While the Department of Agriculture prepares its responses to African Farming’s urgent enquiry regarding South Africa’s current and projected stock of foot-and-mouth disease (FMD) vaccine, Dr David Gerber, chief executive officer of Dunevax Biotech (Dunevax) in South Africa and Namibia – Dollvet Biotechnology’s Southern African partner – has confirmed that vaccine supplies from the Turkish company are likely only to be available in two to three months’ time.
By Lloyd Phillips, Senior Journalist at African Farming and Landbouweekblad
Other reliable sources have confirmed that the Botswana Vaccine Institute (BVI) – currently the sole supplier of vaccine against South Africa’s SAT strains of FMD – has temporarily halted production to carry out mandatory sterilisation and maintenance procedures. Reports indicate that the BVI will only resume production sometime in January.
Gerber says he finds it inexplicable that Dunevax does not have the full support of the South African government to test Dollvet’s vaccine against the currently circulating FMD viruses in South Africa – despite the company having initiated discussions with the state months ago.
Samples Last Submitted in 2011
“The Pirbright Institute [in Britain] is the world reference laboratory for foot-and-mouth disease,” Gerber explains. “They receive, test and identify the field strains of FMD outbreaks worldwide. Pirbright [do] not manufacture vaccines – they test, upon request from vaccine manufacturers, whether their vaccines match the latest field strains from an outbreak, provided those strains have been submitted to Pirbright. This determines whether a vaccine can effectively control an outbreak.”
“Viruses can mutate. Other Southern African countries, such as Zambia, Zimbabwe and Namibia, regularly send samples from their most recent outbreaks to Pirbright for analysis. The last time South Africa submitted samples was in 2011. South Africa said it would send new samples in June this year, but that has not happened.”
Gerber explains that several procedures and adequate time are required before large-scale production and distribution of a new vaccine against South Africa’s FMD epidemic can begin. In addition to manufacturing, the vaccine must be tested at Pirbright to confirm its effectiveness – which can only be done if the latest field strains are submitted there.
The fact that South Africa’s veterinary authorities have not sent these field strains, he says, is a major obstacle preventing Dollvet from proving that its vaccine offers full protection against the current South African virus strains. He also firmly rejects the notion that these field strains constitute the intellectual property of the state or its parastatal institutions.
“It’s a naturally occurring organism and should be made available to anyone who can help limit its spread and devastating effects.”
He adds that Pirbright has conducted vaccine-matching tests with field strains available from the SADC region.
Also read: Is South Africa going to run out of foot-and-mouth disease (FMD) vaccine?
Onderstepoort Still Not Ready
Dunevax and Dollvet have submitted serum from cattle vaccinated with their vaccine to South Africa’s state-run Onderstepoort Veterinary Institute (OVI).
“The OVI laboratory should conduct virus neutralisation tests (VNTs) using these serum samples against the field strains from current outbreaks to confirm that the vaccine protects against the viruses causing these outbreaks,” says Gerber.
“However, OVI has informed Dunevax that it still needs to optimise its methods before such tests can be carried out – even though OVI has known for weeks that the serum samples were ready for testing. It’s concerning that OVI appears so unprepared and slow while the disease continues to cause immense damage to our cattle industry.”
He adds that he has also heard unconfirmed reports that some individuals within the government are allegedly opposed to using Dollvet’s vaccine, claiming it is the “wrong vaccine”.
Gerber remains determined. He is submitting an application to the South African authorities under Section 21 of the Medicines and Related Substances Act (Act 101 of 1965) seeking authorisation for the import and use of Dollvet’s current FMD vaccine as a veterinary medicine that is not yet registered in South Africa.
As African Farming has established, the BVI’s FMD vaccine has for years been used in South Africa as an unregistered veterinary medicine following the approval of a similar Section 21 application.
It is currently unknown, however, whether BVI’s vaccine provides protection against all the latest FMD strains present in South Africa.
Also read: FMD vaccine: Second shipment delayed
No Vaccine in the Near Future
Gerber points out that even if Dunevax were to receive immediate authorisation to use Dollvet’s vaccine in South Africa, it would still take time before sufficient quantities became available.
“As soon as the import and use of Dollvet’s vaccine are approved, Dunevax will order just over a million doses. Dunevax and Dollvet are in continuous communication, and Dollvet is ready to start production as soon as all approvals are in place. Production takes a few weeks, followed by a month of strict quality control. Thereafter, it will take no more than another month to distribute the vaccines throughout South Africa.”
Initial batches of Dollvet vaccine will be distributed in South Africa under the Dollvet brand. A dossier is already being prepared to register the vaccine, after which it will in future be marketed under the Dunevax Biotech brand.
African Farming will publish the Department of Agriculture’s responses as soon as they become available.
Also read: Australia poised to produce its own FMD vaccine
