Industry organisation TLU SA has welcomed Agriculture Minister Willie Aucamp's announcement that qualifying local and international entities may collaborate with the Agricultural Research Council (ARC) to manufacture Foot-and-Mouth Disease (FMD) vaccines on a larger scale.

Aucamp on September 21 announced that the ARC and its board have approved access for qualifying private companies to the ARC’s intellectual property relating to the FMD vaccine through conditional licensing agreements. The aim is to help overcome the ARC’s current production constraints and make larger quantities of the vaccine available.

TLU SA regards the decision as an important step forward in combating FMD and protecting South Africa’s livestock industry by creating the potential to unlock additional production capacity and improve vaccine availability.

Local or international entities will be required to enter into an appropriate licensing agreement with the ARC and will still have to comply with the prescribed scientific, regulatory, manufacturing and quality requirements, TLU SA GM Bennie van Zyl explains.

Vaccine production will, therefore, continue to take place within a strictly controlled environment and will have to be undertaken by appropriately accredited and authorised entities, he adds.

“There are certainly still regulatory realities that need to be taken into account. Private-sector involvement does not mean that the existing requirements and controls fall away. The vaccine must be manufactured in accordance with the ARC’s licensing conditions and within the applicable regulatory framework."

According to TLU SA, veterinarians and academics working with FMD, the ARC vaccine is currently particularly well suited to the virus strains occurring in South Africa.

“The information we have received from veterinarians and academics indicates that this is currently probably the most suitable vaccine for addressing the South African strains and helping to build the necessary immunity in herds,” Van Zyl explains.

A further advantage is that the ARC vaccine is expected to provide longer-lasting immunity than some of the vaccines currently being imported. According to TLU SA, the ARC vaccine could provide immunity for up to a year, while certain imported vaccines provide immunity for approximately three to six months.

“Longer-lasting immunity could be a significant advantage for the livestock industry. It could help producers protect their herds more effectively and could also reduce the practical and financial burden associated with more frequent vaccination,” Van Zyl states.

TLU SA ultimately believes greater participation by competent manufacturers could also potentially lead to increased competition, improved availability and lower costs. The eventual price of the vaccine will, however, depend on factors including licensing conditions, regulatory requirements, manufacturing costs and the commercial viability of production.

Aucamp says that although the implementation of this decision will not happen overnight, it is a huge step forward in combating the FMD outbreak.

Further to this development, and on the request of Aucamp, the ARC will also submit representative FMD field-circulating virus isolates from South Africa to the Pirbright Institute in the UK in October for a second round of vaccine-matching assessments. The purpose of this exercise is to provide an additional scientific assessment of the suitability of available local and imported vaccines against FMD viruses currently circulating in South Africa.

On this matter, TLU SA says it is important to continually test whether the vaccine still adequately addresses the strains occurring in South Africa.

"Changes in the virus and possible mutations must be identified in time to prevent a vaccine from becoming less effective over time. We believe the current approach represents a more responsible and targeted path towards improving the control of FMD," Van Zyl concludes.