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Lenacapavir Regulatory Approval

Regulatory approvals, pending decisions, and appeals as of January 2026.

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January 2026


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.

January 2026


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).

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January 2026


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.

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January 2026


PxWire Volume 16, Issue 1

This issue showcases the status of access to oral PrEP with the best data available since the US foreign aid freeze disrupted PEPFAR operations. Stakeholders are digging deep to meet the moment, which includes an unprecedented opportunity to drive down HIV incidence with the rollout of lenacapavir. Lastly, our update on the HIV vaccine R&D pipeline documents an evolving and diverse portfolio of products, which remains essential for a durable end to HIV as a global health threat.

January 2026


Global Health Watch: Budget stalled, Gag Rule expanded, US leaves WHO, AAP’s own immunization recommendations

As this issue goes to publication, the US fiscal year budget remains unresolved in the Senate, adding to uncertainty for global health funding. This week’s issue tracks the expansion of the Global Gag Rule, the US’s formal withdrawal from the WHO, growing pushback on concerning vaccine policy, and the new finding that nearly half of US CDC surveillance databases have been paused or stopped.

January 2026




Roundup: Must-Read Conversations and Resources from the Last Week 

Last week marked one year since the US president took office and began systematically dismantling global health and equity. Here is a roundup of essential conversations and resources summarizing the past 365 days and what’s at stake as we move forward.

January 2026


AVAC Calls for the Immediate Rejection of the Global Gag Rule and Any Expansion of it

AVAC calls for the immediate rejection of the Global Gag Rule and any expansion of it and urges US lawmakers to uphold science, human rights, and public health.

January 2026


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