Julien Rashid

The US Agency for International Development (USAID) released a new report on its global health research and development (R&D) programs for fiscal year 2022 that includes unprecedented insight into the product development programs the agency supported—and highlights the need for additional, dedicated resources for global health research.Why it matters: The report gives insight into an agency that is a key sponsor of global health product development.Due to a lack of commercial incentive for industry investment, most global health research is supported by public funders, most notably the US government.Several US agencies support global health research, but USAID is the only agency with a mandate to improve global health and development. The agency excels at pushing products through the end of the research pipeline and advancing tools to suit the needs of people in low-resource settings.What’s new: This report includes an unprecedented 13-page appendix detailing USAID’s individual product-level investments. By our count, USAID supported at least 59 products in 2021 covering multiple health areas and product types.By the numbers: In 2021, USAID spent US$165 million in baseline funding and $50 million in COVID-19 supplemental funding on health product development and research to assess the best way to implement new products and practices.Research spending from baseline funds increased slightly over the prior year (+$4 million) — but continued to decline as a proportion of total global health spending. In 2021, proportionate spending on research dropped slightly to 5.1 percent, continuing a years-long pattern. If the trend continues, GHTC estimates that proportionate spending on R&D will drop to 4.2 percent by 2026 unless Congress passes a policy like the Supporting Innovative Global Health Technologies (SIGHT) Fund to direct more dedicated funding to R&D.Our take: GHTC applauds the release of the report and the additional detail provided by USAID. We call policymakers’ attention to the continued need for additional, dedicated resources for global health research at USAID that this report exposes.

On Friday, President Joe Biden signed into law a US$1.7 trillion spending bill that will fund the US government through fiscal year 2023 (FY23), which ends September 30, 2023. The package includes significant funding increases across nearly every line relevant to global health research and development (R&D), as well as complementary directives that will support global health R&D across several agencies.How it passedUntil mid-December, the outcome of the spending package was still uncertain. Many Republicans in the House and some in the Senate were hoping to see a continuing resolution—a stopgap measure to postpone negotiations—into next year when they would hold more leverage with control of the House. Top House appropriator Rosa DeLauro (D-CT) responded by threatening to only pass a full-year resolution if no progress was made. As talks froze, Democratic lawmakers turned up the tension forcing a breakthrough weekend negotiation in early December. A few more bumps laid in the way, especially in the Senate, where energy permitting reform and Title 42 amendments were set on the table but ultimately shoved away, clearing a last-minute path for passage.New fundingPassage of the bill is mostly great news for global health R&D. Nearly every funding line across the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), the US Agency for International Development (USAID), and the State Department relevant to the sector has increased. Some notably large increases include:A 10 percent increase for universal influenza vaccine research at the National Institute of Allergy and Infectious Diseases (NIAID).A 50 percent increase for the Advanced Research Projects Agency for Health (ARPA-H).A 10 percent increase for NIH’s Fogarty International Center.A 9 percent increase for CDC.A 7 percent increase for the CDC Center for Global Health.A 9 percent increase for the CDC National Center for Emerging and Zoonotic Infectious Diseases.A 21 percent increase for global tuberculosis programs at CDC.A 16 percent increase for Global Public Health Protection at CDC.A 26 percent increase for BARDA.A 28 percent increase for the Global Fund to Fight AIDS, Tuberculosis and Malaria.A 7 percent increase to USAID global health programs, of which most goes to a 29 percent increase for global health security at USAID.New directivesIn addition to funding, spending bills are passed with corresponding plain-language texts called bill reports. which include directives from Congress. These reports do not hold the same legal power as the spending bills themselves, but they are a way for Congress to urge or direct agencies to change their policies or to spend their funding in specific ways. Nearly all GHTC’s requests for report language to Congress were reflected in the final FY23 package (either through the House bill reports or the joint explanatory statements, for those keeping count). Some notable wins include:Direction for USAID to increase health-related R&D funding and to consult with representatives of affected communities, as well as technical experts and nongovernmental organizations specializing in biomedical product development (House report).General continued support for USAID’s role in health-related R&D (House report).Requirement for USAID to submit a report on its health-related R&D investments (joint explanatory statement; also includes request for details on investment in antibiotic research).Request for an update from the Department of Health and Human Services on coordinating global health research activities using metrics (House report).Recognition of the need to increase resources for NIH’s Fogarty International Center and expand their role in pandemic preparedness and health research capacity-building (House report).Support for CDC’s role in global health security and developing and validating new global health tools (House report).Support for BARDA to provide robust funding for emerging infectious diseases and naturally occurring threats to global health security and to account for the constraints of low-resource settings in the development of new products (joint explanatory statement).Urges BARDA to publicly and regularly report on pathogen-, product-, and project-level data for all its funding (House report and joint explanatory statement).Relevant RidersThis year’s package also included quite a few riders—bills less relevant to funding that were amended onto the omnibus package. Nearly all elements of the PREVENT Pandemics Act were attached, including:Authorization of ARPA-H as a new entity within NIH. Despite its technical placement under NIH, the accompanying report language encourages ARPA-H to be physically and culturally separated. The authorization includes prioritizing awards to entities that conduct their work in the United States (a provision that GHTC has opposed).Establishment of a NIAID-BARDA “multidisciplinary research program with research centers to advance the discovery and preclinical development of antivirals and other medical products to combat priority virus families.”Expansion of the FDA fast-track designation for new antimicrobials that are biologics.The bill also includes several amendments to the US Food and Drug Administration (FDA) that had been dropped from the FDA user fees negotiations earlier this year. These include:Requesting a Government Accountability Office report on nonprofit pharmaceutical organizations, including the “impact of such organizations on the development, availability, and cost of prescription drugs, and any challenges to manufacturing or other operations.”Establishes a pathway for accelerating the review of advanced manufacturing technologies that either combine or incorporate novel technologies or techniques for manufacturing drugs, biologics, or active pharmaceutical ingredients.Requires sponsors of new drugs and devices to submit diversity action plans for clinical trials (exceptions permitting).Requires FDA to convene wide stakeholder meetings to solicit input on “increasing the enrollment of historically underrepresented populations in clinical studies.”Requires FDA to submit a report to Congress on progress for diversity action plans in aggregate.Requires FDA to issue guidance on decentralized clinical studies for drugs and devices and “how to advance the use of flexible and novel clinical trial designs” to increase diversity of participants.Requires FDA to issue guidance on the use of digital health technologies in clinical trials.In summaryDespite the delay, GHTC applauds lawmakers for passing increased funding, smart report language, and riders that will strengthen global health security and medical product regulation. The FY23 omnibus package is a significant win for most global health and global health research programs. Many pundits predict that in the next Congress we are less likely to see similar funding increases given the split control. Regardless, GHTC looks forward to working with offices on both sides of the aisle to advance bipartisan priorities for global health R&D.

The 2022 midterm elections on November 8 were expected to deliver a decisive power flip from Democrats to Republicans. However, as the new landscape comes into focus, it appears that Democrats will hold the Senate, and Republicans are likely to win the House of Representatives by a handful of seats. These margins and the composition of new committees will determine the trajectory of global health research and development policy over the next two years.Both chambers on a knife edge splitRepublicans underperformed most analysts’ projections in both chambers. In the House, they are expected to eke into power by only a handful of seats. In the Senate—where several Republican candidates failed to overtake their competitors in close races—Democrats have retained control and may even net gain one seat, depending on the outcome of a special runoff election in Georgia on Tuesday, December 6, between incumbent Senator Raphael Warnock (D) and Herschel Walker (R).Implications on makeup of key committeesNext steps for both parties include electing new party leaders, which is expected to happen later this year. Following that, early next year, the parties will designate committee assignments, which will impact oversight and policymaking for the next two years of global health research. In the House, committee majorities will be determined by who holds the majority in the full House. In the Senate, if the final split is 50-50, then committees will also be evenly split. But if Senator Raphael Warnock wins his reelection in Georgia, then the Senate will be 51-49, and Democrats will take the majority on each committee with one extra seat.Though we do not yet know exactly how the committees will look next year, we do know which members from the 117th Congress will return to the 118th and which current members will be stepping down.Leadership of most committees relevant to global health research and development (R&D) are expected to remain relatively stable with top Democrats and Republicans trading positions as chairs and ranking members. Some exceptions include Representative Karen Bass, chairwoman of the Subcommittee on Africa, Global Health, Global Human Rights and International Organizations, who is stepping down in pursuit of becoming the next mayor of Los Angeles and Rep. Hal Rogers (R-KY), ranking member of the House Appropriations State, Foreign Operations, and Related Agencies Subcommittee, who may become chair of the subcommittee or may be replaced by Rep. Mario Diaz-Balart (R-FL).Among the members currently serving on the House Foreign Affairs Committee who have retained their Congressional seats are Reps. Susan Wild (D-PA), Maria Elvira Salazar (R-FL), Young Kim (R-CA), and Abigail Spanberger (D-VA). Members who were defeated include Reps. Tom Malinowski (D-NJ) and Steve Chabot (R-OH). Some other members of Congress on relevant appropriating and authorizing committees to global health research who are retiring or lost their primaries earlier this year include Reps. Albio Sires (D-NJ), David Price (D-NC), Lucille Roybal-Allard (D-CA), Cheri Bustos (D-IL), Jaime Herrera-Beutler (R-WA) and Fred Upton (R-MI). In the Senate:There were no major losses among incumbents on the Foreign Relations Committee; Health, Education, Labor, and Pensions (HELP) Committee; or the Appropriations Labor, Health, nor on the Human Services, Education, and Related Programs (LHHS) and State and Foreign Operations subcommittees. Some big names will be retiring, including Sens. Richard Shelby (R-AL), ranking member on the Appropriations Committee; Roy Blunt (R-MO), ranking member on the LHHS Subcommittee; Richard Burr (R-NC), ranking member on the HELP Committee; and Rob Portman (R-OH).Some leadership changes are expected. Sen. Patty Murray, previous chair of the Senate HELP Committee, is expected to become the head of the Senate Appropriations Committee. The Senate HELP Committee will likely be led by Sen. Bernie Sanders (I-VT) and Sen. Rand Paul (R-KY) or Sen. Bill Cassidy (R-LA). The Senate LHHS subcommittee may be led by Sen. Joe Manchin (D-WV) and Sen. Marco Rubio (R-FL). Both 2022 GHTC Innovating for Impact award winners, Sen. Sherrod Brown (D-OH) and Sen. Todd Young (R-IN) retained their seats.  A potentially challenging landscapeWith Democrats elected to retain control of the Senate in the 118th Congress, leadership in both parties of the current Congress may be more interested in passing an end-of-year funding package so that the 118th Congress can begin with a clean slate. The same may not be true next year, though. If Republicans have a slim majority in the House as projected, it could empower more conservative members to dangle threats to regular governance, such as annual passage of an appropriations package, as bargaining chips—a threat some members have already referenced. Such a dynamic may also lead to hardball negotiations over raising the debt ceiling, a final agreement on which is due in July of next year. Ultimately, these dynamics could limit the potential for global health R&D funding growth in the next two years, despite the need for greater resources. Beyond the funding picture, if Republicans win control the House, they plan to increase oversight over many US government agencies, including several public health and research agencies such as the National Institutes of Health and the Centers for Disease Control and Prevention. Oversight over the executive branch is a critical function of Congress, but aggressive oversight can also threaten the basic functioning of these agencies as staff efforts are redirected. This could ultimately impact the pace of progress for global health research and science in general.Looking aheadGlobal health R&D has historically received bipartisan support, yet this will be the first Congress to be seated after the COVID-19 pandemic, a global health catastrophe that has provoked some policymakers to question the value of certain types of research and the global health status quo. The results of this election are still being finalized, but regardless of who is in charge, there will remain opportunities for crafting and passing good policy. Whether progress happens and at what pace will largely depend on the ability of advocates to make the bipartisan case for why global health R&D is a force multiplier for creating a healthier and safer future for Americans and all global citizens.  

The first annual progress report on the American Pandemic Preparedness Plan (AP3), released earlier this month by the White House Office of Science and Technology Policy (OSTP), builds on the initial AP3 published by OSTP in September 2021 and frames global equity as a keystone of research and development for pandemic preparedness. GHTC applauds the report while acknowledging significant funding and political will are critical to achieving its objectives.The annual report’s emphasis on global equity in product development represents a significant and growing shift in the many plans, frameworks, and strategies issued by the US government to support pandemic preparedness over the past few years. It resonates, for example, with the recently released five-year strategic plan for the Biomedical Advanced Research and Development Authority that includes a greater focus on working with global partners and developing products for diverse populations living in different contexts.Early in the pandemic, the success of many research efforts was defined by the safety, effectiveness, and speed at which a product could be developed. Fortunately, those efforts led to safe and effective first-generation products that were quickly implemented in places with strong health care systems, such as Washington, DC, and Houston, Texas. What was missing, however, were safe and effective first-generation products that could easily meet the needs of people living in places where there are fewer resources, both in the United States and in many other countries. For example, in places with poorly funded health care systems, few highly trained health care workers, and limited refrigeration, it can be especially challenging to access, rapidly distribute, and administer millions of intramuscular vaccines that require ultracold storage.An important part of global health equity is developing products that are designed for and with the communities that will use them. This is true even in pandemic emergencies, and so GHTC advocates for pandemic preparedness research agendas to prioritize the needs of communities in low-resource settings. Safety, effectiveness, and speed are critical—but deliverability, availability, affordability, and ease of administration cannot be afterthoughts saved for the development of second- or third-generation tools.Some language in the AP3 annual progress report aligns with this vision. While the initial AP3 recognized that “vulnerable communities” face the greatest risk in public health emergencies and that the United States must work to strengthen global research systems and coordinate with global research partners, the new report goes further. Its executive summary states that “scientific and technological advances must be paired with public engagement, trust-building, and recognition and resolution of previous harms and challenges in public health.” The report goes on to recognize that for future responses, medical products need to be developed simultaneously with community engagement processes.Perhaps the most significant items in the new report are the key goals that weave in global health and the development of products that are designed for low-resource settings. The goals include:Exercising pandemic preparedness by “addressing infectious and global health challenges” such as influenza, antimicrobial resistance, and other infectious disease threats.Strengthening clinical trial networks and “warm base” research globally to develop next-generation vaccine technologies, therapeutics, and diagnostics, especially in “geographic regions most likely to see emergence of pathogens of pandemic potential.” Supporting diversified manufacturing for vaccines in low- and middle-income countries (LMICs).Developing vaccines that are easier to administer, more efficient to produce, and provoke a broader immune response. Strengthening national regulatory systems in LMICs to facilitate vaccine production. Supporting health care technologies that can be used at home and in remote locations. Developing a better understanding of global product manufacturing capacity and global investments to inform investments in essential medical product manufacturing in LMICs.Developing multiplex, “pathogen-flexible,” and “pathogen-agnostic” diagnostic tests and minimally invasive, simple-to-use diagnostic tests.It must be noted again, however, that although the AP3 annual report outlines laudable goals and provides a strong signal of White House priorities, for many of its goals to be achieved, Congress would need to provide additional funding and authorizations, which GHTC would support.Despite its limitations, the report is a step toward more equitable research agendas for product development and pandemic preparedness. Further US government commitments to such principles would go a long way toward ensuring that in future health crises, those in low-resource settings are not left behind and are able to quickly and equitably benefit from the development of new tools to protect and restore health.

COVID-19 is an unprecedented global health crisis. Just as every sector is grappling with unforeseen challenges, global health advocacy has been continuously adapting to a policy environment in flux. As part of this community, the Global Health Technologies Coalition (GHTC) has been responding by:Reporting on the latest developments in COVID-19 research and development (R&D).Tracking COVID-19’s impacts on the R&D ecosystem.Sharing key US and multilateral policy updates with our members and partners.Developing and advancing specific policies that would drive creation of new tools for countering COVID-19 in low-resource settings, especially in low- and middle-income countries (LMICs).GHTC applauds many of the actions taken by lead US policymakers over the last several months. Congress has appropriated more than $10 billion for research to respond to COVID-19 through four emergency supplemental bills, and this funding is driving high-impact innovation at record speed. Yet many of the new products that result from this innovation will be ill-suited for low-resource settings, which often lack electricity, adequate hygiene, highly trained health care workers, laboratory networks, robust supply chains, and other attributes often taken for granted in well-resourced systems. For these settings, we need different innovations:Drugs that are easily transported and administered without the need for highly trained health workers.Rapid diagnostic tests that can deliver results at point of care without using complex laboratory equipment.Vaccines that are single dose, can be stored at room temperature, can be rapidly produced and distributed, and are easily administered (ideally through ingestion, a patch on the skin, or an electrical pulse rather than an injection). Medical devices, such as specially designed non-invasive ventilators, IV infusion monitors, and oxygen delivery devices, that require minimal technical expertise, have fewer and more easily replaceable parts, are quickly manufactured, and are battery operated.Personal protective equipment that is durable, reusable, open-source, and can be quickly manufactured and adapted in a variety of settings.Through our US and multilateral policy efforts, GHTC has been advocating for policies that would foster these needed products. In our US advocacy, we are pushing Congress for three funding lines that would drive innovation at the US Agency for International Development (USAID), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Centers for Disease Control and Prevention (CDC):$200 million for Global Health Programs at USAID to advance and deliver innovations to help LMICs prevent, prepare for, and respond to COVID-19 and other pandemic threats. These innovations should be specifically designed for low-resource settings and should include vaccines and vaccine delivery systems; diagnostics; therapeutics; medical devices; personal protective equipment for frontline health workers; health facility innovations; and the financing, manufacturing, and delivery systems these essential resources require.At least $200 million to CEPI to advance vaccine candidates for SARS-CoV-2. CEPI is advancing nine vaccine candidates and has put forward a $5 billion global ask to advance this portfolio. US support for CEPI will help ensure that vaccines developed will be deployed effectively and affordably worldwide.Robust funding for the CDC Center for Global Health and National Center for Emerging and Zoonotic Infectious Diseases to support the development and deployment of essential tools to combat COVID-19 globally.In our multilateral advocacy, GHTC has been pushing back against the United States’ retreat from international leadership on COVID-19 R&D, including the decision to withdraw from the World Health Organization (WHO) in the middle of the pandemic. GHTC advocates that the United States should work with other global leaders to proactively invest in global product development, manufacturing capacity, and product delivery mechanisms, including the Access to COVID-19 Tools (ACT) Accelerator, which could be instrumental in helping LMICs finance the purchase and administration of COVID-19 vaccines, treatments, diagnostics, and other tools. GHTC has also been pushing other G7 and G20 leaders to fill the funding gaps for the ACT Accelerator and to support other financing mechanisms such as a World Bank global health security challenge fund and health systems strengthening investments by regional development banks.GHTC is also engaging with the Global Health Security Agenda (GHSA) and pushing for the explicit inclusion within GHSA of R&D for diagnostics and medical countermeasures to respond to emerging health threats.Finally, GHTC has been working with other global stakeholders to assess how new COVID-19 product development and deployment mechanisms could be used to reshape the global R&D ecosystem and benefit other critical global health priorities.To support our US and multilateral policy asks, GHTC is tracking US government and multilateral-supported COVID-19 R&D, publishing materials to help policymakers and the public better understand these research efforts, and leading and supporting our partners with aligned messaging:GHTC COVID-19 R&D Tracker [Editor note: This was discontinued in 2021]COVID-19 Vaccine 101: The Facts that MatterGHTC maps the US agencies involved in Global Health Security R&DGHTC-led Congressional letter to support R&D for the international responseGHTC featured in Global Citizen: “To Defeat COVID-19, the United States Must Invest in Innovations for All”GHTC defends WHO’s role in global R&D response to COVID-19GHTC condemns US withdrawal from WHOGHTC endorses FIND’s Call to Action on COVID-19 testingThis is the first global health crisis in this century to significantly affect every person living in the United States and around the world—a catastrophe that could raise awareness and support for global health R&D. GHTC will continue to leverage this moment and emphasize the narrative that links all the issues we work on, that global health and global health security can never be assured until we have a robust, coordinated, and global R&D ecosystem that includes the populations, diseases, and conditions too often overlooked.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. The US Department of Defense is providing US$71 million for increased production of Inovio Pharmaceutical’s Cellectra devices—small, hand-held tools that are used to deliver Inovio’s vaccine candidate, INO-4800, directly to the skin without the use of needles. The device works by using a small electrical pulse that enables the DNA-based virus to pass into the recipient’s skin. Cellectra operates on AA batteries, and it is designed to "function reliably in challenging environments and can be stockpiled in large quantities without maintenance.” The vaccine, INO-4800, is expected to remain effective for up to one year in room-temperature storage. These durable qualities could make this vaccine system effective for low-resource settings. Inovio expects to begin a phase 2/3 trial in July. On Wednesday, the University of Oxford launched the first clinical trial in Africa of a COVID-19 vaccine. The vaccine being evaluated, AZD1222, was invented at the University of Oxford and is being developed in partnership with AstraZeneca. The trial is being conducted in South Africa, which has 120,000 of the continent’s 340,000 total cases. It represents a key moment for a continent that has so far been elbowed out of the global competition for medical supplies during the pandemic. Africa Centers for Disease Control and Prevention Chief John Nkengasong said, “unless we act now, Africa is at risk of being left behind on the global vaccine.” Others noted that several African countries have clinical trial capacities to contribute to global research and development. The University of Oxford is also running trials of AZD1222 in Brazil and Britain.Remdesivir, the first drug to demonstrate a benefit for treating COVID-19, has so far been delivered intravenously but will now be evaluated in an inhalable form in clinical trials. The inhalable version will be delivered via a nebulizer, a tool commonly available in the United States. Scientists at Gilead, remdesivir’s sponsor, hope that the availability of nebulizers will make it easier to use remdesivir at earlier stages of infection, such as when a patient tests positive but is presymptomatic. While delivering remdesivir as an inhalant may help overcome some of the limitations of intravenous delivery, it may also present other issues. Some physicians are worried that using a nebulizer could enable the spread of viral particles, and at improper doses, remdesivir can be toxic.