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.
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.
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.
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.
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.”
“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: PEPFAR, US foreign aid strategy, CDC turmoil, LEN for PrEP, vaccine policy
As the US government approaches its September 30 fiscal year deadline, the Supreme Court of the United States (SCOTUS) is weighing whether to uphold the District Court’s order in the AVAC v. Department of State lawsuit, which compels the US government to spend billions in congressionally-appropriated foreign aid, or allow the Administration to “run out the clock” as part of the “pocket rescission” maneuver. This ruling, alongside SCOTUS decisions on tariffs, could dramatically expand executive power over spending historically controlled by Congress. Coupled with CDC and vaccine policy turmoil, changes to PEPFAR’s planning process, and the State Department’s new “America First” global health strategy, these developments represent high stakes for HIV programs and the future of foreign aid for global health.
New “America First” Strategy for Global Health Released
Under the plan, the US would initially cover 100% of commodity and frontline healthcare worker costs through the start of the next fiscal year but would shift an increasing share of expenses to partner governments over time. The plan also signals a reshuffling of which countries will receive US investments and may involve “third-country” allies in future agreements to reduce overlap. The plan does prioritize “innovation” and specifically names the importance of lenacapavir (LEN) for PrEP and the recent re-commitment of the Biden Administration first announced in December.
IMPLICATIONS: This new strategy prioritizes US interests over traditional development goals and represents a fundamental overhaul of US global health assistance, with major consequences for HIV prevention and treatment programs worldwide. Moving toward bilateral agreements and compacts risks fragmenting coordination, intensifying the politicalization of assistance, slowing disbursements, and creating uncertainty for countries already grappling with budget shortfalls. While the new strategy appears to reaffirm US commitments to global targets for ending the HIV epidemic, there is concern whether current indicators will continue to be tracked and many unknowns in the details of pending bilateral agreements. For programs like PEPFAR, which have long relied on predictable, multi-year, large-scale US support, the new approach could mean sudden funding gaps and weaker negotiating leverage on pricing or access for new prevention tools. And while it is good (and smart) to see LEN prioritized, the continued unilateral focus on PrEP for mother-to-child transmission reflects a continued blind-eye to the epidemiology of HIV/AIDS and the need to provide LEN and prevention generally more broadly.
PEPFAR has initiated a “Bridge Plan” process to determine programming for a six-month stopgap funding period running from October 2025 to March 2026 and incorporating a 40% budget cut from previous allocations. For decades, countries and civil society have prepared Country Operational Plans (COPs) months in advance with clear budgets, targets and plans. Instead, this Administration began by freezing foreign aid and proposing a 40% cut to global health in the President’s fiscal year 2026 (FY26) Budget Request. In place of COPs meetings, PEFPAR instituted this temporary bridge plan process—with limited time and no stakeholder engagement. Country plans are due on September 24, leaving partner governments and civil society scrambling to meaningfully engage in decisionmaking with sharply reduced resources. Advocates warn that prevention services, key population programs, and the introduction of innovations like lenacapavir could all be delayed or excluded. The process also signals an attempt to go around Congress to enact the President’s requested FY26 budget cuts.
IMPLICATIONS: The Bridge Plan keeps PEPFAR technically alive but with scaled-back funding, compressed timelines, and weaker accountability structures. If granular targets and community voices are sidelined, countries may lose hard-won gains in prevention and treatment and see stalled or reversed progress on HIV. Missing or delaying the rollout of LEN for PrEP, especially for key populations, would exacerbate the setback. Over the next six months, how these plans are finalized will shape the trajectory of global HIV programming for years to come.
After the departure of US Centers for Disease Control and Prevention (CDC) leadership in the last month and Senate testimony by its former Director a day prior (see below), the CDC issued new clinical recommendations endorsing injectable lenacapavir as a twice-yearly option for HIV PrEP, marking a major milestone in the expanding PrEP landscape.
IMPLICATIONS: These recommendations are an important step forward, but equitable implementation remains a challenge in the US, especially the very high list price. This progress underscores the importance of strong policy protections like the Affordable Care Act, which requires most private health plans to cover PrEP, including visits and labs at no cost. However, ongoing legal threats to the ACA’s preventive coverage mandate could jeopardize access to LEN and all PrEP options. Tools alone don’t end epidemics; they must be delivered with equity.
Given the political turmoil at CDC, these recommendations reflect – as so eloquently stated by Francisco Ruiz, former director of the White House Office of National AIDS Policy – “the tireless work of colleagues and partners who push science forward despite adversity. Their dedication underscores the need to keep investing in research, our workforce, and the infrastructure that ensures providers, communities, and people everywhere have access to proven HIV prevention tools. This is CDC in action … dedicated people, strong science, healthier communities.”
CDC Turmoil as Former Director Testifies Before Senate Committee and ACIP Prepares Vaccine Recommendations
Meanwhile, former CDC Director, Susan Monarez, testified Wednesday at the Senate HELP Committee hearing on her unjust firing. Monarez said she was forced out of the CDC after refusing to pre-approve vaccine recommendations and to fire career officials without cause. “He [HHS Secretary Robert F. Kennedy Jr.] just wanted blanket approval…Even under pressure, I could not replace evidence with ideology.” Monarez’s former chief medical officer, Debra Houry, who resigned shortly after Monarez was removed, echoed these concerns and called for RFK Jr.’s resignation warning that the upcoming Advisory Committee on Immunization Practices (ACIP) meeting could cement dangerous new policies.
As this issue went to publication, the ACIP had just voted 8 to 3 to change the current recommendations that allow children under 4 to receive the combination vaccine for measles, mumps, rubella and varicella (MMRV). The ACIP is expected to vote today on shifting routine Hepatitis B vaccination (HBV) currently given at birth and to make recommendations on vaccines for COVID-19. These shifts raise important questions about sustainability, access, and equity moving forward.
IMPLICATIONS: The testimonies of Monarez and Houry, their departures and the departures of other trusted CDC leaders are eroding confidence in the agency’s ability to make independent, evidence-based decisions. This raises serious questions about whether future CDC guidance will be evidence-based and can maintain credibility in an increasingly politicized environment. When public health decisions are perceived as politically pre-determined rather than evidence-based, public confidence in recommendations will erode and public health will be compromised. Departed leaders are encouraging individuals to seek advice of their medical professional over national recommendations. Health officials are warning that vaccine uptake will be lower, disease outbreaks will be more likely and health responses will be weaker.
Earlier this week, nearly 5,000 scientists, researchers, advocates and members of the community came together for the online marathon to showcase and support decades of US investment in HIV research: what it has achieved and what’s now at risk. Since January 20, the US Presidential Administration has been making massive cuts to HIV research, dismantling the infrastructure for conducting research and spreading disinformation on the benefits of research. For 24 hours, more than 60 researchers from all over the world broadcast the facts, countered the lies and showed what HIV research has achieved. All recordings will be posted soon.
Global Health Watch: SCOTUS decision keeps foreign aid frozen, US FY26 budget updates, Global Fund’s new report and shifting focus
Issue 33
This week Global Health Watch covers major developments from a Supreme Court decision stalling foreign aid disbursements (again), to the US House’s fiscal year (FY26) budget drafts, and the Global Fund’s updated report and shifting focus.
Supreme Court Pause in AVAC’s Foreign Aid Case
The AVAC and Global Health Council cases against the US presidential administration on the foreign aid freeze continue to play out in the courts. Tuesday, US Supreme Court Chief Justice John Roberts issued a one-person decision, which granted the Administration a temporary administrative stay (or pause) on the recent District Court ruling. This temporary ruling means the government would not have to spend the congressionally appropriated funds by the September 30th fiscal year deadline despite the District Courts order last week that required them to do so.
IMPLICATIONS: Chief Justice Roberts’ order effectively keeps the Administration’s “pocket rescission” strategy alive by temporarily suspending the District Court’s order. AVAC and its partners are preparing their Supreme Court brief due by Friday to make clear that allowing the Administration to “run out the clock” would not only devastate lifesaving programs but also set a dangerous precedent that erodes democratic oversight of federal spending.
US FY26 Budget Proposal Maintains NIH Budget, but Cuts CDC
The US House Labor, Health and Human Services (LHHS) Appropriations Subcommittee released its fiscal year 2026 (FY26) draft spending bill, which allocates $184.5 billion, of which $108 billion is designated for Health and Human Services (HHS). This is approximately 6% less than the current year funding levels, and, notably, the proposal includes steady funding for the National Institutes of Health (NIH) at $48 billion. However, the bill includes deep cuts to the HIV prevention program at the Centers for Disease Control and Prevention (CDC) at 19-20% and eliminates the Title X family planning program.
IMPLICATIONS: While NIH funding is preserved for now in the House bill, deep cuts to CDC, Title X, and key public health infrastructure pose a serious threat to HIV prevention, STI research, and community health programs. The upcoming full committee markup and potential amendments by Democrats will reveal where bipartisan opportunities remain, and where the fight for global health funding must focus next.
The Global Fund released its 2025 Results Report, which shows increased access to HIV treatment and historic progress on TB and malaria prevention in countries where it invests.
However, the Fund is facing serious funding shortfalls. As foreign aid declines, especially from major donors like the US, the Global Fund on Wednesday said it will prioritize funding “even more to the very poorest countries,” especially those facing conflict, high disease burden, and climate stressors, which have fewer alternative funding options.
IMPLICATIONS: As we’ve been saying for months, gains in HIV, TB, and malaria could stall or reverse without urgent intervention. Prioritizing the poorest is necessary, but cuts could still undermine infrastructure, limit access, and exacerbate inequities globally. There is also a risk that countries dependent on Global Fund grants may face disruptions just when demand for prevention tools is growing and when new options (like long-acting PrEP) need stable funding to scale.
The South African AIDS Conference spotlighted resilience across communities amid funding shocks and setback with advocates insisting that their work must intensify. AVAC and partners emphasized that products don’t end epidemics, programs do – and called for urgent, scalable, and people-centered approaches to turn innovation in research and development into options and choices that impact lives. The takeaway: protect prevention, invest in locally led systems, and keep communities at the heart of HIV response and research.
AVAC and partners are hosting a 24-hour livestream event with scientists, researchers and advocates from around the world to share insights, answer questions, and inspire action!
Join AVAC and partners as we host 24 Hours to Save AIDS Research on September 16-17. This all-day, online marathon will include more than 70 speakers from around the world sharing their work and experiences with HIV research. Registration is open and the interactive event will stream on YouTube.
Since January 20, the US Presidential Administration has been making massive cuts to HIV research, dismantling the infrastructure for conducting research and sharing misinformation on the benefits of research. The commitment and actions of the scientific and advocacy communities have been successful in reversing some of these actions and the pressure must continue.
For more ways to make the case for sustained investments in biomedical research and development and to track the devastating impacts of recent cuts on HIV and STI research and development, visit Research Matters, which shares a toolkit for researchers, and see our impact trackers below.
Impact Trackers
HIV Prevention R&D at Risk Want to understand how the US policy shifts are endangering the future pipeline of HIV prevention tools? Check out our HIV Prevention R&D at Risk tracker.
Impact of PEPFAR Stop Work Orders Want an in-depth look at how the PEPFAR stop work orders and contract terminations have disrupted PrEP access? Check out our PEPFAR PrEP impact tracker.
Why STI Funding Matters: Worldwide Prevention, Shared Protection Want to know about the global threat posed by defunding STI research and programming? See our Why STI Funding Matters tracker.
Delivering Lenacapavir for PrEP
As the fight to protect HIV research from devastating cuts continues, we must also push to ensure that the breakthroughs it generates, like innovative new PrEP options, reach the populations most in need of prevention.
PEPFAR Reemerges to Support Rollout of Lenacapavir for PrEP
PEPFAR and Gilead Sciences announced plans to procure injectable lenacapavir for PrEP (LEN) in “countries with the largest HIV/AIDS epidemics… with a focus on preventing mother-to-child transmission” last week. This is not new news, since PEPFAR and the Global Fund had already announced an ambition to reach two million people with LEN in the first three years—and the Global Fund recommitted to the ambition in their July announcement with Gilead. “It’s a step forward from where we’ve been in a fairly paralytic state for the last seven months, and I hope that this breaks the logjam and at least can get prevention back on the agenda,” AVAC’s Mitchell Warren told NPR.
Resources to Deliver LEN with Speed, Scale and Equity
See AVAC’s in-depth resources to inform an equitable and effective rollout of LEN.
The Gears of Lenacapavir for PrEP Rollout: Outlines a plan to specifying priorities by stakeholder and evaluates volume and pricing strategies with near term priorities over the next few years.
Moving a Product to the Real World graphic shows the delays in past efforts to rollout PrEP and hopeful signs for accelerated rollout this time, if we work collectively with speed, scale and equity.
Getting PrEP Rollout Right This Time shares key insights from earlier rollouts of PrEP (such as oral PrEP) to inform a faster, smarter and more equitable introduction of LEN and future PrEP products.
The miracle of mRNA: What’s possible beyond SARS-CoV-2—understanding mRNA, its history and potential challenges for HIV vaccines
Thursday, September 11 at 9am ET Approved in July, lenacapavir for PrEP has tremendous potential to increase access and engagement in the United States, reaching individuals who have been unable to embrace PrEP in its previous formulations. Please join the Choice Agenda and the HIV BLUPrInt team for a deep dive into rolling out LEN in the US.
Global Health Watch: PEPFAR Reemerges, Budget Deadlines, Gov’t Shutdown Risks, Vaccine Policy Unraveling and What’s Next for FY26
Issue 32
Members of the US Congress reconvened this week following their extended August recess. They now face a looming deadline of the end of the fiscal year on September 30 to avert a government shutdown if they cannot agree to a bipartisan fiscal year 2026 (FY26) federal budget by then. In this context, the FY26 appropriations process, the President’s request for “pocket rescissions” to claw back Congressionally appropriated funds, AVAC’s court case (AVAC v. State Department), and PEPFAR’s reemergence to rollout long-acting PrEP take on heightened urgency.
PEPFAR Reemerges to Support Rollout of LEN for PrEP
The President’s Emergency Plan for AIDS Relief (PEPFAR) and Gilead Sciences yesterday announced plans to procure injectable lenacapavir for PrEP (LEN) in “countries with the largest HIV/AIDS epidemics…with a focus on preventing mother-to-child transmission.” This is not new news, since PEPFAR and the Global Fund had already announced an ambition to reach two million people with LEN in the first three years – and the Global Fund recommitted to the ambition in their July announcement with Gilead. But given the past seven months and PEPFAR’s absence from planning, it is good to see PEPFAR committing to prevention and PrEP again.
IMPLICATIONS: Yesterday’s announcement at least gets PEPFAR back, but there are still many questions to be answered and critical work to be done to ensure this initiative achieves impact for all populations in need of prevention: which countries and which populations; what volumes and what prices; and how to invest in this important innovation when PEPFAR budgets are being slashed by the Office of Management and Budget (OMB)? But “it’s a step forward from where we’ve been in a fairly paralytic state for the last seven months, and I hope that this breaks the logjam and at least can get prevention back on the agenda,” AVAC’s Mitchell Warren told NPR.
NIH Budget Preserved Under Appropriations Bill, But for How Long?
The House Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee (LHHS), which oversees NIH funding, issued its draft FY26 spending bill and summary. It notably preserves NIH funding at approximately $48 billion. Significantly, this bill reflects the Senate version, which rejects the President’s proposed 40% cut and retains all 27 NIH institutes and centers. Next week, the committee will issue a report detailing how the money should be spent, setting the stage for a broader spending debate across Congress. Meanwhile, the action to terminate nearly 800 NIH grants was ruled “illegal and potentially racially discriminatory” by a federal judge, triggering talks of a settlement to restore funding that could conclude later this week.
IMPLICATIONS: While NIH funding levels in Congressional bills reflect continued bipartisan support for biomedical and implementation research, proposed deep cuts to the Centers for Disease Control and Prevention (CDC) and broader Health and Human Services (HHS) have the potential to further dismantle public health infrastructure in the US. And what happens after next week’s appropriations Committee report will shape not only the stability of NIH and CDC, but the future of US global health commitments. As FY26 appropriations move forward, the House and Senate bills will need to be reconciled with agreement on final spending levels between the two chambers. Perhaps more importantly, though, is whether the President and the OMB will spend Congressionally appropriated funds next year, given their current attempts to usurp Congress’s power of the purse.
Earlier this week, the US President issued a “pocket rescission” request, a questionable budget maneuver, which would effectively run down the clock without disbursing nearly $4.9 billion in Congressionally appropriated FY25 foreign assistance funding. This week, advocates rallied in Washington, D.C., to demand the release of global AIDS funding warning that a “pocket rescission” defies the law, sabotages programs like PEPFAR, and jeopardizes lives. See AVAC’s statement condemning the President’s pocket rescissions request.
Then on Wednesday night, the US District Court issued a new preliminary injunction in AVAC v Department of State and Global Health Council v Trump, blocking the US government from withholding funds that Congress has already appropriated. Of importance, this is the first case to explicitly reject the legality of a “pocket rescission.” The government immediately filed yet another appeal of this ruling to the US Circuit Court of Appeals.
IMPLICATIONS: These developments underscore both the urgency and the stakes. On one hand, the District Court’s injunction in AVAC and GHC affirms that the “pocket rescission” is unlawful, protecting billions in global health funding from executive overreach. On the other, the Administration’s ongoing maneuvers in the courts reveal its intent to undermine Congress’s constitutional “power of the purse” and strip away resources from foreign assistance programs. AVAC and partners will continue to press in court, in Congress, and with communities to ensure that funds flow as appropriated, because at stake is not only the survival of HIV prevention and treatment programs worldwide but also the fundamental balance of powers in US governance.
New developments that have been building to further undermine vaccine policy and scientific expertise in the US are coming to a head. This week, Paul Offit, a pediatrician and co-inventor of the rotavirus vaccine, was removed from the FDA’s Vaccines and Related Biological Products Advisory Committee; Florida rolled back its mandate requiring pediatric vaccines for entry into the public school system; the President publicly challenged pharmaceutical companies to prove that their COVID‑19 vaccines still work; and HHS Secretary Robert F. Kennedy Jr. continued to muddy the waters regarding vaccine safety and efficacy. Meanwhile, two leading NIH scientists filed whistleblower complaints, stating they were stripped of leadership roles after objecting to the Trump administration’s efforts to undermine vaccines.
IMPLICATIONS: These developments signal a dangerous escalation in the US government’s ongoing assault on vaccine science and policy. The politicization of vaccines in the US threatens to reverberate internationally, fueling disinformation and destabilizing decades of progress in immunization and epidemic preparedness.
AVAC and partners are hosting a 24-hour livestream event with scientists, researchers and advocates from around the world to share insights, answer questions, and inspire action!
A Resource Round Up Covering Funding Fights & A New Generation of PrEP
Policy Fights and Funding — From Further Cuts to Foreign Aid to Defunded STI Prevention
The news is moving fast, and the need for advocacy is moving even faster. AVAC is providing resources, updates on its fight against the US government on the foreign aid freeze, documenting impacts on STI prevention, and sharing new opportunities for education and advocacy in HIV prevention.
AVAC Condemns US Administration’s ‘Pocket Rescission’ Request to Withhold Billions in Foreign Aid
The latest move by the US Administration to undermine congressional checks and balances and gut funding for foreign assistance involves a so-called “pocket rescission” whereby the President asks Congress to approve the cancellation of funds late in the fiscal year. Read AVAC’s statement and NPR’s coverage, White House goes after more foreign aid cuts for more context.
And late last night, the US District Court issued a preliminary injunction blocking the government from withholding funds Congress has already appropriated. Most significantly, the judge addressed the illegality of “pocket rescissions”.
The Real-World Impact of Defunding STI Research
The impact of US funding cuts on STI research and prevention remains largely overlooked—even as the consequences grow dire. These cuts are devastating STI surveillance, prevention, diagnostics and research and development. In a new piece for TheBodyPro, AVAC’s Alison Footman documents these losses through the voices of seven leading researchers whose work—and communities—are directly at risk. Read it on TheBodyPro.
Will Lenacapavir be a Lever or a Let-Down? Lessons, Resources and Considerations for Implementation in the United States
Hosted by The Choice Agenda and the HIV BLUPrInt team, this webinar will explore what’s next for rolling out injectable lenacapavir for PrEP (LEN) in the US, and the advocacy to increase HIV prevention access, empowerment, and reach. Find additional resources on rolling out LEN globally, how to achieve impact on the epidemic, and an overview of the efficacy trials here.
South Africa AIDS Conference (SAAIDS), September 8-11
Attending the 12th annual SA AIDS conference in Johannesburg, South Africa, next week? Don’t miss the Advocates’ Corner, a keynote plenary where AVAC’s Mitchell Warren shares perspective on the future of HIV prevention, and an important satellite on Wednesday, Bridging the Gap and Identifying Opportunities: Innovative Strategies to Accelerate HIV Prevention, Treatment, and Care for Key and Vulnerable Populations in South Africa.
AVAC and partners are hosting a 24-hour livestream event with scientists, researchers and advocates from around the world to share insights, answer questions, and inspire action!
For busy advocates, we hope these resources and opportunities will support your work in the fight to save investment in research, to speed access to choices in HIV & STI prevention, and to bolster the HIV response in this time of transition.
Global Health Watch: CDC leaders depart, updates in the AVAC v Department of State case on foreign aid
Issue 31
This week, political overreach that is destabilizing global health programs and policy was on full display with the political interference and departure of leaders at the US Centers for Disease Control and Prevention (CDC) and the US Administration’s emergency appeal to the Supreme Court in AVAC v. Department of State case.
US CDC Leadership Departs Citing Weaponization of Public Health
The CDC Director and several senior leaders were removed or resigned from the agency this week. The White House announced that Director, Susan Monarez was fired after a month into her new position, saying that she is “not aligned with the president’s agenda”.
In protest, three senior CDC leaders, including Demetre Daskalakis, director of the National Center for Immunization and Respiratory Diseases, and former director of the Division of HIV Prevention in the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and Debra Houry, chief medical officer, resigned. Daskalakis’ resignation letter, which he made public, warned that the actions of Health and Human Services (HHS) Secretary, Robert F. Kennedy Jr. pose dire risks to vulnerable communities and undermine scientific credibility. “I am unable to serve in an environment that treats CDC as a tool to generate policies and materials that do not reflect scientific reality and are designed to hurt rather than to improve the public’s health.” Houry wrote in her resignation, “For the good of the nation and the world, the science at CDC should never be censored or subject to political pauses or interpretations.”
US Senator Patty Murray, Democrat from Washington called for the immediate termination of HHS Secretary, RFK Jr. in a statement. Separately, Sen. Bill Cassidy, a Louisiana Republican who chairs the Senate Committee on Health, Education, Labor and Pensions, called on HHS to “indefinitely postpone” its vaccine advisory committee meeting next month amid the slew of departures from the CDC and growing anti-vaccine sentiment and intentional misinformation from the administration.
IMPLICATIONS: These developments at the CDC continue the dangerous shift to ideology over evidence under the current HHS leadership. And they also show how difficult scientific independence can be in the face of political overreach. These shifts are destabilizing trust, credibility and leadership in the US public health system and undermining vaccines and vaccination programs. “If the [vaccine advisory committee] meeting proceeds, any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership,” Cassidy said in a statement.
Thursday evening, the DC Circuit Court of Appeals denied AVAC’s petition to rehear the AVAC v Department of State case on the foreign aid freeze in front of the full panel of judges (“en banc”). This comes just two days after the US government filed an emergency application to the Supreme Court of the United States (SCOTUS) seeking to “stay” (i.e., suspend) the injunction that is compelling the US government to pay out congressionally-appropriated funds as the case continues to be litigated. While this decision is a setback, the Appeals Court panel modified its previous opinion agreeing that the plaintiffs – AVAC and the Global Health Council and their co-plaintiffs – do, indeed, have legal standing to bring their cases back to the District Court for further consideration. The District Court issued the original temporary restraining order and preliminary injunction earlier this year.
As AVAC’s Mitchell Warren shared with Politico after the Government’s emergency application to SCOTUS, “Time and again, this administration has shown their disdain for foreign assistance and a disregard for people’s lives in the United States and around the world. But even more broadly and dangerously, this administration’s actions further erodes Congress’s role and responsibility as an equal branch of government. The question being put to SCOTUS is whether they will be complicit in further eroding the constitutional commitment to checks and balance.”
IMPLICATIONS: While the lower DC District Court of Appeals’ ruling moots the governments emergency application to SCOTUS, the fight is far from over. AVAC and partners commit to accountability and will defend global health and the principle of separation of powers.
The EXPrESSIVE Trials Test a Monthly Pill for PrEP: Advocates Speak
Read a statement by advocates and tune into AVAC’s podcast to learn why these trials of a once-monthly PrEP pill matter, how communities shaped them through Good Participatory Practice and what this means for expanding choice in HIV prevention.
AVAC Responds to Government’s Emergency Appeal to SCOTUS
In response to the US government’s August 26 emergency application to the US Supreme Court seeking to stay the preliminary injunction in the AVAC v Department of State legal case against the foreign aid freeze, AVAC’s Executive Director, Mitchell Warren wrote:
“It is no surprise that the administration has taken our case directly to the Supreme Court, especially after the District Court’s very clear and firm denial of their request yesterday to suspend the requirement to obligate Congressionally appropriated funding for foreign assistance. Time and again, this administration has shown their disdain for foreign assistance and a disregard for people’s lives in the United States and around the world. But even more broadly and dangerously, this administration’s actions further erode Congress’s role and responsibility as an equal branch of government. The question being put to SCOTUS is whether they will be complicit in further eroding the constitutional commitment to checks and balance.”
