Global Health Watch: Zimbabwe steps away from US health MoU, new domestic funding in SA, LEN launched in Kenya + Zim, investment case for Global Fund

Issue 57

This week’s issue covers Zimbabwe’s decision to halt negotiations on its Memorandum of Understanding with the US for global health funding; new domestic funding in South Africa; a new investment case for US funding for the Global Fund; the launch of injectable lenacapavir for PrEP (LEN) in Kenya and Zimbabwe; and key takeaways from CROI 2026 on the links between science, funding, and delivery.

Zimbabwe Declines US Health MoU, Zambia May Follow 

This week, the government of Zimbabwe formally terminated negotiations on the proposed Memorandum of Understanding (MoU) with the United States under the America First Global Health Strategy. In a public clarification, Zimbabwe’s Secretary for Information, Publicity and Broadcasting Services, Nick Mangwana, said the government’s decision followed an inter-ministerial review and reflected concerns that the draft agreement did not reflect an equitable partnership. While acknowledging the historic role of US health assistance, including PEPFAR, the government cited risks to data sovereignty and misalignment with Zimbabwe’s commitment to ongoing negotiations on the WHO Pathogen Access and Benefits Sharing (PABS) mechanism under Pandemic Agreement adopted last year. “Zimbabwe was being asked to share its biological resources and data over an extended period, with no corresponding guarantee of access to any medical innovations—such as vaccines, diagnostics, or treatments—that might result from that shared data,” Mangwana wrote. “In essence, our nation would provide the raw materials for scientific discovery without any assurance that the end products would be accessible to our people should a future health crisis emerge. The United States, meanwhile, was not offering reciprocal sharing of its own epidemiological data with our health authorities.”  
 
Other countries are also taking critical reviews of their MoUs: Kenya’s MoU is suspended pending a court challenge. Zambia is reported to have rejected its agreement as well. A leaked draft has drawn criticism for containing weaker protections and more onerous terms than other agreements. 
 
IMPLICATIONS: These developments, along with the abrupt withdrawal of other forms of US humanitarian assistance from seven African countries, raise serious questions about the power dynamics embedded in the new bilateral approach. For many governments, the choice may not be between partnership models, but between accepting unequal terms or losing support altogether, which puts health systems, sovereignty, and long-term equity at risk.

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South Africa Mobilizes Domestic Resources for HIV

Following the termination of USAID grants in South Africa, the country’s Finance Minister announced new domestic funding (R26 billion) to provinces for HIV programs, with an additional R410 million to be reprioritized from the national Department of Health over the medium term to offset research grant funding withdrawn by the US. The new allocation is intended to support core interventions, including prevention of mother-to-child transmission and continued access to treatment. 
 
IMPLICATIONS: South Africa’s response underscores both resilience and vulnerability in the current global health landscape. While the government’s decision to mobilize domestic resources reflects strong political commitment and a recognition that HIV programs are essential services, it also highlights the scale of the gap left by abrupt external funding withdrawals.

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New Investment Case for Global Fund

Following the conclusion of the Global Fund’s 8th Replenishment Conference last year, Friends of the Global Fight released a new FY2027 US Investment Case urging US Congress to appropriate funding in the fiscal year (FY) 2027 budget to protect hard-won gains against HIV, tuberculosis (TB), and malaria and to prevent further disruption to services already under strain. Advocates are calling on Congress to appropriate $1.533 billion for the Global Fund in FY27, or one third of the $4.6 billion US pledge for the 8th Replenishment. The investment case underscores the Global Fund’s role as a core pillar of global health security, highlighting its impact on saving lives, strengthening health systems, and advancing country-led responses. 
 
IMPLICATIONS: This new call for continued US government investment comes just after the Global Fund fell short of meeting its $18 billion target and as the Board endorsed a shift toward a rolling, longer-term replenishment model, as well as greater emphasis on country transitions. Without predictable, robust donor commitments from public and private sectors, ambitions for achieving sustainability, methodical transition, and ending these three diseases will remain fragile.

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Lenacapavir for PrEP launches in Kenya and Zimbabwe Amid Uncertain Future for Access

This week marked a major milestone for the rollout of lenacapavir for HIV PrEP (LEN). Both Kenya and Zimbabwe held national launch events to mark the rollout of LEN in their countries. Kenya received its first 21,000 doses last Friday and announced at the launch that the Global Fund committed an additional Sh256 million (approximately $2 million) to support rollout activities, including service delivery support, training, community engagement and systems to ensure consistent access. Zimbabwe’s initial phase of the rollout, supported by PEPFAR and the Global Fund, is expected to reach approximately 46,000 people across 24 sites. 
 
IMPLICATIONS: These rollouts mark major milestones, but the future sustainability of access remains unclear. Scaling LEN beyond this initial phase will depend on reliable financing, supply chains, health workforce capacity and long-term political commitment, all of which are under strain amid broader disruptions to global health funding. Zimbabwe’s decision to decline the MoU with the US underscores this fragility: with the transition to conditional, transactional bilateral health arrangements, access to public health tools (like LEN) risks becoming vulnerable to shifting geopolitical priorities, rather than being guided by data and public health need.

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CROI 2026: Progress in HIV Science, Pressure on the Systems That Deliver It 

The Conference on Retroviruses and Opportunistic Infections (CROI) 2026 convened this week in Denver with a clear and urgent message: scientific progress in HIV treatment, prevention, and cure cannot be separated from the global infrastructure, sustained funding, public trust, resilience, and activism needed to sustain it. Across three and half days, researchers, policymakers, regulators and advocates heard advances—from durable PrEP options like lenacapavir and MK-8527 to advances in treatment, cure and vaccine research. And critical questions on whether the world is willing and able to currently and eventually deliver these tools equitably and at scale. Speakers warned that funding cuts, dismantled programs, and political interference threaten infrastructures that took decades to build, stressing that the interruption of HIV research and delivery “is not a policy choice.” 
 
IMPLICATIONS: As the science accelerates, CROI made clear that access, delivery, and trust are the main challenges. Data presented on service disruptions after the foreign assistance freeze, alongside warnings about threats to PEPFAR and global HIV infrastructure (read this new Lancet comment), underscored that breakthrough science and innovation mean little if systems fail to deliver them equitably and at scale. Community advocates emphasized that “country ownership” must be matched by activism, real-time data, and accountability that runs in both directions.

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What We’re Reading

CROI 2026: Meaningful Progress, Expanding Choice

AVAC’s continued coverage of CROI summarizes key themes from the final two days of the conference, including the vital importance of choice and steps needed to make choice a reality. See AVAC’s summary of the first two days of CROI here.

Day 3: From Innovation to Impact

Day 3 kicked off with a Community Breakfast Club focused on prevention science: From Innovation to Impact. Moderated by Adaobi Olisa of Root to Rise and AVAC’s Clinical Trial Design Academy, the conversation previewed data on PrEP, and panelists Renee Heffron from University of Alabama, Brian Minalga from the Office of HIV/AIDS Network Coordination (HANC), and Linda-Gail Bekker of the Desmond Tutu HIV Centre and AVAC Board member emphasized that scientific breakthroughs only matter if they reach communities and are implemented equitably, inclusively and at scale.

Progress and Challenges in STI Prevention and Treatment
In a plenary session, IDSA CEO and AVAC Board member, Jeanne Marrazzo, highlighted advances and challenges in STI treatment and prevention. While DoxyPEP reduces syphilis among gay, bisexual, and other men who have sex with men and transgender women, the effect is not seen across all U.S. populations, and incidence of congenital syphilis continues to rise. Resistant gonorrhea remains a pressing challenge, but two newly approved antibiotics offer new treatment options. Marrazzo called for increased efforts to address structural barriers putting cisgender women at higher risk for STIs and for innovation in diagnostics, antimicrobials, and vaccine development. Read coverage of her plenary in AJMC.

Expanding Access, Improving Inclusivity
Echoing Marrazzo’s plenary, various sessions underscored the need to address structural and scientific barriers to expand choice and deliver person-centered solutions to meet the needs of people and communities. 

  • Gabriel Chamie presented data from the SEARCH study, a community health intervention pairing digital tools with tailored in-home HIV services provided by trained community health workers that reduced HIV incidence by 70%. The findings underscore the power of bridging communities and health systems through technology and locally driven care.
  • In a Malawi study presented by Deborah Hoege, people initiating long-acting injectable cabotegravir had higher continuation rates than those on oral PrEP (61% vs. 21% at month 1; 41% vs. 7% at month 5).
  • Rena Janamnuaysook shared how community-generated data from the Tangerine Clinic was used to advocate for gender affirming services in Thailand’s national health insurance program, reinforcing the power of community leadership, data, and policy advocacy to increase access to services for trans and gender diverse individuals.
  • Gabby Chromhout presented Azaphile pediatric ATI trial findings that about one-third of children treated as young as age 3 achieved remission. The data point to the critical importance of early ART initiation, potential sex differences in control, and the remarkable capacity of pediatric immune systems.
  • Gilead presented trial design and dose modeling for a new study testing once-yearly lenacapavir for PrEP. PURPOSE 365 is a single-arm, open-label study that will enroll 300 people who would benefit from PrEP. Based on population pharmacokinetic (PK) modeling, a dose of 3000 mg delivered intramuscularly was chosen, including 600 mg of oral loading doses on Days 1 and 2.
  • Andrew Hill highlighted the stark gap between PrEP need and access and suggested that more than 40 people must be reached with PrEP to prevent a single HIV acquisition – but that only 122 countries reached this 40:1 target. Only 2.3 million people are currently on oral PrEP, far below UNAIDS targets, and injectable cabotegravir and lenacapavir represent just 2.9% and 0.9% of use, respectively.
  • Edith Namulema presented findings from a study that trained taxi drivers to offer self-testing kits to friends, family, passengers, and other contacts. Over 12 months, they distributed 2,474 kits, of which 97% were successfully used. This helped identify new cases and connect people to care, reinforcing that community networks can expand HIV prevention.

Advances in Cure Research

  • Jeff Murray presented a promising new IL-15 molecule designed to target CD4 cells. In animal models, pairing this agent with bNAbs delayed viral rebound longer than comparators, but clade diversity questions mean cautious optimism as this advances toward human trials.
  • Katie Fisher highlighted the power and limits of autologous antibodies. In participants who achieved control in a bNAb study, strong autologous neutralizing antibodies and CD8 responses initially suppressed rebound virus. However, viral escape emerged after ~2 years, reinforcing that durable remission will likely require layered, combination immune strategies.
  • Brad Jones presented research showing how properly guided T-cell responses could gradually reduce viral reservoirs, offering a promising path toward HIV control and potential cure.
  • Check out the recording from Monday’s Community Breakfast Club on cure at CROI.

Day 4: New Tools, New Approaches

Focus on Long-Acting Treatment
The final CROI Community Breakfast Club highlighted advances in long-acting HIV treatment. As moderator Sean Hosein of EATG noted, “while long-acting therapy may not be for everyone, it gives choice to many people.” Panelists highlighted sessions, demonstrating that science is moving fast. Community activist Shari Margolese noted that access is not keeping pace: “as a community we need to get much angrier about the fact that we can’t get access to the drugs.” Francois Venter of Ezintsha in South Africa warned that the field risks celebrating breakthroughs that never reach communities. He noted that without action, “we might be sitting here again in 10 years’ time” with innovation benefiting only a tiny fraction of people.

Subsequent CROI presentations included a range of long-acting treatment options in early development including a new injectable HIV-1 capsid Inhibitor, VH-499, which was found to be safe and generally well tolerated in its first human trial, suggesting that it could be dosed as infrequently as twice a year; GS-3242 data demonstrating a favorable safety profile, antiviral activity, and PK data supporting possible dosing interval of 3 months; and tolerability and PK data on VH-184 supporting long-acting dosing.

Progress in HIV Vaccine Design
Kevin Saunders of the Duke Human Vaccine Institute delivered a plenary on the HIV vaccine research landscape. He outlined the germline targeting and discovery clinical trials that dominate the field, reminding the audience that developing broadly neutralizing antibodies (bNAbs) is a formidable scientific challenge. But progress is happening, and clinical and animal data shows it is possible to initiate and hone specific protective bNAb responses. He shared progress in developing CD8 T-cell inducing vaccines – there is consensus that a successful vaccine will ultimately need to induce both bNAbs and T-cells. He capped off his talk by describing how AI and machine learning are being used to identify mutations and sequences necessary for the germline targeting approach.

Looking Forward: Heading in the Right Direction
As John Frater noted at the start of CROI 2026, this year’s conference is about the incremental steps that push boundaries and are “building out that evidence that gives confidence and strength to say we are moving in the right direction.” From innovative delivery models to advances in vaccine design, the science presented this week delivered exactly that.


Seeking more CROI coverage? Be sure to check out our friends at Aidsmap.

CROI 2026: Science, Solidarity and High Stakes for the HIV Response 

CROI 2026 opened with a sobering message and defiant acknowledgment: progress in HIV treatment, prevention, and cure depends not only on scientific discovery, but also on global infrastructure, sustained funding, public trust, resilience, and activism that make science possible. Against a backdrop of funding cuts, dismantled programs, and growing political interference, speakers on the first two days of CROI warned that interrupting support for HIV research “is not a policy choice; it threatens infrastructures that took decades to build.” 

Day 1: Opening Session

The call to collective responsibility followed presentation of CROI’s inaugural Lifetime Achievement Award to former Director of the National Institute of Allergy and Infectious Diseases (NIAID) Carl Dieffenbach, whose leadership at NIAID was consistently rooted in partnership—championing community engagement, global collaboration, and the principle that science only succeeds when it serves and engages the people most affected.

Sharon Lewin, Director of the Peter Doherty Institute in Melbourne, Australia, delivered the opening Bernard Fields Lecture with an expansive look at Thirty Years of Persistence, Progress, and Partnerships in HIV Cure Science, tracing how decades of basic research have shaped the many cure strategies now being explored. She highlighted the central challenge of the HIV reservoir—why infected cells remain hidden despite effective treatment—and how newer approaches are working to reveal, reduce, or control them. Lewin described innovative work using mRNA to deliver Tat, a viral protein that “wakes up” latent virus so it becomes visible to the immune system, as well as advances in CRISPR-based activation and immune-mediated control. Across these approaches, her message was clear: progress toward a cure is real, but it depends on sustained collaboration and investment across disciplines and communities. 

The Martin Delaney Lecture was then presented by longtime activist Peter Staley, cofounder of Treatment Action Group and PrEP4All, who urged the field to prepare for what comes next. Tracing the shared evolution of activism and science forged during the early HIV epidemic, Staley described how advocates and researchers learned from one another, reshaping clinical trials, access programs, and ultimately the field itself. He was clear that today’s moment presents an equally grave challenge. Drawing stark parallels between past and present, Staley warned that renewed attacks on science, public health, and HIV programs—including threats to PEPFAR—are part of a broader authoritarian playbook in which dissenters and institutions are deliberately targeted. His message was unmistakable: the same collective power that transformed the HIV response in the earliest days must once again be mobilized to defend science, health, and human rights.

“Believe that the pendulum that has been swinging against us this past year will, if we fight for it, eventually swing back. You are a community that gives us miracles, with empathy as your driving force, you save lives, history will pull that pendulum back,” Staley said.

The Opening Session closed with Linda-Gail Bekker, Director of the Desmond Tutu HIV Centre and AVAC Board member, reframing HIV prevention through The ART of Prevention: People, Science, Progress. She offered a new “ABCs” for the current moment with a framework requiring scientific advances, political will, urgency and community-led action to end the epidemic: A calls on the field to Advocate, Agitate, Act, and Accelerate; B urges Bold scale-up of proven and emerging tools; and C emphasizes Creating demand, providing choice, and working with communities most affected.

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Day 2: Spotlight on Cure and Prevention Science 

AVAC’s Jessica Salzwedel opened Monday by leading the first of three Community Breakfast Club sessions, this one focused on HIV cure. In an excellent session, Salzwedel and leading cure researchers John Frater, Katherine Bar and Allison Agwu helped participants break down the complex landscape of cure approaches highlighted at the conference. Salzwedel summarized cure strategies as working in two complementary ways: strengthening the body’s immune system, and directly targeting the virus by waking it up, keeping it dormant, or cutting it out. “Most often, these work together in combination,” she noted, reflecting a recurring theme across CROI sessions.

That emphasis on combination and durability carried into new prevention research presented at the conference. New PrEP research underscored the durability of new PrEP options and the importance of strong delivery systems to support their impact.

  • In the first plenary of the day, Ilesh Jani of the Instituto Nacional de Saúde in Maputo, Mozambique, reviewed progress in HIV over the past 30 years, described the challenges the past year has brought, and highlighted “4 I’s” in the way forward: Integration, Inclusion, Innovation and Impact.
  • In the second plenary session of the day, Wes Sundquist of the University of Utah described the HIV capsid and its importance in the development of LEN. His research collaborations, which began in the early 1990’s, led to understanding the structure, functions, and inhibition of the HIV capsid. As he shared with AVAC on a June webinar, “LEN didn’t emerge overnight. It’s the result of patient, persistent basic science—of believing we could understand a virus deeply enough to target it effectively.” He closed by reflecting on the “bench to bedside to community” journey that made LEN possible, crediting clinicians, regulators, and community activists, and warned that while the field now has “a really powerful new tool in the arsenal,” forces are blocking its use. “It will be a human tragedy,” he said, “if we don’t overcome those.”
  • Data on dose selection for the investigational monthly oral PrEP candidate MK-8527 showed that a once-monthly 11 mg dose could maintain protective drug levels in at least 95% of participants, including pregnant people and adolescents, while allowing an additional week of coverage for late doses. The cumulative data from Phase I and II studies informed the dose selection in the newly launched Phase III EXPrESSIVE efficacy studies.
  • Long-term follow-up of the ANRS PREVENIR study, presented by the study’s Principal Investigator, Jean Michel Molina, assessed 3,209 PrEP users in France across more than 13,000 person-years. Results showed HIV incidence of 0.11 per 100 person-years, with no significant differences between daily, on-demand, or switching regimens, reinforcing PrEP’s real-world effectiveness.
  • Resistance data from the PURPOSE 1 and PURPOSE 2 lenacapavir for PrEP (LEN) trials were presented by Stephanie Cox of Gilead, which showed that across both studies, resistance was rare and occurred in the context of waning drug levels of monotherapy. Of two HIV acquisitions occurring among participants taking LEN in PURPOSE 1, one was diagnosed at Study Day 365 with the capsid resistance–associated substitution N74D, while the other acquired HIV at Study Day 670, more than a year after their final LEN dose and with no resistance observed. In PURPOSE 2, two previously reported participants developed the N74D capsid substitution, while one newly identified case developed Q67H+K70R. The five total infections across the two trials highlight that while not perfect protection, LEN is clearly a remarkably safe and effective prevention option.

What’s at Stake: Funding, Evidence and the Human Cost 

The first two days of CROI made clear that the systems needed to deliver scientific advances to the real world are at extraordinary risk. Jen Kates of KFF opened the session Sleepless in Denver: Impact of Funding Changes on HIV Care by describing a “fundamental rupture” in global HIV service delivery following the US Administration’s funding and policy changes. PEPFAR, one of the most consequential global health achievements, has saved more than 25 million lives since 2003. In a post-foreign-assistance freeze world marked by a dissolved USAID and disrupted services, Kates emphasized that concern about human impact is widespread and so should be concern for real-time data. 

New research presented during the session began to do just that. Aaron Richterman shared results from a rapid survey of AIDS Drug Assistance Programs across three US states showing that 47% of clinics reported HIV service disruptions, including medication shortages, while Lindsay Vlatru reported that 40% of clinics in KwaZulu-Natal experienced disruptions affecting an estimated 830,000 people with HIV. Speakers warned that these disruptions threaten the resilience of HIV prevention and care systems and risk long-term population health consequences. Moving ahead means closing evidence gaps and finding ways to gather real-time data on how these funding changes are affecting people’s lives.  

Speaking on behalf of communities and partners across Africa in the symposium session, Strategic and Resilient Responses to the Funding Crisis Across Africa, Solange Baptiste, Executive Director of ITPC and AVAC Board member, shared the effects of the foreign assistance freeze. “When finances pause abruptly, it’s not just a marginal adjustment, it’s really a systemic shock… where the speed and the severity of those cuts really matter.”  
 
She showed how confusion, service interruptions, and loss of trust followed. Referring to Geoff Garnett’s presentation on the impacts of funding shifts, Baptiste noted that what is really missing from national data and mathematical models “is the community intelligence” to see the full picture. Meeting this moment, she said, requires a response that is “country owned, but community driven,” and that vision must be backed by action. “Community power has to be funded, not just praised,” engagement must be “baked into the design” of programs rather than added on later, and accountability must be “bi-directional,” with communities recognized as “co-pilots and co-architects,” not just watchdogs.

Looking Ahead

Across the first two days of CROI, it’s clear that the science is advancing, the tools are within reach, and that “we share a responsibility to defend and sustain funding for international HIV programs and research,” as Nicolas Chomont, CROI Conference Chair from Université de Montréal in Canada, said in the Opening Session. As the conference continues, the challenge is not only to push the science forward, but to ensure that science can be delivered, equitably and at scale, to everyone who needs it.

Community Breakfast Club

Join CROI, AVAC, EATG, Fiocruz, TAG, and other partners tomorrow at 7:00am MT for the last virtual Community Breakfast Club webinar on Advances in Long-Acting HIV Treatment: Science, delivery and equity. Register here.

And be sure to follow our partner, Aidsmap, as they report during the conference and afterward.

Global Health Watch: Leadership Changes at US Health Agencies, Global Fund Replenishment and What’s Next for Vaccine Regulation

Issue 56

This week, researchers, advocates, and policymakers are reflecting on the escalating war on science. Two recent pieces in Think Global Health and in The Nation illustrate how budget decisions and policy priorities are reshaping US scientific and global health leadership and undermining the stability of programs relied on by hundreds of millions of people – in the US and around the world. This week’s GHW newsletter also tracks the consolidation of power across US health agencies, mounting uncertainty in vaccine regulation, and the Global Fund’s ongoing replenishment.

Leadership Changes at US CDC Raise New Concerns about Scientific Independence

US National Institutes of Health (NIH) Director, Jay Bhattacharya, was also named acting director of the US Centers for Disease Control and Prevention (CDC). This represents the administration’s fourth leadership change at the agency in just over a year and a move widely seen as further centralizing federal public health authority. Many are critical of this appointment and fear scientific independence given Bhattacharya’s public alignment with Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and his negative views on pandemic response and public health governance.
 
IMPLICATIONS: Concentrating leadership across NIH and CDC blurs lines between research, surveillance, and public health practice, while raising the risk that evidence-based decision-making will be deprioritized to political priorities. Together, these events point to a coordinated re-shaping of US health agencies that could weaken regulatory stability, disrupt research pipelines, and further undermine confidence in public health guidance around the world.

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Global Fund Concludes Replenishment Falling Short of Target

The Global Fund to Fight AIDS, Tuberculosis and Malaria concluded its 8th Replenishment with US$12.64 billion in total pledges, which was endorsed by its board last week. Shifts approved by the Board move toward a longer-term, rolling replenishment approach and emphasizing country transitions to reinforce sustainability.

IMPLICATIONS: The US$12.64 billion outcome falls short of the original US$18 billion target for this replenishment cycle, showing ongoing vulnerability in global health financing amid broader donor retrenchment. Key pledges, including France’s, have yet to be confirmed. Flat or reduced support from major donor countries compared with previous cycles reflects a trend among wealthy nations to re-prioritize or constrain foreign health investments. Reliance on scaled domestic resource mobilization, private philanthropy, and public-private partnerships is unlikely to fill funding gaps quickly enough to prevent disruptions in HIV, TB, and malaria services or to repair damage already inflicted by abrupt aid terminations. Without robust, predictable commitments from major donors, the gains against the three diseases and the goal of ending them as public health threats remain at risk.

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Uncertainty at the US Food and Drug Administration (FDA) 

The US FDA reversed its decision and agreed to review Moderna’s mRNA-based influenza vaccine after initially refusing to consider the application last week. They cited concerns about the clinical trial design, specifically the choice of the comparator vaccine used in studies of adults over 65. This decision drew much criticism across industries, leaving many questioning what seemed like a shift from regulatory standards. 

Additionally, this reversal occurs amid a debate within the FDA about the role of randomized clinical trials in drug approvals, with the FDA reconsidering the long-time standard of requiring two rigorous studies. The FDA Commissioner wrote in the New England Journal of Medicine (NEJM) that the “default position” would be to require only one trial, upending decades of regulatory science and practice.  

IMPLICATIONS: These developments deepen concerns about unpredictability and politicization in US vaccine regulation. The FDA’s initial refusal to review Moderna’s flu vaccine followed by a rapid reversal shows regulatory chaos as agency leaders are publicly questioning the long-standing expectation of multiple randomized trials for new medicines. While flexibility in trial requirements can be appropriate in some circumstances, shifting the “default” to a single study risks blurring standards and weakening confidence. The broader pattern of reversals, public disputes, and narrowing vaccine recommendations continues to erode trust.

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A Year of Crisis and Promise

2025 tested global health like few years before it. Funding freezes, political disruption, and rising misinformation collided with historic scientific breakthroughs. Read how AVAC protected progress and pushed prevention forward. 

What We’re Reading

Resources

AVAC’s Year in Review

What We Protected. What We Accelerated. What Comes Next.

“In this moment of crisis and possibility, AVAC did what it has done for 30 years: We showed up, spoke out and worked with partners to push the field forward.” — Mitchell Warren, Executive Director

In a year marked by funding freezes, political disruption and historic scientific breakthroughs, we are proud to share our 2025 Year in Review — one defined by crisis and resilience.   

The last year tested global health in unprecedented ways. AVAC showed up: helping protect hundreds of millions of dollars for global health; defending HIV programs and research; delivering trusted data, tools and analysis; and accelerating equitable access to innovations, like long-acting PrEP.  

None of this would have been possible without you — our partners, our donors, and our community. 

Inside the report, you’ll find:

  • How AVAC equipped advocates, researchers, and partners with the context and tools needed to understand and act in a volatile environment. 
  • How our legal action and advocacy helped unlock global health funding – and hold the US Administration accountable.
  • What it took to move lenacapavir for PrEP (LEN) faster into the market than any prevention product before it. 
  • Why defending global health requires sustained vigilance, strong leadership and robust partnerships. 

AVAC — like the field at large — enters 2026 in transition. We stand ready for the future: supporting African leadership, strengthening bridges from R&D to delivery, and preparing for a new chapter as we move forward into our fourth decade as an organization. 

As we look ahead, challenges remain. But the science is strong, new options are in the pipeline, and, with smart analysis, rigorous science, good policies and global partnerships, progress is possible — and essential. Thank you for standing with AVAC and helping to shape what’s next for HIV prevention, R&D and global health. 

CROI 2026: Resources and what to watch

Resources and What to Watch

The annual Conference on Retroviruses and Opportunistic Infections (CROI), taking place February 22–25, 2026, in Denver, Colorado, will once again kick off the year as the premier scientific convening for our field.   

AVAC will be tracking the HIV and STI science at CROI 2026, including advances in long-acting HIV preventionevolving science around cure, and important discussions on the impact of the global funding crisis on research, development, and delivery. Here we share ways to follow and join in the conversation, in-person or virtually. 

Share the Latest Data: AVAC infographics

For those presenting at CROI (as well as anyone interested in tracking the field), AVAC’s latest infographics on HIV R&D and the delivery pipeline, the current landscape of prevention options, and the impact of US funding cuts are available here in an easy-to-use slide format. We hope these visuals are useful for presentations and discussions at the conference and beyond.

Join the Conversation: Community Breakfast Clubs

Each day during CROI, AVAC, EATG, Fiocruz, TAG, and other partners will host virtual webinars called Community Breakfast Clubs featuring researchers and advocates breaking down important prevention, treatment and cure science presented at CROI and the implications for the field. Registration is open to all.

Follow Along: News from the conference

AVAC will be tracking news and developments from the conference. Be part of the conversation by following AVAC on BlueSky at @hivpxresearch.bsky.social, and sign up for our Advocates Network newsletters if you were forwarded this email. And be sure to follow our partner, Aidsmap, as they report from the conference.

Sessions of Interest: What to watch

Check out the CROI program for sessions of interest. Some of the things we’re watching include:  

Sunday, February 22 

  • Scott Hammer Workshop for New Researchers 
  • Clinical Trial Design and Analysis Workshop 
  • Opening Session with Named Lectures by Sharon Lewin, Peter Staley and Linda-Gail Bekker

Monday, February 23 

  • Plenaries on Meeting the Moment: HIV Treatment and Prevention and Structure, Function, and Inhibition of the HIV Capsid 
  • Sleepless in Denver: Impact of Funding Changes on HIV Care 
  • Strategic and Resilient Responses to the Funding Crisis Across Africa 

Tuesday, February 24 

  • Plenary on Cutting-Edge Issues in Sexually Transmitted Infections
  • HIV Reservoirs and Cure Strategies 
  • Counting and Caring for Transgender and Gender-Diverse Individuals 

Wednesday, February 25 

  • Manipulating the HIV Immune Response for Prevention and Treatment 
  • From Good to Great: Advancing Treatment and Prevention 
  • Test and Tell 
  • Harnessing B-Cells and Antibodies for HIV Control 
  • Some Assembly Required: Self-Blood Collection and Testing 

Global Health Watch: States Sue Over Public Health Funding, Vaccine Systems Strain, Advocates Press Merck on Equitable Access

Issue 55

This week marks one year since AVAC and the Global Health Council filed their lawsuits over the sweeping foreign assistance freeze — cases that challenged the Administration’s withholding of Congressionally appropriated funds and underscored the stakes for global health and HIV programs. That broader dispute over executive power and federal spending continues to reverberate, as four US states sued the administration this week over its decision to withhold $600 million in public health grants supporting disease surveillance, emergency preparedness, vaccination, and HIV prevention. This Global Health Watch issue also examines ongoing signs of erosion in vaccine confidence and regulatory stability and calls for early global access planning for Merck’s investigational monthly oral PrEP candidate

Four US States Sue HHS Over $600 Million in Public Health Grants 

Last week, the US administration announced it would withhold approximately $600 million in previously allocated public health grants for disease surveillance, emergency preparedness, vaccination programs and HIV prevention from states it argues are not aligned with administration priorities. In response, these states, which are led by Democrats: California, Colorado, Illinois and Minnesota, filed a lawsuit against the US Department of Health and Human Services (HHS), seeking to block the cuts. The funding is primarily distributed through the US Centers for Disease Control and Prevention (CDC) and the states argue that the administration cannot retroactively impose new conditions on congressionally appropriated funds or withhold them based on policy disagreements.

IMPLICATIONS: This case mirrors broader disputes over executive authority and federal spending, including AVAC’s lawsuit, that have surfaced repeatedly over the past year. Beyond the immediate budget impact, the decision to withhold public health funds risks destabilizing prevention and preparedness systems that rely on sustained, predictable financing. For HIV and other infectious diseases, interruptions in surveillance, community outreach, and prevention programming can quickly translate into increased transmission and weakened response capacity. While $600 million in funding is on the line, so is the principle that public health infrastructure cannot function effectively if appropriated funds are subject to shifting political leverage. 

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Vaccine Confidence Continues to Be Undermined 

Vaccine confidence continues to be undermined across multiple fronts this week. The US Food and Drug Administration (FDA) declined to review Moderna’s mRNA seasonal influenza vaccine candidate, raising questions about the regulatory pathway and timeline for review and introduction of new flu products. At the same time, the American Medical Association (AMA) announced its plans for its own independent vaccine safety and effectiveness review initiative, which signals growing concern about trusted scientific assessment processes. And a survey found declining public perceptions of the safety of COVID-19, influenza, and MMR vaccines, underscoring persistent erosion of vaccine confidence. 

IMPLICATIONS: This week’s developments signal mounting stress on the scientific and governance systems that underpin vaccine confidence and access and risk fragmenting systems that were grounded in evidence and transparency. At a moment when routine immunization rates remain fragile and misinformation continues to spread, sustained regulatory clarity, transparent scientific review, and stable engagement in multilateral vaccine processes are essential to maintaining public trust and global health security.

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Advocates Urge Early Access Planning for MK-8527 

More than 170 groups representing people living with HIV, advocates and providers across 30 countries called on Merck to commit now to a global access strategy for its investigational monthly oral PrEP candidate, MK-8527. Signatories argue that early decisions on pricing, licensing, and regulatory pathways will determine whether the product becomes a transformative addition to the HIV prevention toolkit or follows the slow, inequitable rollout patterns seen with the rollout of oral PrEP. The groups urged Merck to build on the momentum of Gilead’s accelerated work on lenacapavir and pursue regulatory pathways through the European Medicines Agency and the World Health Organization to accelerate approvals in low- and middle-income countries; seek registration in at least 10 high-burden African countries within six months of a major regulatory approval; commit to pricing at or near generic oral PrEP levels (under $40 per person per year); and negotiate non-exclusive voluntary licenses before approval to enable timely generic production.

IMPLICATIONS: This moment reinforces a lesson the HIV field has learned repeatedly: that access needs to be embedded in the design and development of new products. Decisions made during product development around pricing, licensing, regulatory strategy, and manufacturing shape whether innovation translates into impact or inequity. We are already seeing how early, proactive access planning with lenacapavir for PrEP can accelerate timelines, align donors and regulators, and drive what is now the fastest rollout of a new prevention product since oral PrEP. Advocates are pressing Merck to apply those same principles to MK-8527 now, before trials have results, to avoid the delays and disparities that have historically limited uptake of new prevention options in low- and middle-income countries.  

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AVAC vs. Department of State: One Year Later

This week marks one year since AVAC sued the US government over the sweeping foreign aid freeze that halted HIV and global health programs overnight.

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What We’re Reading

Global Health Watch: Foreign Affairs Bill Passes, Aid Cuts Projected to Cause Millions of Deaths by 2030, UN & WHO in Financial Crisis

This week a $50 billion US foreign affairs spending bill was signed into law, averting severe proposed cuts; a new modelling analysis projects millions of additional preventable deaths by 2030 if global aid cuts continue; and the financial crises facing the UN and WHO continue. We are also following plans to transition or close the Oregon National Primate Research Center, a leading research institution that has contributed enormously in biomedical and HIV research.

US Signs Foreign Affairs Spending Bill Amid Ongoing Uncertainty 

The US Congress passed the $50 billion foreign affairs spending bill and the President signed it into law Tuesday, ending a brief government shut-down. The appropriations bill restores billions in foreign assistance, along with companion bills that restore critical support for biomedical research at the NIH and domestic HIV programs, that had been at risk of deep proposed cuts, though it still represents a reduction from previous years and questions remain about how fully the administration will implement the funding and priorities laid out by lawmakers.

IMPLICATIONS: While this bill averts the most severe proposed cuts and sends a strong signal for continued engagement by Congress, the reduced funding level and uncertainty of whether global health and humanitarian programs will receive the funding Congress appropriated leave many reluctant to celebrate. Coordinated advocacy and sustained Congressional oversight will be needed to ensure all appropriated funds are obligated and spent. 

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New Modelling Quantifies the Impact of Aid Cuts 

A new modelling analysis published in The Lancet Global Health finds that ongoing cuts to official development assistance, particularly from long-time donors like the US, UK and Germany, could lead to between 9.4 million and 22.6 million additional deaths by 2030 across 93 low- and middle-income countries. This includes more than 5 million children under age five. 

IMPLICATIONS: This analysis reinforces the need to sustain strategic investments now to avoid deaths and setbacks on all fronts, from HIV to maternal and child health to chronic diseases. 

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UN and WHO Face Deepening Financial Crisis

Global health and humanitarian institutions are facing an escalating financial and political crisis. UN Secretary-General António Guterres warned that the United Nations risks “imminent financial collapse” if member states, specifically the US, do not pay their dues on time, or fail to agree to revise the financial rules, which require the UN to repay governments hundreds of millions of dollars in credits for programs, even ones that were never implemented. At the same time, the World Health Organization (WHO) launched its 2026 emergency appeal amid its biggest financial decline in a decade and while the US withdrawals and other countries question their engagement.  

IMPLICATIONS: While WHO and the UN pursue reforms toward more sustainable and flexible financing, failure by member states to stabilize funding and modernize governance could strip capacity from global institutions at a moment when they are needed most with major implications for health security, equity, and trust in the global response system. 

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NIH to Transition Primate Research Center Amid Broader Shift Away from Animal Testing

In the last week, NIH Director, Jay Bhattacharya, confirmed plans to transition the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) into an animal sanctuary. This is the first of possibly seven of the NIH’s National Primate Research Centers to close or transition and is part of a broader national push to reduce animal testing. The NIH said last year it would spend $87 million to develop a standardized alternative to animal testing. OHSU’s board of directors will meet Monday to consider negotiations with the NIH. They previously estimated it would cost $241 million over eight years to close.

IMPLICATIONS: This move reflects a broader pattern of policy decisions that risk eroding the foundational research systems underpinning early-stage biomedical science, including HIV prevention, treatment, and cure research. While developing alternatives to animal research is important, rapidly dismantling animal research—particularly nonhuman primate capacity at these centers and at the CDC—without validated replacements could weaken the early-stage pipeline that has been critical to breakthroughs such as HIV PrEP, PEP, long-acting prevention, vaccine and cure research and development.

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What We’re Reading

New Issue of PxWire

AVAC’s latest issue of PxWire shows reduced initiations of oral PrEP following the US foreign aid freeze; the accelerated rollout of injectable lenacapavir (LEN) for PrEP; and what’s next in the HIV vaccine R&D pipeline.

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Impact of US Withdrawal from WHO, New Data on PrEP, Cure Academy Applications Open

AVAC Roundup

New this week: resources on the impact of harmful US policies on the HIV response; updated infographics on the ups and downs in PrEP; and an opportunity to apply for the US HIV Cure Academy in North Carolina this April.

The US withdrawal from WHO has made Americans less safe, further damaged diplomatic relationships and will ultimately make America less healthy, writes AVAC Executive Director Mitchell Warren in Positively Aware.

Milestones for access to injectable lenacapavir for PrEP (LEN) are being met faster than any other PrEP product before it. Learn how and why.

The PEPFAR stop-work order resulted in major declines in initiations of PrEP. Between January–September 2024 and January–September 2025, PrEP initiations dropped by 13-66% in high-volume countries, with the steepest declines occurring in PEPFAR-dependent programs disrupted by stop-work orders.

From Devex’s The AID Report, this article features the voices of veteran HIV advocates including AVAC’s Maureen Luba and HEPS-Uganda’s Kenneth Mwehonge. The article traces the impact of the US foreign aid freeze, illuminating how outreach, prevention and monitoring systems are fraying across four African countries critical to the HIV response.

This Bhekisisa piece explores how HIV programs must adapt after US funding cuts. AVAC’s Mitchell Warren argues that survival requires consolidation, new partnerships, boosting domestic government contributions, and sharply refocusing on HIV prevention.

The US HIV Cure Research Academy: April 22-24, 2026 

The US HIV Cure Research Academy brings together researchers and community members from across the United States to learn about HIV cure science and translation. This two and a half-day intensive training program includes interactive discussions, skill-building workshops, and networking sessions. Full scholarships will be awarded for up to 15 attendees. Applications close February 13 at 11:59pm ET. Apply here: US HIV Cure Research Academy 2026!  For further information please contact [email protected].

Global Health Watch: Budget stalled, Gag Rule expanded, US leaves WHO, AAP’s own immunization recommendations

Issue 53

As this issue goes to publication, the US fiscal year (FY26) budget remains unresolved in the Senate, adding to uncertainty for global health funding. A short-term funding deal reached last night would delay, but not resolve, a potential government shutdown, as negotiations over the administration’s deadly mass deportation efforts continue. For global health programs already under strain, this limbo continues to carry serious consequences. This week’s issue tracks the expansion of the Global Gag Rule under the new “Promoting Human Flourishing in Foreign Assistance” (PHFFA) policy, the US’s formal withdrawal from the World Health Organization (WHO), growing pushback on concerning vaccine policy, and the new finding that nearly half of US CDC surveillance databases have been paused or stopped.

Weaponizing Foreign Aid with the Expanded Global Gag Rule

Last Friday, the US administration expanded the harmful Global Gag Rule (GGR), also known as the Mexico City Policy, under a new Promoting Human Flourishing in Foreign Assistance policy, which broadens restrictions on US foreign aid. Originally enacted in 1984, the GGR barred non-US organizations receiving funding for global health from providing or promoting abortion services (even with their own, separate resources). Each Republican president enforced the GGR, while each Democratic president rescinded it. Now, this administration’s restrictions are being drastically expanded and extend to programs that engage in what the administration labels “gender ideology” and diversity, equity, and inclusion initiatives. It now applies not only to non-governmental organizations (NGOs) based abroad, but US NGOs, multilateral organizations and direct aid to foreign governments. Many organizations, including AVACGlobal Health CouncilPAIPlanned Parenthood, Health GAP, and others called for the immediate rejection of the policy as weaponizing US foreign assistance and imposing political ideology at the expense of improving global health and international cooperation.   

IMPLICATIONS: As this Think Global Health editorial from Stephanie Psaki states, “PHFFA applies not just to global health funding but to all non-military US foreign assistance, approximately $30 billion annually—or 50 times more than what was covered by the original Mexico City Policy… At best, the rules will waste US taxpayer dollars and impede the administration’s ability to implement its America First Global Health Strategy. At worst, the policy will cost lives, stall progress against key global health challenges including HIV/AIDS, and further damage US credibility with key partners—particularly across Africa.” Our colleagues at KFF, provide a very useful analysis of this latest expansion here.  

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US Formally Notifies WHO of its Withdrawal 

As this issue was going to publication last week, the US formally notified the World Health Organization (WHO) of its decision to withdraw. This triggered responses from WHO and the United Nations noting that the US was a founding member in 1948 and a central partner in major global health gains ever since, and warning that the US departure makes the US and the world less safe.  

IMPLICATIONS: The US withdrawal from the WHO underscores a deeper shift in global health governance where health is a bargaining chip for a new imperialistic ideology around foreign policy and national interest. This move heightens, rather than diminishes, the importance of multilateral cooperation. As Chatham House Fellow, Ebere Okereke, writes in Think Global Health, the “US withdrawal from the WHO increased the relevance of multilateral cooperation for Africa. The WHO remains the primary source of global health norms and coordination, even in its weakened state. Disengagement would leave African countries more exposed to power-based bargaining during crises.” 

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American Academy of Pediatrics Issues its Own Immunization Schedule

As US policy shifts and vaccine mis- and dis-information fuels mistrust and confusion—including this week’s chair of the CDC’s Advisory Committee on Immunization Practices (ACIP) shockingly questioning longstanding recommendations for polio vaccination—many organizations are stepping up to defend vaccine science and evidence. The American Academy of Pediatrics issued its own 2026 immunization schedule, continuing to recommend routine vaccination against 18 diseases, a broader program of vaccine protection than the new schedule of vaccines released by the US administration a few weeks ago. The AAP’s recommendations are backed by numerous professional groups including the American Medical Association and National Medical Association. The Center for Infectious Disease Research and Policy (CIDRAP) also launched an effort to boost evidence-based vaccine information by partnering with communicators and rapid-response teams to counter misinformation and clarify vaccine safety and effectiveness.

IMPLICATIONS: The AAP’s decision to publish its own comprehensive vaccine schedule, and the broad coalition endorsing it, signals a powerful pushback and commitment to evidence over ideology. This mixed guidance with the medical and scientific community differing from federal recommendations will continue to erode trust and will undermine routine immunization and confidence in public health, ultimately threatening the gains achieved against vaccine-preventable diseases such as measles, influenza, and polio. 

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Nearly Half of US CDC Surveillance Databases Stopped Updating 

New research published in the Annals of Internal Medicine shows that nearly half of US Centers for Disease Control and Prevention (CDC) data systems have been paused. Of 82 databases meant to update monthly, 46% show unexplained pauses, most lasting six months or more, and of those paused, approximately 87% track vaccinations. 
 
IMPLICATIONS: As Infectious Diseases Society of America (IDSA) CEO Jeanne Marrazzo writes in an accompanying editorial, “Until the United States restores the CDC and its partner agencies to their former stature, we are not only flying blind in the face of emerging and reemerging threats to human health and well-being—we are being deprived of effective weaponry.”

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What We’re Reading