TLU SA Raises Concerns Over ARC FMD Vaccine Production

TLU SA has expressed serious concern regarding the recent statement issued on 1 April by the office of Minister of Agriculture John Steenhuisen about Foot-and-Mouth Disease (FMD) vaccine production at the Agricultural Research Council (ARC). While the statement aims to reassure the sector, TLU SA warns that significant questions remain over both implementation and effectiveness.

During a visit to the ARC’s Onderstepoort facility on 6 February, TLU SA observed that a trivalent vaccine covering the SAT 1, SAT 2, and SAT 3 strains was planned and production was set to begin in March, with a target of 20,000 doses per week. However, current reports suggest that only vaccines for a single strain are being produced and distributed.

TLU SA is also examining the regulatory compliance of the vaccine. The trivalent vaccine observed in February actually comprises five components: strain 1 and its mutation, strain 2 and its mutation, and strain 3. Scientists warn that producing and distributing only one component is not permissible without separate registration or specific approval from the registrar.

Henry Geldenhuys, president of TLU SA, stresses the risk: “If approval has not been obtained to produce these five components individually, a vaccine is being used outside its registered composition. You cannot simply take one part of a combined vaccine, use it on its own, and assume it meets the same standards.”

Geldenhuys added: “It is irresponsible to roll out vaccines targeting only one strain when all three occur in South Africa. Farmers cannot be sure that the vaccine matches the strain in their area. Without proper testing, this exposes producers to unnecessary risk.”

TLU SA criticises the deviation from the original February plan, highlighting that responsible disease control requires blood testing and identification of the dominant strain before vaccination.

The organisation also points to slow decision-making and regulatory delays. Over two months have passed since the first Section 10 applications were submitted to Minister Steenhuisen, yet clarity remains elusive. “Valuable time is being lost while farmers pay the price,” Geldenhuys says.

Current production capacity of 20,000 doses per week of a single strain is insufficient for the scale of the FMD challenge in South Africa. TLU SA recommends outsourcing vaccine production to international laboratories with the capacity and expertise to meet demand promptly. “Had this route been followed in February, we would now have sufficient, effective vaccines,” Geldenhuys notes.

The organisation also flags unnecessary costs and delays introduced by the current reliance on Onderstepoort, given that much of the required testing and quality control is already performed by international manufacturers.

TLU SA calls for a collaborative, expertise-driven approach, urging all stakeholders to provide input before regulations, including those relating to Section 10, are finalised. Geldenhuys concludes: “Why control this process alone if we lack the capacity or expertise? It is time to make the right decisions for the agricultural sector and the country’s economy.”