Carlton player Liam Jones refusing vax - Update: Jones retires from AFL

[Gruffles]

And the point you were arguing that the German head of Bayer said wasn't saying the RNA vaccines were gene therapy, because someone with English as their second language said "for" instead of "of", was wrong. He further clarified that if people knew that mRNA vaccines were gene therapy most wouldn't accept the vaccine.

In their own written words both Pfizer and Moderna admit their mRNA products are gene therapy, and considered to be so by the FDA.

Do we have disagreement on what gene therapy is?

As you've pointed out above, they also make clear there has been no approval for mRNA medicines before and they accurately predict their preclinical and clinical trials may be approved on different criteria that has been established for gene therapy products, which means many requirements like reproductive toxicity, ADE studies were not completed.

Both Pfizer and Moderna's own documents make it clear "No mRNA drug has been approved in this new potential class of medicines, and may never be approved as a result of efforts by others or us. mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines."

Regulatory requirements governing gene and cell therapy products have evolved and may continue to change in the future, and the implications for mRNA-based therapies are unknown.

Even if we obtain regulatory approval for an investigational medicine, including mRNA-1273 (Moderna), our products will remain subject to regulatory scrutiny. For example, the holder of an approved BLA is obligated to monitor and report adverse events and any failure of a product to meet the specifications in the BLA.

safety or efficacy concerns regarding our product candidates may result from any concerns arising from nonclinical or clinical testing of other therapies targeting a similar disease state or other therapies, such as gene therapy, that are perceived as similar to ours

It's pretty clear that you and I disagree on whether these vaccines are gene therapy. I don't see that changing so is there any point continuing?

 

[kingswood71]

I was asking abut COVID trials, but I can't see any trials stopped for not being statically "significantly effective" unless they were commercially unable to be produced.

Conclusions and Relevance Roughly half of investigational drugs entering late-stage clinical development fail during or after pivotal clinical trials, primarily because of concerns about safety, efficacy, or both. Results for the majority of studies of investigational drugs that fail are not published in peer-reviewed journals.

If you were only asking about covid trials, you need to be more specific. You said "When has that ever happened before the end of a trial? Serious question, as it hasn't unless there have been serious safety issues as well" and I linked you an article that shows that "Among the 344 unapproved agents, the clinical development for 195 (57%) failed for lack of efficacy".
Whilst ignoring that, you then copy the conclusion which in itself says "safety, effficacy, or both"....Note that is 3 reasons....The research I linked studied those 3 reasons and stated that "59 were stopped due to safety concerns". The majority were stopped for lack of efficacy.
Now, when you say "but I can't see any trials stopped for not being statically "significantly effective" unless they were commercially unable to be produced" are you referring exclusively to covid trials again??

 

[Gruffles]

If you were only asking about covid trials, you need to be more specific. You said "When has that ever happened before the end of a trial? Serious question, as it hasn't unless there have been serious safety issues as well" and I linked you an article that shows that "Among the 344 unapproved agents, the clinical development for 195 (57%) failed for lack of efficacy".
Whilst ignoring that, you then copy the conclusion which in itself says "safety, effficacy, or both"....Note that is 3 reasons....The research I linked studied those 3 reasons and stated that "59 were stopped due to safety concerns". The majority were stopped for lack of efficacy.
Now, when you say "but I can't see any trials stopped for not being statically "significantly effective" unless they were commercially unable to be produced" are you referring exclusively to covid trials again??

I'm also not really sure what the relevance of focussing ONLY on covid medication trials is in this particular regard. If there are none, then it may just mean that Merck's trial is the first to fail for low efficacy reasons. There may be more failures to come. The fact that they are happy to continue the trial on mild cases points to efficacy issues in moderate cases rather than safety issues.

In any case... BlueE has established that they were purely speculating in regards to it ceasing due to safety concerns so I'm ejecting myself from this discussion as I feel like it's been bled dry.

 

[kingswood71]

I'm also not really sure what the relevance of focussing ONLY on covid medication trials is in this particular regard. If there are none, then it may just mean that Merck's trial is the first to fail for low efficacy reasons. There may be more failures to come. The fact that they are happy to continue the trial on mild cases points to efficacy issues in moderate cases rather than safety issues.

In any case... BlueE has established that they were purely speculating in regards to it ceasing due to safety concerns so I'm ejecting myself from this discussion as I feel like it's been bled dry.

He changed the discussion mid discussion
"When has that ever happened before the end of a trial? Serious question, as it hasn't unless there have been serious safety issues as well" became "But I only meant covid studies"
But if you want a covid example: CVnCoV from Germany. Didnt show required efficacy so application withdrawn......
And another covid one: "On June 19, 2020, enrollment was stopped for futility based on recommendations from the DSMB after it reviewed information both internal and external to the trial. Enrollment was stopped at the fourth interim analysis, which included 371 patients with primary outcome data and an additional 108 patients who had not reached 14 days after randomization for primary outcome assessment. At that time, trial data did not meet the prespecified threshold for futility (defined as >90% probability of an aOR < 1.1 for the primary outcome) but demonstrated an 81% probability for an aOR less than 1.1. Furthermore, a post hoc conditional power analysis showed less than 1% probability of the trial reaching the prespecified threshold for efficacy (defined as >95% probability of an aOR > 1.0) if it continued to a sample size of 510 participants"

Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19

This randomized trial compares the effects of hydroxychloroquine vs placebo on clinical status at 14 days (home, requiring noninvasive or invasive ventilation or extracorporeal membrane oxygenation, hospitalized, died) among adults hospitalized with coronavirus disease 2019 (COVID-19).

jamanetwork.com

 

[BlueE]

90% of what they post is copied and paste, or regurgitated from another source. I've asked them to reiterate some things in his own words but as yet to do so.

I have used my own words and clearly asked you to point out what weren't my words and you haven't.

However, I do use correct terms wherever possible and this may be where we've had communication challenges?

When you say "Vaccines are just microorgamisms, in this case we are talking about a virus, hence viral vaccine. Othesrwise they are part of the virus or just the genetic material orderded to stimulate the antibody reposne against infection." to explain what you mean by "traditional viral vaccines" and I challenged that as talking about attenuated virus in COVID vaccines, which doesn't apply to any in use in Australia so not what we're talking about, although it does describe the Chinese Sinovac injection.

 

[BlueE]

eer reviwed

If you were only asking about covid trials, you need to be more specific. You said "When has that ever happened before the end of a trial? Serious question, as it hasn't unless there have been serious safety issues as well" and I linked you an article that shows that "Among the 344 unapproved agents, the clinical development for 195 (57%) failed for lack of efficacy".
Whilst ignoring that, you then copy the conclusion which in itself says "safety, effficacy, or both"....Note that is 3 reasons....The research I linked studied those 3 reasons and stated that "59 were stopped due to safety concerns". The majority were stopped for lack of efficacy.
Now, when you say "but I can't see any trials stopped for not being statically "significantly effective" unless they were commercially unable to be produced" are you referring exclusively to covid trials again??

Safety, efficacy or both was what I posted as being the reasons to stop the Indian trials of Merck's red pills, which was also the conclusion of the data you posted.

A trial being terminated just for not being "significantly efficient" is rare, or non existent except for commercial reasons.

Important to see the peer reviewed, published trials because Australia have already purchased millions of doses of this drug. But unfortunately as your analysis states, "Results for the majority of studies of investigational drugs that fail are not published in peer-reviewed journals."

Having one Indian manufacturer state they wanted the trial terminated because they couldn't get enough subjects, is not related to efficacy and is extremely concerning.

 

[BlueE]

safety or efficacy concerns regarding our product candidates may result from any concerns arising from nonclinical or clinical testing of other therapies targeting a similar disease state or other therapies, such as gene therapy, that are perceived as similar to ours

It's pretty clear that you and I disagree on whether these vaccines are gene therapy. I don't see that changing so is there any point continuing?

I don't see how that quote somehow disqualifies mRNA being gene therapy products.

You have both Pfizer and Moderna disclosing the FDA considers their mRNA technology to be gene therapy.

 

[Roby]

I have used my own words and clearly asked you to point out what weren't my words and you haven't.

However, I do use correct terms wherever possible and this may be where we've had communication challenges?

When you say "Vaccines are just microorgamisms, in this case we are talking about a virus, hence viral vaccine. Othesrwise they are part of the virus or just the genetic material orderded to stimulate the antibody reposne against infection." to explain what you mean by "traditional viral vaccines" and I challenged that as talking about attenuated virus in COVID vaccines, which doesn't apply to any in use in Australia so not what we're talking about, although it does describe the Chinese Sinovac injection.

For the purpose of this thread and so lay people can understand I have split the terminology to differentiate from viral vaccines to MRNA vaccines. There is an obvious differences in those groups of vaccines as the delivery methods, how they fuse into the cell and then their function at cellular level are very different.

Using acute medical terminology to make you self "appear" smart or knowledgable doesn't necessarily do you any good, particuarly when I have noticed you don't understand the science like you think you do.

If you cannot reword what you say and explain it very basic language so anyone can understand then you probably don't really understand it at all.

 

[Gruffles]

I don't see how that quote somehow disqualifies mRNA being gene therapy products.

You have both Pfizer and Moderna disclosing the FDA considers their mRNA technology to be gene therapy.

It's pretty clear that you and I disagree on whether these vaccines are gene therapy. I don't see that changing so is there any point continuing?

 

[faible]

You have both Pfizer and Moderna disclosing the FDA considers their mRNA technology to be gene therapy.

And there's been further statements made regarding this. Which if you actually understood the stuff you pretended you understood, would clarify the above.

 

[Roby]

I don't see how that quote somehow disqualifies mRNA being gene therapy products.

You have both Pfizer and Moderna disclosing the FDA considers their mRNA technology to be gene therapy.

You don't see it but everyone in our industry knows what it is. You may be the only person on the planet who continually calls it that despite contrary advice.

This goes back to my previous point. You think you are reading, you think you know "gene therapy" is but you don't. Something, something, genes, something, something, DNA or RNA, something, something, "theraputics is vaccination" and you assume incorrectly it's gene therapy. You have no clue but you keep showing you ignorance and it does not help your cause at all.

 

[Gruffles]

Safety, efficacy or both was what I posted as being the reasons to stop the Indian trials

However, India did it's own trials on the drug which they had to halt for safety reasons.

You originally said it was for safety reasons. That's what prompted my question.

A trial being terminated just for not being "significantly efficient" is rare, or non existent except for commercial reasons.

Just to clarify given you put it in quote marks, they say: "significant efficacy" not significantly efficient

"A source with the Drug Controller General of India said the pill has not shown "significant efficacy" against moderate COVID-19, though it was having success against mild cases."

 

[BlueE]

You don't see it but everyone in our industry knows what it is. You may be the only person on the planet who continually calls it that despite contrary advice.

This goes back to my previous point. You think you are reading, you think you know "gene therapy" is but you don't. Something, something, genes, something, something, DNA or RNA, something, something, "theraputics is vaccination" and you assume incorrectly it's gene therapy. You have no clue but you keep showing you ignorance and it does not help your cause at all.

I assume you read the documents and you disagree with the FDA, Pfizer, Moderna, CEO's of big Pharmaceutical and many experts in Australia and around the world.

You are the one that's making assumptions, jumping to conclusions and making vague statements on vaccines that don't apply to what we have approved in Australia.

"Vaccines are just microorgamisms, in this case we are talking about a virus, hence viral vaccine. Othesrwise they are part of the virus or just the genetic material orderded to stimulate the antibody reposne against infection."

Differentiating between a traditional attenuated virus vaccine, and "genetic vaccine" as used by many experts, including Professor Clancy to describe mRNA and adenovirus vector DNA vaccine are important but basic distinctions to understand in any discussion about the COVID vaccines.

 

[Roby]

I assume you read the documents and you disagree with the FDA, Pfizer, Moderna, CEO's of big Pharmaceutical and many experts in Australia and around the world.

No I don't disagee.

You are the one that's making assumptions, jumping to conclusions and making vague statements on vaccines that don't apply to what we have approved in Australia.

"Vaccines are just microorgamisms, in this case we are talking about a virus, hence viral vaccine. Othesrwise they are part of the virus or just the genetic material orderded to stimulate the antibody reposne against infection."

Again this just shows you don't know you are talking about. This is just basic microbiology and you don't understand it.

I've asked you before if you could explain in layman's terms so every body can understand, what is the mechanism which the current vaccines cause death? This the third time I've asked you but you keep dodging the answer and then you wonder why others have suggested you are out of your depth.

 

[faible]

I assume you read the documents and you disagree with the FDA, Pfizer, Moderna, CEO's of big Pharmaceutical and many experts in Australia and around the world.

You are the one that's making assumptions, jumping to conclusions and making vague statements on vaccines that don't apply to what we have approved in Australia.

"Vaccines are just microorgamisms, in this case we are talking about a virus, hence viral vaccine. Othesrwise they are part of the virus or just the genetic material orderded to stimulate the antibody reposne against infection."

Differentiating between a traditional attenuated virus vaccine, and "genetic vaccine" as used by many experts, including Professor Clancy to describe mRNA and adenovirus vector DNA vaccine are important but basic distinctions to understand in any discussion about the COVID vaccines.

Moderna literally says it's not gene therapy.

About mRNA | Moderna, Inc. (modernatx.com)

1. How does mRNA differ from gene therapy?
   Helping the body make its own medicine using mRNA sounds like it might be similar to gene therapy or gene editing. While these treatment approaches seek to treat disease through genetic information, they take fundamentally different approaches. Gene therapy and gene editing alter the original genetic information each cell carries. The goal is to produce a permanent fix to the underlying genetic problem by changing the defective gene. Moderna is taking a different approach to address the underlying cause of MMA and other diseases. mRNA transfers the instructions stored in DNA to make the proteins required in every living cell. Our approach aims to help the body make its own missing or defective protein. Unlike gene editing and gene therapy, mRNA technology does not change the genetic information of the cell, and is intended to be short-acting. It acts like traditional drugs that can be adjusted over time based on the dose and frequency needed. In simple terms, we are working to provide physicians and patients with a “controllable” way to start and manage their therapy over time.

 

[Jibroni]

But does giving airtime to people making unsubstantiated claims add any value to the discussion? I mean, I could film myself saying '0 teachers that I know have refused getting a vaccination' in a dramatic and emotional tone and post it on telegram. I wouldn't be lying as I don't know any teachers who have left work, meaning they'd have refused the vaccine.

How do you think those that share an anti-covid vaccine view would take my video?

Can I ask why the focus seems to always only be on transmission? What about the idea of reducing the chances of teachers getting severe symptoms from a possible infection and not being able to teach, impacting the students learning?

Also the mandate has been in place for some time in Victoria and I honestly know of 0 teachers who have left the industry. I'm certain there would be for whatever reason, but the numbers would be few rather than many.

The intention of posting the video was to highlight the lack of information being presented to the Community by the media, not to paint a picture of reality in ones eyes. They would probably turn a blind eye like everyone else and sadly negating meaningful conversation.

I would have thought they would go hand in hand (transmission v protection) but my assumption is that unvaccinated teachers are not convinced the Vaccine is better than natural immunity, albeit the evidence for vaccination would indicate otherwise. On face value this would seem a crazy comment but I understand some teachers (no idea how many) will be protesting on Friday regarding this.

 

[Gruffles]

The intention of posting the video was to highlight the lack of information being presented to the Community by the media, not to paint a picture of reality in ones eyes. They would probably turn a blind eye like everyone else and sadly negating meaningful conversation.

Sorry, I understand your intention and completely agree that open, honest, and clear information would absolutely aid in discussion, however, I just don't think giving any energy to clips like that one help the discussion at all. That's just my opinion, so feel free to ignore it.

I would have thought they would go hand in hand (transmission v protection) but my assumption is that unvaccinated teachers are not convinced the Vaccine is better than natural immunity, albeit the evidence for vaccination would indicate otherwise. On face value this would seem a crazy comment but I understand some teachers (no idea how many) will be protesting on Friday regarding this.

I understand that, but the point that I was aiming to discuss is the risk of symptomatic infection (in order to get that natural immunity) would impact the student learning while the teacher is recovering. If most teachers were unvaccinated and even a small percentage of them were 'out of action' due to a covid infection, coupled with the usual number of staff absences at any point in time, there would be significant impact on students who have already had 2 years of much less than ideal education.

My point is student learning focused, not teacher focused, in the same vein that I see mandates for healthcare workers being for reasons that are patient focused, not healthcare worker focused.

 

[kingswood71]

A trial being terminated just for not being "significantly efficient" is rare, or non existent except for commercial reasons.

It wasnt rare in the review I posted....Did you read the actual study?
Its called stopping a trial due to futility and is more common that you think it is...and isnt related to "side effects"....
This review found 28 cancer Rx studies stopped due to futility: "Out of these 93 papers, 65 were subsequently excluded for the following reasons: 4 trials were stopped after an interim analysis because of harm (toxicity) and 28 because of futility (lack of efficacy)"

DEFINE_ME

Do you really think scientists would persist with a trial, especially in cancer patients, if the study wasnt showing any efficacy?
If I said the car was blue, you would say its green.

 

[Gruffles]

If I said the car was blue, you would say its green.

And then you would diagnose tritanomoly... Right?

 

[faible]

Did you read the actual study?

 

[kingswood71]

And then you would diagnose tritanomoly... Right?

I have the ishihara plates ready to go

 

[Gruffles]

I have the ishihara plates ready to go

Expect a stern email from the Nuremberg restaurant... I've just let them know that you stole their plates.

 

[Higgs Boson]

Not all opinions are equal and not all opinions are worthy of respect. This decision is born out of ignorance and an arrogance that his ‘research’ is superior that of this nation’s medical experts. It’s not worth respect; pity, perhaps. Yes, it’s a shame that his decision is known by significantly more people than a cop that walks off the job for the same reason, but at the same time, no one is going to remember or care in a couple of weeks. If I were him, I’d be more concerned by the large number of friends, family and teammates who also likely think he’s a bit of a dill.

Dunning Kruger is a hell of an effect.

 

[azlou]

As the other poster was challenging my view on the amount of doctor/nurse resignations, we should know what the official numbers are and accurately. I have yet to see this reported hence my estimation.

Similarly if many (or few teachers) were to resign as a result of this mandate it should be known and what their concerns are. Particularly as I have yet to see any evidence or reporting of the effects/transfer of Delta on/from children at school.

Happened at my sons Kindergarden one teacher gave it 6 4year olds

 

[azlou]

Not all opinions are equal and not all opinions are worthy of respect. This decision is born out of ignorance and an arrogance that his ‘research’ is superior that of this nation’s medical experts. It’s not worth respect; pity, perhaps. Yes, it’s a shame that his decision is known by significantly more people than a cop that walks off the job for the same reason, but at the same time, no one is going to remember or care in a couple of weeks. If I were him, I’d be more concerned by the large number of friends, family and teammates who also likely think he’s a bit of a dill.

Not all venues ask for vax passport but the fines are significant I’m sure some can slide
I cant see how Liam can do anything with out drawing attention ist a lonely road he’s chosen