Updated Covid immunisation compensation ‘still falls short’
New eligible Covid immunisation side effects have been added to Australia’s beleaguered vaccination compensation scheme.
New eligible Covid immunisation side effects have been added to Australia’s beleaguered vaccination compensation scheme, more than 12 months after some of these adverse reactions were reported by the medicines regulator, the Therapeutic Goods Administration.
The compensation policy, introduced as a “simple” no fault safety net for people who suffered rare side effects to a Covid jab, has been heavily criticised for its limited scope and lengthy, complex processes.
Only some vaccine injuries can be claimed but last week the federal Health Department added new disorders and clarified others.
Brisbane personal injuries lawyer Donna McManus says while some of the updates are welcome, the scheme still falls short of the promised safety net for people with genuine, established injuries.
“The addition of the new conditions might appear attractive at first glance but do not appear to go far enough … this is a token attempt to create the appearance that there are meaningful additions to the scheme,’’ she says.
Seven conditions relate to the AstraZeneca vaccine, which is no longer available in Australia following the expiry of existing batches. It was phased out in March due to the availability of other vaccines that target newer Covid-19 strains.
A new claimable medical condition has been added for the mRNA products. The serious skin disorder “erythema multiforme – major”, which involves blistering and ulceration to mucosal sites such as the eyes, mouth and genitals, is now an eligible condition for the Pfizer and Moderna Covid vaccines.
The TGA updated the product information for both these vaccines more than a year ago to list this as a potential reaction, although it didn’t differentiate between the “minor” and more serious “major” presentations.
The regulator’s adverse events database shows 20 notifications of erythema multiforme in patients aged 11-60 were linked with Pfizer and five were reported for Moderna.
A report to the database does not necessarily mean a link to the vaccine has been established, and these cases are rare: more than 44 million Pfizer doses and five million Moderna shots have been administered in Australia. The TGA says the benefits of vaccination greatly outweigh the risk of side effects.
The cardiac conditions pericarditis and myocarditis (inflammation of the heart or membrane around the heart), known side effects of the Pfizer and Moderna vaccines, have now been extended to include the Novavax jab.
The TGA database shows Novavax has been reported in 11 suspected cases of myocarditis involving people aged 19-50, and 42 cases of pericarditis in patients aged 23-67.
According to the TGA’s own report, pericarditis was added to the Novavax product information as a potential adverse event in September last year but it has only now been included in the compensation system.
A Health Department spokesman confirmed that serious side effects could only be included in the scheme if they were listed as an adverse event in the Australian production information for the specific vaccine. He did not respond to questions about the delay in adding these known side effects to the compensation register but said the new conditions could be claimed retrospectively.
The serious condition “cerebral venous sinus thrombosis without thrombocytopenia” (a rare type of stroke caused by a blood clot in one of the sinuses in the brain) can now be claimed against the AstraZeneca vaccine.
The department has also clarified the eligibility of demyelinating disorders: Guillain-Barre syndrome (damage to the peripheral nervous system) and transverse myelitis (a neurological disorder of the spinal cord that can cause weakness in the arms and legs or problems with bladder and bowel control) are covered for AstraZeneca but other demyelinating disorders are now not.
The Health Department spokesman said the new eligible conditions were based on advice from the TGA.
However, Ms McManus, of Brisbane practice Murphy’s Law, says it is still unclear why some conditions are excluded. Her firm has advised more than 300 clients about the policy and she says other medical conditions should be added where there is an established diagnosis that links the vaccine to the illness.
The heart conditions myocarditis and pericarditis are still not accepted for the AstraZeneca vaccine despite a Department of Health statement noting that evidence suggests AstraZeneca is probably associated with a small increased risk of both conditions.
Of the 3395 claims made to the scheme so far, just 126 have been approved and $7.2m paid out. A further 2357 are in progress or awaiting further information, 562 have been rejected and 350 withdrawn.
Many people with medically recognised vaccine injuries have told The Australian of their difficulty in navigating the scheme.
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