vaccine injury compensation schemeS
What are they and does Australia need one?
It is one of those things you might hear about and think, that only happens to other people, it won’t happen to me or my family. But although rare, vaccine injury does happen, and in cases where adverse events occur it can be a tragic and overwhelming experience.
With phase three trials of newly developed COVID19 vaccines now underway there has been speculation a vaccine may be available as early as mid-2021. The expected rapid, mass roll out of a COVID19 vaccine in Australia has reignited debate over Australia’s need for a national vaccine injury compensation scheme (VICS).
No-fault compensation for people who have been adversely affected by a vaccine was first introduced in the 1960s. Over 20 countries have been identified as having VICS programs, including the United States, Britain, New Zealand, Germany and France, with Hungary, Iceland and Slovenia being the most recent nations to include VICS as part of their national healthcare system.
However, Australia remains without a national VICS and instead continues to rely on current systems. Such systems include civil law courts tasked with processing personal injury claims, programs such as the NDIS and government disability support payments which provide financial and healthcare support, and, largely passive, vaccine monitoring and surveillance systems using mostly passive surveillance. Active vaccine surveillance is conducted using sentinel sites which provide timely, population based, data driven information.
Vaccine Injured Australians
I first became aware of vaccine injury when I met a young Australian mother online. In 2012, only days after the birth of their fifth baby Tanya and husband, Ben, received a diphtheria, tetanus, whooping cough vaccine known as dTpa. Tanya recounted how the hospital wouldn’t allow them to see their prematurely born baby unless they had the vaccine. 12 days later, Ben was found on the floor of his home, paralysed.
Ben's reaction to the vaccine had left him with chronic pain and permanent injuries requiring extensive rehabilitation, and specialised medical care. Tanya candidly described how with the loss of Ben's income the family was struggling to stay afloat. Compensation would help with Ben’s ongoing care and the mounting costs from medical bills, mortgage repayments and the costs of raising their family. Tanya went on to explain how the Australian court system made vaccine injury compensation extremely hard and the process had placed extra burden on her already devastated family.
Video by 9 News Perth.
In 2016, Western Australia MP, Alannah MacTiernan addressed parliament with concerns the Hammond family had not yet received compensation and were the victims of targeted harassment.
"Ben Hammond, in 2012, received a booster of a whooping cough vaccine and had a rare adverse reaction. He now has a serious permanent disability. This is no-one's fault, but he cannot work and he and his family soon may lose their home," said MacTiernan.
Speaking with Tanya, I remember thinking, this is the type of thing you just do not hear about. But, as Tanya described it, victims of vaccine injury are often marginalised by the system and disregarded by the wider community.
VACCINE INJURY IN AUSTRLAIA
In 1804 the first smallpox vaccine was administered in Australia, since then vaccines have become an integral part of Australia’s healthcare system. However, there are small but inherent risks associated with all vaccines. Each year adverse events or long-term injuries following vaccination can and are experienced by a small number of people. Adverse events following immunisation (AEFIs) can include reactions at the injection site, fever, rash, vomiting, and, headaches. Severe reactions, while even rarer, can include a severe immune response, significant disability, other life-threatening reactions and death.
In Australia, the Therapeutic Goods Administration (TGA) monitors AEFIs using a “national passive surveillance system” known as AusVaxSafety. However, state and territory reporting requirements differ and the system is not standardised, which has resulted in information gaps. Currently, AEFI reports can be submitted to the TGA by various stakeholders, including states and territories, doctors, pharmacists, and pharmaceutical companies.
Solicitor Katherine Driscoll, Carrol and O’Dea Lawyers, has extensive experience in personal injury law and has had first hand involvement in Australian vaccine injury compensation. Driscoll raises various concerns, including how a lack of VICs may be detrimental to uptake of the COVID19 vaccine, and, the suitability of Australia’s current vaccine monitoring and surveillance systems to adequately cope with a mass roll out of a newly developed COVD19 vaccine.
“To my understanding of the system is it's very reliant on recording, both from individuals and also from ... local health organizations. I think that is a real concern,” says Driscoll.
“But I think, certainly the system that we do have in place at the present time, with respect to surveillance is effective and has been effective up to the present time; but obviously we are dealing with a situation that's unprecedented.”
Also, concerns have been raised over the complex system which vaccine injured Australians must navigate in order to seek compensation. Personal injury law presents limited circumstances where a claim can be made based on negligence, and historically, medical negligence claims pose extremely strict requirements. It's also difficult to prove harm has been suffered and is directly linked to a vaccine. In terms of NSW personal injury law, Driscoll says vaccine injury is unfortunate for those people have severe reactions, and, a no fault system is an appropriate way forward because current personal injury law and legislation may not be sufficient to cover these particular circumstances.
According to Driscoll, in NSW "claim[s] can be made out and pursued under the Civil Liability Act 2002 NSW the heads of damages that can be claimed are pain and suffering, economic loss, past and future treatment and past and future domestic assistance."
However, "the bar has continually been set high in various respects and there are many justifications for that, and many reasons behind that. Some of them I think are perfectly valid, others I would question.”
% of AEFIs Recorded as Serious
Percentages are calculated for the number of AEFI records where the vaccine was suspected of involvement in the AEFI.
2018 = 16%
2017 = 12%
2016 = 9.8%
2015 = 15.1%
Average annual rates per 100,000 population calculated using mid-2015-2018 population estimates. (Australian Bureau of Statistics)
Total AEFIs Reported 2013 to 2018
Average annual rates per 100,000 population calculated using mid-2013-2017 population estimates (Australian Bureau of Statistics).
Between 2013 and 2108 the highest number of AEFIs were recorded in 2013.Victoria reported the highest number of AEFIs between 2013 to 2018
The Northern Territory and Tasmania reported the lowest numbers of AEFIs between 2013 to 2017.
According to the Journal of Communicable Diseases Intelligence (CDI), in Australia “between 1 January and 31 December 2018 there were 4221 AEFI records for vaccines administered in 2018”; this indicated an 2.9% increase compared to 2017 reporting rates.
The 2.9% increase was attributed “to new additions to the National Immunisation Program schedule."
According to the National Centre for Immunisation Research and Surveillance (NCIRS), in the Australian Capital Territory, New South Wales, and, Queensland, reporting AEFIs is required under state Public Health Acts.
Similarly, AEFI reporting is also required in the Northern Territory under the Notifiable Diseases Act and in Western Australia under Health Regulations.
However, there is no legal requirement to report an AEFI in South Australia, Victoria, or Tasmania, though it is strongly encouraged.
DOES AUSTRALIA NEED A VICS?
The logistics behind developing and distributing a new COVID19 vaccine is convoluted and will no doubt be costly. The Federal Government recently announced in its’ latest budget, $1.7 billion will be invested in what has been described as a “vaccine gamble”.
Fears over vaccine safety have been raised due to the fast pace of vaccine development, and, possible adverse events following vaccination. To date, numerous vaccine trials have been halted due to adverse events among vaccine candidates, including vaccine trials by Astrazeneca, and more recently, Johnson & Johnson’s vaccine study. Such occurrences provide a stark reminder of why vaccine safety guidelines are so stringent.
Accordingly, experts such as Professor Isaacs are again calling on the Federal Government to put a VICS higher on its list of priorities. “I think it [VICS] would be the ethical thing to do, but governments, … in terms of what they see as their priorities, this was not high on the list of any government that I have been able to convince about it,” says Isaacs.
Isaacs says he has raised the issue of a VICS with the Australian Technical Advisory Group on Immunisation (ATAGI) on numerous occasions, but to no avail. ATAGI is the major body tasked with advising government about immunisations, however, as Isaacs points out, even if ATAGI recommended a VICS, “they [the government] will hear what ATAGI says but can perfectly well ignore it if it doesn’t fit in with what it wants to do.”
Serious AEFIs Reported between 2013 to 2018
Average annual rates per 100,000 population calculated using mid-2013-2017 population estimates (Australian Bureau of Statistics).
Adverse events following immunisation records defined as 'serious' (i.e. recovery with sequelae, hospitalisation, life-threatening or death).
Adverse events following immunisation can include reactions at the injection site, fever, rash, vomiting, and, headaches.
Severe reactions, while extremely rare, can include a severe immune response, significant disability, other life-threatening reactions and death.
Severe reactions can involve long term recovery and additional support for families. However, the system is complex and can place additional stress on families who are already coping with an unimaginable situation.
MOVING FORWARD, TOGETHER
Nick Henderson , Assistant Secretary of the COVID-19 Vaccine Strategy Taskforce, said in recent correspondence the Australian government “is not currently pursuing a no-fault COVID-19 vaccine injury compensation scheme.”
“The Government acknowledges the need to manage risk, and is engaging proactively on indemnity positions with a number of COVID-19 vaccine suppliers.
“The Australian Government is aiming to have as many Australians vaccinated as possible,” and is already seeking to expand and enhance its current active surveillance system through a tender process.
There is agreement among experts about a lack of public awareness surrounding vaccine injury and personal injury law in Australia.
“It still surprises me that there are still huge sections of the community who might be injured or suffer harm in various circumstances, and who don't really know until they speak to us what their options are”, says Driscoll.
“And, I would assume that it would be the same for vaccine related injury.
“Most people, if it did happen to them, really wouldn't know where to go or what their options were, so I think … awareness and community education would be hugely important.”
Another key issue facing the Federal Government is growing concern over the human rights aspects of a COVID19 vaccine. “It's a hard job for the government ... you've got to deal with so many competing viewpoints,” says Driscoll.
“You've got anti vaccination, … civil liberties and advocates, you know, for vulnerable communities, whether it be the elderly or obviously, you know, people who are immunocompromised. ... It's a huge number of different viewpoints.”
The Federal Government has not entirely ruled out mandatory vaccination, however, has indicated it will rely on Australia’s strong vaccine programs and incentives to help ensure a high COVID19 vaccine uptake. It is still not clear if the incentives being referred to include current immunisation policy programs, such as “No Jab, No Pay” and “No Jab No Play” programs.
Professor David Isaacs.
Professor David Isaacs.
Katherine Driscoll, Attorney.
Katherine Driscoll, Attorney.
Images and Graphics by Leanne Elliott.
