DoH confirms vaccine indemnity scheme, but questions remain

Any health practitioner, including GPs and nurses, who has participated in the primary care COVID vaccine rollout will be covered by the new professional indemnity scheme announced by Prime Minister Scott Morrison earlier this week.
 
While the details are still being worked out, the Department of Health’s (DoH) First Assistant Secretary for the COVID-19 Primary Care Response, Dr Lucas de Toca, told GPs during a weekly webinar it will be designed to provide ‘greater certainty’ for patients and professionals.
 
‘The idea is that [if you are] a health practitioner that is part of the program and you’re delivering the vaccines according to the guidance … you shouldn’t fear that you’re going to get tied up in complicated litigation if something – despite your best efforts – goes wrong,’ he said.
 
‘The specifics will be worked through in partnership with the peak [bodies] and the colleges [who will be] properly consulted. But the broad scope is to have a scheme that covers health practitioners [who] engage in the Commonwealth vaccine rollout throughout primary care.’
 
Dr de Toca was less clear, however, on when the scheme will be finalised, despite the fact the Federal Government has already expanded eligibility criteria for AstraZeneca to anyone over 18 who possesses no contraindications and has made an informed decision following a discussion with their GP.
 
‘The details will be worked on over the next few days and weeks, and there will be significant specific information on how it’s going to actually work and operate,’ he said.
 
‘The most important message is that the medical advice has not changed … Pfizer is the preferred vaccine for people under 60 years of age, but the medical advice never precluded people under 60 from accessing the AstraZeneca vaccine.
 
‘It’s ultimately about giving people 18–39 the choice to have a conversation with their practitioner and have a fully informed decision on whether that vaccine is right for them, or [if] waiting for Pfizer later on is a better choice.’
 
Dr de Toca was also unable to provide a definitive answer to GPs’ questions about potential changes to the recently created vaccine counselling item number 10660 in order to help facilitate those conversations.
 
‘At the moment those items are restricted for patients who are 50 years and over, but they’re currently being reviewed,’ he said.
 
‘We expect that to be finalised within days on whether we need to change them to expand that suitability.’
 
The GP webinar occurred on the same day the Therapeutic Goods Administration (TGA) released its most recent COVID-19 vaccine weekly safety report, which for the first time documented Australian cases of myocarditis and pericarditis potentially linked to the Pfizer vaccine.
 
The TGA has documented eight cases of suspected myocarditis and 19 cases of suspected pericarditis since the rollout began earlier this year. During this time, approximately 2.9 million Pfizer doses have been administered.
 
In a contrast to other parts of the world, where the cases have been predominantly young men, 18 of the TGA reports were in women, while only eight were in men. Typically, these cases occurred within seven days of vaccination, particularly after the second dose.
 
‘One of the men was 18 years old and another was 23 years old, while the others were aged 41–72 years,’ the report states. ‘The women were aged 23–47 years old. At the time of reporting, the majority of individuals had recovered or were recovering.
 
‘The TGA is actively considering the need for updates to the approved Product Information and has sought advice from the Advisory Committee on Vaccines on this issue.’
 
However, the report also reinforced that myocarditis and pericarditis are ‘much more common’ with COVID-19 and that the risks to the heart can be more severe in this context, while the benefits of protection against the disease ‘far outweigh’ the rare and generally mild side effects linked to the Pfizer vaccine.
 
The safety report also documented a further five reports of blood clots and low blood platelets assessed as confirmed or probable thrombosis with thrombocytopenia syndrome (TTS), likely to be linked to the AstraZeneca vaccine.
 
The recent cases, found in two men and three women aged 52–83, takes the total number of Australian reports to 41 confirmed cases and 28 probable cases from approximately 4.6 million doses of the AstraZeneca vaccine.
 
Three Australians remain in intensive care, while 26 of the 69 cases were graded ‘Tier 1’, as they involved clots in an unusual location, such as the brain or abdomen, and ‘tend to have more serious outcomes than Tier 2 cases’.
 
Meanwhile, the TGA is closely monitoring reports of immune thrombocytopenia (ITP) and investigating whether there may be a link with AstraZeneca.
 
The regulator has received 36 cases of suspected ITP in people who had received the AstraZeneca vaccine and two cases in people who received the Pfizer vaccine. A recent Scottish study has suggested the AstraZeneca vaccine comes with a small increase in the risk of ITP (one in 100,000 vaccinated people).
 
Although many of 36 cases of suspected ITP have recovered or are recovering, one person who had received AstraZeneca has reportedly died, and the TGA has convened an external Vaccine Safety Investigation Group of clinical experts and consumer representatives to assess whether it could have been related to the vaccine.
 
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AstraZeneca blood clots coronavirus COVID-19 indemnity MBS myocarditis Pfizer TTS vaccine counselling