatment administered alongside traditional chloroquine treatment. In 2018, the US Food and Drug Administration and other regulators approved a 300-mg dose of tafenoquine for the radical cure of P. vivax malaria in adults and adolescents 16 and older. The new formulation for children is a 50-mg tablet dispersed in water, making it much easier for children to take than the 7- or 14-day course of pills developed for adults. Further regulatory submissions of the pediatric formulation are planned for malaria-endemic countries as well as the World Health Organization.

Prior to COVID-19, tuberculosis (TB)—another airborne disease—was the world’s leading global infectious disease killer, claiming the lives of around 1.5 million people annually. Insufficient and inadequate tools and treatments, and growing drug resistance, have challenged global efforts to bring the TB epidemic to an end, and more recently, disruptions from COVID-19 have reversed years of TB progress. In 2020, global TB deaths increased for the first time in more than a decade, and about 1 million fewer people were tested and treated for TB compared to 2019. At the same time, global funding for TB diagnostic, treatment, and prevention services fell by $500 million from 2019 to 2020, and total funding for TB research and development dropped by $33 million.Scientists hope the tide can be turned as new technologies and innovations advance to market—but to achieve that, more investment is urgently needed to boost resources and reverse setbacks.In recognition of World TB Day, test your knowledge of innovations to end TB with GHTC’s quiz below:

Last Friday, President Joe Biden signed into law a $1.5 trillion spending bill that will fund the US government through the remainder of fiscal year 2022 (FY22), which began October 1, 2021, and concludes in September. The outcome followed months of tense negotiations by Congress—which had passed a series of temporary funding measures, known as continuing resolutions, to keep the government funded at FY21 levels since the start of this fiscal year—and last-minute maneuvering to try to pair annual spending with emergency aid for Ukraine and the COVID-19 response domestically and globally.While the bill ultimately included welcome boosts across key agency programs that fund global health and medical research, summarized below, in very disappointing news, emergency funding for COVID-19—including $4.5 billion for the global response—was stripped from the final package at the 11th hour due to disagreements on how to cover costs. This leaves an uncertain path ahead for the Biden administration to execute its COVID-19 plan, as previously appropriated funds for the domestic and global response are nearly depleted—raising the prospect of having to halt ongoing government-sponsored COVID-19 research trials, among other impacts. House Democrats have promised to advance a stand-alone COVID-19 emergency funding package, which could provide an influx of urgently needed funds, but it’s unclear whether such legislation could gain the 60 votes needed in the Senate since Republicans are demanding any new bill be paid for via offsets of unspent funds, a requirement many Democrats are opposed to.Below GHTC takes a detailed look at the spending bill and its impact on accounts that finance global health research and development (R&D) programming.State and Foreign OperationsThe final spending bill included $9.8 billion in funding for Global Health Programs at the State Department and US Agency for International Development (USAID), which represents an increase of $630 million, or 6.9 percent, over FY21 enacted levels. The vast majority—$510 million—of that increase is designated for global health security programming at USAID, a 268 percent increase over FY21 funding. This funding includes a $100 million allocation for the Coalition for Epidemic Preparedness Innovations (CEPI) to support vaccine development for potentially epidemic threats, which is both welcome news and higher than the $50 million pledge for this fiscal year announced by USAID Administrator Samantha Power at the CEPI pledging summit just a few days prior.Beyond global health security, the remainder of the increase—$130 million—was spread across other global health accounts. The tuberculosis and maternal and child health program lines at USAID received the largest increases at $52 million (16.3 percent) and $34.5 billion (4 percent) respectively, while nutrition, malaria, and neglected tropical diseases were each increased by $5 million and vulnerable children was increased by $2.5 million. USAID’s HIV/AIDS and family planning lines received flat funding compared to last fiscal year while the President’s Emergency Plan for AIDS Relief, or PEPFAR, under the State Department, was boosted by $20 million (0.5 percent). No global health-related accounts at USAID or State saw their funding cut. In other important news, in the joint explanatory statement accompanying the bill, Congress included language, for which GHTC advocated, directing USAID to develop and publicly release a new multi-year strategy on health R&D detailing its goals and how it plans to invest across health areas. USAID’s current health R&D strategy runs through 2022, so the fulfillment of this congressional directive will help ensure continuity and that research remains a priority for USAID’s global health programming.While it was positive to see Congress provide a major funding boost for health security programming and some modest increases to other global health accounts, overall, these funding increases fell short of what many advocates had hoped for, and in many cases what the House and Senate bill drafts released in 2021 had proposed. The COVID-19 pandemic has increased both the challenges and costs of operating health and research programs worldwide, so this funding package, even with increases, fails to match the scale of today’s expanding needs.Health and Human ServicesThe spending bill provided much larger, but uneven, increases across Department of Health and Human Services (HHS) subagencies and programs that support global health R&D. The National Institutes of Health (NIH) received $44.96 billion in funding, representing a $2 billion, or 4.7 percent, increase over FY21 levels. This included an increase of $253.1 million, or 4.2 percent, for the National Institute of Allergy and Infectious Diseases and a $2.8 million, or 3.4 percent, increase for the Fogarty International Center, which works to strengthen research capacity in low- and middle-income countries.Meanwhile, the Biomedical Advanced Research and Development Authority (BARDA)—an agency that supports development of medical countermeasures against health threats and a central player in COVID-19 R&D through then Operation Warp Speed—received a significant funding boost from Congress. It was appropriated $745 million in funding, a $148 million, or 24.9 percent, increase over the prior fiscal year. This funding envelope supports the agency’s entire research portfolio, which covers chemical, nuclear, radiological, and biological threats—both man-made and naturally occurring—so it is at the agency’s discretion to determine what of this funding it ultimately spends on R&D for naturally occurring health threats, including emerging infectious diseases, pandemic influenza, and antimicrobial resistance. Congress included in the bill’s accompanying joint explanatory statement language requested by GHTC expressing support for BARDA to expand its work on naturally occurring threats and provide more detailed reporting on such spending.The Centers for Disease Control and Prevention (CDC), which is a smaller but still important player in supporting global health R&D, received overall funding of $8.5 billion, a $582.4 million, or 7.4 percent, increase from the prior year. Within that, the Center for Global Health received a $54 million, or 9.1 percent, increase, with 93 percent of that increase designated for the global public health protection line focused on health security and the remainder spread across accounts funding global immunization, HIV/AIDS, tuberculosis, and parasitic diseases and malaria. The National Center for Emerging and Zoonotic Infectious Diseases, which funds select R&D for diagnostics and vaccines against infectious diseases, received a $45 million, or 6.9 percent, increase over FY21 enacted levels. These CDC increases were seen by many advocates as disappointing compared to evident needs. Challenges faced by the agency during the COVID-19 pandemic have underscored the need for a more significant influx of funding for this historically under-resourced agency to modernize its systems and improve staff retention.In addition to providing increases for the three HHS agencies above, Congress appropriated $1 billion for HHS to set up a new Advanced Research Projects Agency for Health, modeled after the Defense Advanced Research Projects Agency, to speed development of medical breakthroughs by funding high-risk, innovative projects. This funding was far lower than the $6.5 billion requested by the Biden administration and interestingly was designated to HHS to establish the agency under the Office of the HHS Secretary, rather than within NIH as the Biden administration and some congressional leaders had proposed. GHTC has pushed for this proposed agency to focus on poverty-related and neglected diseases, as a key area of market failure by industry; however, it remains unclear what health areas this new agency will initially prioritize as it is stood up.While FY22 was a bit of a mixed bag for global health R&D, with important increases across some programs but other areas falling short, advocates are already gearing up for the budget battle ahead for FY23, with the Biden administration expected to release its FY23 budget proposal soon.

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 phase 3 clinical trial of Valneva’s single-shot chikungunya vaccine is now complete, the company announced last week, with analysis confirming a high level of protection and strong immunogenicity profile. One month after receiving the live-attenuated, single-dose shot, 98.9 percent of participants achieved protective levels of neutralizing antibodies against chikungunya virus, and after six months, 96.3 percent of participants showed protective neutralizing antibody titers against the virus. The results represent the first final phase 3 trial data for a chikungunya vaccine candidate. Valneva expects to start the pre-submission process with the US Food and Drug Administration in the second quarter of this year.An investigational antimalarial drug showed effectiveness against blood-stage Plasmodium falciparum malaria in its first stage of human testing, according to new analysis published in The Lancet. The drug, ZY19489, was found through a screening of around 500,000 compounds conducted by AstraZeneca and the Medicines for Malaria Venture. After demonstrating activity at the blood stage of infection in preclinical studies, the phase 1 trial was conducted to evaluate optimal dosing, assess effects of food intake on oral absorption and kinetics, and confirm the parasite was cleared without developing treatment resistance. The drug would likely need to be used in combination with another agent and with possible additional doses to attain a curative regime, but its demonstrated safety, pharmacokinetic profile, and antimalaria activity support its further development as a novel therapy, researchers said.Global leaders and stakeholders last week pledged a total of US$1.535 billion to the Coalition for Epidemic Preparedness Innovations (CEPI) to implement its five-year plan to prepare and protect against emerging diseases with pandemic potential. The five-year road map, for which CEPI has a total budgetary ask of $3.5 billion, includes plans to compress vaccine development to 100 days, develop a broadly protective vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. In addition to monetary pledges, the Global Pandemic Preparedness Summit brought announcements on several research collaborations and commitments, including a partnership to develop a pan-coronavirus vaccine.