Global Health Watch: mRNA vax contracts cancelled, Gates Foundation commits to women’s health R&D, SA invests in research

Issue 28

This week the US administration cancelled $500 million in mRNA vaccine contracts (see AVAC’s statement) while a Government Accountability Office (GAO) investigation found the NIH grant freezes violated the law. The Gates Foundation committed $2.5 billion to women’s health R&D, and South Africa is investing to protect its national research capacity in the face of US funding cuts.

US Administration Cancels mRNA Vaccine Contracts

US Health Secretary Robert F. Kennedy Jr. announced plans to defund $500 million in grants issued by the Biomedical Advanced Research Development Authority (BARDA), which supports 22 mRNA vaccine development projects. He cited unvalidated and spurious concerns that mRNA technology lacks effectiveness against upper respiratory viruses such as COVID‑19 and influenza. The move was widely condemned by vaccine researchers, who expressed alarm that defunding this rapidly scalable vaccine development platform will leave the US more vulnerable to infectious disease outbreaks. This latest action also added to the litany of anti-vaccine decisions. “Actions to take apart the CDC’s Advisory Committee on Immunization Practices (ACIP), to cancel grants to the Consortia for HIV/AIDS Vaccine Development (CHAVDs), to cease contributions to Gavi, The Vaccine Alliance, and now to cancel BARDA support for mRNA vaccines are a red alert all around the world, signaling the US retreat from advancing vaccine development and delivery,” said AVAC’s Mitchell Warren in a statement.

IMPLICATIONS: This decision is part of a broader pattern to systematically decimate investments in vaccine development programs and delivery systems and continue to sow ideologically driven vaccine misinformation. These actions will bring harmful policies that threaten lives and undermine efforts to advance effective, evidence-based health interventions.
 
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US Government Accountability Office Finds Cancellation of NIH Research Grants Illegal

A new report from the US Government Accountability Office (GAO) concluded that the US administration acted unlawfully when it ordered the National Institutes of Health (NIH) to cancel 1,800 research grants and delay funding decisions earlier this year. The GAO found that these actions violated the Impoundment Control Act, which prohibits the executive branch from withholding or canceling Congressionally appropriated funds without proper notification. This is one of at least seven investigations where the GAO has found legal violations by the executive branch, with nearly 50 additional cases under review.
 
IMPLICATIONS: A federal court ruled in June that the grant cancellations were illegal and this report from the GAO is not legally binding, but it does have the power to influence Congressional action. Advocates have continued to push to fully restore NIH grant funding. (See AVAC’s Research Matters resource for more.) As Senator Patty Murray noted, “The longer this goes on, the more clinical trials that will be cut short, labs that will shutter, and lifesaving research that will never see the light of day.”  
 
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Gates Foundation Commits to Funding $2.5 billion in Women’s Health R&D Through 2030

The Gates Foundation announced a five-year, $2.5 billion commitment to accelerate R&D focused exclusively on women’s health through 2030. The funds will support more than 40 initiatives across five critical areas: obstetric care and maternal immunization; maternal health and nutrition; gynecological and menstrual health; contraceptive innovation; and sexually transmitted infection (STI) solutions. According to the Foundation’s announcement, these investments are aimed at a “new era of women‑centered innovation,” particularly focused on low‑ and middle‑income countries where research gaps are most pronounced.
 
IMPLICATIONS: This major pledge is good news and may hopefully spark other donors to align with these priorities, but this commitment is still just a “drop in the bucket” given longstanding underinvestment in female-specific health research. Ensuring future innovations in women’s health are community-centered, equitable, and accessible across diverse settings will require advocates to help shape the R&D agenda, push for sustained funding, and promote integration with the broader HIV and STI landscapes.
 
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South African Government Invests in National Health Research Enterprise

The South African government announced a 400 million Rand investment (approximately $22.5 million) over three years to protect its national health research enterprise. This is in response to the abrupt withdrawal of US funding to South African research and researchers, which is particularly devastating for HIV and TB research. Importantly, this investment will leverage an additional R200 million (approximately $11.3 million), split equally between the Gates Foundation and the Wellcome Trust. This collective funding will be used to support research programs threatened by the cuts, including those focused on HIV, TB, mental health, and maternal and child health. The South African Medical Research Council (SAMRC) has already this week issued a request for applications (RFA) for eligible research programs to maintain vital infrastructure, staffing, and academic capacity.
 
IMPLICATIONS: This emergency investment is a powerful example of local and global partners stepping in to stabilize essential health research amid destabilizing US policy shifts.
 
READ: South Africa and Global Partners Mobilis

Updates From the STI & HIV 2025 World Congress

Last week, more than 1,400 participants gathered in Montreal for the STI & HIV World Congress, where they shared urgent insights, promising innovations, and calls to action. The gathering came at a pivotal moment when rates of STIs are rising globally, highlighting the importance of people-centered approaches, addressing stigma, and the need for new vaccines and diagnostics. All this amid massive disruptions caused by shifts in US policies and funding and decreased investments from other funders.

Read Meeting Highlights

What We’re Reading

Join AVAC and partners next week for two important conversations on what’s needed to achieve equity and scale in the next era of PrEP.

Key Takeaways from the STI & HIV 2025 World Congress

The STI & HIV World Congress brought together over 1,400 researchers, healthcare providers, implementers, advocates, funders and industry representatives in Montreal last week, where they shared urgent insights, promising innovations, and calls to action. The gathering came at a pivotal moment when rates of STIs are rising globally, highlighting the importance of people-centered approaches, addressing stigma, and the need for new vaccines and diagnostics. All this amid massive disruptions caused by shifts in US policies and funding and decreased investments from other funders.

As Jeanne Marrazzo, the NIAID Director currently on administrative leave who spoke in her personal capacity said in the closing plenary, “progress is possible, but only with clear-eyed urgency and coordinated commitment.” She spotlighted promising developments in biomedical prevention, such as new drug delivery tools, vaccines and monoclonal antibodies. She also discussed the mixed results of doxycycline post-exposure prophylaxis (DoxyPEP), which showed effectiveness in men who have sex with men (MSM) and transwomen but not in cisgender women in Kenya (which Elizabeth Bukusi, Chief Research Officer at the Kenya Medical Research Institute and former AVAC Board Member shared in an earlier session).

“Reproductive age women are not gay men, and just because it works in gay men, it doesn’t mean it’s going to work in women. It’s not just an anatomic thing. It’s a behavioral thing. It’s a preference thing. It’s a reason to take the product thing, right?” Marrazzo explained. She emphasized that the real test is not whether we are able to develop tools like long-acting PrEP, vaccines, or DoxyPEP, but whether we have the systems, strategies, and coordination to ensure interventions are tailored to the needs of the people who need them most and that they reach these communities as a priority.

People-Centered Approaches

A familiar message echoed throughout the conference, one that we heard earlier in the month at the International AIDS Society meeting in Kigali, Rwanda: innovation alone is not enough. Many speakers made the case for person-centered design and delivery, recognizing that preference, access and stigma shape whether people can and will benefit from biomedical breakthroughs. WHO’s Remco Peters pointed to a range of innovation that can support person-centered care, including AI-supported models of care, peer-led services, and decentralized platforms.

At the session Achieving Health Equity in STI Care, experts from the WHO and Gates Foundation discussed how selfcare and innovation in vaginal products could reshape sexual health services, but only if women’s real preferences and lived experiences guide product design. “Women have been doing this for a long time,” said the Gates Foundation’s Sharon Achilles. “We must listen to what they actually want, whether it’s relief from symptoms, discretion, or pleasure.” (Achilles’ message was especially prescient, as just this week the Gates Foundation announced a five-year, $2.5 billion commitment to accelerate R&D focused exclusively on women’s health. It will support the advancement of more than 40 innovations in five critical, chronically underfunded areas, including STIs to improve the diagnosis and treatment of these infections and reduce the disproportionate burden on women.)

Similarly, in a pre-conference session on multipurpose prevention technologies (MPTs), partners highlighted the need for integrated, multipurpose products that reflect the complexity of women’s lives.

“Self-care interventions are an opportunity to help increase people’s active participation in their impact,” said WHO’s, Sami Gottlieb.

Stigma Persists

Stigma continued to be cited as a critical barrier that continues to undermine the STI and HIV response. In a powerful plenary, esteemed journalist André Picard of the Canadian Globe & Mail shared a personal and historical reflection on how stigma dehumanizes people, distorts public health efforts, and persists even amid medical advances. “Behind every STI is a story, a policy failure, and an opportunity to do better,” he said.
 
In the session, No Shame in This Game: Using Filmmaking and Storytelling To Combat STI Stigma, independent filmmaker Jolene Hernandez shared the documentary No Shame in this Game, that follows the story of seven people living with an STI, to demonstrate the possibility of living a life of full sexual self-expression, fun, and freedom.

“That’s what stigma means. When an illness affects not only your body, but your soul, & your place in society.” — Andre Picard, Globe & Mail at Monday’s plenary session

Vaccines and Equity

Equity also took center stage in plenary sessions on the STI vaccine pipeline. Helen Rees of Wits RHI in South Africa and also a former AVAC board member presented a comprehensive overview of STI vaccine development from gonorrhea and chlamydia to herpes and syphilis. While scientific progress is accelerating for STI vaccine development, particularly for gonorrhea, where group B meningococcal vaccines show cross-protection, progress is slow, fragmented and underfunded. And access and vaccine hesitancy remain critical challenges. For more information, check out STIWatch.org to track vaccine developments across eight pathogens.

Panelists during the session, WHO Research Priorities for STIs: Advancing the Global Agenda for Syphilis Research, called for urgent investment in vaccine R&D and delivery programs designed with community input. “We cannot afford a repeat of COVID or mpox, where high-income countries hoarded vaccines and marginalized communities were left behind,” Rees warned. Rayner Tan of the National University of Singapore and Lori Newman of the Gates Foundation both stressed the need for inclusive advisory boards, stronger advocacy, and sustainable financing—all key tenets of Good Participatory Practice guidelines.

New Diagnostics

Sessions on diagnostics and service delivery echoed that call. AVAC partner, Mandisa Mdingi of the Foundation for Professional Development in South Africa presented encouraging data on a new point-of-care syphilis test, that was found to be extremely effective in detecting active syphilis cases among people presenting with genital ulcers. This could improve the detection and treatment of syphilis, an infection that has led to more than 8 million new cases in 2022.

Looking Ahead

As STI rates rise and global funding falls, the path forward lies in local leadership, new funding models, inclusive policymaking, and smart integration. In data presented at the conference by AVAC and Impact Global Health, a 127% growth in STI R&D funding between 2018 and 2023 from $96m to $218m was promising, but overly dependent on US governments. This growth is likely not sustainable given recent shifts in US policies, and developers, funders, advocates, and other stakeholders must stay accountable to ensure new tools are community-centered and truly address prevention, detection, and treatment needs.

In an audience Q&A, during the plenary session, The Future of STIs in the Changing Global Health and Funding Landscape, Helen Rees emphasized the disruptive impact of the abrupt foreign aid freeze, noting her own institute had to lay off 700+ staff members nearly overnight (see AVAC’s issue brief, Why STI Funding Matters, which describes the impacts of the elimination and reduction of funding that supports STI research, testing, and prevention programming). Rees urged the audience to use this moment of devastation to rethink ways for countries to rebuild smarter. She called for innovative financing mechanisms and noted “there are a host of ways to do [it] both as governments with innovative taxation and also public private partnerships with innovative bonds and debt relief.” Rees also stressed that “if we keep putting things into weak health systems, we will not win.” So offered that we have to “leapfrog”, particularly in low middle income countries, into new technology, notably AI. She advocated for affordable self-testing, AI-enabled clinical tools, and automated data systems that can strengthen care and track disease burden more efficiently.

AVAC’s presence throughout the meeting amplified the essential role of advocacy in turning science into impact. AVAC’s Senior Program Manager of STIs, Alison Footman, speaking at the same plenary, underscored the urgency of bringing community voices to the center of strategy. “These are scary times,” she said, referencing the destabilizing effects of the U.S. foreign aid freeze. “But what remains important is ensuring that people impacted by STIs are shaping the response, not just being talked about.”

Yet, community participation at the conference was visibly lacking. Many advocates and community representatives were unable to attend due to visa issues and the absence of scholarships and sustained funding. The field must invest in community, not just as beneficiaries, but as co-creators of the response.

AVAC Condemns Administration’s Further Actions to Dismantle and Deconstruct U.S. Government Vaccine Research and Delivery Infrastructure

AVAC condemns a series of actions taken by the U.S. presidential administration to dismantle U.S. leadership in research, development and delivery of lifesaving vaccines. The latest move announced yesterday to defund grants issued by the Biomedical Advanced Research Development Authority (BARDA) for research and development of the mRNA vaccine platform is part of a broader pattern to systematically decimate investments in vaccine development programs and delivery systems and continue to sow ideologically driven vaccine misinformation. Without U.S. government leadership, the country and the world will remain woefully unprepared for ongoing and emerging pandemic threats.

“We are disappointed and alarmed to see the government continue an onslaught against vaccine science and confidence,” said Mitchell Warren, Executive Director of AVAC. “Actions to take apart the CDC’s Advisory Committee on Immunization Practices (ACIP), to cancel grants to the Consortia for HIV/AIDS Vaccine Development (CHAVDs), to cease contributions to Gavi, The Vaccine Alliance, and now to cancel BARDA support for mRNA vaccines are a red alert all around the world, signaling the U.S. retreat from advancing vaccine development and delivery.

This week’s action to unilaterally cancel $500M in BARDA grants for mRNA vaccine R&D come after the U.S. government—through Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr.—implemented several moves to weaken vaccine science and programming within the U.S. government:

  • May 30: NIH notified the leaders of the Consortia for HIV/AIDS Vaccine Development (CHAVDs) that their funding would not be renewed, putting in doubt the realization of HIV vaccine portfolio and decades of historical investment.
  • June 8: HHS Secretary, Robert F. Kennedy Jr removed COVID-19 vaccine recommendations for children and pregnant women and then dismissed 17 members of the CDC’s Advisory Committee for Immunization Practices (ACIP) and installed noted vaccine skeptics in their place.
  • June 25: In a video statement, RFK Jr. stuns the Gavi replenishment conference by withdrawing U.S. support for the multilateral agency, critically undermining its ability to deliver vaccines to vulnerable populations and communities around the world.
  • July 28: Following the decision made by the U.S. Supreme Court in Braidwood vs. Becerra, which affirmed the mandated insurance coverage of preventative services based on recommendations made by the U.S. Preventative Services Task Force (USPSTF) as well as the ability of the HHS Secretary to remove and shape HHS committees at will, RFK Jr. cancelled the next meeting of the Task Force and signaled his intention to disband its membership.

Cancellation of research grants at the CHAVD and BARDA continue a dangerous pattern of impoundment tactics by the administration to bypass Congressional authority to appropriate funding. Even with the potential restoration of funding, damage to the vaccine research infrastructure has already been done.

“We cannot just ‘turn the tap’ of funding back on,” warned Stacey Hannah, AVAC’s Director of Research Engagement. “When the administration stops research funding abruptly, it rewinds scientific progress. It will take time and even more resources to get these studies back online—squandering the potential of future breakthroughs that are based on established, gold-standard science.”

Additionally, by destabilizing evidence-based policymaking and scientifically rigorous recommendations made possible through ACIP and USPSTF, the administration intensifies public doubt and mistrust in vaccines as important public health tools. Vaccine misinformation undermines delivery of the annual flu shot, COVID-19 boosters, and vaccines against measles, hep B, HPV, and mpox, amongst other vaccine preventable diseases.

“These actions dangerously sow vaccine disinformation and mistrust, which has proliferated since the COVID-19 pandemic,” said Alison Footman, Senior Program Manager for STIs at AVAC. “Dangerous ideology results in dangerous policymaking, putting many lives at stake and complicating efforts to both discover and implement clinical and cost-effective interventions to make America and the world healthier, safer, and more prosperous.”

AVAC calls upon Congress to re-assert its power of the purse and its long-standing, bipartisan support for vaccine R&D and vaccination programs, to counteract efforts by the current administration, and to sustain the vaccine enterprise before it is too late.

Global Health Watch: EMA recommends LEN, whistleblower report on foreign aid freeze, changes in NIH policies and new CDC director

Last Friday – just after we published Global Health Watch – the European Medicines Agency recommended injectable lenacapavir for PrEP. This comes amid more political chaos this week that threatens delivery including, a surprise funding freeze and its reversal, a new whistleblower report on the unlawful foreign aid freeze, changes in NIH policies and continued dismantling of federal advisory boards. Read on.

European Medicines Agency Recommends Injectable Lenacapavir for PrEP

The European Medicines Agency (EMA) recommended approval of injectable lenacapavir (LEN) for PrEP across the European Union and globally just weeks after the US FDA granted approval and the WHO issued global guidelines. These regulatory endorsements reflect an accelerated process compared to previous PrEP products and demonstrate the urgency and promise of LEN, with potential to dramatically expand choice in prevention. This is just the second medicine simultaneously reviewed by the EMA for the EU market, under the centralized procedure, and non-EU countries, under the ‘EU-Medicines for all’ program (EU-M4all), and the eighteenth medicine receiving an EMA recommendation under EU-M4all. 

IMPLICATIONS: These milestones represent important steps to advance access to LEN, but much work still remains to be done to ensure LEN reaches those who need it most. Coordination on in-country registrations, financing and procurement, supply chains, health worker training, demand creation, and community-led delivery is needed. See AVAC’s Gears of Lenacapavir for PrEP Rollout plan, which outlines all the moving parts. Now is the time to ensure all of the gears actually begin to turn even faster.

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NIH Disruptions

The US National Institutes of Health (NIH) has proposed changes to how it funds research, which could dramatically reduce the number and amount of research grants in the future. The National Cancer Institute (NCI) confirmed it will reduce the number of new and competing research grants it funds, despite a stable budget, due to rising costs per grant. This is largely due to NIH’s growing reliance on a “multi-year funding” (MYF) model, which requires a larger portion of a grant’s total funding (typically 50%) to be paid in the first year. Although MYF can offer researchers more predictable funding over time, it also creates immediate budget pressures, as more money is tied up upfront. As a result, NIH institutes may be forced to fund fewer grants overall, turning down even top-ranked proposals. Additionally, NIH has signaled that many MYF grants will be limited to four years instead of the traditional five-year period typical of R01 awards. 

In addition, on Tuesday, the administration temporarily halted all NIH funding for research. They then released the funds later in the day. In response to the halt, US Senator Patty Murray (D-WA), Vice Chair of the Senate Appropriations Committee, wrote, “Instead of trying to destroy the NIH, which has long been the envy of the world, President Trump and [OMB Director] Russ Vought should study up on the Constitution, which makes clear they don’t get to decide for themselves that they are going to rip hopes of new treatments and cures away from patients across America.” 

IMPLICATIONS: This new MYF policy undermines the research pipeline by favoring shorter, lower-cost projects, freezing out innovative or large-scale efforts and reducing the long-term funding that research institutions rely on. These maneuvers by the administration bypass Congressional budget authority and could be formalized through additional rescissions.  

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Threats to the US Preventative Services Task Force

It has been reported that US Health Secretary, Robert F. Kennedy Jr. plans to dismiss the 16 members of the US Preventive Services Task Force (USPSTF), which recommends preventive services (including PrEP and cancer screenings) that must be covered by insurers. USPSTF’s decision to recommend HIV PrEP mandates that insurance companies cover it under the Affordable Care Act. The HHS said no final decision has been made, but initial reports cite ideological concerns as the reason for this potential action, similar to how Secretary Kennedy undermined the CDC’s Advisory Committee on Immunization Practices. In response to this reporting, the American Medical Association and 100+ health organizations are urging RFK Jr. to preserve the task force’s independence and evidence-based role. 

IMPLICATIONS: This potential dismissal follows RFK Jr.’s recent dismissal of CDC vaccine advisors and raises concerns for HIV prevention advocates, particularly regarding PrEP. Weakening or politicizing this panel could jeopardize access to HIV prevention and other products for Americans. This is another action undermining science-based decision-making. 

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USAID Whistleblower Shares Details on Termination of Foreign Assistance

A newly released memo by USAID whistleblower Andrea Capellán shares details on the administration’s unlawful termination of nearly all USAID foreign assistance funding. In the memo, Capellán, a senior contracting officer at USAID, describes a six-month period of silence, confusion, and legal violations as staff were ordered to cancel thousands of contracts without proper authority, documentation, or individualized review. These claims are contradictory to the administration’s defense of the process used to carry out the funding freeze. It confirms that terminations were carried out en masse, with some letters even addressed to “Miscellaneous Foreign Awardees,” and that Secretary of State Marco Rubio’s alleged contract reviews were never substantiated.  

IMPLICATIONS: This new account supports AVAC’s ongoing legal battle (see AVAC vs. Department of State) arguing that the foreign aid freeze is illegal. Capellán’s report underscores the need for accountability and urgent restoration of global health programs that were halted midstream.  

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New Director of US CDC Confirmed by Senate 

The US Senate confirmed long-time civil servant Susan Monarez as the new permanent Director of the Centers for Disease Control and Prevention (CDC). Monarez is the first CDC director without a medical degree in 70 years to take on this role. NPR reports that in her confirmation hearing, Monarez “walked a fine line between traditional public health perspectives and those of her boss, Secretary of Health and Human Services Robert F. Kennedy Jr., who has long questioned the safety of vaccines.” 

IMPLICATIONS: Monarez will play a critical role in shaping the CDC’s HIV, STI, and global health work. Her confirmation comes just weeks after mass layoffs across HHS, and as the agency navigates the administration’s directives to reduce contract spending and restructure research funding.  

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What We’re Reading

Resources

Save the Date!

PrEP Implementation — What’s worked and what are we learning

Join AVAC and the South-to-South Learning Network for a webinar exploring lessons from countries that have successfully scaled up oral PrEP and how to apply them to introduce and expand access to long-acting HIV prevention options like CAB, DVR, and LEN.

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EMA Recommends LEN for PrEP

Resources for Advocacy

Momentum continues to build for injectable lenacapavir (LEN) for PrEP as what could be one of the most transformational moments in HIV prevention ever. Just weeks after the US Food and Drug Administration approved LEN for PrEP, the WHO issued new global recommendations for offering LEN, and last week the European Medicines Agency recommended its approval in the EU and globally (even earlier than anticipated).

But getting LEN to those who need and want it depends on addressing an array of complex factors beyond regulatory approvals, including action, coordination and transparency on funding, price and volume agreements, supply chains, health worker training, demand creation, and community engagement. We outlined all of the moving parts in December in Gears of Lenacapavir for PrEP Rollout, and now’s the time to ensure all of the gears actually begin to turn even faster.

The recent advances, of course, arrive amid a cruel irony: just as prevention breakthroughs gain traction, US political decisions are unraveling the systems needed to deliver them. Still, the prevention pipeline continues to grow. In addition to the movement on LEN for PrEP, Merck’s once-monthly oral PrEP pill just entered Phase III trials, another step toward real choice and expanded options in HIV prevention.

Check out AVAC’s resources below (all newly updated) to help advocates track, explain, and take action to meet the moment. And read our insights from the International AIDS Society meeting in Kigali.

Updated Resources

Long-Acting PrEP Status Update
A quarterly update featuring graphic tools for tracking regulatory approvals, implementation science, price and volume agreements, and pipeline overviews. Visit here.

Lenacapavir Regulatory Approval
Regulatory approvals and pending decisions as of July 2025. Download the graphic.

Where We Are Now With LEN for PrEP
A timeline of essential milestones to scaling up LEN for PrEP. View here.

Moving a Product to the Real World
The field is beginning to apply past lessons to accelerate introduction of injectable PrEP options. Download here.

Getting PrEP Rollout Right This Time
Qualitative landscape analysis to identify actionable lessons and recommendations from past PrEP introduction and implications for LEN for PrEP. Read the report.

Now What with Injectable LEN for PrEP?
Outline of what is actually known – and not – and what needs to happen next. Read it here.

All of the LEN for PrEP documents are at avac.org/lenacapavir and be sure to check out PrEPWatch for all of these resources and more.

Global Health Watch: PEPFAR Shutdown Plans + a Bill to Restore its Programs, Contraception & Vaccines Destroyed, IAS Highlights

Issue 26

This week’s issue covers what’s next with PEPFAR, including new reports that the US State Department is planning to dismantle the program, and a new bill in the US Congress that aims to restore its prevention programs. It also highlights a new funding bill that supports global health R&D and spotlights the shocking destruction of contraception and vaccines bound for Africa. Plus: key takeaways from IAS 2025 in Kigali and what they mean for the future of HIV prevention.

What’s Next for PEPFAR

Following last week’s partial victory against the President’s rescissions package, with PEPFAR spared from a $400 million proposed clawback, the HIV community is calling for sustained pressure and bipartisan support to preserve the program’s core budget and fully restore prevention services. This comes as a new report from The New York Times reveals that State Department officials are quietly developing plans to shut down PEPFAR entirely in the coming years.  

IMPLICATIONS: This new reporting confirms what many advocates have warned: PEPFAR is being systematically undermined. Funds are still frozen at FY23 levels, no long-term reauthorization has been secured, and critical program components like PrEP scale up, and community-led service delivery remain unfunded. 

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New Legislation to Expand Access to HIV Prevention Through PEPFAR Proposed

New legislation to guarantee access to HIV prevention through PEPFAR, the HIV Medication Access Act, was introduced by US Representative Yassamin Ansari (AZ-03). The bill would amend the Foreign Assistance Act to include HIV prevention in the definition of ‘life saving humanitarian assistance’ and to ensure all at-risk populations can receive these services. The legislation comes in response to the State Department restricting PrEP to pregnant and breastfeeding women only under the February waiver that supposedly resumed lifesaving foreign aid in the wake of the DOGE fiasco. 

IMPLICATIONS: This new proposed legislation would help protect and restore global access to HIV prevention tools. Advocates are rallying around this bill as a much-needed safeguard against ideologically driven health policies. As AVAC’s Mitchell Warren said, “When access to the fruits of science is dictated by politics rather than evidence, we paralyze progress.” However, the bill faces an uphill battle in the current Congress.  

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New Bill Proposes Strong Funding Levels for Global Health

A proposed bill and report for global health programs in Fiscal Year 2026 (FY26) was introduced Wednesday by the US House Appropriations Subcommittee on National Security, Department of State and Related Programs (NSRP, formerly SFOPs) as part of the annual bipartisan appropriations process. The NSRP subcommittee has jurisdiction over foreign assistance funding, and their report recognizes global health as essential to national security and strongly supports research, innovation, and new technologies to fight HIV, TB, malaria (including positive language on expanding access to microbicides, long-acting PrEP, and PEPFAR). And the bill proposes strong funding levels for key global health priorities including investments in maternal and child health ($528M), Gavi ($300M), TB ($394.5M), malaria ($800M), and neglected tropical diseases ($114.5M). However, it cuts funding for family planning by 24% and includes harmful policy riders that would codify the global gag rule (aka the Mexico City Policy) and bans funding to WHO and UNFPA.  

IMPLICATIONS: While the proposed funding is stronger than expected, it is unclear if the House bill will pass, what the Senate version will look like, and whether the administration would implement the funding. This bill is a positive signal that global health R&D and innovation are being recognized as priorities, which is a testament to the unrelenting advocacy of the HIV community. 

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Contraception and Vaccines Destroyed and Wasted

The new US administration ordered millions of contraceptives including condoms, IUDs and emergency pills intended for sub-Saharan Africa to be destroyed. The Guardian reports that this was $9.7 million worth of contraception. Earlier this month, US Senators Jeanne Shaheen (D-NH) and Brian Schatz (D-HI) introduced the Saving Lives and Taxpayer Dollars Act, legislation to prevent the State Department from destroying family planning commodities instead of donating them to intended beneficiaries. This action is part of the larger destruction of foreign aid. Meanwhile, Politico reports that hundreds of thousands of vaccines purchased by the US for African countries have expired and been wasted due to political delays and a breakdown in coordination. Advocates are working with members of Congress to urge the State Department to act immediately to ship remaining viable mpox vaccines.  

IMPLICATIONS: The destruction of contraception and wasted vaccines reflect a dangerous ideology that is undermining global health and reversing decades of progress. Clinics across Africa are reporting shuttered services and rising unmet need for contraception, while stalled vaccine delivery weakens trust and preparedness in the face of ongoing disease threats. These actions jeopardize integrated HIV prevention strategies and broader sexual and reproductive health goals.  

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International AIDS Society 2025: From Crisis to Resolve

Coverage from last week’s International AIDS Society (IAS) Conference in Kigali, Rwanda, has highlighted the lessons and insights from the shift from a crisis response to the dismantling of foreign aid to collective resolve. The global community is calling for political accountability, funding commitments, streamlined pathways to access, and a pipeline of products that people want and need. 

AVAC’s sessions and resources capture this pivotal moment in the field. Explore AVAC’s full IAS 2025 resource page. 

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Join Us at the STI & HIV 2025 World Congress

The global community will gather next week in Montreal, Canada, for the STI & HIV 2025 World Congress, which comes at a pivotal moment as global STI rates are rising, but investment in prevention, diagnostics and care remain far below what’s needed.

promo tile for this event

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Save the Date! August 14, 2025 @ 7:00am ET

PrEP Implementation — What’s worked and what are we learning

Join AVAC and the South-to-South Learning Network for a webinar exploring lessons from countries that have successfully scaled up oral PrEP and how to apply them to introduce and expand access to long-acting HIV prevention options like CAB, DVR, and LEN.

Register

What We’re Reading

From Kigali: At IAS 2025, the HIV response rallies to face the crises

The IAS 2025 conference in Kigali will go down as a critical turning point in the history of the HIV response. Every session, every meeting, every presentation played out against an existential threat: will the world find the will to end the HIV epidemic, with tremendous advances in technology underway, or will the momentum seen through 2024 collapse as evidence-based interventions fall way to ideology? Leaders across the field are persevering to push forward the science, policies, programs and partnerships that are essential to achieve impact; and they are calling for solidarity. And advocates are leading the way, cutting a path and demanding equity, human rights and community leadership every step of the way. WACI Health’s Rosemary Mburu captured this call to action at the opening session, saying “Community action is not the soft side of science — it’s what gives science its soul, its reach, and its relevance.” 
 
The Kigali Call to Action, to which AVAC is proudly a co-signor, echoes these demands, calling for new partnerships, rapid scale-up of prevention, a diverse R&D pipeline, evidence-based policy, expanded treatment access and durable protections for human rights. At the opening session, Linda-Gail Bekker of the Desmond Tutu Health Foundation (and an AVAC board member) shared findings that the US funding freeze has led to severe disruptions in oral PrEP initiations (28-65% reduction), diagnostic testing (6-39% reduction) and in monitoring viral loads (16-68% reduction), and also to initiation of treatment (2-22% reduction). Calling it a precipice, Bekker connected these numbers to modelling studies forecasting as many as 5,000-16,000 additional new HIV infections over just one year, with some countries projecting additional deaths as high as 10% by 2030, and millions of new cases of HIV by 2030 (See this, this & this from aidsmap for more). Bekker also implored everyone that “we cannot go back”.
 
These are warnings and calls to actions that cannot be ignored. As Yogan Pillay of the Gates Foundation said at a panel discussion on the issue, “I don’t think we should be adapting to this new normal. I think we do need to be transformative.” Solange Baptiste, of The International Treatment Preparedness Coalition (ITPC) and also on the AVAC board, urged the field to see the bigger picture, “The cuts that we’re seeing now are an opportunity to change the system. More studies, more data will not change minds. This is ideological. The HIV field has always been a leader. We have had ambition; now is the time to set the bar high.” Rising to the challenge means critical next steps for the HIV response.

Reimagined and Refinanced: With the loss of US leadership, the Global Health Community Responds

A session hosted by AVAC and the Zambian Ministry of Health, Re-imagining prevention: Planning for sustainable PrEP access in the new funding context, zeroed in on the ground-level work needed to put in place the policies and programs for new and better systems to deliver HIV prevention. Ministries of Health, implementers, and civil society pointed to key priorities: Engaging the private sector to enable delivery of HIV prevention; demedicalizing PrEP to lower costs and simplify expanded access; strengthening monitoring systems to deliver information on preferences and PrEP coverage; aligning donors behind the necessity of integrating HIV-related care with other health services; embedding implementation science into program delivery for ongoing learning; and defining a minimum package of prevention that is tailored to context and balances program costs and choice, among others.
 
While AVAC’s Mitchell Warren called for “making PrEP simple,” Zambia is one place taking the lead in confronting these issues. At the session, Professor Lloyd Mulenga, Director of Infectious Diseases at Zambia’s Ministry of Health, said finding political will underpins the work ahead. “We need to invest in our own systems and also need a budget line that reflects commitment from government.” Learn more about Zambia’s work in the country snapshot from AVAC’s report Getting Rollout Right This Time. See also this aidsmap coverage to learn more about the conversation at the satellite session.

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The crisis for key populations lies at the heart of the challenge. IAS 2025 brought together community and government leaders, convened by GBGMC and COMPASS, to chart a path forward, with the understanding that delivering prevention to key populations could determine success or failure of the HIV response.

The meeting showcased evidence-based strategic plans developed by community organizations, which can anchor an HIV response that is based on partnerships of trust, transparency and coordination between governments, industry, donors and community. GBGMC launched a new report — Global Roadmap for Long-Acting PrEP Among Key Populations — featuring a first-ever Global Forecast of Long-Acting PrEP Need  for Key Populations (2025–2030), co-created with AVAC and Avenir Health.

Accelerating Access to New PrEP Options: The devil’s in the details

As the field regroups, making good on the promise of injectable lenacapavir (LEN) for PrEP hangs in the balance. With the release of new WHO recommendations for offering LEN on the first day of the conference, the success of LEN rollout depends on addressing an array of complex factors. Funding, transparent price and volume agreements, supply chain coordination, empowered and trained health care workers, and comprehensive community engagement are required.
 
“I can feel the excitement about these [WHO] guidelines. It now calls for collective action. The next step is the difficult one, access! Access is it, or we go back to the disappointment and mistrust,” said Florence Anam, Co-Executive Director of GNP+.
 
Check out AVAC’s Now What with Injectable LEN for PrEP? that outlines what is actually known — and not — and what needs to happen next.

WHO guidelines for LEN also extended the recommendation to pregnant and lactating populations (PLP), an important advance in access to PrEP. This aligns with data Gilead presented showing efficacy of LEN for PrEP for PLP (see this aidsmap story to learn more). Other announcements at IAS similarly signal progress in this area.

And while much of the buzz centered around rollout of next-gen PrEP injectables, AVAC notes the importance of ongoing research to develop additional products to fill the prevention toolbox. Merck announced the EXPrESSIVE trials, which will be testing efficacy of a monthly pill for PrEP in diverse settings and populations, including PLP. They also presented Phase 2 data, which apart from a positive safety profile at every dosage tested, indicated a predicted time to protection of one hour after intake. See this aidsmap story to learn more along with this new AVAC infographic showing where the trials will take place.

The Dual Prevention Pill, a daily pill for HIV and pregnancy prevention, was also in the spotlight in Kigali, with the launch of #DPPDecoded, a campaign by APHA to raise awareness by and for young women in Africa for this new option. The DPP could be available as early as next year. For more info on the DPP, see this video and resources, and be sure follow @apha_sa for real-time updates.

New Science, New Technology & Emerging Leadership

Striking examples of the use of artificial intelligence (AI) in the delivery of treatment, care and prevention were presented, demonstrating its potential to expand the reach of HIV and other health services. Several countries are using AI technology for interventions from mobile diagnosis to supply chain improvements and in programs supporting adherence to medication. See this aidsmap story for more.
 
African leadership is on the rise in advancing research for cure and vaccine strategies. The Africa Cure Consortium (comprised of the African Alliance, AVAC, CIDRZ, GGTI, HCAAP, IAS & SANTHE) is incorporating community advocacy and research literacy into its efforts to influence policy and investment in cure research on the continent. Scientific insights from recent cure research include the impact of broadly neutralizing antibodies (bNAbs) on viral rebound and other aspects of immune dynamics (see this & this at aidsmap for more). Another IAS session, Success stories and future directions in African HIV vaccine research, showcased African-based research and initiatives that have transformed the field, from clinical trials to community-driven innovation.
 
These far-sighted initiatives are in advocacy, too; be sure to check out the outstanding vision and energy of youth advocates in this episode of A Shot in the Arm podcast, where African youth leaders, members of APHA’s Ground Forces program, call on the field to be prepared to succeed. “You are going to need sunglasses! Because the future will be bright for HIV prevention,” said Sinehlanhla Gogela.
 
These examples of leadership are just the beginning and must be matched with solidarity from across the field and a commitment to fight like hell. As Kenya’s former Minister of Health James Nyikal said, “When you mobilize civil society and the people, and it becomes a crying need amongst the people, politicians listen. That is how the world works.”
 
Global and country leaders, from communities to advocates, from researchers to implementers, from policy makers to donors, must recommit to the HIV response — or gains against HIV will unravel and the epidemic, with its end in sight, will instead intensify, taking with it countless lives. The discussion in Kigali did not finalize the answers at this pressing hour, but the first steps have begun.
 
For AVAC resources supporting your advocacy, including slide decks addressing key issues discussed above, go to AVAC’s dedicated page on IAS2025. Onwards!

Global Health Watch: PEPFAR saved, PrEP pill advances to Ph3, NIH ad councils, IAS highlights

Issue 25

This week’s Global Health Watch highlights major developments in HIV prevention science and policy, spotlighted at the IAS 2025 conference in Kigali, Rwanda. From new WHO guidelines recommending injectable lenacapavir for PrEP to Merck’s once-monthly PrEP pill advancing to Phase 3 trials, the HIV prevention pipeline is expanding and evolving. All this amid an increasingly intense fight to protect global health funding. This week, the US Senate blocked the President’s attempt to cut $400 million to PEPFAR. These advances and challenges were central to conversations in Kigali, where the message was clear: even in the face of funding threats, the HIV response must regroup, refocus and recommit to translating science into impact.

US Senate Removes $400M Proposed Cut to PEPFAR From Rescissions Package 

The US Senate blocked a proposed $400 million cut to PEPFAR as part of the Presidents proposed rescissions package requesting Congress claw back $9.4 billion in already appropriated Fiscal Year 2025 funding. The amendment was passed with bipartisan support and is an unexpected win amid escalating attacks on PEPFAR. While this protects core PEPFAR funds in the short term, the program has already been significantly weakened by the US foreign aid funding freeze, and prevention programs continue to be limited by executive order to providing PrEP only to pregnant and breastfeeding women. No Country Operational Planning (aka COP) meetings have been scheduled this year, making it unclear which programs will be funded or how PEPFAR leadership, partner countries and communities will decide on priorities for maximum impact. Unfortunately, $500 million in rescissions to other global health programs were approved by the Senate, further weakening sexual health services and the global infectious disease response. The US House of Representatives is expected to approve the rescissions by the end of the week. 

IMPLICATIONS: PEPFAR’s ability to deliver life-saving HIV treatment and prevention could be permanently compromised without full funding and reauthorization. Advocates warn that the program’s current status is a “shell of its former self,” making it harder to respond to barriers to care and stagnating incidence, to support community-led responses and key population programs, and to plan for long-term impact, including the introduction of injectable lenacapavir. Political inaction and right-wing misinformation have weakened the program’s bipartisan foundation, with devastating effects already being felt by implementing partners and affected communities. See AVAC’s Impact of PEPFAR Stop Work Orders on PrEP resource. In addition, Congressional approval of this rescissions package codifies DOGE’s unlawful cuts to USAID and foreign assistance overall, essentially giving the Administration clearance to continue to operate without accountability to make unilateral decisions on Congressionally appropriated funds.

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A Growing HIV PrEP Pipeline: Merck’s MK-8527 Monthly PrEP Pill Moves to Phase 3 Trials, WHO Recommends Lenacapavir 

At the IAS 2025 conference, Merck announced plans to launch Phase 3 trials of MK-8527, a once-monthly oral PrEP pill for HIV prevention, after sharing results from its Phase 2 trial showing MK-8527 to be safe and well tolerated (see the abstract). The EXPrESSIVE-11 trial will begin enrolling in August across 16 countries. It will compare MK-8527 with generic daily oral TDF/FTC among cisgender men, transgender women (assigned male sex at birth), transgender men (assigned female sex at birth), and gender nonbinary person. A parallel study among cisgender women in East and Southern Africa will launch later this year as well. See AVAC’s map of trial sites. Merck emphasized that community input played a critical role in shaping trial design, including the selection of the comparator. For more on how community involvement and Good Participatory Practices shaped the EXPrESSIVE trials watch for next week’s new PxPulse episode, Up Next: A monthly pill for PrEP. 

In addition, the World Health Organization released updated guidelines recommending the six-monthly injectable, lenacapavir (LEN) as a new PrEP option, including for pregnant and breastfeeding people. WHO also recommended rapid diagnostic testing for anyone initiating or continuing long-acting injectable PrEP, such as LEN and cabotegravir (CAB). This endorsement follows the FDA’s recent approval of LEN and adds momentum to global efforts to expand the PrEP toolbox. WHO’s recommendation sends a strong signal to countries, funders, and implementers that LEN should be integrated into HIV prevention strategies as part of a rights-based approach to choice and access.  

IMPLICATIONS: WHO’s recommendations of LEN and MK-8527 expanding to Phase 3 trials add to a growing pipeline that could lead to unprecedented choice in HIV prevention. See AVAC’s Innovation Pileup graphic resource. However, with new oral and injectable PrEP options now advancing in parallel, including cabotegravir, lenacapavir, and MK-8527 alongside daily oral PrEP and the dapivirine vaginal ring, the field faces both extraordinary opportunity and growing complexity, especially in the shrinking fiscal space. The field must act quickly to prepare systems, regulatory pathways, and delivery platforms for a more diverse prevention landscape. Innovative products and guidelines are only the beginning, to get HIV prevention products to those who need it requires political will, procurement commitments, and coordinated delivery strategies that center the needs and voices of those most affected by HIV. 

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Procurement for LEN for PrEP Begins

The Global Fund notified nine countries in East, Southern and West Africa to be early adopters to introduce injectable lenacapavir, signaling the start of procurement planning. The nine countries are expected to use their current Global Fund grants to be matched by central funds. The procurement price has not been released publicly, but countries are supposed to provide three-year forecasts by the end of the month. This is progress, but countries must navigate strict regulatory requirements, align national guidelines, and finalize implementation plans to unlock access.  

IMPLICATIONS: Without disclosure of the LMIC “not-for-profit” price by Gilead or Global Fund, it is not clear what volumes of LEN for PrEP will be available to the nine early adopter countries, or to other countries, particularly countries in Asia and Latin America who are not included in current agreements. This makes planning and budgeting extraordinarily hard. 

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NIH Scientists to be Removed from Advisory Councils

The NIH plans to “disinvite” dozens of scientists who had already undergone vetting from the Biden Administration from serving on its advisory councils. These councils play a critical role in final funding decisions for research grants. Staff who would have served on the Councils have been directed to nominate replacements aligned with the new administration’s priorities.  

IMPLICATIONS: There are many concerns that political appointees may override the traditional vetting processes, which could leave many NIH institutes without the scientific diversity and expertise needed to responsibly guide funding decisions. Some advisory panels are already operating with fewer than half their seats filled, which could delay grant approvals and undermine the agency’s ability to support important and equitable research.  

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IAS 2025: AVAC’s Early Recap

Read about funding cliffs, epidemic-ending possibilities, and essential advocacy in AVAC’s early recap.

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Day 1 at IAS 2025: Funding cliffs, epidemic-ending possibilities, and essential advocacy

IAS 2025, the 13th International AIDS Society (IAS) Conference on HIV Science, started this week amidst unifying calls to confront the collapse of US support for the HIV response with commitments to reimagine funding, research, development and programming aimed at sustaining progress toward ending the epidemic. At the opening session, the voices of advocates led the way. WACI Health’s Rosemary Mburu said, “the journey to ending the pandemic is not paved with policy papers, scientific publications and procurement plans. It’s carried on the backs of communities, and it needs to be led by communities… Community action is what gives science its soul.”

Following her address, advocates stormed the stage, demanding justice and equity in the HIV response. 

Also at the opening session, Linda-Gail Bekker, CEO and Co-founder of the Desmond Tutu Health Foundation, offered critical milestones for transitioning to resilience in this time of crisis:  

  • Find the estimated 9.2 million people living with HIV who do not have access to treatment. 
  • Eliminate the vertical transmission of HIV from mothers to infants. 
  • Double down on primary prevention, including affordable LEN for PrEP. 
  • Do not stop reaching out to those who have been hardly reached. 
  • Center communities in the response and provide resources to support their leadership. 
  • Be relentless.  

“We as a global community need to reset the paradigm on the scale of prevention that will be needed for significant impact…. We similarly cannot stop innovating, researching and developing to stay at least one step ahead [of the virus],” said Bekker.

AVAC’s Mitchell Warren echoed these calls in an earlier session, 2025: Time to bring HIV, sexual and reproductive health together for better care, sharing guiding principles for the way forward. “We have to collaborate differently. And sustainability cannot just mean budgets; we have to sustain the impact,” he said. 

Released just ahead of the conference, the 2025 Global AIDS Update from UNAIDS, AIDS, Crisis and the Power to Transform, calls for “radical shifts” by countries as imperative to counter the impact of sudden and widespread funding cuts. The report documents the toll of those cuts on communities around the world, from plummeting rates of PrEP use to an anticipated additional six million new cases of HIV between 2025-2029.

At the session Re-imagining Prevention: Planning for Sustainable PrEP Access in the New Funding Context, Warren painted a stark picture of what’s at stake if global HIV prevention continues to be underfunded.

While acknowledging past delays and missed opportunities in the rollout of oral PrEP, the panel made of government officials, donors, implementers and civil society reflected a community that does learn and can be more ambitious. Hiu Yang of the Global Fund talked about their new agreement with Gilead to hopefully reach at least 2 million people with injectable lenacapavir (LEN) for PrEP within three years. But she emphasized, “The two million target for LEN is not a ceiling, it’s a starting point for broader, faster, more inclusive PrEP rollout.” 

Going one step further, Yogan Pillay of the Gates Foundation talked about being more ambitious to reach 7.5 million people over the next few years on the road to a sustainable market with multiple generic manufacturers supplying LEN at a much lower price. This ambition is aligned with AVAC’s recent brief, Now What with Injectable LEN for PrEP?, as well as a new Lancet HIV publication from Sharonann Lynch, Pillay, Raphael, Bekker and others: Lessons for long-acting lenacapavir: catalysing equitable PrEP access in low-income and middle-income countries. 

The kickoff to IAS 2025 mirrored tensions between the resilience needed for sustainability with the stark realities of the impact of funding cuts on lives and livelihoods. Key announcements on Monday also put a spotlight on scientific progress that holds great potential.

WHO LEN and Testing Guidelines Released

The latest WHO recommendations on HIV prevention featured new guidelines on LEN and testing strategies for long-acting injectable pre-exposure prophylaxis. In addition to recommending the six-monthly injectable LEN as a new PrEP option, including for pregnant and breastfeeding people, WHO updates also recommended rapid diagnostic testing (RDT) for anyone initiating or continuing long-acting injectable PrEP, such as LEN and cabotegravir (CAB). HIV self-testing (HIVST) continues to be a recommended option for oral PrEP, the dapivirine vaginal ring (DVR), and for post-exposure prophylaxis (PEP). The guidelines call for further implementation research to “determine the role of HIVST in delivering long-acting injectable PrEP.” 

Experts shared the fundamental role of these recommendations in informing policy and practice. 

With only 3.9 million PrEP users currently, and new cases of HIV plateaued at 1.3 million globally, the HIV response “has to do better,” WHO’s Michelle Rodolph said. LEN, as an additional choice in HIV prevention is part of the solution. “Not all PrEP can be made available everywhere, but the data is clear that choice is critical…as is training providers to offer PrEP.”  

The guidelines call for countries to include models of differentiated service delivery (DSD) and integration.

Injectable LEN is Effective Among Adolescents and Pregnant People

Gilead announced more data from the PURPOSE trials showing that LEN for PrEP was effective in preventing HIV in pregnant and lactating people, in adolescents, and for those taking medication for tuberculosis and other conditions. Researchers also presented preference data showing that 75% of users favored twice-yearly injectable PrEP over daily oral PrEP because they felt more protected from HIV (69%) and were more confident about not missing a dose (77%). 

Merck Launches Phase 3 Trials of a Monthly Pill for PrEP

Merck announced the results of a Phase 2 safety and pharmacokinetics study of an oral monthly pill for PrEP that will now advance to Phase 3 trials known as the EXPrESSIVE trials. The monthly pill under investigation, MK-8527, is a novel, oral, nucleoside reverse transcriptase translocation inhibitor (NRTTI). Phase 2 results found the pill was well tolerated, with a similar safety profile to placebo, among 350 individuals in the randomized study. Merck Principal Scientist Rebeca Plank said, “We envision that monthly oral dosing could transform PrEP delivery and implementation models. If the Phase 3 studies are successful, this product could expand the range of delivery settings beyond medical clinics to locations that allow for flexibility and privacy.” 

See AVAC’s Nandi Sikwana describing the importance of these trials, including the role of Good Participatory Practice in their protocol development. Also stay tuned for a PxPulse episode with Rebeca Plank and AVAC’s Grace Kumwenda, coming soon.  

Find a roadmap of HIV prevention sessions at IAS 2025 and other resources to support your advocacy at AVAC’s dedicated IAS 2025 page. And stay tuned for more coverage ahead.

Global Health Watch: Next steps in LEN for PrEP rollout, new UNAIDS report, reprieve for South Africa and the latest in AVAC’s lawsuit

Issue 24

This week the Global Fund and Gilead announced next steps in the process to rollout injectable lenacapavir, the new UNAIDS Global AIDS Update was released, and South Africa saw a partial reprieve for NIH-funded research. We also track AVAC’s court case against the foreign aid freeze and Congressional advocacy to protect NIH funding. Read on, and be sure to follow AVAC next week as we cover the important discussions at the International AIDS Society (IAS) 2025 conference.

The Global Fund and Gilead Announce Next Steps on LEN for PrEP

The Global Fund and Gilead Sciences announced an access agreement to procure injectable lenacapavir (LEN) for PrEP, an important step in the process of rolling out LEN. The announcement re-confirms their ambition from December with PEPFAR to reach 2 million people over three years with LEN, once WHO recommendations are in place, which are expected to be announced on Monday at the IAS conference. 

IMPLICATIONS: While these announcements mark welcome progress in advancing LEN rollout, key questions remain. The announcements did not include specific volumes or price – and the target of 2 million people over three years is stated as an ambition, not a commitment to procure the full volume required to meet this target. In addition, achieving this ambition will depend on Global Fund replenishment for the next three-year budget. As AVAC and partners have noted, ambitious targets require coordinated, transparent planning and financing to prevent delays and ensure LEN fulfills its promise. Check out AVAC’s new brief that explains it all and proposes an even more ambitious introduction. 

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UNAIDS Releases Global AIDS Update 2025 

Ahead of next week’s IAS 2025 Conference, UNAIDS released its Global AIDS Update 2025, AIDS, Crisis and the Power to Transform, showing that another 1.3 million people acquired HIV in 2024, which is far from the target of reducing infections below 370,000, by 2025. The report warns of severe disruptions to HIV prevention services as US foreign aid and global health financing abruptly collapsed. “This is not just a funding gap—it’s a ticking time bomb,” Winnie Byanyima, UNAIDS executive director said at the launch. She emphasized that community-led services, which are critical for reaching marginalized populations, are being defunded at alarming rates. 

IMPLICATIONS: This year’s report underscores the need for bold, sustained action and funding, calling on donors, governments, and communities to step up and invest urgently in scaling proven prevention, including PrEP in all its forms, to protect gains and advance the goal of ending AIDS as a public health threat by 2030.

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NIH Lessens Blow to South Africa Research 

The National Institutes of Health (NIH) shared guidance with its staff on an “alternative payment scheme” that could allow human clinical research studies in South Africa to continue as “supplements” to existing grants until the agency puts a new tracking system in place, which is expected September 30. While new grant awards to South Africa are still blocked, “ongoing prime awards to South African researchers, ‘may proceed’,” Science reports. The NIH also lifted a hold on many payments for existing grants to South Africa. 

IMPLICATIONS: This slight reprieve for South African research is a positive step forward, but damage has already been done through months of staff layoffs, paused trials and stalled collaborations. And the uncertainty surrounding NIH’s broader, ideologically driven crackdown on grants continues to impact science, collaboration and progress.  

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AVAC vs. Department of State in the Foreign Aid Freeze 

Oral arguments in the AVAC vs. US Department of State lawsuit (joined with Global Health Council vs. Trump) were heard in the Washington, DC Circuit Court of Appeals on Tuesday. The cases seek emergency relief from an Executive Order that inhumanely froze all funding for foreign assistance and challenge the Administration’s shutdown of USAID and foreign aid. AVAC and GHC, and their partner have consistently won in the District Court, and the government appealed the judgements against them to this higher court. A panel of three Circuit Court judges heard the arguments and are expected to rule on the case by August 15. The Administration’s defense argued that the Congressional appropriations are merely “ceilings” rather than binding requirements. The panel of judges seemed to push back, noting that US law and constitutional separation of powers give Congress authority to set spending levels, not the executive branch. 

IMPLICATIONS: The hearing exposed the Administration’s strained arguments attempting to justify the foreign aid freeze and underscored the high stakes of the case: whether the Administration can disregard congressionally mandated funding for global health and foreign assistance programs, including PEPFAR and USAID’s initiatives. Watch AVAC’s Mitchell Warren on the latest in the case. 

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HIV Organizations and Advocates Host NIH Congressional Briefing 

Scientists and leaders in infectious disease research presented at a Congressional briefing, co-hosted by AIDS Action Baltimore, Treatment Action Group, AVAC and 11 other organizations, on the lifesaving impact of NIH-funded infectious disease research. They shared the impact of NIH investment—calling the NIH a “national treasure”—which has driven innovations in HIV prevention, cure, and treatment, TB diagnostics, viral hepatitis treatment, and pandemic preparedness, and underscored how recent funding cuts and threats to NIH-supported research jeopardize public health progress. They urged Congress to sustain support for lifesaving NIH research.   

IMPLICATIONS: The briefing reinforced that continued and expanded NIH investment is critical not only for advancing science, but also for equitable global health outcomes, pandemic readiness, and US health security. As Congress debates the Fiscal Year 2026 budgets and potential rescissions for past years, advocates called on policymakers to protect NIH funding, reject proposed cuts, and recognize research as essential infrastructure for global and domestic health. READ:  

IAS 2025: What you need to know

Follow AVAC’s roadmap to find sessions where prevention and the larger issues of global health equity and sustainability are in the spotlight.

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