Marissa Chmiola

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.Solidarity, a global clinical trial led by the World Health Organization, will resume its efforts, testing three new treatments among hospitalized COVID-19 patients: artesunate, an antimalaria; infliximab, an antibody used to treat autoimmune disease; and imatinib, a cancer drug. The original Solidarity trial, which took place across dozens of countries simultaneously in 2020, found that none of the four treatments it tested showed benefit. While the original trial included antivirals, this new phase will focus on drugs that target the body’s immune response, rather than the virus itself, given the two drugs that have shown success in reducing mortality in hospitalized patients, dexamethasone and tocilizumbab, work by dampening patients’ immune reactions. Medicines have shipped to Finland as the first country to begin the trial with 40 more countries in the process of seeking ethical and regulatory approvals to join.Use of the monoclonal antibody therapy REGEN-COV reduced the risk of developing symptomatic COVID-19 infection by 81 percent in those exposed to an infected patient, according to a study published last week in the New England Journal of Medicine. The study, which included individuals over 12 who had a household member test positive within the prior 96 hours, found that by day 28, 1.5 percent of participants who received the therapy developed symptomatic infection compared to 7.8 percent who received the placebo. When including asymptomatic infections, risk reduction from the treatment was 66.4 percent. The study also found that patients who did become infected after receiving the therapy were more likely to have milder disease. These findings were used to support a decision late last month by the US Food and Drug Administration (FDA) to expand emergency use authorization for REGEN-COV to be used as a post-exposure prophylaxis among high-risk populations.Valneva shared positive results last week from the phase 3 trial of its single-dose vaccine against chikungunya, which found that 98.5 percent of participants saw protective antibody concentrations 28 days after receiving the shot. This protection rate exceeds the 70 percent threshold set by the FDA. The trial also found that the VLA1553 vaccine was generally well-tolerated and induced a high immune response among elderly trial participants. The trial will continue with outcomes evaluated until month six. VLA153 is currently the only chikungunya vaccine in phase 3 trials that targets long-term protection from a single-dose, according to its developer. The company signed an agreement earlier this year with the Instituto Butantan in Brazil for development, manufacturing, and marketing, with the goal of making the product more accessible in low- and middle-income countries.

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.

Malaria is one of the world’s oldest and deadliest diseases. For generations it has devastated families, communities, and countries. Thanks to international efforts to develop and scale up prevention tools and treatments, significant gains have been made over the past few decades in fighting this dangerous disease. But challenges, such as growing drug and insecticide resistance, continue to hamper control efforts—underscoring the need for continued research and development of new tools. In recognition of #WorldMalariaDay, test your knowledge of this deadly foe and the innovations being advanced to #EndMalaria: Loading... (function(i, s, o, g, r, a, m) { var ql = document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if (ql) { if (ql.length) { for (var k = 0; k

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, as well as the growth of drug resistance, have challenged global efforts to bring this epidemic to an end. But scientists hope that tide will turn as more new technologies and innovations advance to market. In recognition of #WorldTBDay, test your knowledge of innovations to #EndTB with GHTC’s quiz below: Loading... (function(i, s, o, g, r, a, m) { var ql = document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if (ql) { if (ql.length) { for (var k = 0; k

2021 is shaping up to be an extraordinarily consequential year for US policy for global health and medical research, as a new presidential administration and Congress take charge against the backdrop of a global pandemic that has killed 1.6 million people worldwide and set back decades of progress in global health. As 2021 begins, here are some of the top policy issues GHTC will be tracking: 1. Will the United States remain missing in action on the global COVID-19 response or finally step up? Global health advocates spent much of last year repeating the aphorisms “no one is safe until everyone is safe” and “a global crisis requires a global response”—which seemingly fell on the deaf ears of a Congress and administration consumed by the magnitude of the COVID-19 crisis within our own borders. Though Congress last year appropriated roughly US$2 trillion in emergency funding to respond to the pandemic, plus that much more in loans and tax relief, less than one-half of 1 percent of that funding was earmarked to support the international response—marking a major departure from the US government’s approach in past global health emergencies like Zika and Ebola, when it stepped up with both resources and global leadership.  While the $4 billion in funding for Gavi, the Vaccine Alliance, was a bright spot in the fifth emergency supplemental funding package passed at the end of December, it only meets a fraction of the interconnected needs for a strong global response to this global health emergency. As a new administration and Congress take the helm later this month, advocates are continuing to push for $20 billion in emergency funding for the global COVID-19 response. Within this are specific asks for the United States to join and contribute to the Access to COVID-19 Tools Accelerator (ACT-A) and its lead partners, including the Coalition for Epidemic Preparedness Innovations (CEPI), and for Congress to resource the US Agency for International Development (USAID) to advance COVID-19 innovations designed for low-resource settings. With greater political support for these proposals coming from the Democrat-controlled House than the now Republican-controlled Senate, future prospects may depend as much on the outcome of today’s Senate runoffs in Georgia as the hard work of advocates. Yet, beyond these budget battles, the incoming Biden-Harris administration can pursue other direct means to support the international response, including leveraging existing efforts like Operation Warp Speed to continue to advance next-generation tools suited for the needs of low-resource settings and donating any excess vaccines globally once immediate US needs are met. [Editor's update: On January 20, the Biden-Harris Administration announced that the United States would join ACT-A. The administration also outlined a proposal for a sixth emergency supplemental package that includes $11 billion in funding to support the international response to COVID-19 and mitigate the pandemic's impact on global health, though it will ultimately depend on Congress as to whether the plan will move forward. The two Democratic Party candidates, Jon Ossoff and Rev. Raphael Warnock, won the Georgia runoffs giving Democrats functional control of the Senate with Vice President Kamala Harris as a tie-breaking vote.] 2. Will we recommit to multilateralism—and fund it? The last four years have been a dark era in US multilateral engagement, punctuated most conspicuously by the Trump administration’s move last July to initiate US withdrawal from the World Health Organization (WHO). While the Biden-Harris administration has thankfully pledged on day one to end this withdrawal, this is only the first step in rebuilding US credibility on the global stage and advancing meaningful multilateral reforms. As COVID-19 has shown, much work needs to be done to build a smarter, more responsive international system for public health and emergency preparedness, including for research and development (R&D). We hope that the Biden-Harris administration will work alongside allies now leading these processes and signal strong support for reform efforts. In addition to pushing for the US government to re-engage with WHO—and fulfill outstanding financial obligations—and join ACT-A efforts, GHTC is also calling for the United States to formally join CEPI via a $200 million annual commitment and work alongside our partner countries in the Global Health Security Agenda (GHSA) to revamp GHSA’s Workforce Development & Medical Countermeasures Action Package to address gaps in R&D capacity. [Editor's update: On January 20, the Biden-Harris Administration sent a letter to United Nations Secretary-General António Guterres ending US withdrawal from WHO.] 3. Will we pursue and finance a “build back better” agenda for global health?  The COVID-19 pandemic has exposed how our nation has woefully underinvested in our domestic and global health infrastructure. And while the burden and death toll of COVID-19 is staggering on its own, the full impact of the pandemic is coming into clearer view. Due to pandemic-related disruptions, health programs worldwide have faced challenges sustaining routine immunization programs and treatment services for HIV and tuberculosis, which could cause millions more deaths, and many health researchers have had to pause promising projects. The latter is a key finding from a report GHTC released last month which found the global health R&D sector is being weakened by pandemic pressures that are diverting funding and expertise away from other long-standing threats, multiplying costs for supplies and operations, and putting clinical trials and other scientific endeavors worldwide on indefinite hold. Reflecting on this devastation, it’s clear that an “appropriations as usual” approach will no longer suffice. After years of largely flat-funding health agencies and programs like the Centers for Disease Control and Prevention, USAID Global Health Programs, and the Biomedical Advanced Research and Development Authority (BARDA), Congress must take bold action to boost their budgets—and sustain strong growth at the National Institutes of Health—to ensure these programs have the resources needed to fulfill their important mandates and help their implementing partners restart activities and mitigate added costs and challenges from the pandemic. 4. Will the incoming administration reinvigorate and tap USAID capabilities after four years of neglect? USAID has faced a tumultuous last four years, as the Trump administration has repeatedly sought to slash the agency’s budget and instill controversial appointees. And when President Trump mobilized his administration’s pandemic response infrastructure for COVID-19, he exposed his ignorance of the agency’s value once again. The White House did not include the USAID administrator—the head of the US agency foremost charged with advancing global health—on the Coronavirus Task Force, and it floated proposals to shift US leadership of global pandemic preparedness and response activities away from the agency. Meanwhile, Congress provided USAID with minimal emergency funding to support partner countries in responding to the pandemic, stretching already thin global health programs. Despite taking these bruises, USAID, with its expansive on-the-ground presence worldwide, continues to possess unique capabilities and expertise in global health that will be vital for the incoming Biden-Harris administration to tap and reinvigorate as it seeks to end this pandemic—while also combating long-standing and future health threats. One area the agency has rich expertise in is developing and adapting health technologies for use in low-resource settings where barriers like lack of reliable cold chains or laboratory capacity can necessitate different types of tools. To leverage this expertise and bolster the agency’s leadership in this arena, GHTC is calling for the creation of a Chief Science and Product Development Officer role to coordinate and elevate best practices across the agency’s health area–specific innovation programming and the establishment of a new USAID Global Health Security Grand Challenge program to rapidly elevate and advance innovation solutions for these settings. [Editor's update: The Biden-Harris Administration has nominated Amb. Samantha Powers for the position of USAID Administrator and announced that the USAID Administrator position will be elevated as a member of the National Security Council.] 5. Will we proactively bolster BARDA’s role in pandemic preparedness in COVID-19’s wake? BARDA entered 2020 as a relatively obscure federal agency responsible for developing medical countermeasures against health threats and ended it as a household name entrusted with an influx of COVID-19 emergency funding 42 times the size of its annual appropriated budget—as the agency became a key player in the US government’s ambitious Operation Warp Speed. Prior to the emergence of COVID-19, GHTC had pushed unsuccessfully for Congress to provide dedicated funding for BARDA to grow its R&D activities for naturally occurring health threats, including emerging infectious diseases (EIDs), antimicrobial resistance, and pandemic influenza, recognizing the real and present danger they pose alongside that of bioterror and man-made threats which precipitated the agency’s founding in the wake of the anthrax attacks of 2001 and have remained its historic focus since then. While the agency has been previously engaged in advancing products for EIDs, including Ebola and Zika, much of its funding to do so has come through emergency funding packages, rather than through annualized, sustained funding. This “boom and bust” cycle of Congress providing funding to the agency only after a crisis hits is not a good recipe for improving epidemic preparedness and must change. In the wake of COVID-19, GHTC is continuing to push for a permanent funding line, with an annual appropriation of $300 million, to enable BARDA’s sustained work on a range of EIDs and other naturally occurring health threats. GHTC is also advocating for the agency to place greater priority on ensuring, where possible, that the products it funds are designed to be readily deployable in low-resource and austere settings—recognizing we can’t prevent and end epidemics and pandemics unless we can ensure lifesaving tools can reach everyone, in every corner of America and the world. 6. How do we harness lessons learned to supercharge a new era of innovation? As the first COVID-19 vaccines are being delivered to health workers across our country, much is being written about this historic achievement and the power of science: just 11 months after scientists got their hands on the genetic sequence of the virus, we now have two effective vaccines approved by the US Food and Drug Administration for emergency use—a truly staggering achievement. Backed by considerable resources and building on the backbone of decades of investment in HIV/AIDS, tuberculosis, malaria, and other infectious disease research, scientists and product developers have poured their energy into fighting COVID-19, and in doing so, they have leapfrogged science to incorporate emerging approaches like mRNA vaccines, monoclonal antibodies, novel clinical trial designs, and more that could revolutionize the fight against other global health challenges. While there are many R&D lessons yet to be gleaned from this crisis, two already stand out: 1) With adequate resources and political will, science can solve health challenges that once appeared insurmountable, and 2) When governments pursue and finance product development with a clear end-to-end plan in mind—working in partnership with product developers to advance products each step of the way from early research through product procurement—we can achieve progress at speeds previously unimaginable.  It is our hope US policymakers will embrace these lessons learned in structuring and financing global health research efforts so we can supercharge a new golden era of global health innovation.

One of the great things about working at GHTC is that every day we get to read stories about incredible innovations in global health. Most of the technologies we read about are inventive, some are revolutionary, and a few are so unusual, one might think they were ripped from the pages of a science fiction novel. So, to enjoy a bit of fun and mischief this Halloween, we’ve created TRICK or TREATment, a quiz to test our readers’ knowledge of global health technologies. For each question, we will present a description of a global health technology. Choose TREATment if you believe this innovation exists and has market approval. Choose TRICK if you think we are trying to pull one over on you and, instead, the product is still in development or just a figment of our imagination.  Loading... (function(i, s, o, g, r, a, m) { var ql = document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if (ql) { if (ql.length) { for (var k = 0; k