TLU SA notes the statement issued on 1 April by the office of the Minister of Agriculture, John Steenhuisen, regarding vaccine production at the Agricultural Research Council (ARC). While the statement seeks to provide reassurance on the handling of Foot-and-Mouth Disease (FMD), serious questions remain about the practical implementation and effectiveness of the current strategy.
According to TLU SA’s involvement and observations during a visit on 6 February this year, it was clearly indicated that a trivalent vaccine – covering the SAT 1, SAT 2 and SAT 3 strains – would be developed and made available. It was further confirmed that production would commence in March, with a target of 20,000 doses per week.
The current reality, however, appears very different. Instead of a trivalent vaccine being rolled out, it seems that vaccines for only a single strain are presently being produced and distributed.
TLU SA is also scrutinising the regulatory aspect of the vaccine. The vaccine viewed on 6 February at the ARC’s facility in Onderstepoort was presented as a registered trivalent vaccine for three strains (SAT 1, SAT 2 and SAT 3). In practice, however, this composition comprises five components, namely strain 1 and its mutation, strain 2 and its mutation, as well as strain 3.
According to scientists, such a vaccine cannot simply be broken up to manufacture and distribute only one strain separately, unless specific approval has been obtained from the registrar, or unless that single-strain vaccine has itself been separately registered.
“The question that must be asked is whether approval has in fact been obtained to produce these five components, which together form one vaccine, individually,” says Henry Geldenhuys, president of TLU SA. “If not, it means that a vaccine is now being produced outside its registered composition. You cannot simply take one part of a combined vaccine, use it on its own, and assume that it meets the same standards.”
“It is simply irresponsible to roll out vaccines that address only one strain, while we know that all three strains occur in South Africa,” Geldenhuys adds. “There is no guarantee for a farmer that the strain they vaccinate against is the one present in their area. Without proper testing and differentiation of strains, this approach exposes producers to unnecessary risk.”
TLU SA questions the deviation from the original plan as communicated in February and makes it clear that the current approach does not align with responsible disease control. The organisation emphasises that blood testing and proper identification of the dominant strain in an area should be a necessary starting point before vaccines are administered.
Furthermore, TLU SA expresses serious concern about the pace at which decisions are being taken and implemented. It has now been more than two months since the first applications in terms of Section 10 were submitted to Minister Steenhuisen, and there is still no final clarity. This delay, together with the lack of alignment with Section 9 regarding movement control, is leading to further uncertainty and economic damage for producers.
“From the outset, we emphasised speed and urgency. Yet we see no tangible progress. Valuable time is being lost while farmers pay the price,” says Geldenhuys.
TLU SA further points out that the current production capacity – approximately 20,000 doses per week of only a single strain – is merely a drop in the ocean given the scale of the FMD challenge in South Africa. “This pace and approach will not get us where we need to be in time,” Geldenhuys continues. “It would make far more sense to outsource manufacturing to international laboratories that have the necessary capacity and expertise to make sufficient, effective vaccines available within a short period. At present, we are struggling on with an approach that does not match the urgency of the situation.”
Had this route been followed as early as February, South Africa would by now have had sufficient, effective vaccines available.
The organisation also states that the current role of Onderstepoort introduces unnecessary costs and delays, as much of the required testing and quality control is already carried out by international manufacturers.
TLU SA urgently calls for all stakeholders to be given the opportunity to provide input before any regulations, including those relating to Section 10, are promulgated. It is essential that a collaborative, practical, and expertise-driven approach be followed to manage the FMD crisis effectively.
“The question the department must ask itself is simple: why do we want to control this process alone if we do not have the capacity or expertise?” Geldenhuys concludes. “It is time to take the right decisions in the interest of the agricultural sector and the country’s economy.”
