The Australian Government is implementing a claims scheme for people who suffer a moderate to significant impact following an adverse reaction to a TGA approved COVID-19 vaccine.
The scheme will provide a simple, streamlined process to reimburse / compensate eligible people for their injuries without the need for complex legal proceedings.
The scheme will cover the costs of injuries $1,000 and above due to administration of a TGA approved COVID-19 vaccine or due to an adverse event that is considered to be caused by a COVID-19 vaccination.
The list of those who can claim is very short...
The list of adverse effects for claims purposes under the scheme include the following clinical conditions that are diagnosed by a treating doctor and are included in the approved product information for the specific vaccine:
Anaphylactic reaction
Thrombosis with Thrombocytopenia Syndrome
Myocarditis
Pericarditis
Capillary leak syndrome
Demyelinating disorders including Guillain Barre Syndrome (GBS)
Thrombocytopenia, including Immune Thrombocytopenia, identified as a final diagnosis.
Harm not covered by the scheme includes:
COVID-19
psychological and psychiatric conditions (e.g. shock)
secondary injuries (e.g. injury suffered when fainting, or a haematoma at the injection site that becomes infected)
the following other injuries unless they form part of the symptom complex of a clinical condition listed above: headache; fatigue; injection site reaction; muscle or joint pain; dizziness; diarrhoea; pain in extremity; fever; insomnia; nausea; vomiting; lethargy; hyperhidrosis; chills; decreased appetite; malaise; lymphadenopathy; somnolence; abdominal pain; puritus; urticaria or rash; influenza-like illness; angioedema; anxiety-related reactions such as hyperventilation and fainting.
Specified Administration Related Injuries which are clinically diagnosed will also be covered under the scheme.
For claims between $1,000 and $20,000, claimants need to have been hospitalised for at least one night and provide applicable evidence of:
the nature of the injury and medical documentation of its likely relationship to a COVID-19 vaccination
hospitalisation, due to a vaccine-related injury
medical costs
lost wages
The hospitalisation requirement may be waived if outpatient treatment is received and the COVID-19 vaccine recipient was not admitted to hospital, when they otherwise would have been, because:
of the nature of their clinical condition; or
the recipient was in a rural or remote area making it difficult to access a hospital.
The evidence requirements for claims $20,000 and over, including death, will shortly be advised as part of additional information to be published  on the scheme in November 2021. Claims relating to a death will not require evidence of hospitalisation.
Injuries with only mild impact would likely be made ineligible by virtue of the $1,000 cost threshold as well as requirement for hospitalisation.
It is anticipated that these thresholds will exclude most claims for;
needlestick injury;
dosage error;
incorrect administration route; and
incorrect vaccine administered.
Required forms:
Senate Select Committee on COVID-19
Tuesday, December 7 2021, 11:50
Video Link:
Full transcript:
Senator RENNICK
"I noticed that in this latest release of data—the first 500 pages—Pfizer has conceded that there is a large increase in the type of adverse event reactions to the vaccine. I know we've had this conversation before, where you've said that basically there are a limited number of recognised side effects. Given the latest release of this data, will you expand the number of recognised side effects as a result of the vaccine and, therefore, allow doctors to say injuries are, No. 1, related to the vaccine, and also expand the indemnity scheme, allowing people to claim for other injuries?
Dr Skerritt (TGA)
Our role is merely, as you say, to recognise side effects. At the risk of sounding trite, we'll recognise a side effect as caused by the vaccine if the evidence, on the advice of an expert panel of specialists in that area, and in consultation with international regulators, shows that there's a cause and effect relationship. If there's not a cause and effect relationship then it's not a side effect due to the vaccine.
Senator RENNICK
What's your onus of proof on that?
Dr Skerritt (TGA)
It's a rather detailed onus of proof.
Firstly, you've got to show that, in time, it was related to the adverse event.
Secondly, you've got to show that there's no other plausible mechanism.
Thirdly, you need to identify how it could be medically related.
Then we also look at background rates. There are a number of other measures—observed versus expected. We slice it by the population. We look at the background rates not just for the whole community but also in the particular age group and gender and even racial cohort, to get together with our colleagues overseas.
It's a detailed analysis, but we don't just do it ourselves. If it's a neurological side effect, we bring in some of Australia's top neurologists. If it's a haematological side effect, as we did for TTS, we bring in some of the Australia's top haematologists, and so on.
Senator RENNICK
I'll be more specific with that onus of proof. Are you going to go on the balance of probabilities, like in a civil case, or are you going to go beyond reasonable doubt—and these people have to prove beyond reasonable doubt versus the balance of probabilities?
Dr Skerritt (TGA)
With the scheme that you're talking about—and our role is the medical assessment of information provided by relevant specialists and the treating doctor—it is that, on the balance of probability, when there's no other likely cause for that effect. It is different from the broader TGA adverse event scheme. It is a balance of probabilities scheme, and that information will shortly be made available in detail, if it isn't already, so that the detailed claims can be prepared.
As Dr Skerritt from the TGA eluded, the onus of proof related to this compensation scheme is different than the broader TGA adverse event scheme.
If you or a family member has been affected, we wish you every success with your claim!
More importantly, we wish and hope and pray for your return to better health
