Global Health Watch: US shutdown continues, WHO prequalifies lenacapavir, NIH recompetes AIDS networks

Issue 37

As the US government is in its second week of being shut down, the ripple effects across global health shows the interconnectedness of the public health infrastructure in the US and globally and uncertainty about the future of foreign aid. Amid this turmoil, the World Health Organization has prequalified injectable lenacapavir for PrEP in record time, using a new, expedited process. This development marks an important bright spot, signaling momentum toward broader HIV prevention access.

WHO Prequalifies Oral and Injectable Lenacapavir 

The World Health Organization (WHO) prequalified both the oral tablet and injectable forms of lenacapavir (LEN) for PrEP. The prequalification was done through a new, expedited prequalification pathway that can facilitate national registration through the Collaborative Registration Procedure for Prequalified Products (CRP-PQ), which may streamline access to these products beyond the traditional approval routes. WHO prequalification followed the European Medicines Agency’s (EMA) positive scientific opinion and happened 36 days after filing. As Meg Doherty, WHO’s Director of Science for Health and former visionary director of WHO’s Global HIV, Hepatitis and STI Programmes, pointed out, this is the first example of 12-month alignment of WHO guidelines and prequalification of a product within 12 months of the clinical trial evidence. 

IMPLICATIONS: This milestone represents major advances in speeding access for global HIV prevention. The speed and flexibility of WHO’s accelerated process represents regulatory innovation that can accelerate access to essential health products. For lenacapavir, prequalification means that countries may be able to move more quickly through the process of licensing and delivering the product with fewer regulatory barriers and faster timelines. Now, other aspects of the delivery chain – procurement, supply chains, equitable distribution mechanisms, demand creation, monitoring and evaluation and implementation science – need to adapt this commitment to speed in reaching large-scale impact.  

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US CDC Deleted Critical Health Information from Websites Silently 

The decisions and actions at the US Centers for Disease Control and Prevention (CDC) continue to spiral downward. Earlier this week, key public health content was removed from its websites, including guidance on HIV and STI prevention, testing, and treatment. These deletions occurred without notice or explanation, which prompted public health leaders and organizations, including AVAC, to condemn the actions: “Removing these resources undermines transparency, public trust, and efforts to eliminate health disparities, especially for communities most affected by these epidemics.” 

IMPLICATIONS: The CDC’s quiet removal of crucial HIV and STI content has not been done in isolation. We’ve witnessed a quick erosion of scientific leadership and transparency and an uptick in mis-information. Together, these actions continue a troubling shift, where political agendas override scientific transparency. 

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NIAID Initiates Network Renewal Process 

The US National Institute of Allergy and Infectious Diseases (NIAID) initiated a public consultation to gather feedback on the future of its four Division of AIDS (DAIDS)-sponsored HIV clinical research networks: the AIDS Clinical Trials Group (ACTG), International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), HIV Prevention Trials Network (HPTN), and HIV Vaccine Trials Network (HVTN). The goal of this process is to incorporate external perspectives from researchers, advocates, and others into the planning and renewal of network cooperative agreements and the priorities they reflect. These agreements are set to be recompeted in 2026 and awarded for the 2027–2034 cycle.  

IMPLICATIONS: The NIH has a longstanding mandate to advance fundamental scientific knowledge. Many of the most transformative innovations in HIV prevention and treatment are the direct result of decades of NIH investments in the clinical trial networks. This mandate must be protected and strategically resourced, even amid broader funding pressures. An evidence-based, balance research portfolio, including robust clinical trial infrastructure globally, is essential to ending the HIV/AIDS epidemic in the US and around the world. 

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Inclusion Made Simple, In Difficult Times

“Not even a week after the American Journal of Public Health published our paper, Addressing Transgender Erasure in HIV Clinical Trials, the US NIH moved to prohibit scientists from collecting data about gender,” write HANC’s Brian Minalga and AVAC’s Cindra Fuerer in a new blog post.

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What We’re Reading

AVAC Resources

Upcoming Webinar

Presented by The Choice Agenda: join our panelists for an unflinchingly honest—and interactive—conversation as we assess 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 will be explored.

New LEN Resources, Publications on PLP and TG Inclusion and More!

This roundup from AVAC highlights key developments across the field of HIV prevention from accelerating access to injectable lenacapavir (LEN) for PrEP, to advancing inclusion of pregnant and lactating people, and trans and gender-diverse communities in research. It also features a new initiative reinforcing the highest standards in ethical research conduct and tools for the fight to sustain funding in HIV research.

Read on for the details!

The Latest on Speed, Scale and Equity in the Rollout of LEN for PrEP 

In the midst of profound disruptions to US leadership in global health, the world has seen sustained momentum behind the rollout of injectable LEN for PrEP.  

The latest news came on October 6, with the WHO issuing a prequalification for Gilead’s lenacapavir pill and injection products using a new “abridged prequalification pathway” that took just 36 days. WHO prequalification, based on the positive scientific opinion of the European Medicines Agency (EMA), adds lenacapavir to a list of products evaluated as safe, effective, and crucial for improving public health. Speeding up evaluation and regulatory approvals has been a long-standing advocacy priority in HIV prevention, and spurs momentum toward scaling up LEN for PrEP. 

AVAC’s updated infographics and resources feature the latest information on the price and the process for accelerating access:

WHO Launches Global Clinical Trials Forum 

This week, the World Health Organization launched the Global Clinical Trials Forum (GCTF), a global network to strengthen clinical trial environments and infrastructure at national, regional and global levels. The GCTF has shown vision and commitment to the ethical conduct of research by incorporating the Good Participatory Practice Guidelines into its work.

“The work of the Global Clinical Trials Forum (GCTF) is exciting and necessary. Best practices in clinical trials can be strengthened and sustained with meaningful and informed guidance and coordination such as that under the GCTF. AVAC applauds the WHO’s ongoing commitment to the Good Participatory Practice Guidelines within the GCTF, which ensure ethical, inclusive and effective stakeholder engagement in research. We are proud to be founding member.” — Cindra Feuer, AVAC Senior Program Manager

Advancing the Inclusion of Pregnant and Lactating Populations in Research

Cathy Slack of HAVEG, AVAC’s Breanne Lievense, former AVACer Manju Chatani and partners published a review of ethics guidelines supporting access to HIV clinical trials for pregnant and lactating individuals, a population too often excluded from research. Find related resources, including an Advocate’s Guide on the issue created as part of the Coalition to Accelerate & Support Prevention Research (CASPR), on AVAC’s dedicated page.

A Scorecard for Including Trans and Gender Diverse Communities in HIV Prevention Research

The American Journal of Public Health just published Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion, by AVAC’s Cindra Feuer and Brian Minalga of HANC. In it, they share findings from this first cross-sectional review of trans participation in HIV clinical trials and chart the movement from TGD invisibility to a recent uptick of inclusion. In addition to the article, Cindra and Brian’s blog, Inclusion Made Simple, In Difficult Times, puts these findings in the context of the US policy attacks on TGD people. Find additional advocacy resources at avac.org/transgender-manifesto.

Upcoming Webinar
And coming up, don’t miss The Choice Agenda & AVAC hosted webinar on this critical issue, Do Not Check That Box—Impacts From the Assault on Transgender Communities and DEI + Strategies to Sustain and Rebuild.

Advocating for Sustained Investment in HIV Prevention Research

The field of HIV prevention is confronting an unpreceded need to defend sustained investment in research. AVAC and our partners have been meeting the moment—these resources can support advocacy across the field.

We hope these resources support our collective advocacy. We know the scope of the threats to HIV prevention research and global health are broad and deep. But the fight is ours to win, with an abiding passion and commitment from fierce advocates. Together we have already achieved major gains against HIV, and the fight continues.  

Jirair Ratevosian said it well: “Hope isn’t naïve—it’s an act of defiance. And in a moment like this, choosing hope is its own kind of leadership.” 

Inclusion Made Simple, In Difficult Times 

By Cindra Feuer and Brian Minalga

Not even a week after the American Journal of Public Health published our paper entitled, Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion, the US National Institutes of Health (NIH) moved to prohibit scientists from collecting data about gender, according to draft policy reported in the Chronicle of Higher Education.   

It’s one of the latest blows from the Trump Administration’s anti-science antipathy for trans and gender diverse (TGD) people. Starting on his first day in office, Trump himself proclaimed, by executive order, federal recognition of only two, unchangeable, biological sexes determined at birth. And thus, he halted diversity programs. His administration has also sought to end gender-affirming medical care–deeming it chemical and surgical mutilation—while trying to prohibit changes to gender in national passports, among other moves to obliterate trans visibility.  

Most glaring is the administration’s termination of more than 1,000 US NIH grants on lesbian, gay, bisexual, trans and queer (LGBTQ) health, according to the database Grant Witness. The New York Times estimates that together these grants are worth more than $800 million. More broadly, the US Supreme Court, in a 5-4 decision on August 21, sided with the Trump Administration and allowed some $783 million in cuts to NIH grants related to diversity, equity and inclusion. 

Trump’s timing slaps up against a swelling undercurrent of trans resiliency, which was just starting to pay off in the field of HIV research after decades of neglect. The AJPH paper is the first cross-sectional review of trans participation in HIV clinical trials, which charts the movement from TGD invisibility to the recent uptick of inclusion. The key takeaway: a mere 1 percent (2,532 out of 178,893) of trial participants identified as TGD, between 1991-2023, in 41 milestone studies (table 1, page 4)

The first study to report TGD enrollment was the iPrEx PrEP trial in 2007, with TGD representation continuing to increase over time. However, more than two thirds of studies conducted since 2007 still failed to account for TGD participation, including studies implemented as recently as 2020. This despite evidence that no community is in greater need of HIV prevention than TGD populations.  According to the most recent data from UNAIDS, the median HIV prevalence of TGD communities, among reporting countries, is 8.5 percent. The next highest is among gay men, at 7.6 percent. Data by region can show astounding prevalence in some communities, as high as 50 percent, indicating extreme levels of unmet need for HIV prevention.  

This urgent need for inclusion can be advanced by attention to critical indicators, outlined in the HIV Research Scorecard for Trans and Gender Diverse Inclusivity (Figure 1, page e3), a twin-purpose tool to both guide study design and provide metrics for TGD-inclusive research. The scorecard, informed by global TGD advocates and their contributions to the Trans Manifesto: No Data No More, assesses 14 indicators under four primary areas for inclusion: study design; study implementation; study reporting; and language. As an example, within trial design, it asks if eligibility criteria explicitly include gender-nonbinary individuals, and transgender men and women. If they are not included, is their exclusion explicitly justified? Are measurable goals for the enrollment of TGD participants set forth? Is gender-affirming hormone use accounted for as a variable?  

Other indicators ask if data collection captures TGD HIV status, if TGD inclusion in a study is made explicit in published findings, and if TGD participation is in alignment with best practices, such as DAIDS’ data collection recommendations. Similarly, the scorecard grades whether language related to study documents, outreach materials and communications adheres to best practices in gender-inclusive language as outlined in NIAID’s HIV Language Guide.  

The scorecard’s continued use could lead to much needed and long overdue equitable representation of TGD people in HIV research. Researchers can and should use the scorecard when designing and implementing trials, and advocates must use it to hold them accountable when they do not. It’s a purpose-built tool for ensuring greater inclusivity in these challenging times.   

But the inclusion of TGD populations in research relies on the very language the US administration is trying to erase, with the latest policy attack aimed at NIH research. According to the Chronicle, researchers inside and outside the agency “shall not use NIH funds to request, collect, or disseminate information related to gender…” unless that, data on sex reflects Trump’s flawed view that there are only two sexes.  

To measure only sex and not gender jeopardizes scientific accuracy and equity, especially against a global backdrop where TGD communities are among the most stigmatized people. TGD communities struggle to access care, resulting in a staggering unmet need for prevention.  

As we lay out in our article, “the lack of TGD representation in HIV clinical trials indicates a historical erasure of TGD communities with potential public health consequences.” These consequences are indeed grave; they result in missing data, poor access to newly proven options, a research and development pipeline that is not built to reach those who need it most, and a stalled HIV response at large, with countless lives needlessly left exposed to virus and disease.  

This is not the time to scrub TGD inclusion from HIV trial designs and protocols, regardless of attacks and misguided fury aimed at our communities. In fact, now is the moment to use everything at our disposal, including the new scorecard, to set in motion an era of HIV research that meaningfully responds to TGD needs.

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. 

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Where Are We With PEPFAR?

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.

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US CDC Recommends LEN for PrEP

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.”

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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.  

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24 Hours to Save AIDS Research

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.

What We’re Reading

Resources

Global Health Watch: SCOTUS decision keeps foreign aid frozen, US FY26 budget updates, Global Fund’s new report and shifting focus

Issue 33

By Cindra Feuer

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. 

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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. 

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Global Fund Results and Shifting Focus 

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. 

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SA AIDS 2025 Highlights

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.

What We’re Reading

Resources

Join Us September 16-17

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 Us for ‘24 Hours to Save AIDS Research’

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 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

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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. 

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The Latest in Foreign Aid

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. 

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Vaccines Unraveling

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.  

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Join us September 16-17

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!

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What We’re Reading

Resources

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.


Resources

Events

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

Register 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.

Learn more.

24 Hours to Save AIDS 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 us on YouTube, and track the conversation on Bluesky (@saveaidsresearch.bsky.social‬) and Instagram (@saveaidsresearch). Starting on September 16 at 11am ET and continuing for 24 hours!

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. 

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Updates in AVAC v Department of State Case 

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.  

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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.

Read Now

What We’re Reading

Resources

Save the Date!

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.”