25/12/2019
Source:. https://www.theland.com.au/story/6355621/hendra-vaccine-under-microscope-in-court-class-action/
Case claims vaccine maker overstated Hendra virus
John Ellicott
30 Aug 2019, 11:30 a.m.
Vets attend to a possible case of Hendra on a Mid-North Coast property. Vets have been the victims of most Hendra cases in humans reported since 1994 (about 7).
The Thoroughbred industry is increasing its vaccination of horses against the bat-carrying Hendra virus as a class action is underway challenging the vaccine manufacturer over its statements about the threat of the virus.
The class action listed for hearing shortly in the Federal Court alleges Zoetis Australia overstated the risks of Hendra virus to the horse community.
Zoetis Australia denies the claim and in a statement provided for The Land said:
"The vaccine is safe, effective and fully approved by Australia's highly regarded regulator. Since 2012, Australian veterinarians have administered hundreds of thousands of vaccinations, including to some of the most expensive racehorses in the world. Vaccination protects horses and everyone who comes into contact with them. The action has no merit."
The class action, that has 130 people or more joined to it, conducted by LHD lawyers, also alleges a number of severe reactions to the vaccine have occurred in horses.
The vaccine sold as Equivac HeV was developed by the CSIRO and has full approval from the APVMA. The vaccine must be administered by a veterinarian. It follows a pattern of an initial vaccination, followed a few weeks later by a second vaccination, another one six months later and then a booster every year. The cost for each vial of vaccine is about $50, plus vet costs, which could be as high as $200 per vaccination.
The vaccine was created after the first fatal case of Hendra passing from a horse to human in 1994, the death of Vo Rogue's trainer Vic Rail after contracting the disease in his Hendra stables in Brisbane, that also killed 20 horses. The event sent shockwaves through the public that a virus, virulent but not as contagious as Ebola virus, could be so deadly. It is passed on to horses from bats, specifically four species of flying foxes, with horses eating feed contaminated by bat urine, saliva or birth products.
A Queensland parliamentary committee in 2016 declared that Hendra virus (HeV) was "relatively rare and difficult to catch. However, if a horse or human does contract the virus, there is no cure and they will most likely die."
All confirmed human cases so far to date have been where people have had high exposure to a horse's body fluids, such as doing autopsies on horses. The virus can incubate for up to 21 days in a human, has devastating effects of the body, attacking the nervous system with possible meningitis or encephalitis (inflammation of the brain), headaches, high fever, and sometimes convulsions and coma.
Four of the seven people in Australia infected during the period 1994 to 2012 died. Five of the seven were either veterinarians or were assisting vets.
From 1994 to 2016 inclusive, there have been more than 70 sporadic confirmed cases of Hendra virus infection in horses. (There are 900,000 domesticated horses in Australia).
A statement of claim for the case says "between 1994 and 2011, there were: (a) 23 incidents of Hendra in horses in Queensland affecting a total of 55 horses; (b) 9 incidents of Hendra in horses in NSW affecting a total of 11 horses; and (c) no other incidents of Hendra in horses in other parts of Australia."
The first test of the vaccine started in 2012 before its public release, and world-leading animal vaccine manufacturer Zoetis (formerly Pfizer) obtained the rights to manufacture it. The vaccine research by the CSIRO won an international award. It was a world-first commercial vaccine for a bio-safety level-4 disease agent and the CSIRO said it was "vigorously tested". The CSIRO says the vaccine "enhances security for the Australian horse industry and reduces time spent in quarantine" and minimised the chance of Hendra virus mutating.
The Australian Veterinary Association recommends that all horses in Australia are vaccinated against the Hendra virus, but there is no legislated vaccination.
Zoetis says there has has been infinitesimal reactions in horses from receiving the HeV vaccination.
In the applicant's statement of claim it says: "From on or about August 2012, Zoetis presented to each registered veterinary surgeons who undertook the registration module materials , in which Zoetis stated: 'Vaccine Safety Update: analysis of the first 25,500 doses administered to horses have shown a low adverse reaction rate, with no serious or life threatening reactions involved. 0.22 per cent adverse reaction rate to date'"
The claimant says at "the risk of a horse becoming infected with Hendra in those parts of Queensland and NSW in the vicinity of the incidents identified" in its claim "was and is low", and also that in those parts of Australia where fruit bats are present outside the vicinity of the areas identified "was and is extremely low".
The claimant alleges that Zoetis From 2 March 2013 and throughout the relevant period of the claim, Zoetis represented that there was a serious risk of horses contracting Hendra in all areas of Australia in which flying foxes were present. "By making the Geographic Spread Representation, Zoetis engaged in conduct in trade or commerce within the meaning of s 18 of the Australian Competition Law (ACL). The Geographic Spread Representation was misleading or deceptive, or likely to mislead or deceive within the meaning of s 18 of the ACL."
The case is soon to head to court after interlocutory hearings over costs.
CASE STUDY
Each afternoon, Sharon watches her daughter Mia, 9, come home from school and walk out to the stable to sit quietly by her Welsh pony Angel.
She waits and waits, waiting for the time she can ride Angel again - but it may be a fruitless wait.
Angel suffered from severe laminitis shortly after she received the Hendra vaccine back in May at a Gold Coast property. The laminitis unusually was in all four of Angel's feet, making her having to have special shoes to ease the pain in the laminae soft tissue. A first vet did not give any basis for the laminitis, while a second vet who inspected the horse said he believed it was a reaction to the virus. Blood tests taken for Ross River fever and other possible sources, paid for by the manufacturer of the vaccine, Zoetis, proved inconclusive. Zoetis also wanted Angel tested at a facility at Gympie, but she was too sick to move.
Zoetis had paid for all the subsequent vet bills - amounting to about $3500, but have not admitted to liability to do with the vaccination. Sharon has been in phone conversation with a Zoetis Australia executive but has received nothing in writing.
For Sharon, a former NSW resident who now lives on the Gold Coast, it has been heartbreaking watching her daughter wait by Angel's side. They've bought a new pony for her (Charlie) - and the family has vowed not to get the new horse vaccinated for fear the same thing could happen again.
"At one stage after the vaccination Mia was competing on Angel and I said to myself 'oh my god, Angel has stopped still, I've got to get Mia off, she's going to roll'. We got Angel back home. She was up the top of the paddock and wouldn't walk. A vet came on the Monday and said he wasn't sure what Angel had, he had the Hendra gear on. I got a second vet's opinion and he said straight off the bat "she's had a Hendra (vaccine) reaction'. I didn't even know you could get a reaction."
Zoetis paid for multiple tests, including for Ross River fever but nothing was discovered. "Every test came back negative," Sharon says.
Angel is slowly recovering and is about 40 per cent back to her original health. But she is likely to stay stabled for another six months.
"The hardest part for me is seeing my daughter, she is so upset at what's happened, she's changed," Sharon said.
Sharon says she has now paid over $10,000 for horses and faces a bill of about $200 a week for hay for the two horses. They would never sell Angel or have her euthanased, as she was part of the family.
COURT CLAIMS
The class action claims that Zoetis over-stated the risks of horses contracting the Hendra virus in a number of pamphlets. About 130 people at his stage have joined the class action. When the case proceeds, applicants will have to opt in or opt out - meaning if the court finds against Zoetis, only those involved in the action would benefit from any possible damages decision. A damages decision could be global, or made on a case by case basis.
The lead applicant is Rachael Abbott, who allegedly lost her job after she refused to get her horse vaccinated for a second time while she was working at a Central West NSW feedlot. Ms Abbott started work as a stockperson with JBS Caroona Feed Lot (JBS) in June 2014, and owned a stockhorse Primetime, an 11-year-old mare, and had an interest in another horse Ervines Jive, a five-year-old mare.
She claims that JBS told her the horse need to be vaccinated for Hendra virus. The claim alleges after the first vaccination "Primetime had suffered an injection site reaction, oedema, pain and Pyrex/a and became depressed and touch sensitive after the administration of the HeV injection. She experienced swelling in her joints and over kidneys, pale or white gums, rapid breathing, weight loss, disorientation and was stiff in her movements. As a result of this, Primetime required four months of veterinary care." She said her $30,000 horse could not be sold.
"The Applicant was directed to allow but refused to have any further injections administered to her horses and as a result her employment was terminated on 20 March 2015."
THOROUGHBRED INDUSTRY
The thoroughbred industry is vaccinating most of its horses, especially following the scare from a case of Hendra at a property outside of Scone. The case sent shockwaves through the Hunter breeding industry, one of the most important thoroughbred centres in the world, and it is now a requirement that any mare presented to a Hunter stud must be vaccinated.
Leading Australian horse trainer Chris Waller has directed all his horses be vaccinated. Waller's pre-trainer Ollie Koolman, who looked after star mare Winx, said it was proper practice to get a horse vaccinated because of the threat to humans.
"Chris Waller racing has directed all its horses be vaccinated," Koolman said. "We've embraced the vaccination concept. We've done a number of them already, a few have had a temperature, but that is about it. You have to remember we are protecting humans as well as horses. We've never done it before, but now we are taking a blanket approach. The vet administers and it's well regulated. it's just part of our vaccination program that includes protecting against strangles and tetanus."
Scone trainer Rod Northam has had 40-50 of his horses vaccinated. "As soon as we heard of the Scone case we got our horses vaccinated. I employ staff so if any of my staff or myself got the virus that would be terrible as it is preventable.I believe most of the stud farms are doing it now. We've done 40 to 50 horses and just one was a bit swollen in the injection area for three to four days. Some have been a little flat after the second shot. The vets say that from 24-48 hours the horses can be a little low. As far as their racing I have seen no effects at all. It is expensive, but what is the cost of a human life? It is a no-brainer to get them vaccinated."
He said he didn't believe bats were frequently at the Scone property where the infection occurred but they might have been feeding on the gum trees. He said horse owners should be aware of that when paddocking animals.
THE CASE AT SCONE
A case of Hendra was discovered for the first time in the Hunter at Scone in early June. The last Hendra case in NSW was an unvaccinated horse on a property near Tweed Heads in September 2018. The most southern case reported previously was at Kempsey in 2013.
Three tests confirmed Hendra in the Scone horse, from a property that was well away from the major breeding studs.
The case was highly unusual in terms of what actually happened on the ground and for it being way out pf the normal zone for Hendra.
In its summation of the case supplied to The Land. The DPI said: "Samples from the horse infected with Hendra at Scone in early June were taken by the District Veterinarian.
"The horse was found to be positive on PCR (DNA detection of the virus) on separate swabs (re**al, nasal and oral) as well as on blood (clotted and EDTA) by the State Veterinary Laboratory. The positive results were also confirmed at the Australian Animal Health Laboratory.
"Flying foxes including black headed flying foxes were detected in the area within flying distance of the property.
"The property was under restriction for 21 days and animals thought to have been exposed to the positive horse or its discharges were segregated and their health status monitored. All remained healthy during the 21 days. All restrictions on the property under the NSW Biosecurity Act have been removed.
"NSW Health identified 10 people with varying levels of exposure to the positive horse and they were all assessed. All remained healthy during the 21 days.
"Tracing of horses who had moved off the property during the risk period determined that all were low risk and no action required.
"Meetings have been held with veterinarians around Scone to update them on the case and provide information and resources."
QUEENSLAND INQUIRY
On 25 February 2016 the Queensland Legislative Assembly agreed to a motion that the "Agriculture and Environment Committee inquire into and report on the Hendra virus (HeV) EquiVacc® vaccine and its use by veterinary surgeons in Queensland".
The parliamentary committee concluded that that "Hendra virus vaccination not be made mandatory but left to the discretion of equestrian event organisers to require as a condition of entry and for horse owners to decide based on risk".
"The APVMA, Zoetis and the AVA have argued that the levels of adverse reactions to the HeV vaccine are low and well within the normal acceptable range. The APVMA has reported only seven deaths of horses 'possibly' linked and no deaths 'probably' linked to vaccinations to date," the report tabled in parliament said.
"Despite these statistics, many horse owners are adamant that adverse reactions to the vaccine are more prevalent and under-reported (by vets to Zoetis to APVMA, and then reported by APVMA), and that vets and Zoetis have clear vested interests in not reporting adverse reactions."
The committee's own survey of horse deaths highlighted challenges with adverse event reporting. They decided not to recommend legislation to make the Hendra virus vaccine mandatory.
Many of these issues will be subject to submissions in the court case. The lawyers representing the class action are filing an FOI application to learn more about the Scone Hendra case.
The horse was a 25-year-old ex polo horse and had been there a long time.The legal team is eager to know if any equipment was brought onto the property in horse floats.
There is a directions hearing set down for September 13 before Justice Michael Lee in the Federal Court in Sydney. The court has allowed an amended statement of claim.
