South Africa: FMD Vaccine Private Manufacturing Licensing to Boost Supply

• South Africa will license private companies to manufacture foot-and-mouth disease (FMD) vaccines to meet critical demand.
• The Agricultural Research Council (ARC) board approved this plan, as the ARC cannot produce enough vaccine to combat the nation's largest-ever FMD epidemic.
• Approximately 25 million FMD vaccine doses are required annually for South Africa's 12-14 million cattle population.
• The acting CEO of Onderstepoort Biological Products (OBP) was suspended amid allegations that the entity profited from reselling imported FMD vaccines.
• OBP's board has agreed to remit all profits made from FMD vaccines to the Department of Agriculture for future vaccine purchases.

This strategic shift aims to leverage domestic pharmaceutical capabilities to address the critical shortage of Foot-and-mouth disease vaccine ZA, which has severely impacted the nation's cattle industry.

South Africa is poised to significantly ramp up its domestic production of foot-and-mouth disease (FMD) vaccines, with the Minister of Agriculture, Willie Aucamp, announcing in Parliament on Tuesday that private companies will be invited to manufacture these crucial animal health products. This strategic shift comes amidst the nation's most severe FMD epidemic to date, an outbreak that has already inflicted billions of rands in losses upon the cattle industry.

The Agricultural Research Council (ARC), currently the sole local producer of an FMD vaccine, has been unable to meet the overwhelming demand. To bridge this critical gap, local pharmaceutical companies will be granted licenses by the ARC to produce its proprietary vaccine, a move the ARC board formally approved on Monday. This initiative is vital given the scale of the challenge: South Africa's cattle population, estimated at 12 to 14 million, ideally requires two vaccinations per animal annually, translating to an urgent need for approximately 25 million vaccine doses each year.

Despite the pressing demand, current supply falls short. This year, 21 million doses have either been imported or produced domestically. Key international suppliers include Turkish company Dollvet, which provided 11.5 million doses, and Argentinian firm Biogénesis Bagó, contributing 9 million doses. Additionally, over half a million doses were procured from the Botswana Vaccine Institute, with the ARC itself producing a similar quantity. Of these 21 million doses, 19 million have already been distributed across the country. Notably, the nation's nearly 1.4 million dairy cows have received at least one vaccination, with all dairy cows in the Western Cape and KwaZulu-Natal having received booster shots, and approximately 80% in the Eastern Cape also receiving a booster. The imported vaccines from Turkey and Argentina are priced at around R45 per dose, though the cost of the ARC's own vaccine was not disclosed.

The parliamentary update also addressed the recent suspension of Jacob Modumo, the acting CEO of Onderstepoort Biological Products (OBP), an announcement made earlier this month. Modumo faces allegations that OBP engaged in profit-making activities related to the FMD vaccine. Specifically, it is understood that OBP allegedly purchased FMD vaccines from Biogénesis at R45 per dose and subsequently resold them at prices ranging from R70 to R130.

During the parliamentary session, MP Zwelakhe Mthethwa (MK) challenged Minister Aucamp, questioning the process of Modumo's suspension and suggesting a presumption of guilt. Mthethwa also queried why OBP should not be permitted to profit from vaccine sales. Minister Aucamp, however, affirmed that due process was strictly followed in accordance with legal requirements. He stated that evidence from two independent sources regarding Modumo's actions was presented to the OBP board, which then unanimously voted for a precautionary suspension. The suspended CEO reportedly failed to provide preliminary reasons against his suspension, leading to the appointment of an independent legal firm to conduct a thorough and swift investigation. In the interim, the company secretary has assumed the role of acting CEO for a two-week period.

Minister Aucamp clarified that OBP is not a manufacturer of FMD vaccines. Historically, imported vaccines would arrive at OR Tambo airport, be routed through OBP, and then distributed to state veterinarians nationwide. This intermediary step has since been deemed unnecessary, with vaccines now being sent directly to veterinarians. Aucamp strongly implied that OBP added no value to this distribution chain and therefore had no justification for marking up the vaccine price. The OBP board has since unanimously agreed to cease profiting from FMD vaccines, with any profits already made to be remitted to the Department of Agriculture for the procurement of future vaccine supplies. While OBP does manufacture other animal vaccines, it has not produced FMD vaccines since the ARC lost its capacity to do so around 2005/6.

This strategic shift aims to leverage domestic pharmaceutical capabilities to address the critical shortage of Foot-and-mouth disease vaccine ZA, which has severely impacted the nation's cattle industry. The decision to invite private companies for **South Africa FMD vaccine private manufacturing licensing** represents a significant pivot in the country's approach to animal disease control, moving beyond reliance on a single public entity and international imports.

The historical context of the ARC losing its FMD vaccine manufacturing capacity around 2005/6 underscores the long-standing challenges in **South Africa animal vaccine production**. The current initiative, championed by **Minister Willie Aucamp FMD vaccine** strategy, seeks to rebuild and expand this crucial capability. However, the debate in Parliament, particularly MP Mthethwa's concerns about private companies profiting from vaccines and allegations of unequal distribution benefiting only 'white farmers,' highlights broader societal and ethical considerations that accompany the commercialization of essential animal health products. The move towards private sector involvement, while necessary to meet demand, will undoubtedly require robust regulatory oversight to ensure equitable access and fair pricing for all farmers.

This development creates a new market for South African pharmaceutical or biotech companies to manufacture FMD vaccines under license from the ARC, requiring legal advice on intellectual property and regulatory compliance. It also highlights compliance risks for public entities involved in vaccine distribution, particularly regarding pricing and profit-making.

Source: Original reporting via GroundUp