September 26, 2025
The stakes are high as the US approaches the start of a new fiscal year (FY26) on October 1, currently mired in stalled White House negotiations and a looming government shutdown; the Supreme Court’s pending decision on AVAC’s lawsuit; and the new US “America First” strategy to reshape foreign aid. This issue highlights major global health developments at the UN General Assembly, from debate over the future of UNAIDS to commitments from the Gates Foundation and Unitaid to accelerate access to injectable lenacapavir for PrEP (LEN), alongside new discussions on AI ethics and health.
Gates Foundation and Unitaid Commit to Accelerate Market Development for Lenacapavir for PrEP
The Gates Foundation and Unitaid announced new strategic investments to accelerate the development of, access to and price reduction for generic versions of injectable lenacapavir (LEN), the highly effective six-monthly injection for HIV PrEP. As AVAC’s Mitchell Warren said in its statement, “this could be a transformational moment in HIV prevention if political will, coordination, and further procurement investment meet this moment to deliver LEN with speed, scale and equity to all communities and populations who need and want prevention options.”
IMPLICATIONS: While this progress is encouraging, it is only meaningful if momentum leads to real access. These agreements get LEN closer to the $40 per person per year price of daily oral PrEP for many, but not all, low and middle-income countries, and hopefully will accelerate large scale programs by 2027. AVAC’s publication, Now What with Injectable LEN for PrEP How to Translate Ambition into Accelerated Delivery and Impact, includes forecasts demonstrating that instead of 2 million people in three years that is currently being planned by the Global Fund and PEPFAR with initial supplies from Gilead, the world could reach at least 1.5 million people in just one year, rising to at least five million people per year by 2030. These numbers suggest what is possible and what is necessary to accelerate access, achieve real impact, build a sustainable market, and drive prices down even further.
READ:
- Gates Foundation announcement
- Unitaid announcement
- Twice-yearly HIV prevention drug to be offered at new, low cost—The World
- Philanthropies Strike a Promising Deal to Turn Back H.I.V.—New York Times
- New partnerships bring price parity between lenacapavir and oral PrEP—Devex
- AVAC Applauds Agreements to Accelerate Market Development for Lenacapavir for PrEP—AVAC statement
- Joint Statement: Activists Demand $40-a-Year Generic Price for Breakthrough HIV Prevention Drug Be Made Available to All Low- and Middle Income Countries—TAG, Public Citizen, Health Gap
UN General Assembly Updates
The UN General Assembly (UNGA 80) kicked off this week in New York with global health taking center stage. The US began the rollout of its new “America First Global Health Strategy,” which shifts toward bilateral aid models. Meanwhile, HIV innovation and access, especially for lenacapavir, are being debated in side events as delegates push for clarity on price, procurement, and equity. The WHO is accelerating its health agenda on noncommunicable diseases (NCDs) and mental health and will help lead discussions on a new global declaration.
In its annual Goalkeepers event, the Gates Foundation announced its $912 million commitment in the current round of replenishment to the Global Fund for AIDS, TB and Malaria. The Foundation also recognized ten champions in global health, including AVAC’s partner Jerop Limo, a leading HIV and sexual and reproductive rights activist from Kenya.
Next week, a new topic will take center stage at the UNGA’s high-level meetings: inclusive and accountable governance of artificial intelligence (AI). Ethics and equity will be central to deploying responsible AI for health, with advocates emphasizing that progress must be measured not only by rollout speed but by how well it protects patient privacy and addresses real-life challenges and needs. Development of AI governance to shape how digital tools are designed, regulated, and financed is a key part of the next generation of HIV and health programming.
READ:
- Bill Gates pledges $912 million to global disease fight, urges governments to step up—Reuters
- UNGA80 reporters’ notebook: Day 4—Devex
- Global Health Multilateralism Without the United States: What Comes Next?—Think Global Health
- The Ethics of AI-Driven Health Projects in Africa—Think Global Health
United Nations Secretary-General Proposes to “Sunset” UNAIDS
The UN Secretary-General shared a proposal in his new UN80 progress report to “sunset” UNAIDS by the end of 2026 and fold its mandate into broader UN structures in the face of funding cuts. The NGO delegation to the UNAIDS Programme Coordinating Board (PCB) strongly opposes this move, and was joined by nearly 800 civil society organizations warning that dismantling UNAIDS now would undermine leadership, coordination and accountability at a time of escalating funding cuts, growing inequalities, and service disruptions. UNAIDS was originally created to bring coherence across 11 UN agencies, avoid duplication, and ensure that communities most affected by HIV had a formal voice at the table. The plan endorsed by the UNAIDS PCB would downsize the Secretariat, embed staff in select UN Resident Coordinator offices and relocate programmatic expertise to regional hubs to align with the UN80 “Shifting Paradigms” vision of a more integrated, coherent UN system. As UNAIDS reminded all stakeholders in its statement, it is member states and governing bodies who should determine the way forward on how UN80 reforms are implemented.
IMPLICATIONS: Achieving the UNAIDS goal of ending AIDS by 2030 depends on many factors, including clear accountability; knowing which UN agencies retain their strengths; ensuring they have the resources to deliver; and safeguarding coordination. Sustaining trusted partnerships with civil society and continuing to prioritize equitable rights-based programs, which have been central to UNAIDS’s role for two decades, will also be essential, and all of this risks being undermined if UNAIDS’ functions are dispersed without a coherent strategy. This debate marks a critical inflection point for how the global community organizes and funds the HIV response going forward.
READ:
- With the HIV Response in Crisis, UNAIDS Must Not Be Sunset in 2026—NGO Delegation to the UNAIDS PCB statement
- UN proposes closing UNAIDS in 2026 as funding cuts bite—Reuters
- The world cannot afford to lose UNAIDS—Erasing 76 Crimes
Africa CDC Announces Grant to Support Local Drug and Vaccine Manufacturers
The Africa CDC plans to invest approximately $3.2 billion dollars to support the development of local drug and vaccine manufacturing across the continent. The initiative includes funding and grant support for African manufacturers. This grant aims to reduce dependence on imported pharmaceuticals by strengthening domestic production and establishing a pooled procurement mechanism to guarantee market demand.
IMPLICATIONS: This move could be a turning point for health sovereignty in Africa, offering the promise of more reliable supply chains, lower costs, and greater independence from external donor trends. But it also presents real challenges: scaling production to meet global standards, navigating regulatory harmonization, and maintaining quality assurance and sustainability will be essential. If successful, it could shift power in global health — giving African countries more leverage in pricing and access negotiations for prevention tools such as ARVs and vaccines, while reducing vulnerability during global supply disruptions.
READ:
- Africa CDC Unveils $3.2 Billion Plan to Transform Vaccine and Drug Production—Addis Insight
- Africa CDC earmarks Shs11 trillion to boost local drug manufacturing—The Monitor (Uganda)
What We’re Reading
- CDC Backs Twice-Yearly Injectable for HIV Prevention—MedPage Today
- Public Health Associations Call on RFK Jr. to Resign as HHS Secretary, Healthcare Innovation
- Gold standard science requires gold standard scholarship, Science
- U.S. court orders NIH to restore killed grants to California researchers, Science
- Censorship returns to the CDC. At least 22 webpages are down.—Inside Medicine Substack
- RFK Jr cancelled mRNA research — but the US military is still funding it—Nature
- How ex-USAID staffers turned crisis into action and mobilized $110M—Devex
- 90% of rich countries’ global health R&D goes to domestic institutions—Devex
- Unpacking the Role, Nature, and Need to Sustain Robust Community Responses in Global Systems—Journal of Infectious Diseases
- PrEP4All’s Jeremiah Johnson Responds to CDC Guidelines on Lenacapavir, Calls for a A National PrEP Program for Equitable Uptake—PrEP4All
- NIH outlines new system for awarding research grants to foreign scientists—STAT