Summary: as we know, the Merck/Pfizer presence is strong in Australia. Merck's earlier Vioxx issues also had an Australian flavor - including the falsification of academic reports (see References section below).
And the pro-vaccine push has also been the strongest. Vaccine coverage is strongest in Australia (compared to the UK and US) - and they have also been very strong on lockdowns.
As a results cases and deaths from covid19 have also been very low thus far.
It is thus interesting that the first pro-consumer push also comes from Australia.
This could be due to political pressures on the govt from extended lockdowns and public pushback. Or mandated vaccination which may mean there are just more cases of per capita adverse events - and so not addressing that would lead to political issues later.
It may also not help that the harsh conditions some doctors have been subject to - search and seizure and threats of being struck off from medical accreditation (see References section below).
The claims scheme is prior to arrival/awareness of Omicron (reports of which arrived in December 2021 from South Africa) - so we cannot attribute this move in Australia to the impact of Omicron on relevance of vaccination.
Govt claims website:
Archive.org (Jan 2, 2022):
COVID-19 vaccine claims scheme
The Australian Government is developing a claims scheme to reimburse people who suffer a moderate to significant impact following an adverse reaction to an approved COVID-19 vaccine.
About the scheme
Vaccination against COVID-19 is one of the most effective ways to reduce severe illness and death from infection.
There are 3 COVID-19 vaccines currently in use in Australia – Vaxzevria (AstraZeneca), Comirnaty (Pfizer), and Spikevax (Moderna). Like all medicines, vaccines can have side effects (also known as adverse events). Almost all of these are mild and resolve within a few days.
The Therapeutic Goods Administration (TGA) closely monitor adverse events for suspected side effects, and often find they are not caused by the vaccine itself.
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 adverse effects for claims purposes under the scheme include the following clinical conditions that are diagnosed by a treating doctors and are included in the approved product information for the specific vaccine:
thrombosis with Thrombocytopenia Syndrome
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:
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
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:
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.
Processing for COVID-19 vaccine compensation scheme to begin next month
Around 10,000 potential claims related to adverse reactions have been registered since September.
￼The COVID-19 vaccine claims scheme is being administered by Services Australia, with a portal reportedly due to be launched next month.
Claims made through the Federal Government’s no-fault indemnity scheme for COVID-19 vaccination will be assessed from mid-December, the Department of Health (DoH) has confirmed.
A spokesperson also confirmed the number of potential claimants registered since the scheme’s launch earlier this year, which followed lobbying from the RACGP and other medical groups.
‘Since 6 September 2021, 10,000 people have registered their interest in making a claim under the COVID-19 Vaccine Claims Scheme,’ they said in a statement provided to newsGP.
The no-fault indemnity scheme, which has been backdated to cover the entire rollout, was agreed to provide assurances to both vaccinators and vaccine recipients as the push to immunise a greater proportion of the population became more urgent.
It was announced following an emergency National Cabinet meeting in late June, amid a backdrop of a growing outbreak of the Delta strain and a severe squeeze on vaccine supply.
At the time, the most accessible vaccine was AstraZeneca, which was not then available in state hubs. The pace of the vaccine program had been impacted by shifting guidelines on the use of the vaccine related to very rare but widely reported side-effects.
According to prominent Melbourne GP Dr Mukesh Haikerwal, who estimates his clinic has vaccinated around 25,000 people, the introduction of the scheme played an important part in maintaining the momentum of the rollout.
‘The whole medical legal environment was quite fraught,’ he told newsGP. ‘The whole of the rollout of the vaccine program is dependent on a lot of goodwill.
‘[The Government] have done everybody a service by providing the surety and the backup [with] the scheme.
‘Now they’ve got to deliver by making sure that people who have claimed in good faith and who have unfortunately been injured through the process are looked after.’
Dr Haikerwal was surprised at the number of immediate reactions such as fainting at his Altona North vaccine clinic, but said the number of serious adverse events has been ‘miniscule’. He believes the scheme has allowed GPs and other medical professionals to keep their focus on the largest vaccination program in the country’s history.
‘In those rare cases when there’s a problem, you don’t need to wait three years for someone to put a lawsuit in then defend it. You don’t need that painful process,’ he said.
‘For the person who’s had an adverse reaction, it means they don’t have to go through that process of suing the doctor.
‘If they can prove the case is vaccine related, they’ll be compensated for it straightaway.’
Very rare serious side-effects
The 10,000 registered claims so far stands at around 0.06% of the more than 17.2 million people who have been fully vaccinated in Australia.
Overall, the Therapeutic Goods Administration (TGA) had received nearly 79,000 adverse event reports related to Australia’s three COVID vaccines at the time of publication. The vast majority of these side-effects have been minor, with local irritation and general symptoms like headache and fatigue the most widely reported.
According to data published on the AusVaxSafety website, which is part of a collaboration to monitor vaccine safety led by the National Centre for Immunisation Research and Surveillance (NCIRS), AstraZeneca has had the smallest impact overall on its recipients.
For that vaccine, 19% of respondents to a safety survey reported missing work, study or routine duties following a first dose, and 5% after a second dose.
Those figures stood at 8% and 21% for Pfizer’s first and second doses respectively, while those receiving Moderna have reported the biggest impact on their routine activities so far.
Twelve per cent of respondents to the survey reported a disruption following their first Moderna dose, and 35% after their second dose. However, the number of safety surveys conducted for that vaccine is much lower as it was only introduced into Australia’s vaccine rollout in mid-September.
Serious side-effects for all three vaccines remain extremely rare. The most high-profile of the reported issues, thrombosis with thrombocytopaenia syndrome (TTS) following vaccination with AstraZeneca, has affected an average of two in every 100,000 people. It has been much more commonly reported after a first dose.
The TGA reports myocarditis, which is associated with the mRNA vaccines, as occurring in about one in every 100,000 people following Pfizer, although more commonly in young men and teenage boys after a second dose (4–7 cases per 100,000 doses in this group).
There have been nine confirmed deaths directly linked to COVID-19 vaccination in Australia, with the last one reported in September.
The COVID-19 vaccine claims scheme is being administered by Services Australia, with a portal reportedly due to be launched next month, designed to provide people with a simple process to access compensation.
The scheme covers vaccines administered from the beginning of the rollout and will cover the costs of injuries above $5000 due to a ‘proven adverse reaction’ to vaccination.
According to the DoH website, those claiming between $5,000 and $20,000 will need to prove they have been hospitalised for at least one night and provide evidence of the injury as well as its likely link to a COVID-19 vaccination. They will also need to provide proof of lost wages if applicable.
The level of evidence required for claims of more than $20,000 has not yet been confirmed, but a DoH spokesperson said those details will be available soon.
‘The Government is finalising the policy documentation, including the evidentiary requirements that will be required to support the assessment of a claim,’ they said.
In the meantime, Dr Haikerwal said he had not anticipated such a wide take-up of the vaccine, nor its relatively benign safety profile.
‘I never thought we [would] get the numbers that we’ve got. But that’s because we managed to ramp it up and do it at scale,’ he said.
‘To actually have the vaccine developed and finalised in clinical trials, and actually rolled out in Europe in December, was just ... a miracle.’
The RACGP has said a no-fault injury compensation scheme should extend to all vaccines listed on the National Immunisation Schedule in Australia.
Dr Kate 18/11/2021 11:16:57 AM
I will be interested to hear what the official process will be for GPs who are asked to provide the information about vaccinations and the reported side effects. I have one patient with a severe reaction and ongoing disability who came for a 'normal' appointment with me with a handwritten note from her daughter, stating 'the lady from SA Health told my daughter on the phone to tell me to go to my doctor and get a letter stating what date I had the vaccine, what dates I was in hospital and what my multiple diagnoses were, information on my level of function before the reaction compared to now and assessment of disability level, the prognosis for future recovery, and the names of all the treating specialists I have seen through my 6 week hospital admission.' I was gobsmacked. I am hoping the courtesy of a formal letter of request at the very least will be forthcoming, but hasn't appeared in the 10 days so far since that visit....
Dr. Nikolai Petrovsky Discusses His Novel Vaccine for COVID-19 - TrialSite News (Nov 16, 2021) - potential arrest for physicians mentioning Ivermectin, or comparing two vaccines - Australian constitution lacks free speech guarantees (is this why Australia seems to have many Big Pharma supporters?)
Merck's Vioxx and scandal - Australia:
The most powerful companies you've never heard of: Merck
Philip Soos, Deakin University
October 19, 2011