WHO Okays Twice-Yearly HIV Shot for Global Use

The World Health Organization (WHO) has called for the urgent global rollout of lenacapavir (LEN)—a groundbreaking HIV prevention drug that requires just two injections per year to deliver near-complete protection against HIV and AIDS.

Touted as a long-acting alternative to daily antiretroviral pills, lenacapavir is being hailed as a major advancement in the fight against HIV. WHO Director-General Dr. Tedros Adhanom Ghebreyesus described the drug as “the next best thing” in HIV prevention in the absence of a viable vaccine.

Speaking on Monday at the 13th International AIDS Society (IAS 2025) Conference on HIV Science in Kigali, Rwanda, Dr. Tedros emphasized that clinical trials have shown lenacapavir to be highly effective in preventing HIV infections—particularly among high-risk groups.

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The WHO stressed the critical importance of ensuring widespread access to lenacapavir, urging that it be made available through pharmacies, healthcare clinics, and even via online consultations. This push comes at a time when global progress in HIV prevention is slowing, and new tools are urgently needed to reverse the trend.

As part of its strategy to boost uptake, the agency also advocated for expanded use of rapid HIV testing, enabling earlier diagnosis and timely access to prevention and treatment options.

The WHO emphasized that simple, affordable solutions like lenacapavir should be prioritized over more complex and expensive interventions, especially in settings with limited resources.

According to the agency, an estimated 1.3 million people were newly infected with HIV in 2024, with the highest burden falling on key populations—including sex workers, men who have sex with men, transgender individuals, people who inject drugs, incarcerated persons, and youth.

Although lenacapavir is currently available primarily through clinical trials, the WHO is calling on governments, international donors, and health partners to fast-track its integration into national HIV prevention strategies to help curb new infections.

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The WHO’s recommendation comes on the heels of the U.S. Food and Drug Administration’s (FDA) approval of lenacapavir in June, reinforcing growing global momentum behind the drug.

Lenacapavir now joins a suite of WHO-recommended HIV prevention options, including daily oral PrEP, the injectable cabotegravir (administered every two months), and the dapivirine vaginal ring, designed to give users more flexibility and choice.

The agency’s call for swift action comes at a time of significant funding setbacks in the global fight against HIV/AIDS—most notably within PEPFAR, the U.S.-led program that has been a cornerstone of international HIV response since its launch in 2003.

“We have the tools and the knowledge to end AIDS,” said Dr. Meg Doherty, Director of WHO’s Global HIV, Hepatitis, and STI Programmes. “What we need now is the political and financial will to act.”

“What’s urgently needed now is bold, community-driven action to implement these recommendations—anchored in equity and access for all,” said Dr. Meg Doherty.

By the close of 2024, an estimated 40.8 million people worldwide were living with HIV, with Africa accounting for 65% of the global burden.

That same year, approximately 630,000 people lost their lives to HIV-related illnesses, while 31.6 million individuals were receiving antiretroviral therapy—a notable increase from 30.3 million in 2023, reflecting gradual progress in treatment coverage.

(Source: NAN)