The Dunevax Delay: SA’s FMD crisis isn’t a vaccine shortage — it’s a signature shortage

Key topics:.Second FMD vaccine permit stalled at SAHPRA Single import channel raises supply risk concerns Farmers bear export losses amid regulatory delays.Sign up for your early morning brew of the BizNews Insider to keep you up to speed with the content that matters. The newsletter will land in your inbox at 5:30am weekdays. Register here.Support South Africa’s bastion of independent journalism, offering balanced insights on investments, business, and the political economy, by joining BizNews Premium. Register here.If you prefer WhatsApp for updates, sign up to the BizNews channel here..By Andrew Morphew.South Africa does not have a vaccine shortage problem. It has a signature problem — and farmers are paying for it in real time.On 24 February, Minister of Agriculture John Steenhuisen told Parliament’s portfolio committee that Dunevax - the local agent for Turkish manufacturer Dollvet - would supply six million FMD vaccine doses per month from March. In the same session, he stated that there were “no delays” in the vaccine programme. It was a confident pair of assurances, delivered to a committee that has grown increasingly critical of the government’s handling of the crisis.The continued pending status of the second Section 21 application sits uncomfortably alongside both of them. In January 2026, Dunevax submitted a second Section 21 application to SAHPRA - the Department of Health’s regulatory authority - for the import of additional millions of Dollvet doses. This was not a new product seeking first-time approval. It was the same vaccine, from the same manufacturer, covering the same SAT 1, 2 and 3 strains, under the same emergency conditions that had already justified the first permit. The only thing that changed was the quantity.On 25 January, Dunevax advised industry stakeholders directly: if the second Section 21 permit and the veterinary import permit were granted within that week, the next batch could be landed in South Africa by mid-March. That week passed without a signature.Then another. Then another. No public acknowledgment or published timeline has been issued by SAHPRA. No public explanation has been offered.The mid-March delivery window is gone. Manufacturing takes weeks, followed by a mandatory quality-control period that cannot be compressed. The delay is now physically baked into the supply chain. Each additional week of silence pushes arrival to April, May, or beyond - and the supply that the vaccination campaign depends on remains contingent on regulatory approval that has not come.ONE CHANNEL, ONE QUESTIONWithout the second Dollvet permit, South Africa’s large-scale vaccine supply currently flows primarily through a single operational channel: Biogénesis Bagó’s Argentine vaccine, imported through Onderstepoort Biological Products. Following that import arrangement, OBP has been positioned at the centre of the import and distribution process. In a vaccination programme of this scale - government has publicly referenced a national cattle herd of approximately 14 million animals, requiring an estimated 22.4 million doses - reliance on a single primary channel raises serious questions of redundancy and resilience.Is it responsible to concentrate a vaccination programme of this consequence through one primary import channel, when a compliant, already-approved alternative remains contingent on a signature that has not arrived?If that channel encounters a production hold, a logistics disruption, or a quality issue at any point along a supply line running from Argentina to South African provincial depots, operational flexibility would be constrained. Redundancy appears limited. The second Dollvet permit is not a luxury. It is the difference between a supply architecture that can absorb a shock and one that cannot.When supply channels narrow during a declared emergency, transparency around procurement, allocation and pricing becomes essential to maintaining industry confidence. Comprehensive procurement, allocation and pricing benchmarks have not been publicly disclosed.A PATTERN WORTH NOTINGWhat makes the delay harder to accept as administrative routine is that this is not the first time a private supply channel for an FMD vaccine has stalled at exactly this point. In January, Design Biologix held a publicly announced exclusive agency for the Biogénesis Bagó vaccine and filed its own Section 21 application with SAHPRA. The application never progressed. Department of Agriculture officials communicated that OBP held the mandate instead. Within three weeks the agency was terminated, the private application withdrawn, and the channel collapsed - without public explanation.The application died at SAHPRA. Now the second Dollvet application sits at SAHPRA. Different vaccine. Different upstream department. The same desk. Whether the stalling of both applications at the same regulatory point reflects coordination, institutional instinct, or administrative friction is not for this article to assert. What it does assert is that when the same outcome appears twice in rapid succession - same choke point, declared national disaster, animals going unvaccinated - the burden of explanation falls on the institutions, not on those asking the question.WHAT FARMERS ARE OWEDSouth Africa’s farmers are not passive observers of this crisis. Government has publicly referenced a national cattle herd of approximately 14 million animals at risk. The people responsible for those animals are absorbing movement restrictions, mandatory biosecurity upgrades, production losses, and collapsing export market access. Zambia suspended all South African livestock import permits with immediate effect on 14 February - all previously issued permits revoked, transit banned, no end date given.China imposed a ban on South African beef in 2025, contributing to a 26% decline in beef export revenue that year. The anxiety about which market moves next is not abstract.Is it fair that farmers should carry the cost - in delayed vaccine supply and potentially higher prices - that flows from procurement arrangements that have not been transparently explained or competitively structured?That question deserves a direct answer. What it has received, so far, is silence. The product has already met regulatory standards for emergency use. The outstanding question is whether the second applicant satisfies the same compliance requirements - and if not, which specific requirements remain outstanding. SAHPRA exists to enable rapid access to critical products in emergencies while maintaining rigorous standards.Publishing that answer - clearly, promptly, and without further delay - is the minimum transparency that a declared national disaster demands. South Africa does not need another press conference. It needs a signature, and an explanation for why it has taken this long to get one.

The Dunevax Delay: SA’s FMD crisis isn’t a vaccine shortage — it’s a signature shortage

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