Breakthroughs Blog: HHS

2025 has been a whirlwind year for global health. In the United States, we've seen the integration of the US Agency for International Development (USAID) into the Department of State, transformation at the Department of Health and Human Services (HHS), and a complicated and prolonged budget process. Globally, we've seen setbacks and progress in HIV and malaria, an evolution at the World Health Organization (WHO), a multilateral win with the Pandemic Agreement adoption, and African partners stepping up to boost autonomy.As the year draws to a close, GHTC is reflecting on the innovations, policy shifts, and pivotal moments that defined 2025 and what they signal for the years to come.US global health leadership in transitionOn day one of his second term, President Donald Trump initiated an effort to realign US foreign assistance programs with the goal of making America safer, stronger, and more prosperous. This effort started with an overhaul of USAID, triggering a series of layoffs, stop-work orders that turned into award terminations, and withdrawals from multilateral partnerships, culminating in the agency’s official integration into the State Department on July 1.While this suspension and termination of USAID programs disrupted critical research projects and health services worldwide earlier this year, in September, the State Department unveiled the America First Global Health Strategy, which outlines a plan to reshape the US government’s global health programming, presenting opportunities for global health research and development (R&D).The new strategy centers multiyear bilateral agreements with countries while reducing ties with nongovernmental organizations and narrowing health focal areas. While critical questions remain on implementation—including on whether the agency still retains needed expertise and how it will coordinate with interagency technical partners like the US Centers for Disease Control and Prevention (CDC)—the strategy’s focus on integrating aid more directly into national health systems is a step forward in improving sustainability and self-reliance. The strategy also raises the exciting possibility that funds could be used to support “innovative, breakthrough technologies.”  Building on USAID’s successes and shortcomings in that space, the department has a clear opportunity to establish a centralized R&D fund—in complement to bilateral agreements—to invest in innovative tools that could leapfrog global health progress. Through collaboration with global health stakeholders and interagency partners, State could reshape US global health programs to continue to save lives; foster funding beyond US government resources, including through partner nations; and promote shared security and prosperity.Overhaul of US scientific and public health infrastructureThe United States has long been a leader in global health R&D and science more broadly, with American researchers, universities, companies, and patients benefiting. In 2025, sweeping changes at HHS reshaped America’s public health and research infrastructure. These far-reaching reforms aimed to advance administration priorities of promoting “gold standard science,” improving efficiency, transparency, and oversight and realigning investments to match administration objectives. At the National Institutes of Health (NIH) and CDC, these changes have included significant staff departures, among them seasoned leaders, and the appointment of many officials who were previously critics of these agencies. It has also included new policies to overhaul oversight of foreign awards and cap indirect costs, changes to longstanding vaccine guidance, and the terminations of numerous awards, including a wind-down of mRNA vaccine development activities. The speed and scale of these changes have raised concerns across the biomedical research and public health communities. While thoughtful reforms could yield benefits, experts warn that current actions risk driving US scientists abroad, disrupting promising clinical trials, weakening the pipeline of new tools, eroding trust in public health guidance, and weakening the structures that have sustained US scientific leadership. US budget swings and shutdowns2025 began with a race to fund the government, with President Trump signing the fiscal year 2025 budget into law in mid-March. While the budget maintained global health R&D-relevant funding lines at prior levels, it funded a government that now looked significantly different after sweeping layoffs and restructuring. Months later, the administration issued its budget request, proposing significant cuts and a restructuring of global health and research programs, reflecting far-reaching changes it had already begun to enact.In June, the administration proposed a request to rescind billions in funding for foreign aid. Though Senators stepped in to remove cuts to global programs for HIV/AIDS and several other health areas, the package ultimately became law, cancelling $500 million in previously appropriated global health funds and raising the possibility that this administration will continue to use rescissions as a tool to withdraw funding.  By late summer, Senate and House appropriators advanced interim funding bills that included higher-than-expected funding for global health and medical research, maintaining funding proposed for elimination by the administration. But then stalled negotiations triggered the longest-ever government shutdown, during which the administration implemented unprecedented furloughs and layoffs that affected critical staff at public health and health research agencies.While the shutdown ended on November 12, pushing the funding fight until January, and most associated layoffs were reversed, uncertainty about future funding for global health R&D persists, especially with a deeply divided Congress and the potential of further recissions.A year of setbacks and breakthroughs in HIV and malaria effortsGlobal HIV/AIDS and malaria efforts faced major setbacks in 2025 as declining US and international donor support has threatened decades of hard-fought progress. Funding cuts could lead to millions of additional HIV and malaria cases in the coming years and has already stalled promising research advancing new HIV and malaria tools.Amid these challenges, the June approval by the US Food and Drug Administration of lenacapavir, a twice-yearly injectable drug for HIV prevention, marked a major milestone and a reminder of the incredible progress possible through strong support for research. Developed by Gilead and supported by NIH-backed research, the drug offers an alternative to daily pills or bi-monthly injections, making prevention more accessible and easier to maintain. Global partners are stepping up to expand access, and Phase 3 trials of a once-yearly version are planned.In November, Medicines for Malaria Venture and Novartis shared Phase 3 trial results for GanLum, a new drug found to be highly effective at treating malaria, including drug-resistant cases, and capable of blocking disease transmission. Pending approval, it could help counter rising resistance to current treatments.Other notable R&D advances in 2025 also targeted the growing threat of antimicrobial resistance, including a Phase 3 trial for a novel antibiotic targeting a dangerous antibiotic-resistant pathogen, support for what could be the first-ever vaccine for Escherichia coli, and efforts to harness artificial intelligence to transform antibiotic discovery. These breakthroughs underscore the importance of sustained R&D investment and the efforts to ensure new tools reach those who need them.WHO restructures amid budget shortfallFacing a severe budget crisis and pressure from member states to reprioritize programs, WHO launched a sweeping overhaul in 2025, cutting staff, slashing its budget, and reorganizing core functions. At its February Executive Board meeting, member states approved a $1.1 billion budget reduction, leaving a remaining $1.7 billion shortfall for 2026 and 2027, despite a recent increase to membership dues and appeals for voluntary contributions.In late April, WHO announced a plan to halve its senior leadership team and consolidate departments. Infectious disease and climate and health programs remain relatively well-resourced, and merging several disease-specific initiatives into a new division could strengthen certain programs. However, neglected tropical diseases and health emergency preparedness and response programs face sharp cuts, while reductions in regional and in-house expert posts may weaken global lab and surveillance networks and delay critical guidance, raising concerns about WHO’s outbreak response capacity.One core R&D function spared from the worst cuts was WHO’s prequalification (PQ) program, which evaluates medical products to support regulatory approval and rollout in countries with less advanced regulatory authorities. The program has marked some important achievements this year, launching a new portal to improve transparency for developers, introducing a new streamlined review and guidance process for TB diagnostics, and prequalifying lenacapavir for HIV prevention through a compressed process completed in just 36 days. As WHO and the broader United Nations system grapple with financial strain and diminished donor support, questions remain about the capacity to deliver on their mandate. A major outbreak could test the limits of this leaner system.Pandemic Agreement provides hope in challenging year for multilateralismAt the World Health Assembly in May, delegates adopted the Pandemic Agreement, a milestone win for global health after three years of complex negotiations. However, consensus on a pathogen and access-benefit sharing system was not reached, requiring member states to return to the negotiating table to finalize an annex for adoption at next year’s assembly. Persistent disputes over the voluntary or legally binding nature of participation signal tough negotiations ahead.While the Pandemic Agreement is a huge win, pushback from key countries and declining pandemic preparedness investments raise concerns about global readiness. Annex negotiations and the 2026 United Nations High-Level Meeting on Pandemic Prevention, Preparedness, and Response will further test international unity on this crucial topic.Meanwhile, 2026 brought notable R&D advances to strengthen our defenses against pandemic threats. The Coalition for Epidemic Preparedness Innovations launched the first-ever adjuvant library of 25 immune-boosting substances to improve vaccine effectiveness and awarded $17.3 million for Phase 2 trials of a promising Nipah vaccine, among the first candidates targeting the priority virus to reach this critical stage. IAVI’s vaccine candidate for Lassa virus, another virus with pandemic potential, was also found to be safe and effective in a first-in-human Phase 1 trial, marking further R&D progress against concerning disease threats.Partners step up to fill gaps and boost autonomyAmid steep foreign aid funding losses, African nations are accelerating efforts to boost manufacturing and laboratory capacity on the continent and reduce reliance on external partners. At October’s Conference on Public Health in Africa in Durban, South Africa, thousands of participants endorsed The Durban Promise, a roadmap for Africa’s health sovereignty, urging action on manufacturing, financing, workforce and capacity development, and regulatory strengthening, a signal of growing continental unity.This momentum was echoed by the Accra Reset, led by Ghanaian President John Mahama, to forge further progress toward greater sovereignty and more equitable global cooperation. At the continental level, the Africa Centres for Disease Control and Prevention launched a new biomanufacturing fellowship to help meet the goal of producing 60 percent of Africa’s vaccine dose needs locally by 2040.South Africa held the G20 presidency this year, culminating in the first G20 summit held on African soil and a declaration focused on priorities for Africa and the Global South. The summit was punctuated by the absence of the United States, underscoring the imperative for greater African autonomy as international aid declines and health threats rise. With the United States assuming the G20 presidency next year, its priorities will be closely watched. Looking ahead to 2026If 2025 has taught us anything, it’s that global health is unpredictable and constantly evolving, so we won’t speculate on exactly what 2026 may bring. But a truth remains clear: global health R&D is a strong investment that pays off—saving lives, strengthening economies, and fueling scientific progress. As the United States redefines its approach and role in the broader global health ecosystem, it remains to be seen how it, and others, will step up to ensure that promising technologies in the pipeline are advanced to improve lives around the world.For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2026 and beyond, sign up now to receive GHTC’s R&D News Roundup newsletter.

Last Wednesday, Emergent BioSolutions announced that it has received a $56 million contract extension with the Administration for Strategic Preparedness and Response to supply the US government with doses of a combined smallpox/mpox vaccine. The single-dose vaccine was first approved by the US Food and Drug Administration in 2007 for smallpox and, since 2024, has been one of two approved vaccines for smallpox and mpox. The vaccine doses, which will be stored in the Strategic National Stockpile, aim to boost US preparedness for future public health emergencies. A novel breakthrough method that utilizes artificial intelligence and advanced imaging technologies to more accurately and efficiently identify therapeutic antibodies could transform the way researchers develop treatments for infectious diseases, particularly emerging diseases, by significantly accelerating research. The method reduces the time needed to identify antibodies with potential from weeks to under a day and can also accomplish this task more efficiently, requiring far fewer researchers dedicating their time to screening thousands of candidate antibodies. This could allow researchers to move on from antibody discovery to the later stages of drug and vaccine development earlier and, ultimately, bring lifesaving products to patients faster. A recently published study found promising results for a new approach to developing broad-spectrum antivirals to treat existing viral infections and maybe even to prevent infections from emerging viral threats. Broad-spectrum antivirals are treatments that could combat a wide range of viruses by hitting essential targets that are common across many different viruses. While there are broad-spectrum treatments for bacterial infections, there has not been a similar broad-spectrum antiviral treatment approved for human use, in part because the proteins on the surface of a virus vary widely and change rapidly over time. The researchers focused on small molecules called synthetic carbohydrate receptors (SRCs), which earlier studies have suggested could be a potential target for antiviral medicines. They tested 57 different SRCs against six deadly viruses from three different viral families, including the viruses behind COVID-19, MERS, Nipah, and Ebola, finding several promising SRCs that blocked cells in the lab from being affected by all the viruses, some of which also later demonstrated promising safety and efficacy results in mice. 

On Thursday, Senate appropriators advanced out of committee a fiscal year (FY) 2026 spending bill for the Department of Health and Human Services (HHS) that rejects billions in health spending cuts proposed by the Trump Administration and protects programs vital to global health innovation.The bill increases or flat-funds global health research-relevant agencies, including the National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA), and slightly reduces funding for the US Centers for Disease Control and Prevention (CDC) compared to FY25 enacted—an outcome that is in stark contrast to the President’s Budget Request (PBR), which proposed deep cuts across all three. Funding at this level will enable these agencies to continue to advance medical breakthroughs and operate programs that deliver better health outcomes for people around the world and fortify our defenses against disease threats.Funding highlightsThe legislation allocates $48.7 billion in funding for NIH, which is a $400 million (.8 percent) increase compared to FY25 enacted and nearly $22.2 billion (77 percent) above the PBR, and $1.015 billion for BARDA, which represents level funding from FY25 but $361 million (55 percent) more than the White House request. While the legislation unfortunately cuts funding for CDC by $72 million, or 1 percent, this allocation is $4.8 billion or 112 percent greater than the President’s request.While advocates expected the Senate to reject the steep cuts proposed by the Trump Administration, many still anticipated significant reductions. It is therefore both welcome and surprising that Senate appropriators advanced a spending package that maintains strong funding for many programs the President aimed to slash or eliminate.Beyond topline funding for agencies, the bill and accompanying report also diverge from the PBR in other crucial ways. While the President proposed eliminating the CDC Global Health Center (GHC), this spending bill keeps the center intact, maintaining level funding from FY25. The bill also maintains flat funding for the NIH Fogarty International Center—which supports global health research partnerships and training—and provides a 0.5 percent increase to the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). This stands in sharp contrast to the White House’s proposal to eliminate Fogarty entirely and cut NIAID’s budget by 58 percent. Additionally, it provides level funding to the Advanced Research Projects Agency for Health (ARPA-H), a new agency established under the Biden Administration to support high-risk, high-potential health research, rejecting the President’s proposal to reduce its funding by $555 million.Beyond  funding numbers, the bill’s accompanying report includes welcome directives affirming the Senate’s support for research activities critical to global health, including across health areas like neglected tropical diseases, malaria, tuberculosis, emerging infectious diseases, antimicrobial resistance (AMR), and more, and underscores the importance of international health research partnerships and training programs supported by the Fogarty International Center and global health activities undertaken by CDC GHC and NCEZID.  Taken together, the funding and directives can be viewed as a strong rebuke of the president’s efforts to downsize and dismantle US global health efforts and a strong affirmation of the Senate’s support for programs that save and improve lives around the world and protect Americans from disease threats. The report also dictates stricter reporting requirements to Congress for HHS, indicating bipartisan concern by lawmakers as to whether the agency is dispersing funding as directed and making scientifically-drive decisions.The report also conveys Senate appropriators’ desire to see BARDA devote robust funding to developing countermeasures against emerging infectious diseases, AMR, and pandemic influenza, and directs BARDA to spend no less than $10 million on advancing countermeasures against “Disease X,” which is a term to denote priority viral pathogens that could cause the next pandemic. Despite an overall positive picture, the bill does include some decreases to subaccounts relevant to global health, including an 80 percent cut to  the CDC-wide Infectious Disease Rapid Response Fund, which was a fund originally created to provide flexible funds for the agency to rapidly respond to pandemic and epidemic threats. See the chart below for a more detailed comparison of funding in the Senate bill and percent changes compared to FY25 enacted and the PBR.What comes nextThe bill’s passage out of committee is just an initial step in a lengthy political process. It will next go to the full Senate for a vote, the House of Representatives will need to advance its parallel bill, and then the two bills will need to be conferenced to work out their differences before going back to both chambers for a vote and then to the President for signature.It is anticipated that the House will propose lower spending levels for health programs than the Senate, so these numbers are a likely high watermark where negotiations begin between the two chambers. Nonetheless, if one reads the House’s spending bill on global health as a tea leaf of what’s to come, it’s unlikely the House will cut as deep as the President wishes , so if the two chambers can reach a compromise and pass a budget, we could see funding levels land somewhere below the Senate but still substantially above the PBR. In the House bill, we are likely to see stronger relative numbers for NIH over CDC, given heightened criticism for the latter agency among Republican lawmakers.For many advocates, this bill is welcome news that Congress is reasserting its power of the purse in opposition to the president, yet significant concerns remain. Will the two chambers actually reach a promising compromise? And even if Congress appropriates strong funding for FY26, given all the recent moves by the Administration to rescind, halt, or slow the disbursement of federal spending, will this money actually reach researchers and health implementers to deliver impact? While we can’t predict for certain, GHTC and other advocates will continue to keep a close watch on what’s to come and activate where we can in order to protect vital funding for global health and medical research. 

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. Last week, the US Department of Health and Human Services announced a $500 million investment into a vaccine project under a new initiative called Generation Gold Standard, which aims to advance universal influenza vaccines, hoping to get a vaccine into clinical trials next year and approved by 2029. The initiative, funding for which will come from the Biomedical Advanced Research and Development Authority, seems to be replacing Project NextGen, which had previously funded research into potential COVID-19 vaccines and treatments. Some experts and officials have expressed surprise at the direction of the initiative and the size of the investment.Scientists have discovered that a device used to diagnose bacterial meningitis in blood can also measure it in cerebrospinal fluid, helping speed accurate diagnosis and treatment of the illness, which is the most dangerous form of meningitis and a significant global health threat. The device has demonstrated high sensitivity in multiple cohorts of patients and it’s also affordable and delivers results within a half hour after spinal tap. The test was developed at an impressive speed, now available to patients within just a year of its discovery.Newly shared results from a clinical trial from the National Cancer Institute seem to confirm that a single dose of the vaccine used to prevent human papillomavirus (HPV) virus infection is just as effective as two, a finding that could transform efforts to reach the millions of children globally who are not getting vaccinated according to recommendations. Expanding HPV vaccination will also help reduce the global burden of cervical cancer deaths and deaths from other HPV cancers. While two doses are currently recommended, reducing the required dosage could make dissemination much easier and cheaper for many countries.