PRETORIA – South Africa’s Agricultural Research Council (ARC) has announced a major ramp-up in the local production of Foot and Mouth Disease (FMD) vaccines, aimed at securing South Africa’s livestock industry and preventing the disease from contaminating neighbouring countries and possibly destabilising the economy of especially Namibia that is dependent on livestock exports.
Amidst a devastating national animal health crisis, the ARC confirmed a strategic roadmap to reach a full manufacturing capacity of 20 million doses per year according to a media release dated 11 February.
Immediate Production and Capacity Milestones
The ARC has initiated capacity enhancements to establish an output of 10 million monovalent doses annually within the next 12 months. While the country currently relies on flowing imports to manage the ongoing outbreak, the ARC will contribute an additional 20,000 doses per week to the national supply starting in March.
Once the newly designed factory is fully operational, the 20-million-dose annual capacity will be sufficient to cover the total national herd requirements. The ARC vaccine, a result of over a decade of scientific research, provides protection for up to one year per dose, which aligns with the national FMD mass vaccination strategy.
A Landmark Scientific Achievement
The release of the first batch of ARC-produced vaccines on 6 February 2026 marks the first time in two decades that South Africa has manufactured this critical remedy locally. This breakthrough follows a long-term research and development journey that began in 2010 at the Onderstepoort Veterinary Research (OVR) campus.
The OVR campus is a recognized World Organisation for Animal Health (WOAH) Reference Laboratory for FMD. WOAH Reference Laboratories must meet strict criteria to provide scientific leadership, training, and support to member countries. As part of the WOAH and FAO FMD Reference Laboratory Network, OVR contributes to global surveillance, standardization, and data sharing for FMD diagnostics. This includes the sharing of biological materials and international collaborations that occur in the normal course of scientific work.
The Complexity of Vaccine Development
FMD is a highly contagious viral disease affecting cloven-hoofed animals, causing severe production losses and rapid herd-level spread. Even after clinical recovery, the impact is felt through movement restrictions and economic disruptions to livestock trade.
The ARC clarified that FMD vaccine development is a multi-year process. Research into strains suitable for South Africa began in 2010, utilizing an old factory with adapted systems to meet modern manufacturing requirements.
This involved:
- Identifying new candidate strains.
- Adapting strains for cultivation.
- Conducting long-term trials to determine the strength and longevity of immunity.
Registration vs. Manufacturing Readiness
The vaccine was registered in South Africa in May 2022 as a stock remedy under Act 36 of 1947. While this was a major regulatory milestone, the ARC stressed that registration does not equate to manufacturing readiness.
The council addressed public misconceptions, stating it is incorrect to characterize the current release as a "new" or "different" vaccine. Developing a new vaccine in a short space of time is impossible; instead, the current milestone represents the transition of a registered product into large-scale operational use. Following registration, a proof-of-concept batch was successfully deployed in Mpumalanga to control previous outbreaks.
Regulatory and Biosecurity Strictures
FMD vaccine production is governed by strict legal, regulatory, and biosecurity requirements because it involves handling the live virus. No facility in South Africa is authorized to produce the FMD vaccine outside of the ARC.
The ARC emphasized that while Biosafety Level 3 (BSL-3) containment is a minimum requirement, having such a facility does not automatically mean a laboratory can produce the vaccine. FMD vaccines must be produced in dedicated animal health facilities and cannot be co-manufactured with human vaccines. Furthermore, the ARC noted that it is "incorrect to suggest" that manufacturing could be simply transferred to other parties, as the process requires highly specialized skills and long-term investment.
Bridging the Supply Gap
Since 2006, South Africa has relied on imported vaccines, primarily from the Botswana Vaccine Institute (BVI). BVI has honored every order since then, including during the current outbreak period. Until recently, South Africa had not sought other sources because the BVI supply was assured while national development continued.
The current shift toward local production aims to restore national capability. By March 2026, the local supply will be augmented by 20,000 doses weekly, providing a more resilient buffer against the virus.
Beyond Production: Diagnostics and Support
In addition to vaccine manufacturing, the ARC performs two other vital functions:
Diagnostic Services: Providing monitoring for circulating strains. The ARC has processed an unprecedented number of samples during the current outbreak and plans to expand capacity by activating a broader laboratory network and onboarding more personnel.
Vaccine Matching: Conducting tests to ensure that international imports remain effective against the specific strains currently circulating in South Africa.
Strategic Oversight
The ARC’s mandate is limited to scientific research and production. The distribution, allocation, and rollout of the vaccines are part of the national disease control program managed by the Department of Agriculture.
The ARC expressed recognition of the serious impact the outbreaks have had on farmers and the agricultural economy. The organization remains focused on strengthening scientific production capability to support South Africa’s long-term preparedness. ARC scientists will continue their work to ensure the country is equipped to handle future animal health challenges.
