The European Medicines Agency (EMA) has taken a bold step forward in the fight against HIV. On Friday, it recommended the authorization of lenacapavir — an injectable drug shown to be almost 100% effective in preventing HIV transmission. Marketed as Yeytuo in Europe by California-based Gilead Sciences, this drug stands out for its convenience and duration: just two injections per year could prevent infection.This recommendation is more than just another drug approval. It represents a powerful new tool in a decades-long battle against HIV, one that could fundamentally change how we think about prevention — if access can keep up with innovation.Once the European Commission rubber-stamps the EMA’s guidance, Yeytuo will be authorized across all 27 EU member states, plus Iceland, Norway, and Liechtenstein. The decision marks a milestone in public health strategy, particularly for populations that face social and logistical barriers to current HIV prevention options.Unlike existing daily pills or bimonthly injections like cabotegravir, lenacapavir requires just two injections a year. That’s a huge leap in terms of convenience and adherence — and a potential game-changer for people who can’t or won’t take a daily pill due to stigma, forgetfulness, or limited access to healthcare.The data behind it is strong. In a landmark trial involving nearly 5,000 young women and girls in South Africa and Uganda, not a single participant who received the injection contracted HIV. In contrast, about 2% of those who took daily pills still became infected. The study’s results, published in the New England Journal of Medicine and presented at an AIDS conference in Munich, were so convincing that researchers ended it early to offer lenacapavir to all participants.“This level of protection is stunning,” said Dr. Salim Abdool Karim, a renowned AIDS researcher based in Durban, South Africa, who was not involved in the study.The drug is already approved in the U.S., Canada, and Europe as a treatment for HIV. Now, its preventive potential is gaining traction, fast.More than 40 million people live with HIV globally, and around 630,000 people died from AIDS-related illnesses in 2023 alone, according to UNAIDS. The burden is heaviest in sub-Saharan Africa, Southeast Asia, and the Caribbean — regions that urgently need new prevention tools.Recognizing this, the World Health Organization (WHO) recently recommended that countries adopt lenacapavir as an additional HIV prevention option, not a replacement. It would complement existing methods like condoms, PrEP pills, and cabotegravir injections.Winnie Byanyima, Executive Director of UNAIDS, has called lenacapavir “a drug that could change the trajectory of the HIV epidemic,” stressing that equitable access will be key to its success and therein lies the problem.While Gilead has pledged to allow generic production in 120 low-income countries, it has excluded nearly all of Latin America, where HIV rates remain relatively low but are steadily rising. Critics argue that leaving these regions behind could create new blind spots in the global prevention map — and miss a crucial chance to curb the virus early.Gilead has defended its access strategy, noting that it's focused on countries with the highest burden. But public health experts warn that rising infections in lower-prevalence regions should not be ignored.“Ending HIV isn’t just about treating the hardest-hit places. It’s about staying ahead of new outbreaks,” said one international HIV policy advisor who requested anonymity.Even in countries where the drug may be approved, cost, supply, and health system capacity could hinder rollout — especially in rural or underserved areas. Stigma also remains a significant barrier, deterring many at-risk individuals from seeking preventive care.Now that the EMA has endorsed lenacapavir for prevention, the European Commission is expected to follow suit, likely within weeks. Approval there would greenlight its use in countries representing nearly half a billion people.Meanwhile, the U.S. Food and Drug Administration (FDA) approved lenacapavir for prevention earlier this year, and the WHO’s recommendation is expected to guide policies globally but the question remains: will this groundbreaking injectable be made available to the people who need it most — when they need it most?UNAIDS and other public health advocates are urging a broader global licensing strategy to ensure equitable access. Some have called on leaders — including former President Donald Trump during his term — to broker deals that would fast-track generic production and distribution worldwide.Lenacapavir’s development is undeniably a breakthrough — scientifically, medically, and logistically. Its six-month dosing schedule reduces clinic visits, lowers the burden of adherence, and offers privacy for people facing stigma. For many, it could be the most realistic prevention option yet but if it remains limited to wealthy countries or a select list of high-burden nations, it won’t fulfill its potential to shift the course of the epidemic. It could become another case study in medical innovation outpacing policy.