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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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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AVAC Applauds Agreements to Accelerate Market Development for Lenacapavir for PrEP

Calls for Additional Commitments to Ensure Momentum Translates into Impact 

New York, NY, September 24, 2025 — AVAC welcomes parallel announcements from the Gates Foundation and Unitaid on 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.   

“These investments are a vitally important step in translating the remarkable science of LEN into public health impact,” said Mitchell Warren, executive director of AVAC. “With these agreements, injectable LEN for PrEP gets closer to the price of daily oral PrEP, $40 per person per year, for low and middle-income national governments. This means national programs in many, but not all, countries can begin planning for 2027, at which time ongoing oral PrEP and LEN use will be available at similar prices, meaning many countries will be truly able to offer people who need prevention choice  when it comes to the PrEP method that best meets their needs. 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. Many questions remain, but in this current environment, we need to seize opportunities and good news when we can.”   

These new commitments to accelerate access to generic versions of LEN come on the heels of the Global Fund and PEPFAR re-committing to their December 2024 announcement of reaching two million people with LEN for PrEP  within three years, with drug supplies coming from the originator company, Gilead Sciences. Among the outstanding questions from these new commitments is the price of the required oral loading dose for LEN, which is needed to achieve high efficacy. While the cost of ongoing use of LEN for PrEP would be similar to the cost of a year of daily oral PrEP, anyone initiating or restarting LEN for PrEP needs an oral loading dose of LEN. This oral loading dose is not included in the $40 price mentioned in the Gates and Unitaid deals and will add between $15-$17 in the first year of anyone initiating or re-starting LEN, and supply chains and purchasers need to include this extra cost in their calculations.  

“The ‘two million in three years’ ambition from Global Fund and PEPFAR must be seen as a floor and not a ceiling,” said Warren. “The global PrEP data that AVAC tracks show a more ambitious goal, getting LEN to at least 1.5 million next year alone, is achievable and necessary. Ultimately, LEN must reach more than five million people per year to have real impact, build a sustainable market, and drive prices down even further. This means we must act faster and think bigger.” 

AVAC calls on all stakeholders to do their part. Next steps require coordinated action and further investment to ensure the creation of a viable and sustained market. 

“This is the moment to ensure that LEN for PrEP lives up to its full potential, and to hold each other accountable for what must happen next,” said Wawira Nyagah, AVAC’s director of product introduction & access.  “Demand creation and program design for LEN must be fully resourced, evidence-based and community-centered. Volume commitments, manufacturing, and supply chains must be sustained and stable. But to make a difference at a global level, the HIV response must go beyond these essential, but minimum, steps with a bold vision to accelerate the entry of generics and trigger a virtuous cycle of price drops, which further drive-up PrEP use.”  

LEN, developed by Gilead Sciences, is a twice-yearly injectable PrEP option that showed nearly complete protection against HIV in the landmark PURPOSE 1 and 2 trials. Science Magazine named LEN the “Breakthrough of the Year” in 2024, a recognition that reflects its enormous potential. But fulfilling this potential is far from certain, and all stakeholders have critical work to do, as detailed in AVAC’s 2024 publication, Gears of Lenacapavir for PrEP Rollout. 

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, the world could reach at least 1.5 million people in just one year. Gilead has confirmed that they can manufacture enough injectable LEN to reach in excess of 5 million LEN users over the next three years. These numbers suggest what is possible and this is no time to think small. 

“To achieve true impact against HIV requires early commitments from additional donors to procure large volumes of LEN, which will enable a bigger rollout, exceeding targets, and reaching more people who need PrEP in more places, which in turn secures the kind of market scale that accelerates further prices reductions,” said Nyagah. “It requires country regulators, ministries of health, implementers, advocates and communities where HIV prevention is needed to prepare with policies and programs that will succeed in connecting people with products that work in the context of their lives. The field has learned these lessons before. Technology alone gets you nowhere; it’s delivering the product with speed, scale and equity that gets the job done.” 

Global Health Watch: WHA78, Misinformation at Congressional Hearings, Global Fund Cuts & More

Issue 17

The US Secretary of State and the Secretary of Health and Human Services appeared before Congress this week defending foreign aid cuts and the dismantling of USAID. Advocates are responding, including the Treatment Action Group (TAG) which issued a stark warning: US agencies are engaging in “unethical, dishonorable, and potentially law-breaking machinations” under new leadership, particularly at the NIH. Meanwhile, the US was absent from the World Health Assembly, where the WHO Pandemic Agreement was ratified and where a high-level dialogue on long-acting HIV prevention took place. All this plus looming Global Fund shortfalls, and new COVID-19 vaccine policy changes in this week’s issue. 

Misinformation and Controversy at Congressional Hearings 

The US Secretary of State Marco Rubio appeared in front of the US Congress this week defending radical cuts to foreign aid and a proposed State Department reorganization that deprioritizes global health programs. In front of the Senate Foreign Relations Committee (of which he was once a member), Rubio was corrected when he wrongly claimed that only 12% of US funding goes to direct services. In fact, 12% is the proportion of funds going directly to local NGOs, with 85% of total funding going towards direct services. He also claimed – without evidence – that 85% of PEPFAR beneficiaries were still receiving services and denied any deaths linked to the US cuts. The Secretary repeated these claims before the House Foreign Affairs Committee and Appropriations State and Related Programs subcommittee and ignorantly characterized voluntary male medical circumcision (VMMC) as wasteful spending. VMMC is proven to reduce transmission of HIV. Congressional members challenged Secretary Rubio on the legality of the foreign aid freeze and dismantling of USAID and highlighted reported deaths resulting from the cuts. Meanwhile, some Republican Senators, including Senate State, Foreign Operations, and Related Programs (SFOPs) Chair Lindsay Graham, expressed support for foreign assistance amidst calls for transparency and metrics to transition countries off US funding. 

Department of Health and Human Services (HHS) Secretary, Robert F. Kennedy Jr. appeared before the Senate this week to defend cuts to public health programs and biomedical research. Similar to his appearance last week before the Senate Health, Education, Labor and Pensions (HELP) Committee, Kennedy’s remarks were controversial and contradicting.  

IMPLICATIONS: These hearings underscore the challenges facing US global health policy and programming amid shifting political priorities and leadership. Advocacy to counter mis- and dis-information, and a vision for this new era of global health financing, are more important than ever.  

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An Ethical and Legal Crisis

In a statement, TAG demands immediate action by the NIH to provide Congressionally appropriated and committed funding to the HIV clinical research networks (ACTG, HPTN, HVTN, IMPAACT). 

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World Health Assembly Updates 

The United States was notably missing from the World Health Assembly (WHA) this week, with no official delegation attending. This is a major change from previous years where delegations held leadership and diplomacy roles. In contrast, China sent more than 180 delegates and pledged an additional $500 million over the next five years to help stabilize the agency following the withdrawal of the United States, reinforcing its growing influence in global health governance. 

Meanwhile, the WHA formally voted to adopt the WHO Pandemic Agreement, a legally binding accord that lays the foundation for future pandemic prevention and response, including real-time sharing of vaccines, treatments, and diagnostics. For three years, member states negotiated critical issues, with pressure from civil society to embrace key provisions on equity and intellectual property. Some of those provisions have been addressed, but negotiations on an annex detailing the new Pathogen Access and Benefit Sharing (PABS) mechanism will continue with the aim of concluding at next year’s WHA. PABS refers to a proposed system where countries share genomic information about novel pathogens and share tools developed to combat those pathogens, regardless of which country discovered the pathogen or developed effective tools—it has been one of the most contested areas of negotiation. Though the treaty is less ambitious than earlier drafts, nations at the WHA have largely welcomed the agreement as a major achievement.  

Many events and discussions were held on the sidelines of the WHA, including Wednesday’s high-level dialogue organized by the Global HIV Prevention Coalition (GPC). The event, A New Era of HIV Prevention: Accelerating Access to Long-Acting Prevention Options, was co-hosted by UNAIDS, in collaboration with the United Nations Population Fund (UNFPA), United Nations Development Fund, (UNDP), WHO, the Federal Republic of Brazil and Kingdom of the Netherlands. AVAC’s Mitchell Warren, who also co-chairs the GPC, opened the session with urgency and optimism, calling it “one of our greatest opportunities in 44 years of HIV prevention,” even as global solidarity is waning. Dr. Lilian Benjamin Mwakyosi, a past AVAC Fellow and director of DARE in Tanzania issued a powerful reminder that “choice for HIV prevention is not a luxury. It’s a right,” stressing that adolescent girls and young women need accessible, discreet prevention options like long-acting PrEP. The dialogue underscored the need for political will, financing, and community-centered action to turn scientific breakthroughs like lenacapavir for PrEP into sustained prevention at scale. 

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Global Fund Financial Challenges 

More than 260 civil society advocates joined a conversation organized by the Coalition to build Momentum, Power, Activism, Strategy & Solidarity (COMPASS), Eastern Africa National Networks of AIDS and Health Service Organizations (EANNASO), CHANGE, and others to explore the financial constraints facing the Global Fund following its Board meeting earlier this month. Advocates learned unmet pledges and declining global health aid will mean that the current Global Fund Grant Cycle 7 will reduce allocations to countries to align with available resources, moving from pledge-based to cash-based allocations. Countries will receive reduced funding envelopes in mid-June 2025, which will trigger a two-week reprioritization process to focus on life-saving services like treatment continuity and community-led monitoring while deferring lower-priority items. 

IMPLICATIONS: These changes could jeopardize essential programs, especially those supporting key populations. And they also raise significant questions about the recently launched Global Fund replenishment for the next grant cycle. Civil society must prepare now to advocate for transparent processes, protect vital community interventions and support the Global Fund’s ambition to introduce injectable lenacapavir with speed, scale and equity. 

New US COVID-19 Vaccine Policy 

The US Food and Drug Administration (FDA) outlined in a new blueprint for COVID-19 vaccines, one that shifts from a recommended annual COVID vaccine for everyone 6 months and older, to adults over 65 and individuals with high-risk conditions, such as compromised immune systems. This shift requires vaccine manufacturers to conduct extensive clinical trials before approving vaccines for healthy individuals aged 6 months to 64 years, potentially delaying access for this group. Rather than proposing the new guidelines through the typical regulatory processes, including opportunities for public comment, this framework was devised and published by the head of the FDA along with the new head of FDA’s Center for Biologics Evaluation and Research (CBER).  

IMPLICATIONS: This unorthodox process could complicate future vaccine approvals, as well as leave interpretation and coverage decisions up to insurers, which would create major access barriers for many. 

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New Resources: Tracking the Impact of US Cuts to Foreign Aid, USAID, and Research

As the US administration continues to dismantle foreign aid infrastructure and retreat from its commitments to science and global health, AVAC is tracking the impacts and consequences. 

  • What Happened to PEPFAR? provides an in-depth look at the stop work orders and contract terminations disrupting HIV prevention access. 

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