South Africa has become the first African country to register the twice‑yearly injectable lenacapavir for PrEP (LEN). The approval by the South African Health Products Regulatory Authority (SAHPRA) is the fastest Africa approval of PrEP ever and opens the door for a national rollout beginning in early 2026. Additional regulatory approvals are pending in Kenya, Malawi, Zambia and Zimbabwe. In addition, earlier in October, the WHO pre-qualified both the oral and injectable forms of LEN using an expedited process. 

IMPLICATIONS: LEN’s registration in South Africa is significant progress, and reflects one of several milestones in product introduction that have happened faster for LEN than for any previous PrEP product. See AVAC’s comparative graphic on Moving PrEP Options to the Real World. At the same time, so much more needs to happen to translate this option into public impact, including securing price and volume transparency, aligning global funders, and enabling rapid country-level introduction. A robust and accelerated global rollout will create a foundation for further reduced pricing, greater choice, and real momentum in HIV prevention. See AVAC’s report, Getting PrEP Rollout Right This Time, which can support countries in the early stages of LEN planning. And visit AVAC’s LEN page for a range of resources and graphics, and PrEPWatch.org to track the rollout of all long-acting PrEP. 

READ:  

• SA becomes the first African country to register the twice-a-year anti-HIV jab — at record speed—Bhekisisa  
• Access Strategy for Lenacapavir for PrEP in Low- and Middle-Income Countries—Gilead Sciences  

This week, US government country teams at embassies and missions around the world received a draft memorandum of understanding (MoU) template and guide that will shape bilaterial US global health investments. These MoUs  between the US and individual countries are being developed for PEPFAR but will also extend across other US global health foreign assistance programs, establishing a framework for how the US engages partner governments on health priorities. The bilateral agreements, which the Administration is aiming to finalize by mid-December, outline process and outcome metrics focused on treatment, such as ART coverage and viral suppression. However, the draft template omits HIV prevention indicators, including any reference to PrEP or new products such as injectable lenacapavir, and also also bypasses multilateral coordination, ignoring institutions like WHO or regional public health agencies, and suggests that policies favoring US commercial interests would factor into funding decisions, while providing no framework for civil society or key population engagement. 

IMPLICATIONS: The shift to direct government-to-government MoUs sidelines the community and erodes decades of progress grounded in data-driven, inclusive approaches—violating the core principle of “nothing about us without us.” The exclusion of key populations and civil society voices from these negotiations raises serious concerns about accountability and equity. Equally alarming is the fact that the US government has not released any PEPFAR data this year, leaving advocates, partners, and decisionmakers without the basic transparency needed to evaluate impact or guide decisions. These omissions must be challenged immediately by in-country advocates and Congress. 

READ: 

• Breaking: First Look at the USG Draft Memorandum of Understanding for Global Health—To End A Plague Again Substack 
• How will America's new global health strategy change PEPFAR?—Devex  
• Devex CheckUp: ‘America First,’ but what about PEPFAR?—Devex  
• PEPFAR’s Missing Data: Why Transparency Matters More Than Ever—Center for Global Development (CGD) 
• PEPFAR Has No Plan for World AIDS Day Data Release—Emily Bass Substack  

The European Commission (the executive body of the European Union) plans to potentially phase out funding to Gavi, the Vaccine Alliance, and the Global Fund by 2030 according to a leaked document, which was prepared for the European Union’s Commissioner for International Partnerships. The document makes the case for concentrating EU support on initiatives where the bloc can “truly shape governance.” 

IMPLICATIONS: This signals a dramatic pivot away from institutions that have helped save 90+ million lives through vaccine access and disease prevention. While no formal decision has been made, this move mirrors similar cuts by the US under the new administration, and underscores growing skepticism in major donor governments about traditional multilateral aid. Global health financing is already under significant strain, with donors prioritizing national interests and public-private investments over long-term, predictable health aid. A shift away from core multilateral partners may leave critical gaps in vaccine delivery, HIV prevention and response to emerging disease threats. 

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• EXCLUSIVE: EU mulls copying US with end to aid for global health funds—Euractiv