SA Wants to Make Its Own Six-Monthly HIV Prevention Jabs by 2027
SA wants to make its own six-monthly HIV prevention jabs by 2027—a bold ambition that the South African government believes is the only way to secure the millions of doses required to end the AIDS epidemic by 2043. With the country facing the highest number of new HIV infections in the world, the race is on to establish local generic manufacturing capabilities for the revolutionary drug, Lenacapavir (LEN).
While the plan is ambitious, it faces significant hurdles, including complex licensing negotiations with the drug’s patent holder, Gilead Sciences. However, officials remain adamant that a consortium of local pharmaceutical companies can bridge the gap between the limited donations currently available and the millions of doses the country actually needs.
The Push for Local Generic Manufacturing
The urgency behind the drive for South Africa to produce its own drugs stems from simple math. SA wants to make its own six-monthly HIV prevention jabs by 2027 because the current supply pipeline is insufficient. According to health department data, the country will need between one and two million jabs per year to effectively curb new infections.
Currently, South Africa is heavily reliant on the Global Fund to Fight AIDS, Tuberculosis and Malaria. For 2026 and 2027, the Global Fund has pledged to donate enough doses to keep approximately 456,360 people on treatment. While South Africa is receiving the lion’s share of global donations, this amounts to only about 500,000 shots per year—far short of the millions required.
Health Minister Aaron Motsoaledi recently announced at a Sanac meeting that the department is “earmarking resources in our medium-term expenditure framework” to buy generic Lenacapavir starting in 2027. The goal is to scale up access without interruption once prices drop or generics hit the market.
The Licensing Hitch: Gilead vs. Local Capacity
There is a major snag in the plan: SA wants to make its own six-monthly HIV prevention jabs by 2027, but none of the local companies earmarked for production currently hold a license to do so.
The consortium of companies—including industry giants like Aspen Pharmacare, Adcock Ingram, Kiara Health, and Pharma Q—must secure rights from the drug’s inventor, Gilead Sciences. However, Gilead favors an “end-to-end” manufacturing model, where a single company produces the drug from raw material to finished injection.
This poses a problem for South Africa. Local manufacturers do not yet have the capacity to synthesize the complex Active Pharmaceutical Ingredient (API) required for Lenacapavir. “It’s a complex 28-step process to make the API,” explains Glaudina Loots, Director for Health Innovation. “We need a different plan until 2029, so that we have time to get ready to make the API.”
The proposed solution is a voluntary license that would allow South African manufacturers to import the API and perform the “fill and finish” process locally. Negotiations are ongoing, with Thembisile Xulu of the National AIDS Council leading the charge to convince Gilead to agree to this interim model.
HIV Prevention Strategy and Rollout
The stakes for HIV prevention could not be higher. In 2024 alone, South Africa recorded just over 170,000 new HIV infections. To end AIDS as a public health threat, this number must drop to below 65,000.
The Lenacapavir rollout is a critical component of this strategy. The first shipment of 115,000 doses is scheduled to arrive in February 2025, targeting 360 government health clinics across six provinces.
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Phase 1 (2025): 10% of clinics to stock LEN.
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Phase 2 (2027): Expansion to 30% of clinics as generics potentially come online.
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Phase 3 (2028-2029): Full rollout to 100% of clinics.
Modelling scientists from Wits University estimate that between 35 and 65 people need to take Lenacapavir to avert one new HIV infection. If the rollout is successful and sustained, AIDS could be ended as a public health threat by 2039. However, if supply is limited and patients only receive sporadic doses, that timeline pushes back to 2043.
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Conclusion: A Sovereign Pharmaceutical Hub
The vision extends beyond just one drug. Government officials see this as a stepping stone to positioning South Africa as a regional pharmaceutical hub with full sovereign manufacturing capability. By upgrading facilities at CPT Pharma and leveraging expertise from the CSIR and Wits University, the country hopes to produce the API locally by 2029.
For now, the focus remains on the immediate hurdle. SA wants to make its own six-monthly HIV prevention jabs by 2027, and the coming months of negotiations with Gilead will determine if this lifesaving ambition can become a reality.
References
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Bhekisisa Centre for Health Journalism – SA wants to make its own six-monthly HIV prevention jabs by 2027. But there’s a hitch.
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This is the primary source for the details regarding the 2027 manufacturing target, the specific companies involved (Aspen, Adcock Ingram, etc.), and the licensing challenges with Gilead Sciences.
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MedicalBrief – SA lines up plans to make its own six-monthly anti-HIV jab
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Corroborates the government’s plan to fill the dosage gap using local pharmaceutical companies and details the “fill and finish” interim proposal.
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