Breakthroughs Blog: US budget

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.

In late May, the Biden-Harris administration released its detailed fiscal year 2022 (FY22) budget request. While the budget proposes significant, and welcome, boosts in funding to US health and research agencies—including the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA)—and global health security programming at the State Department and US Agency for International Development (USAID), it falls short in its proposals to address long-standing global health challenges, where it largely proposes flat funding across key global health funding lines. Below we break down the details of the proposal and initial takeaways of how, if enacted, it could impact global health research and development (R&D) programming. State & USAID Global Health Programs In its budget narrative, the Biden-Harris administration touts plans to build on the global health sector’s “demonstrated success” and ensure we are “better prepared to prevent, detect, and respond to future biological threats and pandemics.” It recommends $10 billion in funding for USAID and State Department Global Health Programs—an $855 million, or 9.3 percent, increase over FY21 enacted spending—which is welcome news. Yet as you dive deeper into the proposal, it is clear one issue has risen to the top of the administration’s priority list: global health security. Of the $855 million overall proposed increase, $805 of it, or roughly 97 percent, is directed to health security–related funding lines. This includes $250 million for a new Global Health Security line under the State Department’s Global Health Programs to support a “new health security financing mechanism, which would be developed alongside U.S. partners and allies” and $555 million for USAID’s Global Health Security line. These investments could be transformative and are vitally needed as partner nations work to shore up their health systems to respond to COVID-19 and prepare for future health threats, and the new financing mechanism could support countries in strengthening their R&D capacity. Yet, it is discouraging to see the proposal largely overlook other pressing global health needs. Outside global health security, only two other Global Health Programs funding lines—USAID Maternal and Child Health and USAID Family Planning—receive any proposed increases, and they are modest at $24 million and $26 million, respectively. All other programs and lines are level funded compared to FY21 enacted funding. This was disappointing given most funding for global health R&D at USAID is from these disease/health-area lines, and implementers need additional resources as they face the compounding costs and challenges of maintaining existing research and service delivery programs, while simultaneously battling COVID-19. For more USAID and State budget details, view the chart below. FY21 Enacted 2022 WH Request 2022 WH Request v. 2021 Enacted (%) 2022 WH Request v. 2021 Enacted ($) USAID Global Health Programs $3265.95 $3870.95 +$18.52% +$605 Tuberculosis $319 $319 0% $0 Malaria $770 $770 0% $0 HIV/AIDS $330 $330 0% $0 Maternal & Child Health $855 $879 +2.81% +$24 Nutrition $150 $150 0% $0 Neglected Tropical Diseases $102.5 $102.5 0% $0 Vulnerable Children $25 $25 0% $0 Global Health Security $190 $745 292.11% $555 Emergency Reserve Fund - $90 - $90 Family Planning – all $575 ($233.95 for USAID FP) $483.7 ($550 for USAID FP) 1.1% (4.97% for USAID FP) $8.7 overall ($26.05 for USAID FP) State Global Health Programs $5,930 $6180 4.22% $250 PEPFAR $4,370 $4,370 0% $0 Global Health Security - $250 - $250 Global Fund $1,560 $1,60 0% $0 Global health R&D at NIH, CDC, and BARDA In response to the COVID-19 pandemic and both the scientific promise and public health perils it has exposed, the administration put forward a budget proposal for Department of Health and Human Services subagencies aimed at delivering “a new generation of medical breakthroughs” and “improving America’s public health infrastructure.” Most notable in terms of sheer funding, the budget proposes a $9 billion increase to the NIH budget, of which $6.5 billion, or nearly two-thirds, would go to support the launch of a new Advanced Research Projects Agency for Health (ARPA-H) within NIH. Likely to follow a similar model as the Defense Advanced Research Projects Agency, or DARPA, this proposed program would focus on advancing riskier, transformative breakthrough health innovations that would be unlikely to advance through the private sector alone. While ARPA-H was initially proposed by advocates as a potential mechanism to address market failures in R&D, implying it could touch on neglected global health areas, the president’s budget proposal specifically mentions a focus on cancer, diabetes, and Alzheimer’s, suggesting a narrower initial scope that would likely not encompass poverty-related and neglected diseases. Outside ARPA-H, the budget proposes more modest increases to NIH institutes and programs key to global health R&D, including a proposed 2.9 percent increase to the National Institute of Allergy and Infectious Diseases, where most emerging and neglected disease research takes place within NIH, and a .32 percent increase to the Office of HIV/AIDS. In very welcome news, the budget proposes a 14.6 percent increase to the Fogarty International Center, a center devoted to strengthening international research capacity, reflecting calls by GHTC and other advocates. Beyond NIH, the administration proposes a 10.5 percent, or $825 million, increase to the CDC budget, seeking to reverse a decade-long stagnant budget for the agency. Within that, there is a proposed 17.7 percent, or $105 million, increase to the Center for Global Health (CGH). However, mirroring similar trends seen in USAID and State funding, $100 of that $105 million increase is for global health security–related programming via the Global Public Health Protection line. The remaining $5 is for the CGH Division of Parasitic Diseases and Malaria, which is a welcome addition given this division has been flat funded for years. All other CGH funding lines remain flat funded. The National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), which has supported development of diagnostics and vaccines for infectious disease threats, also receives a proposed $30 million or 4.6 percent increase. Finally, the budget proposes a $226 million, or 37 percent increase, for BARDA to support the development of drugs, vaccines, and other medical countermeasures against public health threats. BARDA, which has been at the center of the US government’s COVID-19 R&D response, faces a dual mandate covering both man-made and naturally occurring health threats, but the latter part of its portfolio has been historically underfunded and over reliant on emergency funding. While GHTC has advocated for a new funding line at BARDA specifically for emerging infectious diseases and other naturally occurring threats, we welcome this overall funding boost, which will allow the agency to pursue a more forward-looking, robust portfolio in this space. For more NIH, CDC, and BARDA budget details, view the chart below. FY21 Enacted 2022 WH Request 2022 WH Request v. 2021 Enacted (%) 2022 WH Request v. 2021 Enacted ($) NIH $42,934 $51,953 21.01% $9,019 NIAD $6,069.619 $6,245.926 2.9% $176.31 Office of AIDS Research $3,090 $3,100 .32% $10 National Center for Advancing Translational Sciences $855.421 $878.957 $2.75% $23.54 National Institute of Child Health and Human Development $1,590.337 $1942.117 22.12% $351.78 ARPA-H - $6,500 - $6,500 Fogarty International Center $84.044 $96.322 14.61% $12.28 CDC $7,874.804 $8,700.00 10.48% $825.20 CGH $592.843 $697.843 17.71% $105 Global Immunization Program $226 $226 0% $0 Global AIDS Program $128.421 $128.421 0% $0 Global Tuberculosis Program $9.222 $9.22 0% $0 Parasitic Diseases and Malaria $26 $31 19.23% $5 Global Public Health Protection $203.2 $303.2 $49.21% $100 CDC-wide Infectious Disease Rapid Response Reserve Fund $10 $35 250% $25 NCEZID $648.272 $678.272 $4.63% $30 BARDA $596.7 $823 37.93% $226.30 While the president’s budget request provides a mixed picture for global health research advocates, with bold transformative investments for global health security paired with primarily flat funding for other critical health areas, it is ultimately up to Congress to decide our nation’s spending. GHTC will continue to track the appropriations process and engage with Congress to push for funding bills that meet the full spectrum of global health research needs.

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.

This blog was authored by Marissa Chmiola, Ansley Kahn, and Julien Rashid.Two thousand nineteen was a tumultuous year for the global health community. From a major reorganization of the World Health Organization (WHO), to steps forward and backward in quashing the smoldering Ebola epidemic, to welcome approvals of new desperately needed health tools, 2019 took us on a topsy-turvy ride.Though the landscape may be constantly shifting under our feet, we at GHTC feel heartened by the clear evidence of our community’s shared progress and impact—and we remain emboldened by our belief that science serves and science saves.So, as the year comes to a close, we are taking a look back at the top global health innovation stories and news that shaped 2019. We hope they will energize and inspire you just as they have energized and inspired us.1. A breakthrough new treatment is approved for drug-resistant tuberculosisIn August 2019, a breakthrough new drug, pretomanid, was approved by the US Food and Drug Administration (FDA) as part of a revolutionary new treatment regimen for extensively drug-resistant tuberculosis (XDR-TB)—the most difficult-to-treat form of the disease. XDR-TB has a treatment success rate below 40 percent, but the BPaL regimen promises to dramatically improve this historically grim prognosis. In clinical trials, it successfully treated 89 percent of patients with XDR-TB. The regimen is also drastically shorter and simpler for patients. It’s taken orally and lasts just six months, compared to prior treatments which can involve injections and take up to two years.The BPaL regimen includes bedaquiline, pretomanid, and linezolid. Bedaquiline and linezolid have been included in older regimens, but this is the premier of pretomanid, which is only the third new compound in the last 40 years approved by the FDA to treat TB. Developed by TB Alliance, BPaL brings new ammunition to the global fight against this ancient, intractable killer, which today claims more lives than any other infectious disease.2. New tools bolster the fight against EbolaThough the Ebola outbreak continued to smolder in the Democratic Republic of Congo (DRC) in 2019, with ongoing conflict hampering response efforts, new innovations brought increased firepower and renewed optimism to the fight. In November, Merck’s Ebola vaccine Ervebo —which has been used on an emergency basis throughout the current outbreak—became the world’s first licensed Ebola vaccine after the European Commission granted it marketing authorization. Shortly thereafter, WHO prequalified it, paving the way for the vaccine’s use in countries at high risk. Meanwhile, a second experimental vaccine produced by Johnson & Johnson, which requires two doses, was introduced in the DRC alongside Ervebo to complement response efforts.On the treatment side, final data from a landmark clinical trial of four experimental Ebola therapies in DRC showed that two of the drugs dramatically reduced the risk of dying from the disease, especially in those who started treatment quickly after the onset of illness. The two treatments, which have also been used on an emergency basis in the outbreak, led to a survival rate of about 65 percent in treated patients compared to 33 percent in the overall outbreak. While there is still work to be done to quash this devastating disease, it is truly incredible that while five years ago we had no vaccine or treatment for Ebola, today, we can say Ebola is both a preventable and treatable disease.3. The world commits to achieving Universal Health Coverage, recognizing R&D’s roleThis September, in a rare moment of unity, the world came together at the United Nations to commit to achieving universal health coverage (UHC)—the concept that everyone, everywhere should have access to quality health care services and products without financial hardship. It’s a pledge that holds promise to radically transform the health and lives of millions around the world. Within this declaration of political will, we were pleased to see world leaders recognize the role research and development (R&D) plays in driving UHC. Many people think to deliver quality health care, we simply need to make sure everyone has access to existing tools. But in reality, we are still without essential technologies to combat many diseases and conditions impacting the world’s poorest; and where tools do exist, they are often not suitable for all types of people and locations. It’s clear to actually deliver the “quality” and “all” in “quality health for all,” we must intensify investment in health R&D.This year’s declaration represents a milestone moment in this quest, but it also marks the start of a mission, not its end. We now hope world leaders will back up their promise with concrete action and financing to realize this bold, shared goal. The health of our world depends on it.4. World’s first malaria vaccine rolled out in sub-Saharan AfricaEarlier this year, the world’s first approved malaria vaccine was introduced in Malawi, Ghana, and Kenya as part of a large-scale pilot program in which 360,000 children annually will be vaccinated. The vaccine, RTS,S, is the first, and to date only, vaccine to significantly reduce malaria in children. RTS,S took more than 30 years and more than US$500 million to develop, and is the result of an international collaboration between GSK, PATH, WHO, US government agencies, other research partners, and a network of African countries. In large scale trials, the vaccine prevented 4 in 10 cases of the disease. RTS,S is a promising new tool in our arsenal to combat malaria, and used alongside other interventions, has the potential to make a substantial contribution to malaria control efforts in sub-Saharan Africa and save tens of thousands of children’s lives.5. A new science division is established at WHOThis year, WHO announced wide-ranging reforms to the organization’s structure intended to help it achieve its “triple billion” targets—including one billion more people benefiting from UHC, one billion more people better protected from health emergencies, and one billion more people enjoying better health and well-being. Among the reforms is the creation of a new Science Division, headed by Chief Scientist Soumya Swaminathan, formed “to strengthen WHO’s core scientific work and ensure the quality and consistency of WHO’s norms and standards.” The new Science Division will serve as the primary hub coordinating R&D activities across WHO and set the innovation agenda for the organization. Though there remains some ambiguity on how this new division will interact with other WHO programs, including the prequalification program and essential medicines and diagnostics list functions, which currently sit outside the Science Division’s structure, this reform creates fresh opportunity to strengthen WHO’s work to accelerate new health technologies from first regulatory approval to widespread availability to people in need worldwide.6. Funding for neglected disease R&D reaches all time highAccording to the 2018 G-FINDER Report, which was launched in January this year, we learned that global funding for neglected disease R&D in 2017 reached the highest level ever recorded. This increase is cause for celebration as it will bring us one step closer to closing the R&D financing gap to meet the world’s greatest health challenges. At $3.56 billion, the 2017 investment was $232 million—or 7 percent—higher than 2016 and the largest year-to-year bump in investment since 2009. It was also the first time that investment grew for two consecutive years.Though other nations contributed most of this new growth, the United States government continued its leadership as the world’s largest funder of neglected disease R&D, adding a fresh $23 million. This bump happened despite the President requesting a fiscal year 2017 budget that hung a blade over global health and medical research programs. That this funding emerged uncut is a strong signal of continued congressional support for global health and medical innovation—even in a moment of deep political tumult and fierce budget battles.7. Race for a chikungunya vaccine shifts into overdriveChikungunya is a debilitatingly painful viral disease spread via mosquito, for which no cure or vaccine currently exists, but with several vaccine candidates now in clinical trials, this could soon change. The three frontrunner candidates are from Themis Bioscience, Emergent BioSolutions, and Valneva, each with clinical-stage candidates. Themis Bioscience raised funding in September from the private sector to launch phase 3 clinical trials of its candidate, MV-CHIK, in the next few months. Emergent BioSolutions is also preparing for phase 3 clinical trials with its candidate, CHIKV-VLP, after revealing positive phase 2 clinical trial results in November. Valneva’s candidate, VLA1553, completed a phase 1 clinical trial and has received funding from the Coalition for Epidemic Preparedness Innovations to further its development. All three frontrunners have received Fast Track designation from the FDA as of the end of 2019, but only time will tell which company might finish that track first.8. President signs two vital bills supporting global health innovationWith impeachment news dominating Washington as we head into the holiday season, you may be surprised to learn Congress and President Trump found some common ground in 2019 in a somewhat unexpected area—strengthening R&D for global health challenges. On January 3, the President kicked off the year by signing into law the Global Health Innovation Act, a bipartisan bill, championed by GHTC, to support efforts by the US Agency for International Development to develop affordable, appropriate technologies to advance global health.Later in June, President Trump signed the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, a vital piece of legislation reauthorizing the work of the Biomedical Advanced Research and Development Authority (BARDA), an agency charged with developing medical countermeasures against both bioterror and naturally occurring health threats. BARDA is a critical piece of the architecture of US support for global health R&D, having advanced lifesaving products for infectious disease threats like Ebola and Zika in recent years; and this legislation, which GHTC influenced, reinforces the agency’s authority and mandate to pursue research against a range of naturally occurring threats, including emerging infectious diseases, pandemic influenza, and antimicrobial-resistant pathogens.9. Researchers pursue creative ways to combat mosquitoesIf there had to be just one antagonist in the grand narrative of human health, it would doubtless be the small, but lethal mosquito. After battling this tiny creature for millennia, it’s possible that in this century, humans might finally grasp victory. Two thousand nineteen brought fresh news of new potential tools to aid in this fight. From novel bednet treatments, to mosquito birth control, to radiation and genetic sterilization techniques, to new larvicides and techniques for their application, to next-generation technologies to improve R&D, it’s clear numerous breakthroughs are within reach, which wielded together, may signal the third act of this ancient drama.10. Drug and vaccine delivery get innovativeFrom the R&D news of 2019, it’s clear that one of the most flourishing frontiers in global health innovation is not only what vaccine or drug you could receive, but also how you will receive it. Delivery issues from maintaining vaccine cold chains to ensuring patients adhere to difficult treatment regimens have proven to be major barriers to care in the world’s poorest places. Thankfully researchers are pursuing creative and innovative ways to overcome these challenges.In the vaccine world, scientists are pursuing wild new ways to make vaccines easy and pain-free, including microneedle patch stickers and other needle-free instruments, as well as pursuing approaches to making them heat stable, like freeze-dryingor transforming them into a dissolvable film similar to breath strips. For HIV/AIDS, new technologies designed to aid patient adherence are expected to come to market soon, including a fruit-flavored drug formulation designed for children and a long-acting, monthly injectable antiretroviral treatment. In the future, taking your TB medicine and contraceptive, could be as easy as inhaling it or absorbing it by wearing your favorite necklace or earrings. Some of these ideas may seem crazy and fantastical, but if history is any indication, science so often finds a way.For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2020 and beyond, sign up now to receive GHTC’s R&D News Roundup newsletter.