South Africa Races to Make Game-Changing HIV Prevention Shot

A twice-yearly injection that's nearly foolproof at preventing HIV could soon be made right in South Africa, bringing hope that the country could end AIDS within two decades.

South Africa's National AIDS Council (Sanac) has invited local drug companies to apply by April 7 to manufacture generic versions of lenacapavir, a groundbreaking HIV prevention shot. The original version, made by US company Gilead Sciences, was registered in South Africa last October and requires just two injections per year.

The stakes are enormous. If 31 million HIV-negative South Africans take the shot for at least a year each between now and 2043, the country could effectively end its AIDS epidemic.

Sanac will review applications and submit a shortlist to Gilead by July. This marks a second chance after three South African companies failed to secure manufacturing licenses in 2024. Instead, Gilead awarded licenses to six companies in India, Pakistan and Egypt, with their generic versions expected in 2027.

The new approach involves four government departments working together: health, trade and industry, science and technology, and the national treasury. International health organizations Unitaid and the United States Pharmacopeia will provide technical and financial support to help South African manufacturers produce the shot at an affordable price of around $40 per year.

Manufacturing lenacapavir isn't simple. The active ingredient requires a complex 28-step process with specialized facilities. Many local drugmakers struggled with this requirement during last year's evaluation.

But Gilead's new assessment will also consider companies' abilities to produce lenacapavir tablets (taken alongside the first injection) and their skill at formulating both pills and injections. Companies will be scored on technical capability and their potential to expand access and improve affordability.

The Ripple Effect

If South African companies succeed in manufacturing lenacapavir locally, the impact extends far beyond one country's borders. Local production could make the life-saving shot more accessible and affordable across the African continent, where HIV prevention remains a critical health priority. Two Indian companies with existing licenses have already received grants to manufacture the shot at $40 per year, proving affordable production is possible.

A webinar in two weeks will answer applicants' questions, and the selection process will take just one month. South Africa already offers daily HIV prevention pills for free at nearly all government clinics, but a twice-yearly shot could revolutionize prevention by removing the challenge of daily adherence.

The path to ending AIDS in South Africa now depends on local innovation meeting global support.