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‘The beginning of the end of this pandemic’


Anastasia Tsirtsakis


16/02/2021 4:17:43 PM

The Oxford University/AstraZeneca coronavirus vaccine has been approved for use in Australia, while the first doses of Pfizer/BioNTech’s candidate will start being administered next week.

Vaccine vile.
AstraZeneca’s viral vector vaccine is the second candidate to be approved for use in Australia by the TGA. (Image: AAP)

The Therapeutic Goods Administration (TGA) has approved the Oxford University/AstraZeneca candidate for use in people aged 18 and older; however, it recommends immunisation for people aged over 65 be decided ‘on a case-by-case basis’ due to limited data for the efficacy and safety in older cohorts.
 
‘The decision to immunise an elderly patient should be decided … with consideration of age, co-morbidities and their environment, taking into account the benefits of vaccination and potential risks,’ the TGA stated.
 
‘The vaccine has been shown to create an immune response in this group and can be used based on the efficacy and safety demonstrated in the general clinical trial population.’
 
Despite the qualification, TGA boss Adjunct Professor John Skerritt said the recommendation does not mean there is an upper age limit for the vaccine.
 
‘[It] goes back to the original design of the trials, where 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.
 
‘But our analysis of the data gives us no reason to suspect that the vaccine would not be fully efficacious in older groups.’
 
RACGP President Dr Karen Price responded to the announcement by reaffirming that general practice is ready and able to support the vaccine rollout.
 
‘Most Australians will get the AstraZeneca vaccine, and many will naturally want to be vaccinated by their usual GP,’ Dr Price said.
 
‘GPs across the country overwhelmingly want to vaccinate their patients. There was a huge response to the Department of Health’s expression of interest with over 5000 practices applying to be a vaccination clinic.
 
‘Initially, not all practices will be able to be involved in the vaccination program, but eventually the expectation is that it will be rolled out more widely, and more practices will become involved as supply increases.’
 
Dr Price said it will be ‘critical’ to vaccinate as many highly vulnerable people as efficiently as possible during phase 1 of the rollout.
 
‘We know there will be high demand for the vaccine, and I urge everyone to please be patient and understanding,’ she said.
 
‘We ultimately would like to see every practice that wants to provide these vaccinations to be able to do so. We need to get to the stage where COVID-19 vaccinations are part of usual patient care as soon as possible – especially if we want to finish this job by October, as the Government has said they want to.’
 
Adjunct Professor Skerritt said Australia has the benefit of looking to the UK’s experience, where the Oxford University/AstraZeneca vaccine has been administered for over a month with ‘very good results’ in older groups.
 
‘[There is] real world evidence of the vaccine going well in older groups, and also there’s evidence from blood tests looking at the response of the immune system to these vaccines, that again shows a strong immune response in people over 60, people over 65, and so forth,’ he said.
 
‘Yes, more data on a lot of things will emerge as months and weeks and years go by, including the duration, how long the vaccines provide protection for.
 
‘On the balance of the evidence, we have no reason and we felt there was no reason to limit its use to particular age groups.’
 
Crucially, the TGA also clarified that the two doses of the vaccine are to be given 12 weeks apart, as recommended by the Australian Technical Advisory Group on Immunisation.
 
In the case that a 12 week interval is not possible, due to imminent travel, cancer chemotherapy or major elective surgery, a minimum interval of four weeks is recommended.
 
Adjunct Professor Skerritt also confirmed that people can receive vaccinations to protect against both COVID-19 and the flu, but that they must be delivered at least two weeks apart.
 
‘This is an issue that’s occupied the minds of regulators around the world because we’re wanting to identify whether there are particular adverse events related to the COVID vaccines, or the flu vaccines for that matter,’ he said.
 
‘If you give both of them together, you don’t know which one may have caused the problem – not that we’re seeing significant problems.
 
‘So if, for example, you’re in a phase 1a group – if you’re say a frontline quarantine worker and you have your [coronavirus] shot in the next couple of weeks – we’d recommend [they] wait a couple of weeks until they have their flu shot.’

AstraZeneca-TGA-approval-article.jpg
TGA boss Adjunct Professor John Skerritt confirmed that while people can receive vaccinations to protect against both COVID-19 and the flu, they must be delivered at least two weeks apart. (Image: AAP)

The Federal Government has secured 53.8 million doses of the vaccine, with initial supplies expected to arrive in Australia by ‘early March, if not sooner’, according to Federal Health Minister Greg Hunt, before locally manufactured doses become available.
 
Prime Minister Scott Morrison said news of the TGA’s approval further confirms Australia’s vaccination program is ‘on track’.
 
‘Our vaccination program has the backing of Australia’s best medical experts and that means that we can proceed along the path that we have set out,’ he said.
 
‘I look forward to working with all the states and territories and medical health professionals across the country, those involved in [the] logistics supply chain, to ensure we can get this out right across the country.
 
‘It’s going to make a huge difference to how we live here in Australia this year, and in the years ahead.’
 
Victorian Chief Health Officer Professor Brett Sutton said he hoped the news would lift people’s spirits, noting the mental health anguish that has resulted from the pandemic.
 
‘Who wouldn’t be delighted at the prospect of another vaccine, especially one locally manufactured that will deliver millions of doses to Australians,’ he said.
 
‘I can’t wait to be vaccinated when my time in the queue comes, and [am] looking forward to seeing it roll out across the country.
 
‘It literally represents the beginning of the end of this pandemic as we roll out a vaccine.
 
‘It is incredibly positive to see that development, and [to] know that [the] Pfizer vaccine will start to roll out in our hotel quarantine system, first ports of entry, our aged care and health sector staff and residents – [it] is fantastic news.’
 
The TGA’s provisional approval is valid for two years, and requires AstraZeneca to continue providing information on longer term efficacy and safety from ongoing clinical trials and post-market assessment, with further information ‘expected in coming months’.
 
While the vaccine has been shown to prevent COVID-19, the TGA notes that it is not yet known whether it prevents transmission or asymptomatic disease.
 
‘Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard,’ the TGA said.
 
‘The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields including consumer representation.’
 
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Dr Michael Lucas Bailey   17/02/2021 7:21:20 AM

The TGA Product Information for both vaccines approved so far specifically notes there is no data on the safety or efficacy of these vaccines in the immune suppressed. Age is mostly a non-issue for vaccines. Immune suppression can cause complications but there has been no information on this provided. Simply is it safe or contraindicated?


Dr Ian   17/02/2021 9:55:07 AM

Australia has the capacity to manufacture vaccines and is doing so through CSL .
The COVID variants are a concern and Australia has the capacity to meet the challenges with excellent scientists theoretical and practical .
As for immune compromised the vaccines ought still work but there is also pre and post exposure with monoclonal antibodies .
Research is showing they can be given subcutaneously as well as by infusions .
Super protective masks are on the market as are high quality face visors .
Then we know an Australian company has developed a rapid antigen test another protective layer and proof of Australian ability .