Seventeen countries are hosting sites for the Phase 3 efficacy trials of a monthly PrEP pill, MK-8527, being developed by Merck (also known as MSD outside of the US and Canada). Merck announced the launch of the Phase 3 trials at IAS 2025 in Kigali. MK-8527 was found to be safe and well-tolerated in Phase 2 clinical trials.
EXPrESSIVE Phase 3 Trials Countries of MK-8527
Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
HIV Vaccine Clinical Trials Pipeline
This graphic summarizes the state of HIV vaccine research, detailing the different immunological approaches in clinical trials, the specific candidates being studied, and the collaborative networks of funders and developers working toward an effective vaccine.
Change in PrEP Initiations from 2024 to 2025 in Five Countries
Between the period January-September 2024 to January-September 2025, PrEP initiations fell between 13% and 66% in selected high-volume PrEP countries where ministries of health (MoH) were able to provide data. Among the five countries depicted, four saw significant decline in PrEP uptake. All four relied on PEPFAR PrEP programs and were disrupted by stop work orders (SWO).
Speeding Up Access to PrEP
The timeline for hitting key milestones in product introduction is moving faster for injectable LEN than for any previous PrEP products, starting from the announcement of efficacy results in Phase III trials. LEN’s accelerated timeline compared to oral PrEP, DVR, and CAB reflects a field-wide effort to learn lessons from previous PrEP rollout and not repeat the mistakes of the past.
Global Health Watch: Reflecting on 1 Year of Chaos and What’s Next, Congress Pushes Back, the Future of WHO, US Undermines African Authority
This week marks 365 days of disruption and chaos across global health, with many organizations and journalists reflecting on one year after the foreign aid freeze and what the future of global health looks like. This week also saw the US Congress beginning to reassert its role on health funding, ongoing US disengagement from WHO, and new reporting on the hepatitis B vaccine trial in Guinea-Bissau.
We are also watching closely for news of an expanded Global Gag Rule, that is reportedly coming out later today, just as this issue goes to press. It is anticipated that this new gag will include a dramatic expansion beyond abortion and now underscore the US administration’s war on gender, diversity, equity and inclusion. We’ll cover this in next week’s Global Health Watch; the struggle, most definitely, continues.
365 Days of Chaos and Disruption, What Comes Next for Global Health
This week marks one year since the US Presidential administration issued a deeply cruel executive order freezing foreign assistance, halting billions of dollars in already-approved funding under the bad-faith claim of a “90-day review”. What followed was not a brief pause, but a drawn-out, chaotic disruption that stopped life-saving work across the globe, shutting down valuable organizations, and harming lives, health, and livelihoods. And that was just the beginning of a year of chaos. Many organizations and media coverage noted a growing recognition that the past year’s disruptions to global health were not just destructive, but catalytic, forcing a reckoning with how systems are built and for whom. Reporting from Bhekisisa reflected on how the sudden halt in US HIV funding exposed deep vulnerabilities in over-reliance on external aid, while also accelerating conversations about domestic financing, integration, and sustainability in the HIV response moving into 2026. At the same time, analyses from Health Policy Watch, Science, Nature, and The Lancet laid bare the human and scientific costs of abrupt policy shifts, shuttered programs, fractured research networks, and lost trust, while underscoring that simply restoring old funding streams will not be enough to meet future challenges.
IMPLICATIONS: Together, these stories and analyses point to the need to rethink and rebuild with stronger country ownership, diversified and predictable financing, resilient research institutions, and governance structures that prioritize equity, accountability, and community leadership. Rather than recreating the same architecture, reimagined global health systems must be less dependent on external donors and political ideology. As Global Health Watch has tracked for 52 weeks, the path forward is not about returning to the pre-foreign aid freeze status quo, but about using this period of disruption to construct a more durable, equitable, and responsive global health architecture. As Canadian Prime Minister, Mark Carney, said so clearly at this week’s World Economic Forum in Davos, Switzerland, “Nostalgia is not a strategy.”
READ:
- Fighting for billions: The legal battle to keep US foreign aid alive—Devex
- [PODCAST] One year after Trump: The day HIV funding changed forever — and what came next—Bhekisisa
- US science after a year of Trump—Nature
- One Year Later: The Effect of US ‘Chainsaw’ on Global Health—Health Policy Watch
- Four paradigm shifts to shape an agenda for global health reforms—The Lancet
- Damage assessment: Which of Donald Trump’s changes are likely to last—and which will fade?—Science
Congress Steps Up In Defending Domestic and Global Health
The US Congress is beginning to reassert its constitutional role in shaping federal spending. The joint House and Senate FY26 funding bill released last week covering foreign operations would maintain funding for core global health priorities, including HIV, tuberculosis, malaria, polio, family planning and reproductive health, neglected tropical diseases, Gavi, and UN agencies such as UNAIDS, UNICEF, and UNFPA. This week, legislators rejected nearly $2 billion in proposed cuts to US domestic HIV and related programs through the Labor, Health and Human Services Education and Related Appropriations Act (LHHS), a “major victory” credited to sustained advocacy by people living with HIV, advocates, and service providers. The proposed bill largely preserves funding for domestic public health and biomedical research. As AVAC’s Suraj Madoori said in a statement, “These crucial wins for global and domestic HIV now require us to not hold back, and urge Congress to swiftly approve all the FY26 bills, push the President to sign them, and for us to ensure accountability in the administration to spend and implement this lifesaving funding as instructed by the people and those who represent us in Washington D.C.”
IMPLICATIONS: Together, these bills signal a return to a bipartisan appropriations process and, if enacted, provide a basis to push back against unilateral cuts by the administration. They also signal bipartisan pushback against attempts to cut health and scientific research investments. By rejecting the steep cuts proposed by the administration, they stabilize lifesaving programs and protect the research enterprise. The House passed the bills on Thursday, and the focus now shifts to the Senate, which must pass the bills by January 30. Then onto the President to sign, and, most critically, for the administration to actually spend all Congressionally appropriated funds.
READ:
- MAJOR VICTORY: Bipartisan FY26 Bills Reject Nearly $2B in Proposed HIV Funding Cuts—Save HIV Funding
- Beyond the Numbers: Three Policy Shifts in the FY26 Funding Bill Quietly Reshaping U.S. Global Health—Lights, Camera, Equity Substack
- Limit on multiyear funding of NIH grants is a sticking point in Senate budget talks—STAT
US Disengagement and the Future of WHO
This week also marks one year since the US announced its intended departure from World Health Organization (WHO). Debate over its future and the US’ role within it intensified as pressure from parts of the administration collided with growing concern over the consequences of disengagement. US officials and policymakers aligned with the “America First” strategy call for WHO to be fundamentally reformed or replaced. Analysts note that the US remains a formal member of WHO until debts are paid. Meanwhile, the US administration continues to withhold funding and delay payments, leaving millions of dollars in unpaid US obligations.
IMPLICATIONS: The current state, where the US remains technically engaged but substantively absent, poses serious risks for global health governance, disease surveillance and pandemic preparedness. As analyses from CSIS underscores, WHO reform is both necessary and possible, but meaningful reform requires constructive engagement, predictable financing, and political leadership, not abandonment.
READ:
- MAGA-backed researchers call for WHO to be ‘reformed or replaced’ on eve of US withdrawal—The Telegraph
- As U.S. prepares to exit WHO, it is stiffing the agency on a large bill—STAT
- The Future of the WHO—and How the United States Can Shape It—CSIS
- A US return to the World Health Organization could hinge on whether Trump approves of its next leader—Politico
Hepatitis B Vaccine Trial in Guinea-Bissau Undermines African Authority
Reporting this week is exposing a pattern of US actions that show deep disregard for African public health leadership, ethical research standards, and sovereignty. The US-funded hepatitis B vaccine trial in Guinea-Bissau is at the center of this. As we reported in previous weeks, the unethical trial would delay birth-dose vaccination for thousands of newborns despite overwhelming evidence, and WHO guidance, that immediate vaccination saves lives. According to Rolling Stone, the study was championed by US officials aligned with anti-vaccine ideology and advanced even as Africa CDC officials raised alarm and indicated the trial should be halted. At the same time, the US administration has been marginalizing Africa CDC more broadly, cutting engagement, undermining its authority, and sidelining African institutions in favor of unilateral decision-making. This is being reinforced, as The Guardian reports, by members of the US administration urging US diplomats to emphasize American “generosity” to African leaders even as USAID programs are shuttered and health funding withdrawn.
IMPLICATIONS: Together, these developments signal a dangerous erosion of respect for African expertise, autonomy, and ethical authority in global health. Pushing forward research designs that would withhold proven interventions—while dismissing objections from Africa CDC and African scientists—revives patterns of extractive and unethical research long condemned by the global health community. Undermining Africa CDC while advancing ethically dubious trials weakens trust, damages partnerships, and threatens progress against hepatitis B, HIV, and other diseases where Africa has led with scientific excellence.
READ:
- Trump administration to block aid from subsizing DEI and trans rights overseas—The Guardian
- Trump’s HHS Trashes Top African Health Organization as “Fake” and “Powerless”—Futurism
- Head of US Africa bureau urges staff to highlight US ‘generosity’ despite aid cuts—The Guardian
- HHS Gave a $1.6 Million Grant to a Controversial Vaccine Study. These Emails Show How That Happened—Rolling Stone
- Lipstick on a Pig: Why the Amended Hepatitis B Birth-Dose Trial in Guinea Bissau Remains Ethically Indefensible—BK’s Substack
- ‘Suspended or Cancelled’: Guinea-Bissau Health Minister Halts Controversial Hepatitis B Trial—Health Policy Watch
Read AVAC’s ‘One Year Later’ series
This five-part series reflects on the tumultuous events of the past 365 days across five global health issues: the erosion of US foreign aid; dismantling of the research enterprise; attacks on vaccine policy; and shifts in the global health architecture.
What We’re Reading
- US cuts to HIV programs in sub-Saharan Africa pose global risk, experts say—CIDRAP
- Trump dismantled USAID. Now these aid workers are running for office—Devex
- EU Parliament Backs Critical Medicines Act, Sparking Supply Concerns In Africa—Health Policy Watch
- A big announcement on AI in Africa—Bill Gates
- Multilateral paralysis is harming global health. Gavi’s ‘minilateralism’ can get us back on track—World Economic Forum
- Trump one year on: How six US researchers plan to protect science amid chaos and cuts—Nature
- Talking back: An unprecedented assault has forced the U.S. scientific community to rethink its advocacy tactics—Science
- The little-known vaccine panel that could have big consequences—STAT
- The near death – and last-minute reprieve — of a trial for an HIV vaccine—NPR
- When Trump Took a Whack at the C.D.C., Atlanta Lost Something, Too—New York Times
- What Does America’s Government to Government Collaboration for Health Look Like?—Emily Bass Substack
- Is the $364 million US-Lesotho Health MoU unconstitutional?—Newsday
- Africa pushes back on US health deals over data, power—SciDevNet
- Judge Orders Trump Administration To Restore $12M to American Academy of Pediatrics—The Hill
- Most Vaccine Hesitancy Can Be Successfully Overcome, New Lancet Study Finds—Health Policy Watch
- Pazdur warns that politics, ‘chaos’ are damaging FDA—STAT
- Gates Foundation unveils $9 billion budget and plans to cut staff—Associated Press

As new IDSA CEO, Jeanne Marrazzo warned in a webinar this week, rising HIV infections threaten progress, but “this is not a time to despair. It’s a time to fight.” Watch the recording and explore the 2025 People’s Research Agenda, which tracks the science, flags gaps, and centers community priorities to keep HIV prevention moving forward.
Resources
One Year Later
“The last year has been one of chaos, anger, panic, and frustration. I think the coming year has to be one of strategic rebuilding and building something different—not building back but building forward. That means a different architecture at the country level, community level, regional level, and global level. A year from now, I suspect we’ll see fewer acronyms, but hopefully the ones that remain will be stronger than ever.” —AVAC’s Mitchell Warren, Bhekisisa podcast
This week marks one year since the US Presidential Administration issued a deeply cruel executive order freezing foreign assistance, halting billions of dollars in already-approved funding under the bad-faith claim of a “90-day review”. What followed was not a brief pause, but a drawn-out, chaotic disruption that stopped life-saving work across the globe, shutting down valuable organizations, and harming lives, health, and livelihoods. And that was just the beginning of a year of chaos.

To mark this moment, AVAC’s One Year Later series reflects on the impact of the past 365 days on five key areas of global health and development:
- The erosion of US foreign aid
- The assault on vaccine science and policy
- The dismantling of the research enterprise
- The cruel irony of funding cuts in the context of the breakthrough technology of long-acting lenacapavir for PrEP
- The profound shifts underway in global health architecture
These pieces show how the field navigated a year defined by disruption and resilience—and how policy decisions reverberate through science, programs, and communities.
The year has been a profoundly transformative one for AVAC. The Devex in-depth retrospective, Fighting for Billions: The legal battle to keep US foreign aid alive, chronicles the ongoing lawsuits brought by AVAC, the Global Health Council and partners challenging the foreign aid freeze. The piece highlights how legal action became a critical line of defense against the dismantling of lifesaving programs and why the outcome still matters.
“For me, the best message I can say is a year later, we as a community are still standing. And that is a resilience in its own right. We are going to succeed in global health and development. Not because of what happened in the last year, but in spite of it.” —AVAC’s executive director Mitchell Warren on Bhekisisa’s new podcast, One year after Trump: The day HIV funding changed forever—and what came next
As Jeanne Marrazzo, the new CEO of the Infectious Diseases Society of America (IDSA) shared on our webinar earlier this week showcasing the 2025 update of the People’s Research Agenda (PRA), “We cannot yell it from the rooftops loud enough that new infections are going to rise and undermine efforts to end AIDS as a public health threat. But this is not a time to despair. It’s a time to fight. It’s a time to dig in and recognize not just what we’ve accomplished and why we need to protect that, but why we need to continue to move forward.” See the recording here and learn more about the PRA, which tracks the science, highlights where investments align—or fail to align—with community priorities and identifies critical gaps that must be addressed to ensure the prevention pipeline meets the needs of diverse populations.
The past year has reshaped global health—and AVAC—in ways that will be felt for years to come. The events of the past year also show that advocacy, evidence, and community leadership matter. Some courts provided the necessary check on power; advocates rallied; and scientists and civil society raised their voices and documented what was lost—and what must be protected (see 24 Hours to Save AIDS Research).
With your support, AVAC’s weekly Global Health Watch newsletter, now in its 52nd week, continues to track what happens, elevate what’s at risk, and help all of us navigate what comes next. Thank you to our community which stops at nothing to safeguard hard-won progress against HIV and in advancing global health equity.
Source of Lenacapavir for PrEP Supply to Early Adopter Countries
The Global Fund, with support from CIFF, and PEPFAR have jointly committed to reaching up to two million people with injectable lenacapavir for PrEP over three years. Supply of LEN began arriving in countries in late 2025 with service delivery planned to start in early 2026.
An “Innovation Pile-Up” in Next-Generation LA-PrEP is Possible
The HIV prevention market is headed toward a period of significant opportunity—and possible congestion—as a slate of new products are on track for continued development and potential introduction to the market in 2027 and 2028. Markets and policies must be built to support the products in the market already, so that new options can be rapidly deployed and deliver impact. Otherwise, the field will squander time and money, with epidemic control slipping further out of reach.
Dapivirine Vaginal Ring Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.