- Daily Despatch Eastern Cape - 29 Sept 2012
By ADRIENNE CARLISLE on September 29, 2012 in News

THE SCIENTIFIC community and the government is questioning the legality, safety and efficacy of a new “vaccine” for the deadly African Horse Sickness (AHS) virus developed by a group headed by the head of apartheid South Africa’s clandestine biological warfare facility.

AHS annually claims the lives of dozens of horses and the equestrian community has been abuzz about the reports of a new vaccine, referred to by its developer, Dr Daan Goosen, as the “inactivated field isolate vaccine”. There has been a vast amount of hype on the vaccine on social networking sites such as Facebook and many claim to have already been using it for up to two years with excellent results. Goosen says the vaccine was produced by his Letaba Veterinary Practice , Pretoria-based Disease Control Africa and La-Bio Research which together operate as a unit, LVP et al, to deliver  comprehensive specialised veterinary services.

Goosen is confident the inactivated vaccine is the most effective one produced to date and says its use is legal “but only on prescription by a registered veterinarian and if produced by LVP et al registered
facilities”. But the Department of Agriculture, Forestry and Fisheries has rubbished this claim, saying the new vaccine has not been registered and should not be distributed or used. “In South Africa all animal vaccines must be registered with the department in terms of The Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies,” said departmental spokesman Steve Galane. Goosen insisted the activities of LVP et al were not subject to the act . He did not elaborate but said LVP et al had met all legal requirements.

Galane said the department was aware of the circulation of the vaccine and was investigating its development. He said nobody had applied to register the vaccine. Galane said that in terms of the Animal Diseases Act, a permit was needed from the department for any AHS investigation,
experiment or research with any vaccine, serum, toxin, anti-toxin or antigen. This meant that without a permit they could not manufacture or evaluate any product or remedy intended for testing, diagnosis,
prevention, treatment or cure of AHS.

But some form of clinical trials have already taken place – despite no permit having being issued. Goosen admits that safety and efficacy of the vaccine was assessed in “several field trials” from 2008 to 2010 in the Tzaneen area in Limpopo province.

The only official, registered vaccine for AHS is the live attenuated vaccine developed by State-run Onderstepoort Biological Product s (OBP). OBP is primarily responsible for the research and development of animal vaccines and has been roundly criticised by among others, the DA , for
not pumping more resources into developing the vaccine further. Goosen claims LVP et al’s “inactivated virus” vaccine i s safe and effective compared to the live attenuated virus vaccines, which could lead to the formation of new, more virulent strains.

But Galane this week warned that the sale and use of unregistered vaccines, was a “transgression of the law” and offenders could be prosecuted. He said that this meant that the vaccine could not even be
used on prescription by a vet.

“The department has been made aware of the circulating vaccine and is following up on such reports.” The chairman of the SA Equine Veterinary Association, Dr Alison Sheppard, said that as long as the new vaccine was not registered, it would not be accepted for the certification of horses moving into the AHS controlled areas of the Western Cape.

The Western Cape is the only area from which horses can be exported – although a ban on exports is put in place when there are AHS outbreaks elsewhere in the country. She said the new vaccine had also not been accepted by the country’s national governing body of equestrian sports, known as SA Equestrian Federation , the national horse-racing authority or any other official body governing equine sport.

“The only vaccine currently recognised for official and legal purposes for the vaccination of horses against AHS is the vaccine produced by OBP,” said Sheppard. She said the OBP vaccine was effective but due to the many different AHS strains, it did not provide 100% protection which was why some horses that had been vaccinated could still succumb to AHS. “But the mortality rate is higher in unvaccinated animals,” she said.

Goosen conceded that horses traveling to the Western Cape would have to have been vaccinated with the OBP vaccine. However, he insisted that equestrian institutions should recognise his inactivated field isolate vaccine for other areas. “It would make much more sense,” he said. Goosen was the first managing director of the country’s clandestine biological warfare facility, Roodeplaat Research Laboratories.