South Africa Aims for 2027 HIV Shot Independence – But Challenges Remain

The South African government claims it may be able to cover the possible shortfall in the number of doses required for the biannual HIV prev...

The South African government claims it may be able to cover the possible shortfall in the number of doses required for the biannual HIV prevention injection needed to eradicate AIDS by 2043.by forming a group of local pharmaceutical companiesto create standard shots from 2027 onward. However, there is a problem. None of the companies that will be involved have a permit from the injection, lenacapavir's (LEN) creator, Gilead Sciences, to develop the vaccine.

• The South African government claims it may be able to cover the possible shortfall in the number of doses required for the biannual HIV prevention injection needed to eradicate AIDS by 2043.by forming a group of local pharmaceutical companiesto create standard shots from 2027 onward.
• SA requires between one and two million vaccinations annually; it is receiving approximately 500,000 doses per year from the Global Fund for 2026 and 2027.
• However, there is a problem. None of the companies participating have a permit from the injection, lenacapavir's (LEN) inventor, Gilead Sciences, to develop the vaccine.

The South African government is firm in its belief that it can cover the possible shortage in the number of doses required for the twice-yearly HIV prevention injection, aimed at ending AIDS by 2043 — sufficient for one to two million individuals annually —by forming a coalition of local pharmaceutical firmsto create standard shots from 2027 onward.

Individuals who are HIV-negative can receive the highly effective vaccine, lenacapavir (LEN) , which was  registered in South Africa in October, once every six months to prevent themselves from contracting HIV. South Africahad more than 170,000 new HIV cases in 2024 , the  highest count for one nation globally .

In 2026 and 2027, South Africa is set to receive free LEN doses funded by the Global Fund for Aids, Tuberculosis, and Malaria, in order to initiate and maintain treatment for 456,360 individuals with LEN —a total of 974,450 injections— across a span of two years,as per health department statistics.

EMBED:  https://bhekisisa.org/wp-content/uploads/2025/11/Lenacapavir-Roll-out-Plan-3.pdf

The initial delivery of 115,000 doses, intended for 360 government health clinics, is set to arrive in February, according to the deputy director general for HIV at the national health department, Nonhlanhla Fikile Ndlovu, who spoke to Bhekisisa, though the arrival date might be advanced.

Although South Africa is  receiving more than three quarters of the LEN dosesthat the Global Fund serves donating to nine countries , this still falls far below the true figure (sufficient quantities for one to two million individuals to use it at least once annually) that modelling scientists have calculated is necessary to create a significant impact on new HIV infections in order to end the epidemic by 2043.

Generic versions are anticipated to be introduced in 2027, allowing the health department topurchase at the same cost as a daily HIV prevention medication from two Indian companieshowever, South Africa might still require significantly more doses than what the companies can supply.

The positive news is: the government is willing to purchase generic medications, instead of solely depending on donations — the nation already acquires all its stock of the daily prevention medication.

Health Minister Aaron Motsoaledi stated at a Sanac meeting in October that the health department will begin purchasing generic LEN in 2027 and that the department will be "allocating funds within our medium-term spending plan to guarantee that when generic alternatives are available or costs decrease, we can expand access seamlessly" .

The government's local manufacturing initiative aims to ensure South Africa has sufficient LEN — and a continuous supply of it.

Glaudina Loots, the head of health innovation at the department of science, technology, and Innovation, stated to Bhekisisa: "Our aim is to be prepared by 2027. It's a collaboration we're forming, so that no single pharmaceutical company has to face this alone."

We managed to accomplish it using the mRNA vaccine in South Africa.Since we combined the process. We can achieve the same with LEN.

Can we do it?

Nevertheless, there is a significant challenge.

None of the companies set to be involved — Aspen Pharmacare, Kiara Health, Adcock Ingram, and Pharma Q — hold a permit from the injection, lenacapavir's (LEN) creator, Gilead Sciences, to do so.

Gilead issued six companies with such permits, mainly in India, such licenses in October 2024. In the case of South Africa, three companies — Aspen Pharmacare, Pharmacare, and Cipla Medpro — were assessed,but all of them did not pass the examination .

That's where the problem arises.

Gilead is seeking that companies produce LEN entirely, from beginning to end, according to Thembisile Xulu, head of South Africa's National Aids Council (Sanac), who is overseeing the discussions, as reported by Bhekisisa.

However, South African companies are unable to do so because they cannot produce the ingredient—the active pharmaceutical ingredient (API)—that enables the vaccine to be effective. Instead, they would need to import it and then assemble the product locally.

It involves a complicated 28-step procedure to develop the API,   Loots says , "we require a new strategy until 2029, so that we can have sufficient time to prepare for developing the API."

State agencies collaborating with pharmaceutical companies include the health department, the department of trade, industry, and competition, the department of science, technology, and innovation, and the national treasury.

Professional guidance will be offered by the South African Medical Research Council, Unitaid and the Medicines Patent Pool, A UN-supported group assisting nations such as South Africa in discovering methods to obtain essential medicines.

Xulu states: "We are aiming to submit a voluntary license request that enables South African producers to import the API from Gilead for evaluation by July (second quarter of 2026)."

Whether we can achieve LEN by 2027 depends on Gilead.

How much LEN is required by SA?

Studies indicate that a significant decrease in HIV cases within a population isonly visible when HIV prevention drugs are accessible to many individuals .

The greater the rate of new infections, referred to as the incidence rate, the fewer individuals need to take the medication to prevent a single infection. This is because when many people are capable of transmitting the virus, the likelihood increases that those taking the medication might be among those who would have otherwise become infected if they had not received the treatment.

For example,  a study shows In regions where the infection rate is 3% or higher, 33 individuals must take preventive medication to prevent a single HIV case; in areas with significantly lower rates, as many as 200 people might need to take HIV prevention drugs to stop one new infection.

Although South Africa's  the overall rate of new HIV infections is 0.32% ,  certain groups , such as female sex workers,teenage girls and young females,and homosexual and bisexual men, along with specific health regions, have occurrence rates as high as 4.5% .

To eliminate AIDS as a public health concern, the infection rate must drop to 0.1% or less. For 2024, which saw 172,994 new HIV cases, this would mean reducing the number to as few as 65,000 new infections if we are to stop the outbreak.

Lise Jamieson, a modeling scientist at theHealth Economics and Epidemiology Research Unit (He2ro)At Wits University, it has been calculated for a study set to be released in the coming weeks that in South Africa, between 35 and 65 individuals must use LEN to prevent one HIV infection.

If the majority of people use LEN for a year (meaning each individual would receive two consecutive doses and attend their second dose on time), we could prevent one HIV infection for every 35 users of LEN, potentially ending AIDS by 2039 (this requires a total of 67 million doses to be administered between now and 2039).

However, if the majority of individuals on LEN take the medication just once (a single six-month dose), we would require 65 people to take it in order to prevent one new infection, and this would only lead to the end of AIDS by 2043 (this equates to a total of 31 million doses needed from now until 2043).

South Africa's contribution to the Global Fund's LEN doses amounts to roughly 3% (974,450 out of 31 million, which is 3.14%) of the total doses required to end AIDS by 2043 (the more cautious scenario calculated by Jamieson).

Since LEN has not been extensively utilized in any country, it remains uncertain whether individuals will discontinue its use after a single dose or continue using it over an extended period.

What are SA's intentions regarding LEN?

Loots mentions that South Africa might be capable of developing LEN's API by 2029, utilizing the infrastructure of CPT Pharma, which is currently undergoing upgrades. Wits University's cutting-edge drug delivery system and the API cluster of the Council for Scientific and Industrial Research will offer specialized guidance.

Fundamentally," Loots states, "our aim is to establish South Africa as a regional pharmaceutical center, equipped with complete independent production capacity for LEN.

Wendy Cupido, the general manager of Gilead Sciences in South Africa, mentioned during the Sanac meeting that the company "would be happy to explore an additional voluntary license," however Xulu states, even after "extensive discussions, the reality is Gilead has not agreed to a license."

The senior director for global affairs at Gilead, Caroline Almeida, addressed Bhekisisa's inquiries on Monday morning: "Although end-to-end manufacturing is still our main approach, we are looking into possibilities for local formulation in South Africa and have supported cooperation with our current generic partners as a possible initial step towards complete production," she mentioned. "We are willing to work with a producer outside South Africa to bring in the API and finish the formulation locally." Read Gilead's full response ).

In the meantime, HIV advocates from across the globe have urged the South African government tostart taking actions to grant a compulsory license —  when a  the government permits another party to manufacture a patented productor procedure without the permission of the patent holder — against Gilead.

Ndlovu mentions that the health department intends to begin administering the first doses no later than April 1 at the 360 clinics it has selected across six provinces — this represents approximately 10% of the country's clinics.

In 2027, when more affordable generic versions are anticipated to enter the market, the health department plans to expand the number of clinics offering LEN to approximately 30%, and by 2028 to 2029, this will reach full coverage at 100%.

The next LEN delivery for South Africa has not been set yet, but Ndlovu mentions that shipments are anticipated every six months.

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