Research Roundup: HIV prevention option safe in pregnancy, Pharmacy-based COVID trial, New RSV monoclonal antibody

How we got hereSince the earliest days of the House Republicans’ current position in the majority, health agencies like the US Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) have been called to testify multiple times before the House Committee on Energy and Commerce (E&C). E&C has used its power as the authorizing committee for domestic health agencies to hold hearings, issue subpoenas, and file reports on what Republican lawmakers perceive as failures of—and a lack of transparency of—public health agencies. More recently, in the committee, there has been a crescendo of opposition to NIH’s status quo—often focused on the work of the National Institute of Allergy and Infectious Diseases (NIAID) and its staff.With that in mind, GHTC and the global health community were prepared for either new legislation or reform plans targeting NIH. Sure enough, E&C, under the leadership of Chair Cathy McMorris Rodgers (R-WA), released a proposal in June to overhaul NIH by restructuring the agency and redirecting the mission of the institutes back to what House Republicans believe should be NIH’s focus. The proposal was outlined in a report and further explained in an op-ed coauthored by E&C Chair Rodgers and Robert Aderholdt (R-AL), Chair of the Labor, Health and Human Services, Education and Related Agencies (LHHS) Appropriations Subcommittee, which oversees NIH funding, signaling Chair Aderholdt’s support of the proposed framework.Later that month, the House’s fiscal year 2025 (FY25) LHHS bill was released, incorporating the newly proposed NIH framework. Rather than go through the typical process of advancing authorizing legislation, House Republicans attempted to put into effect a new NIH structure through the appropriations process. This process signaled House Republicans’ serious intent to reform NIH, even though there is little likelihood that these currently partisan priorities would ever be enacted in the final version of the LHHS bill since the Democrat-controlled Senate and White House must pass it.The frameworkThe proposed framework takes several key Republican talking points and applies them to NIH’s structure, mission, and processes. These broad buckets of change have implications across the entire NIH system, notwithstanding other new rules concerning how many grants a principal investigator can hold and how much overhead research organizations can claim. Here is a quick walk-through:Structure: The framework takes the 27 institutes of NIH and the (currently independent) Advanced Research Projects Agency for Health (ARPA-H) and consolidates them into 15 new institutes. This consolidation reflects a key Republican talking point that health agencies have gotten too large and cumbersome to effectively collaborate internally, which takes them further away from the core missions of the institution.Mission: The framework proposal persistently condemns demographic- and disease-based research and urges a focus on “the whole individual and all populations across the entire lifespan” instead.  Processes: One issue E&C Republicans have been laser focused on is accountability and transparency concerning what and who NIH funds. The framework proposes a heightened degree of oversight on grants and a stricter set of rules for NIH leadership.Of course, proposals to reform and make a more efficient agency are not without merit, but the context in which they were proposed has left some in the advocacy community with many questions. For example, before the pandemic, on the Hill, NIH generally received bipartisan support for its work and typically unquestioned budgetary increases to maintain its status as the global leader in biomedical research. However, since the pandemic, these issues of NIH consolidation, reconsidering demographic-based research, and heightened transparency have been targeted for what is seen by the advocacy community as a political issue, fueled by the fallout from COVID-19.Global health and the frameworkWhen it comes to the global health implications of the proposal, the issues are vast but also technically speculative, solely based on what we know from E&C and House Republicans’ past comments on the future of NIH and their stance on infectious disease research in the wake of the COVID-19 pandemic. The potential implications are as follows:NIAIDOne of the most intriguing developments is the splitting of NIAID, the world’s largest funder of global health research and development (R&D), into the National Institute of Infectious Diseases (NIID) and the National Institute of the Immune System and Arthritis. This fracturing of NIAID is seen as a direct response to the scrutiny that NIAID and its previous director, Dr. Anthony Fauci, have faced for the institute’s infectious disease work. While there may be good arguments for having an institute expressly focused on infectious diseases, this move also has the appearance of utilizing legislative powers and abilities to purposefully single out a critical line of work in global health at NIH, thus making it more susceptible to political pressures and perhaps more vulnerable to cuts in appropriations. This raises natural questions around process—why use this process at this time versus a more vetted and strategic process and why now.Additionally, the schism may disrupt the immunity and infectious disease research conducted at NIAID. Research into pathogens with pandemic potential, neglected diseases, vaccines, antimicrobial resistance, and even long COVID are all issues that intertwine with infectious disease work and work on the immune system. This break in the institute might disrupt or complicate ongoing efforts to combat important disease threats at home and abroad.If this piece of the framework were to be enacted in any way, NIAID advocates would have to take a closer look at the division of resources at the two new institutes to better understand how the work will be distributed and how the research will be financially impacted. From there, advocates will have to work with congressional colleagues to ensure that the infectious disease work at NIID remains independent but is conducted safely through consultation with researchers and advocacy organizations.FICIn the restructuring proposal, the Fogarty International Center (FIC) is lumped together with unrelated and domestic-facing institutes into the National Institute on Health Sciences Research. FIC acts as the global health focal point at NIH and has trained a vast network of around 8,500 professionals from 132 countries in public health threat response, many of whom have gone on to hold high-ranking academic and government positions. By placing FIC with unrelated institutes under the umbrella of “Health Sciences Research,” Congress would minimize its position in global health leadership and would mischaracterize FIC’s core mission and value added to the NIH ecosystem.If these changes were enacted, the onus would be on the advocacy community to make sure FIC is seen as an integral player in the US global health apparatus and to US global health security. In the 2018 President’s Budget Request and the FY25 House LHHS appropriations amendments process, there have been proposals to zero out FIC, leaving advocates understandably on alert for this potential restructuring.ARPA-HAs was alluded to before, in the framework, ARPA-H is moved under NIH’s leadership and merged with other institutes into a new National Institute on Innovation and Advanced Research rather than serving as an independent incubator for next-generation research. If ARPA-H begins operating under NIH’s topline appropriation, this would likely lead to a shrinking budget for ARPA-H—as was seen in the House’s FY25 LHHS bill.These cuts should be a warning sign to any research that exists outside the US-facing work ARPA-H is set to conduct. ARPA-H’s recently built-out Office of International Affairs and potential for global reach will likely be diminished as available resources dry up because of NIH’s primarily domestic mandate and competition for budgets.If the framework were to be enacted and ARPA-H did fall under NIH’s jurisdiction, global health advocates would need to strengthen their messages on ARPA-H's potential for global health research and needed funding. The next-generation innovation the advocacy community hopes to see out of this new agency is only possible if the appropriators sustain past funding levels, even if it rests within a restructured NIH.Going forwardGHTC wants to see a strengthened and streamlined NIH and agrees that improvements can be made to structures and systems, provided that the ultimate goal is to have an empowered, strategically structured, and well-resourced NIH. That way, the institutes can take on the global health R&D demands and challenges of the future that will result in greater innovation for vaccines, therapeutics, and diagnostics.In the wake of the release of this proposal, GHTC is focused on advocating for strengthening NIH’s global health R&D capacity and working with congressional colleagues on a path forward for NIH that reforms what can be improved and doubles down on what is already working. The global health impacts of NIH’s work are expansive, but in the framework, they are less obvious and require a closer look at the current political landscape and how global health-related issues are divided up at NIH.GHTC is hopeful that our colleagues on and off the Hill will work together to strengthen NIH’s global health impact.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A team led by US Food and Drug Administration researchers last week published findings suggesting that three vaccines, already approved and stored in the Strategic National Stockpile, targeting earlier H5N1 clades that circulated in the early 2000s could provide some cross-neutralizing antibodies against the currently circulating 2.3.4.4b clade, which continues to infect dairy herds and some farm workers across the United States. Federal officials are already implementing a plan to produce 4.8 million doses of an updated vaccine targeting the current clade, with the first doses expected to be delivered this month, but, before being administered to people, the shots would still need to get regulatory approval. These new study results offer hope that the old vaccines could provide some protection if there is a need to start vaccinating humans before the updated vaccines become available.Recently published results from a Phase 2 clinical trial conducted in Sudan by the Drugs for Neglected Diseases initiative and the Institute of Endemic Diseases at the University of Khartoum found promising results for a new and improved treatment for people with post-kala-azar dermal leishmaniasis (PKDL), a serious condition that can develop after treatment for visceral leishmaniasis. The current treatment for PKDL is an injectable drug given for two to three months, which can cause life-threatening toxicity and must be administered under close supervision in a hospital. The new treatment is safer, shorter, cheaper, more effective, and more patient-friendly, only requiring patients to be admitted to the hospital for 14 days followed by an oral treatment that can be completed at home, offering hope of a new and improved tool for PDKL for affected populations, like in Sudan where nearly 20 percent of patients treated for visceral leishmaniasis will develop PKDL within six months post-treatment, the highest rate worldwide.The Sabin Vaccine Institute and the Makerere University Water Reed Project recently launched a Phase 2 clinical trial testing Sabin's vaccine against Sudan ebolavirus, which can cause deadly disease, as seen in the recent outbreak in Uganda that ended only last year. Although Sabin’s vaccine was one of three candidates chosen to be included in a trial during the outbreak, the outbreak ended before the trial could begin. The vaccine candidate, which is based on the same platform as Sabin’s Marburg vaccine candidate that is already undergoing its own Phase 2 trial, was found to be safe and elicit rapid, robust, and long-lasting immune responses in Phase 1 clinical and nonclinical studies. There is currently no approved vaccine for Sudan ebolavirus.