Marissa Chmiola

Malaria is one of the world’s oldest and deadliest diseases. 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 and disruptions from COVID-19, have hampered control efforts. Unfortunately, in 2020, both malaria cases and deaths increased significantly from the prior year—indicating progress against the disease has stalled and underscoring the need for continued research and development of new tools.In recognition of #WorldMalariaDay, test your knowledge of this deadly disease and the innovations being advanced to #EndMalaria:

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.

The full and equal participation of women in science is vital to achieving gender equity and advancing progress in global health. Unfortunately, today less than 30 percent of the world’s researchers are women, and female researchers tend to have shorter, less well-paid careers and to see their work underrepresented in top journals.This gender gap has far-reaching implications. Health and gender are inextricably linked. For example, women and girls are at increased risk of a number of poverty-related and neglected diseases (PRNDs), due both to biology and to nonbiological factors like discrimination and gender power dynamics. Women can also feel disproportionate impacts of illness due to wider consequences like stigma, reproductive, financial, and social effects. To meet the health needs of women and girls and better facilitate the integration of sex and gender considerations at all levels of medical research, it’s imperative that women be better represented in leadership and decision-making ranks within research teams.In recognition of International Day of Women and Girls in Science, which aims to inspire and engage more women and girls in science, GHTC is profiling five fierce female innovators who have transformed global health research.1. Dr. Ruth Bishop, discoverer of rotavirusPhoto: Stepping Stone PicturesAs a young bacteriologist working in the 1970s, Dr. Ruth Bishop was on a quest to find the root cause of diarrheal disease—the most common cause of illness and the second leading cause of death among children worldwide. After much research, Ruth concluded that the disease was likely not caused by a bacterial agent, but instead by a virus. To continue her search, Ruth teamed up with colleagues at the University of Melbourne. In 1973, using an electron microscope, the team uncovered a previously unidentified virus in the biopsy sample from an intestinal lining. Ruth and her team went on to confirm presence of the virus in other samples. Their published results elicited a global response and confirmation of the virus’s presence in samples around the globe. The virus identified by Ruth and her team would come to be named rotavirus for its wheel-like shape. Rotavirus is the leading cause of severe diarrhea in children worldwide and the cause of about one-third of all diarrheal-related child deaths. Ruth and her team subsequently developed a diagnostic test for the rotavirus, and their continued research helped pave the way for the development of a rotavirus vaccine, which was first introduced more than three decades after her initial discovery. Gavi, the Vaccine Alliance, estimates that by 2030, 2.4 million lives could be saved through rotavirus immunization. Ruth is now retired, but her legacy lives on in the millions of children’s lives that have been saved by her discovery.2. Dr. Quarraisha Abdool Karim, pioneered use of antiretrovirals to prevent HIV and research on broadly neutralizing antibodiesPhoto: UNAIDSAs a native of South Africa and infectious disease epidemiologist, Dr. Quarraisha Abdool Karim saw the devastating impact HIV/AIDS was having on her home nation, where one out of every five people in the world with HIV lives. While there were many research efforts focused on fighting the growing epidemic, Quarraisha felt too little attention was paid to the disproportionate burden young women bore in the epidemic and solutions to address that. So Quarraisha and her husband, Dr. Salim Abdool Karim, in 2001 brought together a group of top HIV researchers to form the Center for the AIDS Program of Research in South Africa (CAPRISA), which is today regarded as one of the most influential AIDS research programs in the world.In 2010, CAPRISA completed a landmark study proving for the first time that a microbicide gel, using the drug tenofovir—normally used as an antiretroviral to treat HIV/AIDS—could offer some protection from the virus when used before and after sex. While today the field has moved on to other prevention methods like daily pills and long-acting injectables, this research provided the first proof-of-concept that antiretrovirals could be used to prevent, as well as treat, HIV in women and built the foundation for the approach known today as pre-exposure prophylaxis (PrEP), which is widely used globally to prevent HIV infection. CAPRISA research has also led to the development of “broadly neutralizing antibodies,” after it was discovered in 2012 that an HIV-positive woman in one of the center’s studies produced unique antibodies that not only attacked the strain of HIV she had, but also 80 percent of other known HIV strains circulating globally. The isolation and recreation of these antibodies in a lab has led to a growing field of study that could one day lead to longer-acting HIV treatments and pave the way to the ultimate goal of an HIV vaccine. Reflecting on her career, Quarraisha said, “I’ve spent three decades working on preventing HIV infection in young women. Progress has been made, but it’s far from complete. We need interventions that can meet the diverse needs of vulnerable women.”3. Dr. Kizzmekia Corbett, co-developer of Moderna-NIH COVID-19 vaccinePhoto: University of Maryland Baltimore County/Marlayna DemondAs a high school student growing up in North Carolina, Dr. Kizzmekia Corbett knew she wanted to be a scientist, but it was a chemistry internship program for gifted minority students that put her on the path to becoming one of the US government’s lead coronavirus vaccine researchers at a pivotal moment in history. This high school internship program in lab led Kizzmekia to an undergraduate scholarship to study biology and sociology, which in turn led her to a PhD in microbiology and immunology, which ultimately landed Kizzmekia a research fellowship and then job at the US National Institutes of Health’s (NIH) Vaccine Research Center.It was there, on the coronavirus research team, that Kizzmekia found herself in January 2020 when her team first got word of outbreak of an unknown respiratory disease in Wuhan, China, that would later be identified and known as COVID-19. Kizzmekia and her team quickly got to work on trying to develop a preventative vaccine. Applying earlier research she has conducted on making coronavirus spike proteins stabilized in a way that enables the immune system to mount a stronger response and partnering with the biotech company Moderna to use its messenger RNA (mRNA) platform, the research team was able to advance a vaccine candidate into phase 1 clinical trials just 66 days after the virus sequence was released. In a triumph of science, nine months later, on December 18, 2020, the vaccine was authorized for emergency use in adults by the US Food and Drug Administration. While much unfinished work remains to ensure coronavirus vaccines reach everyone worldwide, Kizzmekia has said of her scientific accomplishments, “To be living in this moment where I have the opportunity to work on something that has imminent global importance…it's just a surreal moment for me.” 4. Dr. Tu Youyou, discoverer of artemisinin, a key ingredient in modern malaria medicinesPhoto: Nobel Prize/A MahmoudDr. Tu Youyou was born into a family that valued education, but it was a two-year battle with tuberculosis at the age of sixteen that inspired her to study medicine, so she could find cures for diseases like the one that affected her. After pursuing a degree in pharmacology, with an emphasis on the study of medicinal plants, Tu went on to work at a newly established academy devoted to studying traditional Chinese medicines applying modern research methods. In 1967, Tu was put in charge of an ambitious Chinese government project to find a new cure for malaria, which had become resistant to chloroquine, the standard treatment at the time.In her quest to find a cure, Tu and her team turned their attention to ancient Chinese medical texts, where the team found reference dating back to around 400 A.D. to the use of sweet wormwood to treat fevers associated with malaria. In 1971, Tu and her team isolated one of the compounds from the plant that they believed to have malaria-fighting properties, but after testing it, saw inconsistent results. The team was about to abandon that line of research when Tu had a vital insight: the extraction process used, which involved boiling the plant in water, could be negatively impacting the compound’s medicinal properties. Tu decided to instead use an extraction method with ethyl ether, which boils at a lower temperature. The results were stunning: the compound showed a 100 percent success rate in animal testing and the first 21 patients it was tested on all recovered.The compound Tu and her team isolated—artemisinin—and its derivatives are the basis of combination therapies that are today the gold standard treatment for malaria. In 2015, Tu was awarded a Nobel Prize for her discovery, which she called “a gift from traditional Chinese medicine to the world.”5. Dr. Monique Wasunna, researcher of new treatments for neglected tropical diseasesPhoto: KfWDr. Monique Wasunna, a native of Uganda, grew up in an era when girls were expected to remain in the domestic sphere, but her father’s belief in the power of education and his commitment to advancing equal gender roles in the household helped her realize she could enjoy a different future. While a teen, Monique’s younger sister became severely ill and hospitalized due to measles, and this experience inspired Monique to pursue a career in medicine.For more than 30 years now, Monique has been working to advance treatments for the world’s most neglected patients, most notably as the former long-serving director of the Center for Clinical Research at the Kenya Medical Research Institute and currently as director of the Drugs for Neglected Diseases initiative’s (DNDi) Africa office. Over the course of her career, Monique has been a principal investigator on numerous clinical trials to find better treatment options for neglected diseases and has spearheaded new partnerships to expand clinical trial capacities in the East African region. Her work with DNDi has helped the organization advance several groundbreaking new treatments for neglected tropical diseases, including an improved, affordable therapy for leishmaniasis, which reduced treatment time from 30 days down to 17, and an all-oral cure for sleeping sickness.Monique believes that health is a human right, and that innovation is vital to delivering better health for all. As the world confronts global health challenges, “the most important thing is that we leave no one behind,” Monique said.For a broader look at the gender-related aspects of PRNDs and how policymakers can improve gender equity in global health research, check out this study from DSW.

Many experts have speculated that 2022 could bring the end of this acute stage of the COVID-19 pandemic. But if this proves true, what our new normal will be, and whether we’ll be better prepared for future crises, will depend on the decisions that our policymakers make in the months ahead. As 2022 begins, here are some of the top policy issues GHTC will be tracking.1. Will we achieve targets to vaccinate the world and what curveballs will COVID-19 still throw our way?What trajectory the pandemic will take in 2022 will depend in significant part on how successful efforts are to vaccinate the world. Last year, world leaders coalesced around a goal of vaccinating at least 70 percent of the world’s population by mid-2022, with an interim goal of vaccinating at least 40 percent of people in each country by the end of 2021. But a number of cascading challenges—from unexpected manufacturing disruptions with key suppliers to surging demand for booster shots in wealthy nations—slowed global efforts. As the year drew to a close, more than 90 countries missed the interim target, with many of the poorest nations in sub-Saharan Africa stuck at single digit vaccination rates. In a glimmer of positive news, the COVAX global vaccine facility delivered a record number of vaccine doses in December, hopefully setting a positive trend for the months ahead. Yet it remains clear there is much lost ground to make up as the year kicks off. Reaching the 70 percent target will require a significant influx of resources to boost manufacturing and overcome on-the-ground delivery and administration challenges, as well as continue research to respond to variants and deliver second generation vaccines better suited for distribution in low-resource settings. While leaders of the world’s richest nations have pledged their support for this global goal, few additional commitments of resources have materialized and nearly three-quarters of promised dose donations have yet to be shipped as of December. GHTC will be watching closely in 2022—particularly as President Joe Biden is expected to host a follow-up COVID-19 summit in March—to see whether the world embraces new urgency and accountability to close these gaps. As we’ve seen with the delta and omicron variants, COVID-19 could also still throw some unexpected curveballs our way that could upend existing efforts. 2. Will reams of recommendations turn into meaningful multilateral reforms?One might call 2021 the year of recommendations as several eminent groups, including the Global Preparedness Monitoring Board, the Independent Panel for Pandemic Preparedness and Response, and the G20 High Level Independent Panel on Financing the Global Commons for Pandemic Preparedness and Response, issued reports recommending actions to reduce the world’s vulnerability to pandemic threats. This included several significant proposed reforms to the existing multilateral architecture, including establishing a new Global Health Threats Council to elevate preparedness to the highest level of political leadership, creating a new financial intermediary fund or financing facility at the World Bank to support countries in strengthening their preparedness capacity and to finance surge response during a crisis, making permanent a structure like the Access to COVID-19 Tools Accelerator (ACT-A) to support end-to-end product development for epidemic threats, and advancing a pandemic treaty or framework convention on health preparedness to reform or build upon existing International Health Regulations. Now it remains to be seen whether 2022 will turn into a year of action to make these reforms a reality. GHTC has long advocated that research and development (R&D) is an essential pillar of health preparedness. As these discussions advance, we will be monitoring closely to see how ACT-A evolves and pushing for any such international agreement or financial fund to support countries in strengthening their research and manufacturing capacity.3. Will the US COVID-19 spending spigot still flow in 2022?During the first year of the pandemic, policymakers in Congress seemed willing to throw unlimited money at the problem, passing a series of huge emergency spending bills to finance response efforts and cushion the pandemic’s reverberating economic impacts in the United States—though money for the international response was slower to arrive and lower than advocates and experts recommended. Now that we’re nearly two years into this crisis, many are asking whether Congress has hit pandemic spending fatigue or whether the spigot will still flow. The last major emergency supplemental funding package—the American Rescue Plan Act (ARPA)—was signed in March 2021, more than ten months ago. But the need for additional resources seems as acute as ever as 2022 begins. On the domestic front, omicron is overwhelming US hospital systems and fueling increased demand for tests and boosters, while on the global front, reports are the US Agency for International Development (USAID) is fast running out of resources, as it has already spent or earmarked most of the money it received through ARPA to support global vaccination and response efforts—just as a significant influx of vaccine doses are finally arriving in partner countries and the international response is entering its most operationally intensive phase yet.Political observers are now watching closely whether Congress will put together a new emergency funding package, possibly pairing it with the regular fiscal year (FY) 2022 spending bills that it must pass before the continuing resolution now funding the government expires on February 18. As these talks advance, global health advocates are pushing for any such package to include substantial resources to replenish the coffers of USAID, the State Department, and the Centers for Disease Control and Prevention (CDC) to lead the international response.4. How exactly will the United States build back better for global health innovation?While congressional policymakers spent 2021 largely in emergency response mode, as the new year begins, many are looking to the future of how we can strengthen US agency programs for health preparedness, as well as build upon the research successes and gaps illuminated by COVID-19. Several pieces of legislation are expected to advance this year, which could significantly transform our health innovation infrastructure.For example, the Senate Health, Education, Labor and Pensions Committee is formulating a new pandemic preparedness bill that will look at retooling and refining the capabilities of several Health and Human Services agencies, potentially including the Biomedical Advanced Research and Development Authority (BARDA). This federal agency, which is responsible for developing medical countermeasures against health threats, went from obscurity to a household name during the pandemic as it was entrusted with an influx of emergency funding more than 40 times its annual appropriated levels to advance COVID-19 vaccines, treatments, and tests. GHTC has long advocated 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. Much of the agency’s work on EIDs has been funded via unsustainable “boom and bust” cycles of emergency funding appropriated only after a crisis has begun. This pandemic preparedness legislation opens fresh opportunity for Congress to authorize such a permanent funding line to fuel sustainable, proactive preparedness research.Additionally, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) are advancing bipartisan legislation dubbed Cures 2.0, a follow-up to their 2016 21st Century Cures Act, which among other things would authorize a new Advanced Research Projects Agency for Health (ARPA-H). Modeled after the Defense Advanced Research Projects Agency, this new federal agency would seek to speed the development of medical innovations by funding high-risk, high-reward projects not likely to be advanced by traditional commercial research activities. Given this goal, the agency’s work could encompass research on poverty-related and neglected diseases, a recognized area of market failure. But at the moment, ARPA-H is more of rough concept than a fleshed-out proposal. As Cures 2.0 advances, much will need to be worked out as to what the agency’s research scope will actually include; whether it will be housed within the National Institutes of Health as President Biden has proposed or as a separate entity as some stakeholders have advocated for; and how much money congressional appropriators will be willing to pony up for this new unproven agency.Alongside these legislative efforts, GHTC has also recently unveiled a proposal for the creation of a new catalytic fund at USAID to drive global health innovation, called the Supporting Innovative Global Health Technologies (SIGHT) Fund. Such a fund would allow USAID to supercharge its existing work to advance inclusive innovations for low-resource settings, as well as reverse a declining trend in the agency’s spending on R&D as a proportion of its global health budget. As the year continues, GHTC will seek to advance this proposal with policymakers in Congress and the agency.5. Will calls to decolonize global health be codified into policy and practice?Calls to decolonize global health gained steam last year as the world bore witness to the gross inequities in access to COVID-19 vaccines and other tools between rich and poor nations, and here in the United States, the Black Lives Matter movement forced Americans to reckon with our nation’s history of racism past and present. While many leaders in the global health and development field now recognize the need to correct long-standing power imbalances rooted in the colonial era, individual organizations—from nongovernmental organizations to international institutions to development agencies—are grappling with how to translate this goal into policy and practice. Here in the United States, new USAID Administrator Samantha Power, in one of her first public addresses in November, laid out her vision for a new era of “inclusive development” at USAID. This included targets to direct at least a quarter of USAID funding to local partners within the next four years and by the end of the decade to have 50 percent of USAID programming have in place “local communities in the lead” who are responsible for codesigning, implementing, and evaluating programs. As 2022 continues, the global health community will be watching closely how Administrator Power’s vision leads to concrete changes in programs and practices at the agency.6. Will funding for other global health areas grow to match evolving needs?Much has been documented about how the COVID-19 pandemic has set back progress in other areas of global health, from disrupting routine immunization programs and reliable access to HIV and tuberculosis drugs to increasing the cost and complications of conducting research and clinical trials. The common refrain from health practitioners is that more resources are needed not just to respond directly to COVID-19, but to shore up other vital global health programs to protect fragile progress. Here in the United States, we’ll be watching whether congressional appropriators take this need to heart in 2022 as they finalize FY 2022 spending bills and begin work on FY 2023. Outside of programs focused on health security, most global health-related funding lines at the CDC, State Department, and USAID have been flat-funded in recent years, in practice decreasing their purchasing power as COVID-19 has only increased the cost of doing business. As every country worldwide is feeling the weight of the latest omicron-fueled surge, the first few days of 2022 have unfortunately felt much like “2020, two.” But as the year continues, it is our hope the pandemic will turn a corner and that policymakers will embrace lessons learned from this crisis to ultimately usher in a healthier, safer, and more equitable world for all.

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.