This issue covers the Appeals Court opinion in AVAC v Department of State, a violent attack on the CDC fueled by vaccine disinformation, the continued dismantling of the NIH with a potential pendulum swing toward implementation science and away from basic science and clinical research, and a new executive order politicizing federal grants.

AVAC v Department of State Case – Decision Signals Grave Risks

The US Court of Appeals for the D.C. Circuit issued a 2–1 decision in favor of the Administration’s appeal in the AVAC v. US Department of State and Global Health Council v. Trump cases, which challenge the administration’s abrupt and unilateral freeze on foreign aid. The three-judge panel of the Circuit Court of Appeals overturned the lower court’s preliminary injunction, which ordered the Administration to release appropriated foreign aid funds. It didn’t rule specifically on whether the cuts to foreign assistance are constitutional, but instead ruled that the plaintiffs are not allowed to challenge the President’s freeze on Congressionally approved global health funding. In a statement, AVAC’s Mitchell Warren said, “The ruling hands the administration another victory in their intentional effort to destroy decades of progress in global development, diplomacy, public health and human rights. Time and again, this administration has shown their disdain for foreign assistance and a disregard for people’s lives in the United States and around the world. This decision, which we will appeal to the extent possible, further erodes Congress’s role and responsibility as an equal branch of government, and the majority opinion makes the court complicit.”  

IMPLICATIONS: This decision signals grave risks for global health and development and the larger role of Congress to maintain it’s Constitutional “power of the purse”. By allowing the executive branch to withhold Congressionally appropriated funds, the court’s ruling threatens millions of lives and sets a precedent for politicizing health assistance.  

READ:  

• AVAC Condemns Appeals Court Reversal of Order Directing Trump Administration to Spend Foreign Assistance Funds—AVAC statement 
• Trump Administration Can Withhold Billions in Aid, Appeals Court Rules—New York Times 
• President Trump can continue to withhold billions in foreign aid, court rules—NPR  
• US appeals court backs Trump in fight over foreign aid freeze—Devex  
• Appeals court says Trump officials can withhold billions in foreign aid—Washington Post  
• Appeals Court Reverses Order Directing Trump Administration to Spend Foreign Assistance Funds—Public Citizen statement

Shooting at the US Centers for Disease Control and Prevention

On Friday, a gunman fired shots at the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, killing one responding police officer. Investigations revealed the shooter blamed the COVID-19 vaccine for his mental health struggles and had anti-vaccine writings in his home. No CDC staff were physically harmed, but the mental and emotional toll is significant. 

IMPLICATIONS: This shooting highlights the dangerous convergence of vaccine (and general health) disinformation and targeted violence. The erosion of trust fueled by anti-vaccine rhetoric, especially from political leaders in the Administration, directly endangers the people and programs working to protect communities.  

READ:  

• Suspect and Officer Are Dead After Shooting Outside C.D.C. in Atlanta—New York Times 
• CDC shooter thought COVID vaccine made him suicidal, his father tells police—AP News 

NIH Shift to Implementation Science and Further Takedown of the NIH

The dismantling of US support for global health R&D continues to accelerate. As Science magazine reported this week, the NIH is considering a dramatic shift in its HIV research budget away from basic science toward implementation science, with an emphasis on how best to use existing tools (including lenacapavir for PrEP) to end the epidemic in the US. This news follows the defunding of mRNA vaccine development under the Biomedical Advanced Research and Development Authority (BARDA) earlier this month and a dangerous overhauling of long-standing peer review processes for NIH grants (see more below). AVAC’s updated tracker of cuts to HIV R&D includes these latest developments. 

IMPLICATIONS: LEN for PrEP could have a critical role to play in ending the epidemic in the US and around the world, and implementation science is definitely needed to optimize its potential impact. But LEN is not the only intervention needed, and it will be critically important to embed any implementation science agenda into a comprehensive “R&D and delivery” research agenda that shows the appropriate balance of the overall HIV/AIDS research portfolio. The proposed shift comes at a particularly challenging time, with the President’s fiscal year 26 (FY26) budget request proposing an additional 40% cut to NIH. The field faces a tipping point—if the field doesn’t act now to define itself, the new Administration will. Advocates are pushing back with legal action, Congressional engagement, and an urgent focus on the People’s Research Agenda, a framework to ensure research is driven by communities and focused on equitable access and real-world impact. 

READ:  

• NIH ponders overhauling HIV budget to capitalize on prevention breakthrough—Science  
• HIV Prevention R&D at Risk—AVAC  
• RFK Jr has slashed vaccine research. You need to know how perilous that is for the world—The Guardian 

New Executive Order Gives Political Appointees Control Over Federal Grants 

The US President signed an executive order granting political appointees unprecedented control over federal research grants. This allows them to review funding decisions, terminate existing grants at will, and delay new solicitations. Historically, grants have been allocated through peer-reviewed processes, so this policy shift threatens to further entrench partisan political priorities in scientific funding. 

IMPLICATIONS: This new level of political control over research funding poses serious risks to HIV and broader global health R&D. Agencies are continuing to lose the ability to rely on predictable, science-driven funding streams. The new executive order severely disrupts decades of equitable and evidence-based research support.   

READ:  

• Trump signs order giving political appointees oversight of federal grants—The Hill 
• Trump executive order seeks to centralize control of grantmaking under political appointees—STAT  
• Donald Trump Announces Major Change to ‘Frivolous Grants’—Newsweek

What We’re Reading

• No One in the White House Knows How to Stop Ebola—The Atlantic
• Elton John AIDS Foundation plugging gaps in HIV funding—The Lancet
• WATCH: A Conversation on the Future of PEPFAR With One of Its Chief Architects—Tom Frieden Substack with Mark Dybul
• Is PEPFAR’s Data Going Dark?—To End a Plague Substack
• If We Want to Save Public Health, We Need to Get Out of Our Bubble—The Nation
• Exclusive: USAID officials tour missions worldwide as agency shutter—Devex
• How HIV funding cuts are undermining years of progress in Zimbabwe—Doctors Without Borders
• Inside SA’s multi-million rand plan to fill US funding void—Spotlight
• ‘Kennedy’s case against mRNA vaccines collapses under his own evidence—STAT
• Trump administration threatens to strip Harvard University of lucrative patents—The Guardian
• Vinay Prasad returns to the FDA, weeks after his ouster—STAT
• HHS revives child vaccine safety panel sought by anti-vaccine activists—Washington Post
• Breaking barriers, changing paradigms: Africa’s radical agenda for HIV sustainability—Frontiers in Reproductive Health
• ‘A whole body of health-equity research is being disappeared’ — why I resigned from the NIH—Nature

Updated Resources

• PEPFAR Program Status, amfAR
• Save PEPFAR, Save Lives: Rally & Civil Disobedience in DC, Housing Works
• Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion, American Public Health Association
• Long-Acting PrEP Market Assessment for Key Populations, AVAC, GBGMC
• The Global Need for Long Acting PrEP Among Key Populations: Forecasts of Global Demand 2025-2030, AVAC, Avenir Health, GBGMC

AVAC strongly condemns today’s decision by the U.S. Court of Appeals for the D.C. Circuit to overturn the District Court’s injunction that compelled the restoration of vital foreign aid funding in the lawsuit, AVAC v. United States Department of State, which challenged the Trump Administration’s funding freeze on foreign assistance, arguing that the mass termination of foreign assistance awards as unconstitutional, arbitrary and capricious, and contrary to law. 

This ruling, which allows the continuation of a Trump‑administration–imposed freeze on aid disbursements, poses profound threats to global health and HIV prevention efforts. By enabling the withholding of billions of dollars in funding, the court’s decision directly undermines the delivery of lifesaving HIV services and the ethical principles of equitable access. 

“Today’s Circuit Court ruling hands the administration another victory in their intentional effort to destroy decades of progress in global development, diplomacy, public health and human rights,” said Mitchell Warren, executive director of AVAC. “Time and again, this administration has shown their disdain for foreign assistance and a disregard for people’s lives in the United States and around the world. More broadly, this decision, which we will appeal to the extent possible, further erodes Congress’s role and responsibility as an equal branch of government, and the majority opinion makes the court complicit.” 

The Circuit Court panel of three judges decided in a 2-1 vote. The dissenting judge, Florence Pan, stated clearly what is at stake: “Today, a President defies laws enacted by Congress without any legal basis, and the court holds that he has merely violated a statute, that the Constitution is not even implicated, and that there is no judicially enforceable cause of action to challenge his conduct. By failing to rein in a President who ran roughshod over clear statutory mandates, the court evades its constitutional responsibility to delineate the obligations and powers of each branch of our government… At bottom, the court’s acquiescence in and facilitation of the Executive’s unlawful behavior derails the ‘carefully crafted system of checked and balanced power’ that serves as the ‘greatest security against tyranny—the accumulation of excessive authority in a single Branch.’” 

Lauren Bateman, an attorney with Public Citizen Litigation Group and lead counsel on this case, said “Today’s decision is a significant setback for the rule of law and risks further erosion of basic separation of powers principles. Our lawsuit will continue as we seek permanent relief from the Administration’s unlawful termination of the vast majority of foreign assistance. In the meantime, countless people will suffer disease, starvation, and death from the Administration’s unconscionable decision to withhold life-saving aid from the world’s most vulnerable people.” 

On February 10, Public Citizen filed suit on behalf of AVAC and the Journalism Development Network, Inc, seeking emergency relief from a funding freeze that was put in place by an executive order issued the day that the Trump Administration took office. 

The funding freeze ultimately led to the closure the US Agency for International Development (USAID) and decimated funding for global health, shattering relationships of trust with countries all over the world, upending decades of investment and development, and jeopardizing lives and livelihood. The case was among the first challenges to the Trump Administration’s executive orders to reach the Supreme Court. On March 5, in a 5-4 ruling, the justices rejected White House arguments that District Court judge, Amir Ali, lacked authority to direct payments to be unfrozen.  

In the following weeks, the government had been forced to bring back federal staff in order to issue nearly $2 billion in funds for contractual work completed by February 13 related to USAID programs. Judge Ali also directed the government to promptly restore grants and cooperative agreements that were terminated prior to February 13. But with the complete dismantling of USAID, for many of those programs it was too late. 

While the government has been forced by the court to issue these payments, which are ongoing, one USAID whistleblower has provided an eye-witness account and direct evidence alleging malfeasance by Trump Administration officials, including violations of the law and public trust, termination of contracts by individuals without legal authority to do so, and a so-called foreign aid grant review that was never more than a pretense, resulting in the illegal mass termination of contracts.  

AVAC commends USAID’s workforce, and leaders among them, who are taking a stand against these attacks on the US constitution, global health, foreign aid, and accountability in government. As Public Citizen’s Lauren Bateman said, “The Trump Administration has consistently—preposterously—claimed that its decision to terminate thousands of U.S. foreign assistance awards was legal because those terminations were based on an ‘individualized’ review. This internal agency document corroborates that there was no such individualized review. It also shows that the Administration has ignored both court orders and numerous communications from officials within USAID.” 

The global health ecosystem cannot afford further disruption. Data from a recent Lancet study estimate that the discontinuation of PEPFAR alone—one of the programs most directly impacted—could result in up to 10.75 million new HIV infections and 2.93 million HIV-related deaths by 2030. 

“This court decision exacerbates an already grave humanitarian crisis. AVAC stands unwavering in our commitment to ethical, evidence-based global health programs to develop and deliver HIV prevention, vaccine and contraceptive innovations,” said Warren. “We urge policymakers and the courts to act urgently to reverse this dangerous precedent. The health and lives of millions – not to mention the underpinnings of our democracy – hang in the balance.” 

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.
 
READ:

• Kennedy Cancels Nearly $500 Million in mRNA Vaccine Contracts—New York Times
• Why mRNA Vaccines Are So Revolutionary—And What’s at Stake if We Lose Them—Scientific American
• Watch: Federal mRNA funding cut is ‘most dangerous public health decision’ ever, expert says—PBS News Hour
• Call for Global Strategy to Counter ‘Vaccine Misinformation from the US’—Health Policy Watch
• AVAC Condemns Administration’s Further Actions to Dismantle and Deconstruct U.S. Government Vaccine Research and Delivery Infrastructure—AVAC statement

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.”  
 
READ:

• NIH broke law by withholding funding: GAO—The Hill
• Trump administration violated impoundment law by canceling NIH grants, slowing new awards, GAO finds—STAT

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.
 
READ:

• A $2.5 billion pledge makes women’s health a priority in Gates Foundation spend-down—Associated Press
• Watch: Gates Foundation pledges $2.5B for women’s health worldwide—PBS News Hour
• Why investing in women’s health is good for business—Fortune
• Gates Foundation to Invest $2.5 billion in Women’s Health Amid Debilitating US Funding Cuts—Health Policy Watch

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

What We’re Reading

• The funding scramble: countries desperately seek HIV finance solutions—aidsmap
• US Aid Cuts Could Trigger Global Health Setbacks—Newsweek
• The Trump Administration Is Promoting Its Anti-Trans Agenda Globally at the United Nations—ProPublica
• Harm reduction techniques being phased out under Trump—Rollcall
• Deep dive: The unraveling of USAID—Devex
• African Summit Looks for Solutions to Health Funding Crisis—Health Policy Watch
• The HIV/AIDS pandemic: where are we now?—AIDS
• New strategies for HIV prevention in a shifting funding landscape—Touch Infectious Diseases
• Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion—American Journal of Public Health
• What’s New & Next in HIV Prevention: Update on Research & Development AND Delivery—AVAC and Centers for AIDS Research

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.

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.

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.

READ:

• New injection for easier prevention of HIV infection in the EU and worldwide—European Medicines Agency  
• EMA Recommends LEN for PrEP—AVAC

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.  

READ: 

• A Quiet Policy Shift That Could Devastate American Science—Science and Freedom Substack  
• NIH is shrinking the number of research projects it funds due to a new Trump policy—STAT  
• Alert: The Trump administration is quietly slashing new NIH grant awards, and it’s not via the budget—Don Moynihan substack  
• Trump administration halts, then releases, NIH research funding—The Washington Post 
• Trump Administration Scraps Effort to Pause Health-Research Funding—Wall Street Journal 

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. 

READ:  

• AMA pushes back as RFK Jr. reportedly plans to fire members of preventive care panel—STAT 
• With RFK Jr. reportedly weighing preventative services panel revamp, HIV PrEP drugmakers could be at risk: analysts—Fierce Pharma  
• RFK Jr. to Oust Advisory Panel on Cancer Screenings, HIV Prevention Drugs—Wall Street Journal 
• Important Win for Public Health: Supreme Court Upholds ACA Preventive-Care Protections—AVAC  

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.  

READ:  

• Leaked Whistleblower Memo Shows the Trump Administration Illegally Terminated USAID Foreign Assistance Awards—Public Citizen  
• Exclusive: USAID director alleges ‘malfeasance’ since Trump aid freeze—Devex

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.  

READ:  

• In a first, the Senate confirms a new CDC director—NPR  
• Susan Monarez Faces Daunting Challenges as C.D.C. Director—New York Times

What We’re Reading

• Rethinking the war on AIDS—The Economist
• Persistence is Resistance: The fight to End the HIV Epidemic Hangs in the Balance—Journal of Infectious Diseases
• US Drafts Plan to Change PEPFAR’s Focus From HIV to Diseases that Could Threaten Americans—Health Policy Watch
• FDA’s Top Vaccine Official Resigns—Medpage Today
• There’s a Major Publishing Slowdown at CDC’s Flagship Journal—Medpage Today
• GOP Senator Fights White House Over Billions in Frozen Funds—Wall Street Journal
• Gates CEO opens up about what next 20 years may look like—Devex
• The U.S. is destroying $9.7 million in contraceptives. Is there another option?—NPR Goats & Soda
• IAS2025: Findings give hope for monthly HIV prevention pill—Spotlight
• Potential Trade-Offs of Proposed Cuts to the US National Institutes of Health—JAMA
• New analysis predicts sprawling effects of proposed NIH budget cuts—STAT
• Gavi’s board tasked with strategy shift in light of $3B funding gap—Devex
• Africa needs to invest in science communication — here’s how—Nature

Resources

• HIV Research on Pause: Impacts of US government cuts on HIV R&D, AVAC
• Global HIV Prevention Quarterly Newsletter Q2 2025, Global Prevention Coalition
• Lenacapavir Regulatory Approval, AVAC
• EXPrESSIVE Phase 3 Trials, AVAC
• PEPFAR Program Impact Tracker, Brooke Nichols

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.

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.

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. 

READ:  

• US Quietly Drafts Plan to End Program That Saved Millions From AIDS—New York Times 
• Small win for activists, but SA’s HIV projects won’t get reopened—Bhekisisa  
• PEPFAR’s funding survived — now what?—Washington Post 
• PEPFAR’s been saved—for now. What’s next?—Positively Aware  
• We Are Fumbling the Fight Against AIDS—Bulwark

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.  

READ:  

• Rep. Yassamin Ansari Introduces HIV Medication Act to Enhance Access to Prevention Treatments—Press Release

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. 

READ:  

• House Panel Approves Spending Bill That Rejects Some Trump Foreign Aid Cuts—New York Times 

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.  

READ:  

• US has wasted hundreds of thousands of vaccines meant for Africa, health officials there say—Politico  
• Trump administration to destroy nearly $10m of contraceptives for women overseas—The Guardian  
• Meeks, Frankel, Meng Introduce Legislation to Prevent Destruction of Foreign Aid Commodities—House Foreign Affairs Committee

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. 

READ:  

• From Kigali: At IAS 2025, the HIV response rallies to face the crises—AVAC  
• Does six-monthly PrEP have a future following the collapse of global HIV funding?—aidsmap 
• The US cuts challenge African funders and governments to provide new models of PrEP access—aidsmap  
• Why ‘integration’ has become a ‘dirty word’ in HIV programming—Devex  
• Is HIV integration a response or a death sentence? Communities demand answers—aidsmap

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.

What We’re Reading

• How US aid can appeal to ‘America First’ Republicans—Devex
• Employees’ protests against Trump science policies spread to NSF—Science
• US rejects WHO pandemic changes to global health rules—Reuters
• WHO’s Tedros: US Rejection of International Rules on Health Threats is Based on ‘Inaccuracies’—Health Policy Watch
• The Demographic and Health Surveys brought crucial data for more than 90 countries — without them, we risk darkness—Our World in Data
• We can’t win the fight to end HIV if we cut funding and access to medication—The Hill
• The imperative for increased investment for an HIV cure—Lancet HIV
• Trump Forced to Restore $6.2 Million in Funding for 9 LGBTQ+ Nonprofits Across the US—Them
• WHO projects up to 40% cut in health aid in 2025—Devex
• How economic resilience projects are helping HIV patients survive aid cuts—Devex
• Help save 2 million lives: close the vaccine funding gap—Nature
• The Trump Administration’s Foreign Aid Review: Status of PEPFAR—KFF  

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.

Upcoming Webinar—join us!

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!

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.

READ/WATCH:  

• PEPFAR may escape White House attempt to cut its budget—PBS Newshour  
• Senate blocks $400M cut to PEPFAR, but it’s a shell of its former self—Devex  
• The PEPFAR programme keeps millions with HIV alive – a new push seeks to save it from Trump’s aid cuts—The Independent  
• Senate Approves Trump’s Bid to Cancel Foreign Aid and Public Broadcast Funds—New York Times 

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. 

READ/WATCH: 

• Merck to Initiate Phase 3 Trials for Investigational Once-Monthly HIV Prevention Pill—Merck statement 
• Video: New Phase 3 EXPrESSIVE trials announced exploring efficacy of a once-a-month oral PrEP pill—AVAC  
• WHO Adds Lenacapavir to Its HIV PrEP Recommendations Amid Underutilization of PrEP and Severe PEPFAR Funding Cutbacks—Managed Healthcare Executive 
• Lessons for long-acting lenacapavir: catalysing equitable PrEP access in low-income and middle-income countries—Lancet HIV 
• WHO recommends injectable lenacapavir for HIV prevention—WHO statement 

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. 

READ:  

• SA gets R520-million to buy the twice-a-year anti-HIV jab — but there’s a snag—Bhekisisa  
• Now What with Injectable LEN for PrEP?—AVAC  

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.  

READ:  

• Exclusive: NIH to dismiss dozens of grant reviewers to align with Trump priorities—Nature  
• HIV Research on Pause: Impacts of US government cuts on HIV R&D—AVAC presentation at IAS 2025 

What We’re Reading

• A Venerable AIDS Activist Returns to Battle—New York Times
• Trump Canceled Their Salaries. These Health Workers in Uganda Showed Up Anyway—New York Times
• The future of US funding for HIV treatment and prevention—NPR 1A
• We Didn’t Get Covid Right. But This Is Just Wrong.—New York Times
• Worlds Historic Pandemic Agreement. Will Uganda seize opportunity?—New Vision
• Nearly 400 Experts, Faith Leaders Demand Senate Action To Thwart RFK Jr.’s “Systematic Assault” on Global Vaccination—Public Citizen
• I worked for 20 years for the HHS office that safeguarded people in research studies. DOGE gutted it—STAT
• The growing influence of vaccine skeptics inside HHS—STAT
• IAS 2025: HIV care is political: early focus on the funding crisis—i-Base
• Global Fund Replenishment, Making Sustainability Arguments and Simplification Are Keys To Hitting Goal of 2M on Lenacapavir PrEP, says Mitchell Warren of AVAC | IAS 2025—Managed Healthcare Executive
• ‘Best of Times, Worst of Times for HIV Prevention,’ Says Mitchell Warren of AVAC | IAS 2025—Managed Healthcare Executive

Resources

• The Kigali Call to Action: Standing Together for the Global HIV Response, Action Network
• PxWire Volume 15, Issue 3, AVAC
• Now What with Injectable LEN for PrEP: How to Translate Ambition into Accelerated Delivery and Impact, AVAC