What the TGA means by ‘case-by-case’ basis for over 65s

Anastasia Tsirtsakis

18/02/2021 5:56:11 PM

The approval of the Oxford University/AstraZeneca vaccine has raised some unanswered questions, but RACGP President Dr Karen Price says GPs are still well equipped to handle the rollout.

GP talking to an elderly patient.
Some GPs have raised concerns over the lack of robust data and guidance for vaccinating people aged over 65 with the AstraZeneca candidate.

‘The decision to immunise an elderly patient should be decided on a case-by-case basis with consideration of age, co-morbidities and their environment, taking into account the benefits of vaccination and potential risks.’
That is the guidance issued by the Therapeutic Goods Administration (TGA) on Tuesday for patients aged over 65, following the granting of provisional approval for use of the Oxford University/AstraZeneca vaccine in Australia.
But with the first million doses expected to arrive in just weeks, many GPs have been seeking more clarity, among them Hobart GP Dr Karen Magraith.
‘I’ll recommend that patients have whichever vaccine they are offered,’ she wrote on Twitter.
‘I’m more concerned about fielding lots of questions from anxious patients. Many of us are flat out and this will take time away from other work.’
Geriatrician Dr Kate Miller expressed similar concerns. 
‘I look forward to deep diving into this data for my patients as the TGA doesn’t seem to have,’ she Tweeted. ‘Because they are going to ask me and the TGA doesn’t seem to have done the work to at least broadly categorise. Over 65s are such a diverse group of humans.’
RACGP President Dr Karen Price acknowledged the anxiety among GPs.
‘There are so many unanswered questions and the human brain does not deal well with uncertainty – we like answers,’ she told newsGP.
‘Some of them are more readily available than others, and the college is going to provide as much information as possible, as is the Department of Health [DoH].
‘But whenever you initiate anything new, there’s always some degree of “let’s see how you respond in this instance”.
‘For example, when I give a blood pressure medication to someone, I don’t exactly know how they’re going to respond; there are the studies telling me, but I don’t exactly know.’
However, while the wait for more robust data continues, Dr Price says she is confident GPs have the skillset to navigate the rollout in over 65s.
‘I think that most GPs are going to be able to make this decision, even though some of them may have some degree of caution – that’s why we got trained to such a high level,’ she said.
‘Twelve years of training in patient decision-making gives you a significant set of skills. It also makes you feel uncomfortable at times, but that’s part of being a professional.’

RACGP President Dr Karen Price said the college and Department of Health will be providing as much information as possible, as soon as it becomes available.

She also said further data will soon be available that will allow GPs to become ‘increasingly confident’, and in the meantime those who are uncertain can seek further support.
‘The overseas data is encouraging. We know that compared to the mRNA vaccine, AstraZeneca appears to have fewer side effects in older people, which is really good,’ Dr Price said.
‘So far the data on that is that 100% this vaccine is going to protect older people against severe COVID, hospitalisation and death.
‘I do think, though, that it’s put a lot of risk back on us and this has been a fairly vigorous discussion that we’ve had with the medical defence organisations, and the Department of Health [DoH] and the Government, because we’re doing a public health service and it’s a really tricky area.
‘[So while] we are confident for most people, in terms of the clinical decision making and in terms of managing very, very frail older people or very complicated multi-morbidities, GPs may want to seek advice, which would be the same in any procedure.’
While large-scale trial data for older cohorts is lacking, the TGA has made it clear that the vaccine is safe and induces an immune response. Adjunct Professor John Skerritt, Head of the TGA, has also reassured doctors that the recommendation is not indicative of an upper age limit.
‘AstraZeneca targeted their initial trials towards healthcare workers who are of working age and usually under 65, and only included older people later on,’ he said during a press conference on Tuesday.
‘But our analysis of the data gives us no reason to suspect that the vaccine would not be fully efficacious in older groups.’
In an attempt to further clarify the regulatory body’s position, Adjunct Professor Skerritt suggested the vaccine may not be appropriate for people who are very elderly and frail.
‘If someone only has a few weeks to live, we don’t give them a hip replacement and we may not give them a vaccine, so that’s what we’re hinting at,’ he said.
In the UK, where the Oxford University/AstraZeneca vaccine has been administered since 3 January, Adjunct Professor Skerritt says there have been ‘very good results’ in older cohorts.
The TGA is also expected to know more about the vaccine in older cohorts in coming weeks, as data becomes available from a large US trial.
Regardless, Dr Rod Pearce, GP and Chair of the Immunisation Coalition, agrees the existing data is reassuring.  
‘Talking to the allergists, there’s really not a lot of contraindication for any of the vaccines,’ Dr Pearce told newsGP.
‘It goes back to a one-on-one conversation that you’re going to have anyway. To me, because the data is not there, that initial advice is going to be actually just talk about it [with the patient].
‘There’s really no one who shouldn’t have it. The worst things that can happen are to someone who’s later in life or receiving palliative care, but … you can still give it. It’s not going to lead to an early death and is unlikely to have any serious consequences.’
But what if a GP deems a patient an unsuitable candidate for AstraZeneca? Can they guarantee their patient a spot in line for Pfizer/BioNTech?
Dr Price says that remains unclear. 
‘At this stage, it’s hard to say how that will operate,’ she said.
‘But the consistent message is you’re not going to be able to choose your vaccine because the Department certainly doesn’t want everyone putting off an available vaccine, waiting for something that might come later.
‘That would be a very bad message to get out there.’
The DoH and the TGA have been contacted for comment.
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Dr Carlos Jose Sanchez Caballo   19/02/2021 7:10:13 AM

This article is very reassuring!

Dr Duncan   19/02/2021 8:00:12 AM

Are the TGA 'hinting' that all over 65 are effectively on end-of-life care? This 'clarification' still makes no sense, and is not helpful in the context of trying to have these conversations during level A vaccination appointments.
Maybe it's new govt policy to balance the budget. Withdraw all care for over 65s, and just treat them palliatively, on a 'case by case basis'. It'd save on healthcare costs I suppose?

Dr Graham James Lovell   19/02/2021 10:23:00 AM

It will be fascinating to see how the consenting process works during the initial rolling out to Aged care residents supposedly before the general population .
With Influenza vaccination the RACFs do the consenting for the hundreds of residents.
Nearly all lack testamentary capacity requiring lengthy chasing over days to weeks of their legal representatives, who are often interstate .
I can’t see how this will work for those GPS I know with nearly 100 residents?
Also will we get a clear statement for ALL COVID Vaccines that being Immunosuppressed is NOT a contraindication to using the vaccines.

Dr Ailsa Mary Carole Laidlaw   19/02/2021 4:36:26 PM

This article is probably out of date. It now appears that the AstraZenica vaccine is only effective in 10% of the South African covid variant. Not sure how many patients will want to have a new vaccine which only has a 10% effectiveness for one of the current strains.
Just because the federal health department keeps on repeating that it will still be effective, doesn't make it effective.

Dr Karen Linda Price   27/02/2021 8:59:21 AM

Thanks Ailsa. The pandemic science includes but is not limited to vaccination. The fight in Australia is largely on our borders and quarantine staff received Pfizer. From my briefings there is great awareness of the South African variant. Noting it was a small sample size tested is my understanding. So more research required as always.
Later in the year Novavax is likely to be our third option and who knows about next year.
Right now It is imperative we get as many people vaccinated as quickly as possible. It is also vital that we support Covax initiatives for other countries as uncontrolled virus will yield more mutations.
Pandemic science includes securing the supply chain which is true of Astra-Zeneca and also likely for Novavax with regard to local manufacture. Australia’s ability to manufacture mRNA vaccines at commercial scale is a few years off yet.
The strategy is sound at this stage and likely adaptable for the future as the need arises.

Dr Khodadad Davari   27/02/2021 12:26:43 PM

Our situation is different from UK. Our options are not "COVID or vaccine".
I think we should wait for long term safety data especially for the Oxford vaccine which is first ever human DNA vaccine.