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

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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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.

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

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

US Government Shuts Down as Federal Funding Expires

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

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

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

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

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

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Jeanne Marrazzo Fired from NIAID 

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

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

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

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

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

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

AVAC Denounces Court’s Misguided Late-Day Ruling

Contact: [email protected] 

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

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

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

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

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

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

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

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

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

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UN General Assembly Updates

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

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

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

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United Nations Secretary-General Proposes to “Sunset” UNAIDS 

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

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

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Africa CDC Announces Grant to Support Local Drug and Vaccine Manufacturers 

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

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

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AVAC Applauds Agreements to Accelerate Market Development for Lenacapavir for PrEP

Calls for Additional Commitments to Ensure Momentum Translates into Impact 

New York, NY, September 24, 2025 — AVAC welcomes parallel announcements from the Gates Foundation and Unitaid on strategic investments to accelerate the development of, access to and price reduction for generic versions of injectable lenacapavir (LEN), the highly effective six-monthly injection for HIV PrEP.   

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

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

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

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

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

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

AVAC’s publication, Now What with Injectable LEN for PrEP How to Translate Ambition into Accelerated Delivery and Impact, includes forecasts demonstrating that instead of 2 million people in three years, the world could reach at least 1.5 million people in just one year. Gilead has confirmed that they can manufacture enough injectable LEN to reach in excess of 5 million LEN users over the next three years. These numbers suggest what is possible and this is no time to think small. 

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

Global Health Watch: 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.

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What We’re Reading

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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. 

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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!

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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.

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