The COVID-19 vaccine rollout in Australia has begun

[lovetravellingoz]

Given the urgency you seem to feel is required for everyone to get vaccinated, advising a 6 week wait is more beneficial than being fully vaccinated within 3 seems unwise.

I did not actually advise a 6 week wait for the second dose. How much better the immune response would be exactly is not known, and it may not be materially significant.

What I was indicating is that if anyone has their second Pfizer dose at more than 21 days that they not be at all concerned.





If they did move everyone to 6 weeks, not that anyone proposed that, the date that we would reach heard immunity would be little different as it would only be the last tranche that would extend things by 3 weeks.

Whereas not utilising AZ now for some of the under 60's will say will drag things out longer by say 3 months. The more do so, the better in my opinion. Obviously that will exclude those that GP's rule out.

To jettison AZ completely would drag it out longer again.

 

[Pushka]

SA Health are playing funny b's about giving AZ to people under 40, despite the fanfare they had on their FB page etc when they administered the first AZ to a younger Doctor in 1a group a few months ago. I know of many GP's Who have given AZ to people in their twenties and thirties. Including a GP herself having AZ. What are they playing at? It is extremely unhelpful.

 

[lovetravellingoz]

I agree. However, the reality may be different from what we're seeing now. The fact of the matter is access to Pfizer vaccines remains largely restricted to those between the ages of 40 to 60 and those deemed high priority (e.g. Phase 1a and Phase 1b) whose underlying health condition may prevent them from getting AstraZeneca. At the same time, the supply of Pfizer remains low with many clinics not receiving supplies of the vaccine until sometime in July.

I suspect there will be very many on this forum who are keen on getting vaccinated and do not want to wait 4 or 5 months to get their jab (e.g. those in their 20s), understand the relatively low risks associated with the AstraZeneca jab and want to have some protection now rather than the promise of getting full protection faster later.

Your Trusty,
KangarooFlyer88

Yes so:

• for the young, AZ will get them vaccinated more quickly.
• for the nation, the combined used of AZ/Pfizer/Moderna (and maybe Novavax) will get the nation vaccinated more quickly.

And there is no such thing as thing as no adverse health event/effects. The longer it takes to get the nation to an adequate vaccination level the more likely that there will be adverse health effects from some catching Covid, or other health or mental health problems.

 

[drron]

There is no consensus that 6 weeks gives better response than 3 weeks, and only a small study in elderly.

Whilst it is safe to wait up to 6 weeks, the timeframe most commonly followed in Australia, USA, Israel, NZ and most of Western Europe is 3 weeks.

Given the urgency you seem to feel is required for everyone to get vaccinated, advising a 6 week wait is more beneficial than being fully vaccinated within 3 seems unwise.

Also as you know, Pfizer is approved for use in Australia for ages 16 and up, and whilst it is recommended for 16-69 we know many very elderly people also received it safely in 1A. In USA its approved for ages 12 and up.

First of all there were no studies but the reporting of the real figures both in the UK and Canada which also extended the gap between shots up to 12 weeks.There were many thousands vaccinated.The reason why the reports are about the elderly is because they were the ones prioritised for the vaccines.
And in the elderly the increase in antibody levels was 3.5 times with the 12 weeks compared to the 3 week gap.With that magnitude it is unlikely there would be no difference in young patients.

And the WHO has issued a decree that only chidren and adolescents with co morbidities should be vaccinated.The same was also published by the German vaccine advisory body.I have posted the links before.

Plus young men are more prone to myocarditis/pericarditis especially after the second mRNA shot.Although usually mild there are reports of death due to this complication.It is now accepted as fact.

 

[mviy]

A mixture of headlines on tomorrow's front pages. Some like one in Perth indicating that young people are getting vaccinated. The Age in Melbourne says "Doctors urge under-60s to wait for Pfizer jabs".

 

[kangarooflyer88]

Yes so:

• for the young, AZ will get them vaccinated more quickly.
• for the nation, the combined used of AZ/Pfizer/Moderna (and maybe Novavax) will get the nation vaccinated more quickly.

And there is no such thing as thing as no adverse health event/effects. The longer it takes to get the nation to an adequate vaccination level the more likely that there will be adverse health effects from some catching Covid, or other health or mental health problems.

Whilst I agree that this sounds like a good plan, I find it difficult to square that away with the AMA/ATAGI advising those under 60 not to get the AstraZeneca vaccine. Again it's mixed messaging: the government is encouraging everyone to roll up their sleeves for the jab, regardless of who makes the jab, whilst the ATAGI/AMA directly refutes that statement. I suspect a large number of Australians under 60 are under the (false) impression that they must wait for Pfizer to become available which will take some time.

You are also correct that there is no such thing as a risk-free endeavour during this pandemic. The risks of COVID are substantial with about 3% of all Australians who contracted COVID dying from the disease. At the same time, neither the commonwealth nor the states have made a commitment to returning to COVID-zero (although they are certainly taking steps to get there). However, even if they were successful in stifling this outbreak, there is no guarantee there will not be a breach in quarantine in the future. All it takes is an unvaccinated hotel quarantine worker or someone who contracted COVID during hotel quarantine to spread it in our communities. What we do know is that with either the Pfizer or AstraZeneca vaccine, the risk for complications is relatively low and in many cases when they occur they can be treated in a hospital. I have yet to hear anyone on this forum or elsewhere complain about the non-trivial risks of dying from taking an aspirin yet people take them every day.

Your Trusty,
KangarooFlyer88

 

[jonboixxx]

Love it

 

[Chalkie]

True if its fully approved.

But I suspect after the AZ experience, many will want to see real world (not trial) evidence of safety and effectiveness before lining up for Novavax. It will be interesting to see which first world countries deploys it first.

There is no such thing as "real world" evidence of safety and effectiveness (unless marketing approval is given somewhere else first and Phase IV / pharmacovigilance data happens to be available and submitted as part of an application for marketing approval). An application for marketing to any of the key global pharma regulators (the US FDA, Health Canada, Australia's TGA, and Europe's EMA) can be - and regularly is - made on the basis of clinical trial data ONLY. And there are international arrangements in place between various regulators (including Australia's TGA) where data and information is shared and approval by one regulator can be used in the assessment by another regulator of an application for marketing approval. Some of these arrangements go so far as to give multilateral legal equivalence to approval by one regulator).

All pharmaceutical products get "tested" in the real world in Phase IV trials / through pharmacovigilance AFTER marketing approval is granted.

The suggestion that "many will want to see real world (not trial) evidence of safety and effectiveness" is a suggestion that does not reflect the actual process that regulators globally deploy in granting marketing approval for pharmaceutical products. Anyone waiting to see Phase IV / pharmacovigilance studies could potentially wait a very long time, and possibly well after Australia has already granted marketing approval.

 

[Chalkie]

On a small scale, the AZ trials didnt uncover the TTS, that took real world usage at large volumes.

The AZ Phase III clinical trials were not "small scale". There were 32,449 participants. This is vastly more than virtually all other clinical trial populations for any pharma product on the market (I am unaware of any other Phase III trials for any other pharma products in the modern regulatory world that have had as many as 30K participants, but it is possible they exist and I am simply unaware of them). Most Phase III trials which form the basis for applications for marketing approval have up to a few thousand participants, and for some products, particularly oncology products, Phase III trial subject populations can number in the few hundreds.

All pharma products return instances of adverse effects in the "real world", aka Phase IV / pharmacovigilance studies. Marketing approval is rarely withdrawn just because adverse effects are found. It depends on what the adverse effects are, whether they are medically manageable and what the risk/benefit assessment is.

I lived the pharma regulatory world for many years in my professional role. I acquired first hand knowledge of how it works globally in representing and advising global pharma clients. I have been dismayed by how much misinformation and misunderstanding of how pharmaceutical regulation occurs in the real world has been promulgated during the pandemic. Governments globally could have used this as an opportunity to explain how the processes work - and how effective they are. Instead, silence, and a void filled by inaccuracies.

The conduct of ATAGI (and now the AMA, particularly after doctors were granted indemnity by the government for administering AZ in accordance with its TGA approval) in its dealings with the AZ vaccine has been shameful. It is anti-scientific and, IMO, has taken into account irrelevant considerations or failed to take into account relevant considerations, for ulterior (political) purposes. I cannot of course prove this, but they are the inferences I draw from watching what has happened.

 

[Chalkie]

Greg Hunt has confirmed that advice has not changed, this is the correct message he hasn't gone off script as some are claiming on this thread. As is stated earlier the way has been cleared for younger people to override health advice and get AZ, but the advice itself has not changed, and Pfizer remains the recommended vaccines for under 50s.

From SMH:

Federal Health Minister Greg Hunt said the medical advice had not changed and Pfizer remains the preferred vaccine for under 60s.

“Some GPs have reported that they have excess supply and excess spaces, and so if there are people who wish to access it, by informed consent, via the existing ATAGI rules, then that is simply being enabled,” he said.

Greg Hunt is mistaken in characterising what ATAGI has said as "rules", and that is troublesome as it will mislead people into thinking that ATAGI has a rule-making power. ATAGI's technical advice (in accordance with its terms of reference) is not "rules" and binds no one. ATAGI has no rule-making (or indeed any other) power. No one is obliged to follow what ATAGI has said, and the government itself knows this and has put that into play by granting an indemnity to doctors who administer AZ in accordance with its TGA approval.

 

[kangarooflyer88]

Greg Hunt is mistaken in characterising what ATAGI has said as "rules", and that is troublesome as it will mislead people into thinking that ATAGI has a rule-making power. ATAGI's technical advice (in accordance with its terms of reference) is not "rules" and binds no one. ATAGI has no rule-making (or indeed any other) power. No one is obliged to follow what ATAGI has said, and the government itself knows this and has put that into play by granting an indemnity to doctors who administer AZ in accordance with its TGA approval.

It seems to me that ATAGI has been on a power trip ever since the COVID vaccines came to market. They assumed that a policy of eliminating all possible risks and side-effects from the vaccine was more important than getting the vaccines into as many Aussies arms as possible given the non-existence of COVID in the country. However, what these think tanks like the ATAGI and AMA fail to take into account is the emotional trauma the lockdown Australia has been in since March 2020 has had on all of us. Let's face it, the country was locked down since March 2020, sure shops have remained largely open, but when it comes to travelling domestically or internationally that has been all off the cards for many. Some of us have not seen our relatives in several years right now and the way things are going with the vaccine roll out it may be several more years before this lockdown ends. They also assumed (incorrectly) that we will always be staying at this COVID-zero state when as we've seen in the past several weeks that's frankly not a reality be it in Melbourne or Perth, Sydney or Brisbane, Darwin or Gold Coast. Why is it virtually every other country in the world has accepted AstraZeneca (with few provisos), yet we're still dinking around trying to figure out how to administer vaccines?

At first I could understand why Australia went into a lockdown the way it did, it protected communities and businesses. But one has to wonder at some point, are these measures of keeping the lockdown whilst dragging one's heels when it comes to vaccination actually starting to hurt businesses? When is enough, enough for Qantas? Have they not suffered enough having lost well over a year of international flights? What about the hoteliers, tour operators, and restaurants that could count on tourists landing in Sydney, Adelaide, Melbourne, and Brisbane like clockwork in January?

Frankly, I think it is high time we regulate how the AMA and ATAGI communicate with the public. Just as you wouldn't sell a packet of cigarettes without warning labels cautioning you on the health effects of the product, nor should we allow these "experts" to spew their beliefs without a disclosure that what they are saying are opinions and should not be construed as medical advice. Many Aussies have incorrectly assumed that what the AMA and ATAGI say is gospel and must be followed like a hard and fast rule. In reality, it is one expert's feelings on a subject.

Your Trusty,

KangarooFlyer88

 

[MooTime]

99% of Joe Public wouldn't know who ATAGI or AMA are & never heard of their announcements.

People make their decisions based on other people they talk to, general media & social media. Not some formal semi-gov group.

 

[Pushka]

Greg Hunt is mistaken in characterising what ATAGI has said as "rules", and that is troublesome as it will mislead people into thinking that ATAGI has a rule-making power. ATAGI's technical advice (in accordance with its terms of reference) is not "rules" and binds no one. ATAGI has no rule-making (or indeed any other) power. No one is obliged to follow what ATAGI has said, and the government itself knows this and has put that into play by granting an indemnity to doctors who administer AZ in accordance with its TGA approval.

Unfortunately the Federal Govt messaging though, has been that unless ATAGI gives the advice, (until last Monday that is), then it won't happen.

 

[jakeseven7]

Whilst I agree that this sounds like a good plan, I find it difficult to square that away with the AMA/ATAGI advising those under 60 not to get the AstraZeneca vaccine. Again it's mixed messaging: the government is encouraging everyone to roll up their sleeves for the jab, regardless of who makes the jab, whilst the ATAGI/AMA directly refutes that statement. I suspect a large number of Australians under 60 are under the (false) impression that they must wait for Pfizer to become available which will take some time.

You are also correct that there is no such thing as a risk-free endeavour during this pandemic. The risks of COVID are substantial with about 3% of all Australians who contracted COVID dying from the disease. At the same time, neither the commonwealth nor the states have made a commitment to returning to COVID-zero (although they are certainly taking steps to get there). However, even if they were successful in stifling this outbreak, there is no guarantee there will not be a breach in quarantine in the future. All it takes is an unvaccinated hotel quarantine worker or someone who contracted COVID during hotel quarantine to spread it in our communities. What we do know is that with either the Pfizer or AstraZeneca vaccine, the risk for complications is relatively low and in many cases when they occur they can be treated in a hospital. I have yet to hear anyone on this forum or elsewhere complain about the non-trivial risks of dying from taking an aspirin yet people take them every day.

Your Trusty,
KangarooFlyer88

AMA just appeared on live TV and said they were misquoted...

Personally I think they just miscommunicated themselves as they have a habit of doing... a lot.... but anyway they have clarified that they are are absolutely fine with people under 40 getting AZ after a consult.

They are however annoyed about not being involved and GP’s not getting any notice - said GP’s have been inundated with calls for bookings and a lot don’t have enough vaccine (here we go again...!)

I do see their point about no notice being given but it was an emergency set of meetings... sometimes stuff happens quickly... and that’s rare in Australia - especially when it comes to vaccines

 

[Pushka]

They are however annoyed about not being involved and GP’s not getting any notice - said GP’s have been inundated with calls for bookings and a lot don’t have enough vaccine (here we go again...!)

And therein lies the answer to their initial "misquote" issue. The forum for discussing such issues re communication is behind closed doors and not the media who are salivating for controversy.

 

[jakeseven7]

99% of Joe Public wouldn't know who ATAGI or AMA are & never heard of their announcements.

People make their decisions based on other people they talk to, general media & social media. Not some formal semi-gov group.

Thank goodness the AMA has been pretty much sidelined during this pandemic. They unfortunately have some loony state representatives that shoot from the hip and are not great at clear communication at the best of times.

Anyway I 100% agree with you and they have no real power anyway (thankfully).

 

[Pushka]

Thank goodness the AMA has been pretty much sidelined during this pandemic. They unfortunately have some loony state representatives that shoot from the hip and are not great at clear communication at the best of times.

Anyway I 100% agree with you and they have no real power anyway (thankfully).

AMA rep in SA has rather reshaped the message and said AZ is fine as long as you've had the discussion with GP and understand any risks.

Hmmm. What a difference a day makes....

COVID outbreaks are a 'gamechanger' for AstraZeneca vaccine risk profile​

By Yara Murray-Atfield

The risk-benefit outcomes for young people getting vaccinated with AstraZeneca has changed dramatically in light of the recent outbreaks, the chair of the Australian Medical Association (AMA) Council of General Practice has said.

"From the very beginning, what was very clear was that the AstraZeneca vaccine is an excellent vaccine, very, very safe and extremely effective," Richard Kidd, who is also on the ATAGI COVID-19 working group, told ABC Radio Melbourne.

More

In SA media there's a lot of backtracking on the dangers of AZ now with the message from former SA AMA rep - just get vaccinated with what you can get. And he himself stated he had vaccinated many young people with AZ in recent weeks as they just wanted to be vaccinated.

 

[justinbrett]

Annastacia Palaszczuk just ruined the vaccine roll out in Queensland

 

[jakeseven7]

Annastacia Palaszczuk just ruined the vaccine roll out in Queensland

Was the QLD CHO not AP. She can’t make up that stuff herself. They quoted an online BBC article I mean are they serious?!

And they are attacking the Feds for the decision... using it for political point scoring. Disgusting. They are just pissed off because the Feds have said no on the quarantine facility, no extra vaccine stocks etc.

They are panicking because they have made some awful decisions and trying to deflect. We just need to ignore QLD for four more months.

4 more months and Dr Young is kapoot....

 

[bcworld]

Annastacia Palaszczuk just ruined the vaccine roll out in Queensland

Wasn't watching but I can probably imagine the kind of foot in mouth performance she managed.