AVAC’s formal input submitted on the re-competition of the NIAID HIV/AIDS Clinical Trials Networks. The recommendations were informed by the People’s Research Agenda (PRA), a comprehensive framework developed through consultations with over 130 community representatives across 23 countries.
AVAC Input for Recompetition of the NIAID HIV/AIDS Clinical Trials Networks
US Supreme Court Gives the Administration a Free Pass to Withhold Foreign Aid
AVAC Denounces Court’s Misguided Late-Day Ruling
Contact: [email protected]
Late today in AVAC v Department of State and Global Health Council v Trump, the Supreme Court of the United States granted the US Presidential Administration’s request to stay an injunction that would require the Administration to obligate $4 billion of foreign assistance funds before they expire on September 30, as required by law. The Court’s ruling temporarily grants the Administration’s request to pause a lower court order that the government spend the funds. With just four days until September 30, those funds, which otherwise would have saved lives and advanced global health and national security, will remain unspent.
“With this ruling, the Supreme Court has given the Administration a free pass to run out the clock on the disbursement of foreign aid that Congress appropriated. Since foreign aid was frozen on the first day of this Administration, we have seen thousands of clinics close, hundreds of thousands of communities lose access to essential services and medications, and thousands of lives lost,” said Mitchell Warren, executive director of AVAC, a plaintiff in the case. “This ruling will translate into further devastation, put future global health responses at risk, and set a dangerous precedent that undermines Congress’ constitutional power of the purse.”
“But this is beyond foreign assistance; the Court’s decision is a chilling one for anyone who cares about the US Constitution. While their ruling is only preliminary and should not be read as a final determination on the merits, it is terribly misguided and potentially implies that the Administration can disregard Congressional power of the purse and now seemingly impound Congressionally appropriated funds whenever it wants,” added Warren.
In a powerful dissent, three Supreme Court justices led by Justice Elena Kagan issued a warning that the stakes in this case are far too significant to be decided through the Court’s emergency docket without full briefing or oral arguments, underscoring the extraordinary nature and far-reaching consequences of the Administration’s unlawful actions. “Deciding the question presented thus requires the Court to work in uncharted territory. And, to repeat, the stakes are high: At issue is the allocation of power between the Executive and Congress over the expenditure of public monies,” Justice Kagan wrote in her dissent. “The standard for granting emergency relief is supposed to be stringent. The Executive has not come close to meeting it here.”
Supporting RECs/IRBs to Review the Enrolment of Pregnant/Lactating Individuals in HIV Prevention Trials using International Ethical Guidance
Appearing in the journal Research Ethics, this article written by AVACer Breanne Lievense and partners provides ethics recommendations to be included in future research on pregnant and lactating individuals.
Avac Event
The Fight for Health Justice in an Age of Retreat
Press Release
AVAC Condemns US Administration’s ‘Pocket Rescission’ Request to Withhold Billions in Foreign Aid
AVAC calls on Congress to reassert its constitutional power
Contact: [email protected]
New York, NY, September 2, 2025 – AVAC condemns the US Administration’s intent to withhold billions of dollars in federal foreign assistance through the proposed ‘pocket rescission’ request sent to Congress last Friday. AVAC calls on Congress to reassert its constitutional power in appropriating federal spending and counteracting this executive overreach by the Administration. The Administration is seeking to cancel any Congressionally-appropriated funding at its discretion, with zero oversight or accountability from a co-equal branch of government.
“This is a true constitutional crisis, advancing the Administration’s assault on Congress’ ‘power of the purse’ and putting millions of lives at risk,” said Mitchell Warren, executive director of AVAC, lead plaintiff in AVAC v. State Department. “We have already seen the devastating consequences of the foreign aid freeze: interrupted treatment, shuttered clinics, prevention efforts stalled, and lives lost. Now, by attempting to usurp Congress of its constitutional role and granting the President unilateral authority to decide which appropriations to honor and which to ignore, the Administration is setting a dangerous precedent—one that, if unless prevented, will reverberate globally, jeopardize lives, and undermine the very foundations of US governance.”
The Administration continues to attempt to use questionable budgetary maneuvers to “run out the clock” on the fiscal year and avoid disbursing nearly $4.2 billion of Congressionally-appropriated foreign assistance. These maneuvers are illegal, and represent another step in the Administration’s reckless efforts to pull back billions in unspent foreign assistance funds which were already approved by Congress.
“This crisis has been building since January 20, when the Administration froze foreign assistance funding and forced AVAC and partners to turn to the courts,” said Warren. This past week marked one of the worst yet. On August 28, the D.C. Circuit Court of Appeals denied AVAC’s petition to rehear its case en banc and vacated the District Court’s preliminary injunction that had required the Administration to release billions in Congressionally-appropriated foreign assistance funds. That decision came only two days after the Administration filed an emergency petition to the Supreme Court of the United States seeking permission to continue withholding the funds. While last week’s ruling was a setback, the Court did significantly modify a prior opinion from August 13, paving the way for AVAC, the Global Health Council (GHC), and co-plaintiffs to return to the District Court to pursue relief. Lawyers representing AVAC and GHC have already filed motions for a renewed preliminary injunction.
“AVAC and GHC have gone back to the District Court to seek a new injunction. And our fight doesn’t stop there,” Warren said. “We will continue to press our case in courtrooms, in Congress, and alongside communities to defend global health and the rule of law. The courts must act swiftly to send a strong message against this executive overreach, and Congress must defend democracy by reasserting its constitutional role as the arbiter of how funds are appropriated and spent.”
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About AVAC: Founded in 1995, AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Bluesky and Instagram. Find more at www.avac.org and www.prepwatch.org.
The Real-World Impact of Defunding STI Research
The US presidential administration’s funding cuts and policy shifts are reshaping the public health landscape in profound ways. While many of these changes have drawn significant media attention, the impact on sexually transmitted infection research and prevention has remained largely overlooked, though the consequences are dire, writes AVAC’s Alison Footman writes in TheBodyPro.
Press Release
AVAC Responds to Government’s Emergency Appeal to SCOTUS
In response to the US government’s August 26 emergency application to the US Supreme Court seeking to stay the preliminary injunction in the AVAC v Department of State legal case against the foreign aid freeze, AVAC’s Executive Director, Mitchell Warren wrote:
“It is no surprise that the administration has taken our case directly to the Supreme Court, especially after the District Court’s very clear and firm denial of their request yesterday to suspend the requirement to obligate Congressionally appropriated funding for foreign assistance. Time and again, this administration has shown their disdain for foreign assistance and a disregard for people’s lives in the United States and around the world. But even more broadly and dangerously, this administration’s actions further erode Congress’s role and responsibility as an equal branch of government. The question being put to SCOTUS is whether they will be complicit in further eroding the constitutional commitment to checks and balance.”
Press Release
AVAC Condemns Administration’s Further Actions to Dismantle and Deconstruct U.S. Government Vaccine Research and Delivery Infrastructure
Contact: [email protected]
New York, NY, August 6, 2025 — 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.
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About AVAC: Founded in 1995, AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Bluesky and Instagram. Find more at www.avac.org and www.prepwatch.org.
The Cruel Irony of Prevention
FDA approves LEN, while the administration destroys USAID
It’s been 22 weeks since the US president issued the executive orders that began the chaotic dismantling of USAID. See recent, remarkable, and much-needed New York Times coverage on the destruction of USAID. And check out this new episode of the This American Life podcast on the aftermath of shutting down USAID.
We at AVAC took a public stand against this attack on global health and development in our court case, AVAC v. United States Department of State, filed by Public Citizen on February 10. We took this step because we understood the devastation that would come from such drastic and sudden divestment in the HIV response and global health. We also believe it was illegal and unethical.
In March, US District Court Judge Amir Ali ruled the foreign aid freeze was, indeed, unlawful, and that the administration had “usurped” the authority of Congress. Since that time, some 400 grants have been restored and the government is slowly complying with the Judge’s order to pay all invoices for work conducted through February 13. It’s a mere fraction of USAID’s former self, but each of these restored programs and payments represent an attempt to make America and the world stronger, safer and more prosperous. Just as important, our court case, along with a related one brought by the Global Health Council and colleagues, has forced into the public record the administration’s cynical maneuvers to dismantle global health; information that empowers advocates to fight and, we hope, finally spurs Congress to do its job.
“We cannot cede ground gained against HIV and other global health threats out of fear or paralysis in the face of these reckless actions. It is imperative to hold this administration responsible. And it’s imperative to invest in global health and sustain the gains in HIV. Global health advocates know this better than anyone, and we are fighting back,” said AVAC Executive Director, Mitchell Warren.
Watch AVAC’s Executive Director, Mitchell Warren’s video explaining how this court case is one of many critical steps to safeguard global health and the HIV response.
Nowhere is that fight to safeguard and advance HIV prevention more important than work to rollout injectable lenacapavir (LEN) for PrEP, just approved by the US Food and Drug Administration. LEN approval signals what could be a turning point in the epidemic – but only if the field invests in bold, strategic action.
“The science is remarkable, and the FDA approval is in. But it’s what happens next that makes the science count. It’s whether or not the technology is made available and becomes truly accessible that will bring impact. Will the world get it right this time? Because for 15 years we’ve squandered the potential of PrEP. That hope depends on fierce and effective advocacy,” said Warren.
HIV prevention advocates around the world are demanding and preparing for injectable LEN to reach the communities that need it most with speed, scale and equity. Watch this video for more on status of LEN rollout and advocacy priorities.
“Scientific progress has been made over the years, and we celebrate them, but without truly having a prevention story to tell…yet. Now it’s time for that story to be told,” said APHA Executive Director Yvette Raphael.
Read this report from Friends of the Global Fight Against AIDS, Tuberculosis and Malaria, Principles of a responsible transition of American leadership to end AIDS: Strategic transition or pandemic resurgence?, on how PEPFAR and US leadership can play an instrumental role in reaching epidemic control.
“There’s much work advocates are doing, and much work ahead. Some donors have come forward, but it’s only a start. We also need to advocate with regulatory authorities at the country level, not to mention pushing for an affordable price, and a big enough supply from Gilead now to support demand creation at scale in order to build a sustainable market, which in turn will support generics and further reductions in price. Advocates are now and will continue to be fighting at the country level and the global level to move all this forward,” said HEPS Uganda Executive Director Kenneth Mwehonge and co-chair of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP.
Check out the Caucus statement on priorities for LEN rollout, and these resources to support our collective advocacy:
Recent news headlines, including the just published New Yorker magazine article by Science reporter Jon Cohen, capture the power of this moment to reshape the HIV response and finally control the epidemic. As advocates, we know the stakes very well.
“What all of us working together have tried to do for years and years and years, is to overcome the barriers from stigma to disinformation, that we’ve seen with oral PrEP, and with treatment 20 years ago. It will take Gilead, working with all of us advocates, to collectively ensure that this drug is accessible to all, so that the success depends not on the politics but on the product. We have to hold everyone, including ourselves, to account for keeping on task and for making sure that we do not squander this opportunity. So, let’s do this together and lay the groundwork for all future innovations to go faster, with speed, with scale and with equity for all,” Warren said.
The field is at a major inflection point, punctuated by both political challenges and scientific opportunity – and we can’t let the former overtake the latter.
LEN Generics — Can we go faster?
The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline. For the latest on LEN, visit here.