Despite administrative challenges, Dunevax, the sole agent for the Turkish company Dollvet Biotechnology’s animal health products in Southern Africa, says it remains committed to supporting the Department of Agriculture, the minister and farmers in navigating the foot-and-mouth disease (FMD) crisis. This is according to the company’s CEO, Dr David Gerber.
By Jasper Raats, senior journalist at African Farming and Landbouweekblad
Gerber responded to African Farming’s questions about the lengthy period between Dunevax’s application for a Section 21 permit in November last year and the present, while other importers’ Section 21 permits were apparently issued much more quickly.
Gerber says Dunevax’s first application for a Section 21 permit was submitted on 5 November and the permit was only issued on 6 January after additional information had been requested and provided. The process was then further delayed because of an administrative mistake in the issuing of the permit.
Administrative Error
Gerber describes this as an administrative error that likely arose in the communication process between the South African Health Products Regulatory Authority (SAHPRA) and the Department of Agriculture (DoA).
According to him, the ministerial task team and the Directorate of Animal Health had to provide input on the vaccine before the permit could be issued.
Gerber says the Department itself confirmed by email that he was surprised when he saw the permit had been issued incorrectly. The error then had to be rectified administratively, which, according to Gerber, delayed the process by about a week. He emphasises that this was not a substantive rejection or regulatory problem, but a technical issuing error by SAHPRA.
An import permit for the Dollvet vaccine was issued about a week later and an order for the first shipment was placed.
Since then, the Turkish manufacturer has expedited production as far as possible. Gerber says the time from the order date until now is not due to logistical delays, but forms part of the standard manufacturing and quality control process. After the vaccine is bottled and packaged, a quality control phase of approximately 35 days follows, which includes animal testing to confirm safety and efficacy. “That phase cannot be shortened or skipped,” he says. According to him, the timeline from permit to arrival is relatively short in this case, but certain production and testing requirements remain non-negotiable before the quality control pharmacist at Dollvet can release the vaccine for shipment.
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New Requirements
According to Gerber, the second Section 21 application for 6 million doses has been assessed in a more technical and data-driven manner than the first.
The main requirement now being emphasised is that the vaccine’s efficacy against foot-and-mouth disease serotypes (SAT) 1, 2 and 3 must be clearly demonstrated. He says initially there were confirmed results only for SAT 1 and SAT 2, because an appropriate SAT 3 sample was not immediately available for testing at The Pirbright Institute in the UK. In the meantime, additional SAT 3 results have been obtained and submitted to SAHPRA. He adds that it is essential that any vaccine that is used in the DoA’s vaccination campaign should have all three serotypes (SAT1, 2, &3) as per the World Organisation of Animal Health (WOAH) protocol. If this is not the case the disease could still spread at an alarming rate.
Gerber says SAHPRA has also requested additional technical and administrative information, which Dunevax has provided, and that the application is currently under evaluation.
SAHPRA has also introduced new requirements for the issuing of the Section 21 permit that were not necessary for the previous permit. These relate to the storage and handling of a Section 21 product. Although the cold chain facility is already approved for cold chain products, Dunevax must now also confirm that the facility is formally authorised to handle Section 21 products. “There is no practical difference in handling a Section 21 product compared to a normal cold chain product, except that additional controls are required to provide detailed pharmacovigilance reports to the regulator,” says Gerber.
According to him, there is therefore no “blockage”, but rather a process requiring additional scientific evidence and administrative documentation before the second permit can be granted, which has delayed the permit process. “We are doing our best to ensure the process runs as smoothly as possible by providing information to the regulator as and when requested.”
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Uncertainty About Distribution
Gerber says because the vaccine is imported under a Section 21 permit, a reporting obligation rests with the importer. It must be able to show SAHPRA where every bottle of vaccine has gone, when it was administered, and report any side effects or reactions as part of the permit conditions.
For this reason, Dunevax would prefer to handle the distribution of the vaccines and contracted Buffalo Analytics to develop a digital system to monitor the rollout of the vaccine. He says each bottle carries a unique QR code that can be scanned by a veterinarian or state official at the time of administration. This enables Dunevax and the authorities to see in real time where the vaccine has been used and whether any adverse effects have been reported.
He says the platform can also register outbreaks and calculate a risk zone to support government to determine priorities for ring vaccination or targeted rollout, and it can display buffalo farms and surrounding cattle farms on the same map to better manage risk.
He explains that the QR code system and Buffalo Analytics platform were specifically developed to ensure such traceability. His argument is that if Dunevax does not know where the vaccine is being used, it cannot fulfil its regulatory obligations.
Misunderstanding About Orders
Gerber says there was, however, a misunderstanding between the ministerial task team and Dunevax regarding a preliminary survey conducted on the system. He says some stakeholders interpreted it as “orders” for vaccines, while Dunevax intended it as “requests” to assist the state with planning.
“It is not an order. It is a request from farmers and veterinarians in their areas to help the authorities see where the need is and how many doses may potentially be required so that provinces can decide where vaccination is most urgent,” he says.
According to him, the aim is for farmers and veterinarians to participate in a structured planning process, with the state ultimately determining where the vaccine is delivered and administered.
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R45 Per Dose
Gerber says Dunevax’s offer is to deliver the Dollvet vaccine anywhere in the country at R45 per dose in standard cold chain packaging of 4 000 doses.
In the meantime, Onderstepoort Biological Products (OBP) approached Dunevax with a request to sell the vaccine to OBP so that OBP could distribute it. He says Dunevax’s position is that OBP is not the government, but a state-owned company that competes in the animal health market.
He says Dunevax will nevertheless supply OBP if required. “If the authorities give us written instruction to deliver our vaccine to OBP, we will do so. We just want clear written guidelines,” he says.
According to Gerber, a further question in a multi-vaccine environment is who decides which vaccine goes where. He says that state and authorised private veterinarians should, with proper information, have the space to choose which vaccine best suits a particular situation.
He explains that oil-based vaccines such as those from Dollvet and Biogenesis Bago generally last longer and can work with six-monthly revaccination, while water-based vaccines build immunity faster but offer shorter duration and require more frequent booster doses (up to four inoculations per year, which of course adds significantly to the costs for the stock-owner).
He says the state should set the rules on the rollout plan and minimum requirements for the vaccines, but that implementation and choice within a controlled framework should allow room for competition to maintain quality and keep prices in check. “There is no free-market benefit for farmers who want to vaccinate preventatively if they cannot choose where and which vaccine to buy. Without such competition, farmers are left at the mercy of a single company.”
Long-Term Plan
Gerber says Dunevax was established in 2023 with the aim of building a local vaccine manufacturing plant in Southern Africa over time, with foreign investment, but that this could take at least five years. In the meantime, Dunevax is working with Dollvet to make vaccine available while local capacity is developed in the long term.
He says his company’s preference is that all vaccines, including locally produced ones, be tested at Pirbright so that independent, comparable results are available, and that such results be made public as far as possible, because farmers ultimately carry the risk, even if the state pays for the vaccine.
“We want to be part of the solution to this crisis and help, in collaboration between farmers, veterinarians, industry and the State, solve the problem,” says Gerber.
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