Global Health Watch: PEPFAR negotiations leave communities behind, Global Fund replenishment falls short, continued chaos at CDC and NIH

Issue 44

UNAIDS World AIDS Day report: Overcoming disruption, transforming the AIDS response

Decisions and actions this week further weaken the global HIV response — from the exclusion of communities in the new PEPFAR US global health strategy negotiations to a Global Fund replenishment that falls short of what’s needed to deliver emerging HIV, TB, and malaria innovations at scale. Major disruptions at the US CDC and NIH – including halted non-human primate research, politicized vaccine messaging, leadership changes that jeopardize HIV research, and “skipping” World AIDS Day — continue the erosion of accountability, trust, and the integrity of the public health system. 

US Global Health Strategy Negotiations Leaving Communities Behind 

African advocacy partners including Eastern Africa National Networks of AIDS and Health Service Organizations (EANNASO) and the Coalition to build Momentum, Power, Activism, Strategy & Solidarity in Africa (COMPASS) have been taking stock of the ongoing country negotiations around the US government’s Memorandums of Understanding (MoUs) as part of its new “America First” global health strategy. They are finding that communities are being systematically excluded from the “government-to-government” negotiations for new 5-year PEPFAR MoUs, a direct reversal of the community engagement that has defined decades of the HIV response. Efforts to ensure program effectiveness, implementer accountability, programs for key populations, and commodity security are all at stake. The new framework would also require partner countries to share pathogens and patient data, potentially with US commercial interests, without privacy safeguards or assured access to resulting products — for decades longer than the life of the actual MOUs. With an MoU signing deadline of December 12, there is a great need to mobilize to demand transparency, inclusion and fair terms for all parties. 

IMPLICATIONS: The exclusion of communities from the new MoU negotiations is an abrupt shift away from the community-centered model that has been at the center of PEPFAR’s success for decades. These closed-door, government-to-government negotiations undermine the hard-won progress on reaching key populations, protecting data privacy, and delivering services that are responsive to the real-life needs of communities. Sidelining communities threatens the effectiveness, and legitimacy of the next phase of the HIV response and without immediate transparency and meaningful engagement, these MoUs risk weakening impact and trust. 

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Global Fund Replenishment Support, But Falls Short of Target 

Last Friday, donors pledged just over $11 billion at the Global Fund’s 8th Replenishment in Johannesburg. This was an important show of support, especially given the challenging political and economic climate, but well short of the $18 billion target needed to fully harness today’s unprecedented scientific advances against HIV, TB and malaria. The US pledged $4.6 billion, a decrease from the previous cycle, even as it reaffirms the 1:2 matching commitment, placing renewed pressure on Congress to fully appropriate funds, and on other donors to step up.  

IMPLICATIONS: As long-acting HIV prevention, new malaria tools and improved TB treatments enter the market, this shortfall threatens the speed, scale and equity of their rollout. And with communities already facing service disruptions, this shortfall could cost millions of lives and squander a historic opportunity to turn innovation into impact. 

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Big Disruptions at US CDC and NIH – and World AIDS Day

In the last week, decisions and actions at the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health’s (NIH) Division of AIDS (DAIDS) further jeopardize the future of HIV research and confidence in vaccines. The CDC abruptly ordered an end to all non-human primate research, including critical macaque studies that have long supported HIV prevention science. The agency also altered language on its website implying a link to vaccines and autism and contradicting established scientific consensus. At the NIH, long-time DAIDS Director, Carl Dieffenbach, was reassigned to the Fogarty International Center, a move that removes a trusted leader who played a central role in guiding HIV research. See AVAC’s resource, HIV Prevention R&D at Risk, which tracks the impact of all this and more. Also, just ahead of December 1, the US administration announced that it will no longer commemorate World AIDS Day. 

IMPLICATIONS: Together, these actions continue the decline in US global health leadership, unraveling decades of scientific progress and trust in vaccines and public health institutions. Halting essential preclinical research in macaques, politicizing vaccine messaging and sidelining experienced leadership weakens the pipeline of innovation and threatens the integrity of HIV science at a moment when sustained investment and credibility are most needed. As for World AIDS Day, Congressman Mark Pocan, who leads the Congressional HIV/AIDS Caucus, said the administration’s refusal was “shameful and dangerous.” But it’s important to remember that World AIDS Day is not decided by the US government; it belongs to everyone – and the new UNAIDS report provides the theme: Overcoming disruption, transforming the AIDS response. Or as the International AIDS Society says: Rethink. Rebuild. Rise. 

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What We’re Reading

UNAIDS World AIDS Day report: Overcoming disruption, transforming the AIDS response

UNAIDS’ new report shows that we were closer than in decades to ending AIDS by 2030, yet new HIV infections stayed flat in 2024, even before funding cuts, and resources were not enough to drive them down. We must double down with bolder, more strategic action to drive real decline.

Read the Report

Global Health Watch: Global Fund replenishment, LEN for PrEP arrives, HIV funding uncertain post gov’t shutdown

Issue 43

This week’s newsletter publishes just as the Global Fund’s 8th Replenishment Summit in South Africa is taking place. The Global Fund represents one of the strongest symbols of global solidarity in the fight against HIV, TB, and malaria, but, despite early pledges from several European Union member states and private partners, key donors (including the UK, Germany and France) appear to be stepping back, with smaller or uncertain pledges at this critical moment, and it is not yet clear what the US will do. A budget-constrained Global Fund raises serious concerns about losing ground against all three diseases and failing to seize opportunities to scale up new innovations in all three, including long-acting injectable PrEP for HIV. This Global Fund Advocates Network (GFAN) tracker tallies pledges, and this resource for scenario building shows how potential donor pledges could impact the funds available for health programs. Be sure to watch AVAC’s channels for the latest on the pledges.  

Read on for more including the arrival of injectable lenacapavir for PrEP in Eswatini and Zambia, the uncertain future of US health funding post-shutdown, and new research exposing the impact of NIH clinical trial cuts.

Lenacapavir Arrives in Eswatini and Zambia  

The first doses of injectable lenacapavir for PrEP (LEN) arrived in Eswatini and Zambia. These initial deliveries mark a historic acceleration in PrEP access, moving faster than we’ve seen with past introductions (see  AVAC’s new graphic comparing the rollout of LEN to past PrEP products) and signaling momentum and an ability to apply lessons from past delays. With additional regulatory reviews underway across the region, this early action represents a promising step forward. 

IMPLICATIONS: While these first shipments are worth celebrating, they’re just a down payment on what’s needed to deliver LEN at scale with equity. The joint Global Fund and PEPFAR commitment to reach two million people in the first three years is far more ambitious than past introductions, but falls short of delivering the impact that is needed. For LEN to have maximum impact, global donors and governments must align on transparent volume commitments, prioritize high-need markets and ensure that rollout strategies are rooted in community-led approaches. While South Africa is slated to receive LEN with Global Fund support, the fact that they are excluded from PEPFAR’s program is a huge, missed opportunity. If we really want to build a sustainable market as quickly as possible, one that will drive volume up and prices down and deliver real impact, South Africa must be THE center of the market and needs PEPFAR and Global Fund both to work with the South Africa government. AVAC’s full LEN resource library, including infographics on supply and demand, is designed to support advocates working to make that vision real. 

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US Government Reopens, Health Funding Remains Uncertain 

The US Congress officially reopened the federal government after the longest shutdown (43 days) in the country’s history. Funding for most agencies is now extended until January 30, and three appropriations bills were passed to cover several departments through all of fiscal year 2026 which ends next September. However, key health initiatives remain vulnerable: the deal keeps major health programs, including the nation’s HIV response, on a short-term continuing resolution only through January, and does not address spiking US health insurance costs. 

IMPLICATIONS: HIV prevention, treatment, and care programs will continue at last year’s levels through January 30, which avoid devastating cuts for the time being, with the fight to increase investments ongoing. The broader budget agreement also sidesteps major reforms demanded by lawmakers that threaten to gut these programs. It’s not clear if or when future disruptions might further impact public health programs and US global health engagement. 

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Clinical Trials Affected by NIH Research Grant Terminations 

A new study published in the Journal of the American Medical Association (JAMA) shows that more than 74,000 clinical trial participants were affected when 383 clinical trials lost funding from the National Institutes of Health (NIH) between February 28 and August 15, 2025. These cuts disrupted research across a range of diseases, but most of the targeted trials were outside of the US and were testing preventive or behavioral interventions, primarily in infectious diseases. “Those findings suggest that there’s a bias towards termination of grants that have nothing to do with the quality of research being conducted,” the authors wrote.  

IMPLICATIONS: This is one of the first studies to officially document the impact of the Presidential Administrations’ hostile policies and funding cuts to science. The political willingness to gut science without warning erodes trust in public health institutions and undercuts the foundation of long-term innovation. The impact is being seen across geographies, industries, communities, and diseases. 

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What We’re Reading

Resources

Sexually Transmitted Infections: ‘Self-testing’ versus ‘self-collection’: the critical role of consistent language in the field of STI diagnostics

This editorial from AVAC’s Alison Footman and colleagues makes the case for precise and consistent language around self-testing and self-collection. because clarity impacts policy, expectations, and access.

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Beyond Borders

Join ISSTDR, IUSTI, the STI & HIV 2025 World Congress, and AVAC for a special webinar spotlighting speakers who were not about to join the congress due to financial and political barriers. Presenters will share their findings, debate their results, and discuss the work still ahead for the STI field. Don’t miss this opportunity to engage directly with cutting-edge research and the people driving it forward.

AVAC Input for Recompetition of the NIAID HIV/AIDS Clinical Trials Networks

AVAC’s formal input submitted on the re-competition of the NIAID HIV/AIDS Clinical Trials Networks. The recommendations were informed by the People’s Research Agenda (PRA), a comprehensive framework developed through consultations with over 130 community representatives across 23 countries.

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Avac Event

Do Not Check That Box – Impacts From the Assault on Transgender Communities and DEI + Strategies to Sustain and Rebuild

Our panelists had an unflinchingly honest—and interactive—conversation assessing the impacts of the ongoing assault on transgender communities, gender affirming health care, data collection, and Diversity, Equity and Inclusion writ large. Strategies to restore trust, sustain programming, and rebuild from the ashes were explored.

Panelists:

  • Dr. Joseph Cherabie
    Washington University St. Louis
  • Dr. Melanie Thompson
    AIDS Research Consortium of Atlanta
  • Dr. Asa Radix
    New York City
  • Leigh-Ann van der Merwe
    Social, Health & Empowerment Feminist Collective, South Africa

Recording / Resources / Transcript

Global Health Watch: US government shuts down, foreign aid funding expires, Jeanne Marrazzo fired from NIH, issue 36

The US government shutdown that began at midnight on October 1 has stalled key public health operations just as the Supreme Court issued a ruling in AVAC v. Department of State that allowed $4 billion dollars in foreign aid to expire, eroding both health and human services and constitutional checks and balances. Meanwhile, Jeanne Marrazzo was officially fired as Director of NIAID, underscoring how politically motivated attacks on science are dismantling the infrastructure that has underpinned decades of progress in HIV prevention and research. 

US Government Shuts Down as Federal Funding Expires

At midnight on October 1, US federal funding expired and a government shutdown began after Congress failed to agree to pass a Fiscal Year 2026 (FY26) budget or even a temporary continuing resolution. The shutdown is largely rooted in disagreements over healthcare policy, especially access to healthcare coverage under the Affordable Care Act and Medicaid. The shutdown means “nonessential” federal work is stopped, including many public health operations. Approximately 750,000 federal employees are furloughed, including 40% of Health and Human Services (HHS) staff. CDC disease surveillance is disrupted, many NIH clinical trials are on hold, as is NIH grantmaking and basic research. Many PEPFAR staff have been furloughed as well, but essential “lifesaving” work is continuing. 

IMPLICATIONS: The shutdown further destabilizes the US health system and public health infrastructure already weakened by deep cuts. It now comes against the backdrop of a Presidential administration that is using official federal agency websites and social media as propaganda to blame Democrats for the crisis, while the Office of Management and Budget (OMB) director openly threatens mass firings across federal agencies, which is part of the Project 2025 vision he led. For the global health field, the situation highlights how fragile US commitments have become, with billions in foreign aid still frozen and HIV research and prevention programs facing uncertainty. Beyond the immediate loss of services, intimidation tactics on display during this crisis threaten to erode trust and stall science, which will extend beyond the US with consequences for health and human services worldwide. 

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US Supreme Court Grants Administration Request to Keep Foreign Aid Frozen as Clock Runs Out 

Just prior to the US government shutdown, the US Supreme Court (SCOTUS) handed down a decision in AVAC v. Department of State and Global Health Council v. Trump cases, challenging the foreign aid freeze. In a 6-3 decision by emergency order, the court granted the Administration’s request to not spend $4 billion of Congressionally appropriated foreign assistance funds before they expired on September 30, as required by law. This means that, despite the law, and a lower court order, those funds remain unspent. In its statement, AVAC’s Executive Director, Mitchell Warren, warned that the ruling gave the Administration a “free pass” to block disbursement of foreign aid, citing devastation with clinic closures, disruptions in essential services, and lives lost. Moreover, Warren said the ruling undermines constitutional checks on presidential power. “This is beyond foreign assistance; the Court’s decision is a chilling one for anyone who cares about the US Constitution.” In a dissent from the three other Justices, Justice Kagan cautioned that the stakes are too consequential to be decided through emergency orders without full briefing and oral argument and argued that the Administration has not met the stringent standards for such relief. 

IMPLICATIONS: While the SCOTUS ruling is not a final judgment, it signals a willingness to allow the President and the Executive branch to withhold funds that Congress has appropriated, potentially whenever it chooses. If unchecked, this precedent could erode the checks and balances that constrain executive overreach and jeopardize not only global health funding but every area of federal spending. 

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Jeanne Marrazzo Fired from NIAID 

Jeanne Marrazzo, former Director of the National Institute of Allergy and Infectious Diseases (NIAID), was terminated on October 1 by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. after being placed on administrative leave in April. This comes 22 days after Marrazzo and former Fogarty International Center’s director, Kathy Neuzil, filed a whistleblower complaint with the Office of Special Counsel. In her complaint, Marrazzo detailed the Administration’s unlawful cancellation of critical research grants, politicization of science, hostility toward vaccines, and censorship of research. Marrazzo’s lawyers claim that her firing was an act of clear retaliation for her defense of scientific integrity and public health research. Marrazzo succeeded Anthony Fauci as the director of the NIAID in 2023. 

IMPLICATIONS: The Office of Special Counsel has been severely weakened by the Administration as have other oversight mechanisms- leaving few pathways for federal scientists and other federal employees to resist politically motivated attacks on research. Holding federal offices accountable to standards of practice that protect the scientific enterprise from political and ideological gamesmanship is essential. Without those standards enforced, decades of progress in science and research are at risk. Marrazzo’s dismissal represents another blow to the independence of US science agencies.  

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FOLLOWING: The US May Expand Mexico City Policy / Global Gag Rule 

According to the Daily Signal, the US Department of State plans to extend the scope of the Global Gag Rule (often referred to as the Mexico City Policy), which is an executive order that restricts foreign non-governmental organizations (NGOs) from receiving US global health assistance if they provide, refer, or advocate for abortion services. The Global Gag Rule first enacted by the Reagan administration, has been rescinded by every Democratic president and put back in place under every Republican president. Reportedly, the language in this latest iteration of the policy would be expanded to also ban US funding for foreign assistance that promotes “gender ideology” or DEI initiatives. The inclusion of gender affirming care and DEI continues this Administration’s ongoing mischaracterization of existing foreign assistance programs, and attacks on programs that are trans inclusive or seek to address racial and gender disparities.  

IMPLICATIONS: This expansion of the Global Gag Rule would fulfill a long-standing conservative goal, explicitly named in Project 2025, to reshape US global public health funding away from evidence-based programs that affirm the needs and dignity of sexual and gender minorities. Turning away from these vulnerable populations further threatens and sets back progress towards ending the global HIV epidemic.   

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What We’re Reading:

Resources

US Supreme Court Gives the Administration a Free Pass to Withhold Foreign Aid 

AVAC Denounces Court’s Misguided Late-Day Ruling

Contact: [email protected] 

Late today in AVAC v Department of State and Global Health Council v Trump, the Supreme Court of the United States granted the US Presidential Administration’s request to stay an injunction that would require the Administration to obligate $4 billion of foreign assistance funds before they expire on September 30, as required by law. The Court’s ruling temporarily grants the Administration’s request to pause a lower court order that the government spend the funds. With just four days until September 30, those funds, which otherwise would have saved lives and advanced global health and national security, will remain unspent. 

“With this ruling, the Supreme Court has given the Administration a free pass to run out the clock on the disbursement of foreign aid that Congress appropriated. Since foreign aid was frozen on the first day of this Administration, we have seen thousands of clinics close, hundreds of thousands of communities lose access to essential services and medications, and thousands of lives lost,” said Mitchell Warren, executive director of AVAC, a plaintiff in the case. “This ruling will translate into further devastation, put future global health responses at risk, and set a dangerous precedent that undermines Congress’ constitutional power of the purse.”  

“But this is beyond foreign assistance; the Court’s decision is a chilling one for anyone who cares about the US Constitution. While their ruling is only preliminary and should not be read as a final determination on the merits, it is terribly misguided and potentially implies that the Administration can disregard Congressional power of the purse and now seemingly impound Congressionally appropriated funds whenever it wants,” added Warren.  

In a powerful dissent, three Supreme Court justices led by Justice Elena Kagan issued a warning that the stakes in this case are far too significant to be decided through the Court’s emergency docket without full briefing or oral arguments, underscoring the extraordinary nature and far-reaching consequences of the Administration’s unlawful actions. “Deciding the question presented thus requires the Court to work in uncharted territory. And, to repeat, the stakes are high: At issue is the allocation of power between the Executive and Congress over the expenditure of public monies,” Justice Kagan wrote in her dissent. “The standard for granting emergency relief is supposed to be stringent. The Executive has not come close to meeting it here.” 

Global Health Watch: A generic price for LEN, Future of UNAIDS, UNGA 80, AI for Health, Issue 35

The stakes are high as the US approaches the start of a new fiscal year (FY26) on October 1, currently mired in stalled White House negotiations and a looming government shutdown; the Supreme Court’s pending decision on AVAC’s lawsuit; and the new US “America First” strategy to reshape foreign aid. This issue highlights major global health developments at the UN General Assembly, from debate over the future of UNAIDS to commitments from the Gates Foundation and Unitaid to accelerate access to injectable lenacapavir for PrEP (LEN), alongside new discussions on AI ethics and health. 

Gates Foundation and Unitaid Commit to Accelerate Market Development for Lenacapavir for PrEP 

The Gates Foundation and Unitaid announced new strategic investments to accelerate the development of, access to and price reduction for generic versions of injectable lenacapavir (LEN), the highly effective six-monthly injection for HIV PrEP. As AVAC’s Mitchell Warren said in its statement, “this could be a transformational moment in HIV prevention if political will, coordination, and further procurement investment meet this moment to deliver LEN with speed, scale and equity to all communities and populations who need and want prevention options.”  

IMPLICATIONS: While this progress is encouraging, it is only meaningful if momentum leads to real access. These agreements get LEN closer to the $40 per person per year price of daily oral PrEP for many, but not all, low and middle-income countries, and hopefully will accelerate large scale programs by 2027. AVAC’s publication, Now What with Injectable LEN for PrEP How to Translate Ambition into Accelerated Delivery and Impact, includes forecasts demonstrating that instead of 2 million people in three years that is currently being planned by the Global Fund and PEPFAR with initial supplies from Gilead, the world could reach at least 1.5 million people in just one year, rising to at least five million people per year by 2030. These numbers suggest what is possible and what is necessary to accelerate access, achieve real impact, build a sustainable market, and drive prices down even further.  

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UN General Assembly Updates

The UN General Assembly (UNGA 80) kicked off this week in New York with global health taking center stage. The US began the rollout of its new “America First Global Health Strategy,” which shifts toward bilateral aid models. Meanwhile, HIV innovation and access, especially for lenacapavir, are being debated in side events as delegates push for clarity on price, procurement, and equity. The WHO is accelerating its health agenda on noncommunicable diseases (NCDs) and mental health and will help lead discussions on a new global declaration.  

In its annual Goalkeepers event, the Gates Foundation announced its $912 million commitment in the current round of replenishment to the Global Fund for AIDS, TB and Malaria. The Foundation also recognized ten champions in global health, including AVAC’s partner Jerop Limo, a leading HIV and sexual and reproductive rights activist from Kenya. 

Next week, a new topic will take center stage at the UNGA’s high-level meetings: inclusive and accountable governance of artificial intelligence (AI). Ethics and equity will be central to deploying responsible AI for health, with advocates emphasizing that progress must be measured not only by rollout speed but by how well it protects patient privacy and addresses real-life challenges and needs. Development of AI governance to shape how digital tools are designed, regulated, and financed is a key part of the next generation of HIV and health programming. 

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United Nations Secretary-General Proposes to “Sunset” UNAIDS 

The UN Secretary-General shared a proposal in his new UN80 progress report to “sunset” UNAIDS by the end of 2026 and fold its mandate into broader UN structures in the face of funding cuts. The NGO delegation to the UNAIDS Programme Coordinating Board (PCB) strongly opposes this move, and was joined by nearly 800 civil society organizations warning that dismantling UNAIDS now would undermine leadership, coordination and accountability at a time of escalating funding cuts, growing inequalities, and service disruptions. UNAIDS was originally created to bring coherence across 11 UN agencies, avoid duplication, and ensure that communities most affected by HIV had a formal voice at the table. The plan endorsed by the UNAIDS PCB would downsize the Secretariat, embed staff in select UN Resident Coordinator offices and relocate programmatic expertise to regional hubs to align with the UN80 “Shifting Paradigms” vision of a more integrated, coherent UN system. As UNAIDS reminded all stakeholders in its statement, it is member states and governing bodies who should determine the way forward on how UN80 reforms are implemented.  

IMPLICATIONS: Achieving the UNAIDS goal of ending AIDS by 2030 depends on many factors, including clear accountability; knowing which UN agencies retain their strengths; ensuring they have the resources to deliver; and safeguarding coordination. Sustaining trusted partnerships with civil society and continuing to prioritize equitable rights-based programs, which have been central to UNAIDS’s role for two decades, will also be essential, and all of this risks being undermined if UNAIDS’ functions are dispersed without a coherent strategy. This debate marks a critical inflection point for how the global community organizes and funds the HIV response going forward. 

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Africa CDC Announces Grant to Support Local Drug and Vaccine Manufacturers 

The Africa CDC plans to invest approximately $3.2 billion dollars to support the development of local drug and vaccine manufacturing across the continent. The initiative includes funding and grant support for African manufacturers. This grant aims to reduce dependence on imported pharmaceuticals by strengthening domestic production and establishing a pooled procurement mechanism to guarantee market demand. 

IMPLICATIONS: This move could be a turning point for health sovereignty in Africa, offering the promise of more reliable supply chains, lower costs, and greater independence from external donor trends. But it also presents real challenges: scaling production to meet global standards, navigating regulatory harmonization, and maintaining quality assurance and sustainability will be essential. If successful, it could shift power in global health — giving African countries more leverage in pricing and access negotiations for prevention tools such as ARVs and vaccines, while reducing vulnerability during global supply disruptions. 

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What We’re Reading

Avac Event

The Fight for Health Justice in an Age of Retreat