COVID-⁠19 Vaccination Requirement for Entering USA Dropped from 11th May 2023

Comments

                    • @cfuse:

                      There is a grand total of one antigen vaccine approved for use in Australia. It was provisionally approved on 20 January 2022 as a primary course, and as a booster on 9 June 2022.

                      Right, but you said non mRNA vaccine, and AstraZeneca isn't an mRNA vaccine. Now you're moving the goal posts. There was a significant overlap with the AZ vaccine available 3 weeks after the Pfizer vaccine and only ceasing completely in March 2023.

                      Oh hooray, a genetically modified adenovirus that does exactly the same thing that the mRNA vaccines do, just with the older tech. Why wouldn't I want the Pepsi to mRNA's Coke?

                      Why do you want AC Cola instead? Or worse, cocaine.

                      t least you didn't have to put up with being harassed by the VIC cops for daring to be a pregnant woman and using a public bench. It was her choice to dare to be in public

                      What an amazing straw man.

                      Would you like to keep your job? Leave your house? Travel between states or overseas? Shop for food?

                      There's no universe where people had to be vaccinated to drive between states (though driving between states at times itself was restricted for most people) and I'm beginning to wonder what universe you lived in the last 3 years if you think there was ever a requirement to be vaccinated to shop for food. Yes, some jobs required people to be vaccinated. That's about other peoples rights just as much.

                      They don't give a damn what happens to anyone they don't care about, because they can never put two and two together and figure out that the vulnerable or despised are the attack surface for eroding rights.

                      Yes, have been listening to the nonsense about very specific situational interventions being permanent I was absolutely assured the restrictions would be forever by plenty of people. And oh look, now they're not. There's plenty of rights being eroded, but this isn't it. No one bothered to raise a peep when multiple bills passed like The Assistance and Access Act 2018, and few care abut things like this https://www.theguardian.com/technology/2022/jun/16/australia…

                      But temporary restrictions based on a virus that was killing, in Australia in 2020, 3% of the people that contracted it. That's what people are worried about because they're part of paranoid online groups that would sooner chase ghosts than go after the real government overreach.

                      I don't want random tissues in my body making spike proteins.

                      This is literally what your body when it catches many viruses (eg the common cold) just because 'spike' sounds scary doesn't mean it is. Why you're ok being injected with them or catching them naturally but no ok with what can be a much smaller amount created in-situ by something deliberately engineered to self destruct. I'm really not sure.

                      I avoid all medications I don't need

                      That's really your choice. I suggest your GP give you advice on what you need and you consider that. 'Need' is an interesting line to draw because there's certainly medications that can help with mental state that some might not say they 'need' but they can certainly prevent unhealthy fixation on certain issues. At the end of the day you can't decide you need a vaccine after you get seriously ill with a virus. There were plenty of people dying begging for the vaccine when it was already too late.

                      Our entire pharmaceutical industry and the government's pharmaceutical benefits scheme is built on the principle of unique patentable characteristics to determine the right to exclusive sale, and by extension the ability to set pricing and profits.

                      This simply isn't true. The PBS scheme is actually extremely brutal, favoring generics where possible etc. It leverages approval for inclusion to the scheme to negotiate the best value for the taxpayer. Yes, sometimes that will mean a medicine that has 3% less chance of causing a rash, is declined for inclusion over one that costs 10x less. But usually what happens is the manufacturer lowers the prices of the 'better' medicine to match the price of the other one to get their new medicine included. It's why the taxpayer in Australia pays dramatically less for most medicines than anyone can get them for in places like the USA. Insurance providers, hospitals, individuals there just don't have that bargaining power. It's extremely anti big Pharma and they'd love to see it go.

                      There are a mountain of GRAS substances that are not for sale domestically because they're off patent and nobody wants to bear the TGA approval costs.

                      These are not very high fees, you would not need to sell many doses.
                      https://www.tga.gov.au/sites/default/files/2022-09/fees-and-…
                      They can also be waived if there isn't a medication available already for that condition.

                      Moderna's stock price at the end of Jan 2020 was $20.51 USD. Moderna's stock price at the end of Sep 2021 was $449.38 USD. We are starting to get the documents from FOIA requests now, so we know exactly what the government knew, and when they knew it. We don't have to speculate as to motives for any of the players here. We know who got rich, where the tax dollars went, etc. As I said elsewhere, this was the greatest global transfer of wealth from the public purse to private hands in the shortest amount of time I've ever seen. This makes the financial corruption of the Ukraine conflict look like a joke in comparison. And that's before we get to all the other winners and losers of shutting down the entire world's economy for years.

                      Who would have guessed inventing a vaccine during a global pandemic would be profitable? I'm not sure you know what the word 'corruption' means. It's weird people who think corruption is so prevalent, focus on particular issues, ignoring most of the real corruption, all while thinking it actually mattered to the people selling the vaccines if people took them or not. A sold expired vaccine is just as profitable as one people used, actually much better, they can sell it again. There's no need to mislead people to make money. And yet all the data since shows it was exceptionally good value for the taxpayer. The economy was slower to open up on places where vaccine rollouts were slowest, and the economic damage higher where vaccine rates were lower. And yet it's still an overstatement to say the world economy was shut down. Certainly some sectors were gutted, but overall other than a few months the world economy overheated if anything. It was the knee-jerk reaction to the pandemic that caused private business to be unprepared when the economy didn't slow as much as expected, leading to parts shortages when their cancelled orders couldn't be instantly restarted.

                      We already paid for something like three times the amount of vaccines required for our entire population. Barring expiry those shots are as good as the day they were delivered. We have a surfeit of vaccines, not a deficit.

                      The last AZ vaccine we had in stock expired in March 2023, The 'barring expiry' there is doing all the heavy lifting. Basically that was the reason for withdrawal, the government didn't order more when the last lot expired because they had better choices available, so AZ didn't seek a continuance of their approval.

                      Vaxzevria has lost approval in Australia due to unacceptable risks of thrombosis with thrombocytopenia syndrome.

                      This is untrue. Show me one Aust Gov source that claims that's the reason. Go on. It's more fantasy universe stuff. They had to reapply for approval as all provisional approved medicines do, and they chose not to because they government didn't order more. It lost approval on the date the last vial expired. Vaxzevria is significantly less effective against Omicron than the new bivalent vaccines. The less than one in a million fatal cases gives it a much better safety profile than many medicines which retain approval. There are simply better alternatives. All medication has risks but it's important to balance those vs the risks of NOT taking certain medications as that's not a risk free endeavor.

                      no possibility of legal action for individuals if it did happen to turn your blood to tar

                      I mean, there's a government scheme. If your blood turns to tar, see your GP. There's been a few thousand claims submitted total, and so far only 263 people have provided enough information to have their claim determined (either way), from 65 million+ doses. That's a pretty good safety record as anything goes. We're looking at a higher national road toll over the period than people willing to claim anything at all from the government scheme.

                      https://www.health.gov.au/our-work/covid-19-vaccine-claims-s…
                      https://www1.racgp.org.au/newsgp/clinical/changes-made-to-co…

                      It's also worth noting there was no legal indemnity provided for vaccine providers if they committed any kind of fraud in their approval. It was simply for unforeseeable events like TTS due to their rarity, or those indicated in the original trials. So the problem preventing legal action isn't so much one of indemnity, but actually how few people were seriously injured and how those are covered through normal government schemes.

                      Besides, anyone looking at the data without blind panic overwhelming all rationality would conclude that for the vast majority of individuals no treatment of any kind was required.

                      The vast majority of car accident victims don't either, so, no seatbelts then?

                      We've all had the flu before.

                      The flu is horrible. Seriously, kills a lot of people, but still a fraction of those killed by Covid, and much less contagious. Also completely unrelated to Covid bar sharing a few symptoms.

                      We're all mortal and we all will die from something with certainty.

                      Yes, of course, though the management of Covid in the US led to life expectancy dropping by a whole year in 2020. So a lot of years worth of life lost, it's generally not regarded as healthy to voluntarily hasten death.

                      People get sick, and they die, and that is the natural course of living things. You will never stop that. Maybe you'd understand that better if you'd been around more sick people and dead bodies. That's how I did.

                      I've been around plenty of sick people and a (very) small handful of dead bodies. Fortunately I didn't become morbidly obsessed with death. Yes, people die, they used to die a lot earlier on average before vaccination. No one believes we're going to stop death. The average person who died of Covid in Australia, despite the average age being high, could have expected to live for 7-8 more years on average. Some much more, some less. Why make that chance 20x higher than it has to be?

                • @cfuse:

                  I support your right to have as many shots as you like. I don't support either of us having no right to decline them. Now you tell me why that's wrong?

                  It's interesting how the authorities framed this argument. It was along the lines of nobody is being coerced or forced to take the shots, but there are consequences for ones actions. There definitely was a twisted logic to their reasoning. The saddest part was that a lot of people believed it was right.

                  • +1

                    @mrdean: It takes nothing more than the myopic hubris of people saying "It won't ever happen to me" to bring them to committing the most evil acts imaginable.

                    If you live your life on the assumption that how you behave to others will eventually be returned to you or those you love then you'll automatically spend a lot less time being an evil POS running around stamping on other's rights. I don't understand why saying "I wouldn't like it, so I won't do it to anyone else" is such an abnormal stance, but apparently it is.

                    • -2

                      @cfuse:

                      It takes nothing more than the myopic hubris of people saying "It won't ever happen to me" to bring them to committing the most evil acts imaginable.

                      'It won't happen to me' is literally the logic people are using to avoid vaccination and increase their risk of death from Covid 20x.

                      I think you lack imagination if you think 'the most evil acts imaginable' was asking people to mostly stay inside for a few weeks, except while exercising, or shopping. Unless you were in that one public housing block in Melbourne, you're exaggerating just a little bit.

                      If you live your life on the assumption that how you behave to others will eventually be returned to you or those you love then you'll automatically spend a lot less time being an evil POS running around stamping on other's rights. I don't understand why saying "I wouldn't like it, so I won't do it to anyone else" is such an abnormal stance, but apparently it is.

                      If people lived their life on that assumption they'd have gotten vaccinated.

                      I don't understand why saying "I wouldn't like it, so I won't do it to anyone else" is such an abnormal stance, but apparently it is.

                      You really need to reflect on that yourself I certainly agree with the sentiment, but you don't appear to.

                      People who lost their jobs because they wouldn't take a risk proven to be less than that of driving to work, so they could keep putting other vulnerable people at a much greater risk, is exactly that behavior being returned to them, not eventually, but almost immediately.

                      It's exactly that attitude, of your rights to do what you want when you want being more important than others lives that leads people to not get vaccinated. I hate to tell you, most people don't agree that a right to work a specific job, overrides other people's rights to life. And that's what living in society is, deciding which rights come first. Because we don't live in a world where everyone can have the right to do anything they want without affecting others. Ultimately one persons rights WILL be stamped on, the debate we're having is simply whose rights, which rights and how hard. I'm a huge fan of people having the right to do whatever, provided those rights don't infringe on others rights. And if they do, it's a simple matter of deciding who is rationally in the right. And here it's not people that didn't get vaccinated for no good reason. Those people are the evil POS running around stamping on other's rights, they just don't see it, because they're self obsessed.

                      • +1

                        @JumperC:

                        It's exactly that attitude, of your rights to do what you want when you want being more important than others lives

                        No, it's not that, although it is a clever argument that superficially blames those that refused the injection & scapegoats them as "others".

                        Who is really to decide what constitutes putting someone else "at much greater risk", & based on what. That specific argument is tunnel vision, it does not take into account the fact that piercing someone's skin with a needle without their informed & agreed consent without coercion, could be seen as assault in legal terms.

                        All those vague terms with built in presumptive probabilities like "less likely", "greater risk" can be used to justify more or less anything.

                        And as for being "rational", well what is called "vaccination" is probably the most irrational procedure ever developed that has now done way more harm than good. If anyone "rational" spent the hours required to read widely on the topic, then that should be the only conclusion one could draw.

                        The most obvious example is that within the mainstream system it is acknowledged that vaccinating against respiratory viruses is not a great idea, simply because of the mutation involved. It's why for other illnesses like measles which doesn't mutate, the vaccines are alleged to confer herd immunity, but this is definitely not the case for influenza or other respiratory viruses. So then, hard questions need to be asked as to why the push the inject the entire world population. Another hard question would be related to the so called variants that emerged. Remember some of them came out of India, South Africa, Brazil, all places where the initial clinical trials were being conducted. Interesting, aye, in terms of how the variants came to be.

                    • @cfuse:

                      I don't understand why saying "I wouldn't like it, so I won't do it to anyone else" is such an abnormal stance, but apparently it is.

                      It's hard to put into words, but there's been a heavy amount of conditioning involved, not to mention behavior nudging, practically since birth for at least the last 2 generations. I understand it better now, but it wasn't until I turned about 40 that I started to come out of the fog. Before that period I would of agreed with the majority.

            • @JumperC: If I find a paper that is conducted poorly that finds in favour of evolution that is not evidence of evolution being a specious theory, it's evidence the paper is flawed. If I present it as evidence that evolution is flawed then what does that say about my trustworthiness?

              I couldn't even find your quoted study

              It's their first cited paper in the list they give. Their citations, their strongest evidence. Which you didn't bother to read.

              If you didn't even read what the people who you're pointing to as authorities wrote then what hope should I have that you'll ever read anything I write fairly?

              These are all the individual studies cited, one quote per study.

              1. How did you find studies you claim not to have known about to read and then miss the very first one?

              2. How did you manage to turn 38 papers into 10 citations without reading or cherry picking?

              What does this say about your trustworthiness? Which is it: witless or malicious?

              A few early studies pushed by people that sought to profit from IVM doesn't overrule the later, larger independent double blind studies that proved unequivocally that it didn't work.

              Ivermectin is a generic, nobody's making money off it. All of the mRNAs are patented (and as they're gene therapies, incredibly difficult to rip off in practice), and were overbought by governments world wide in one of the largest and swiftest transfers of wealth in history. Your follow the money argument points in the wrong direction.

              a scientific mind bows to the overwhelming weight of evidence, realizes the difference between a well conducted study and one that's unreliable.

              Oh, this is going to be fun. Why don't we discuss the sex and race differences in IQ scores and distributions? There is plenty of research that is absolutely radioactive for political and cultural reasons, and that's even before we get to money. A lot can be said of covid but the idea that it hasn't been overly politicised is not one of those things.

              The thing I am willing to trust in the case of the poisoned well is not an appeal to authority, it's time. The truth will out, because it always does. If this treatment is as good as advertised then it will be as good as advertised in ten, twenty, or thirty years as it is today. I'm perfectly happy for others to be my testers here.

              Finally, a scientific mind is willing to do two things a human mind has a very hard time with:

              1. Accept uncertainty.

              2. Accept individual error.

              We already know the error rates for scientific study and they're massive. Most of what we 'know' to be true today is wrong. We have a mountain of precedent for that. Why people are so myopic about a past littered with scientific mistakes and bias whilst being utterly convinced of the infallibility of science today is something I'll never understand. I'm sure people can understand why I see faith on witnessing that behaviour.

              As for individual error, I fail to see how my mistakes are your problem. You don't know me, don't care about me, and the only reason you're even talking to me is because you're annoyed that someone isn't caving in the second you bully them. I have a choice as to what I think, do, and say, and you hate that.

              Faith is finding a the one in several million people that have a fatal reaction to a vaccine and ignoring the hundreds per million that a proven to be saved by vaccination.

              Medication side effects are quantifiable and we have a system for doing so. Vaxzevria is no longer approved in Australia for that reason. We were also told it was perfectly safe whilst it was being handed out to everyone without question. Turns out, science is mutable.

              I will say the same thing to you that I did (and do) to my siblings: you make the best decisions you can at the time with the information you have, and you do that within the bounds of the consequences you're willing to accept. They asked me for advice on being vaccinated, and because I was giving them an answer for them and not pushing a personal barrow for me I advised them both to have it. One of them regrets it to some degree, the other doesn't. I didn't make their choices for them, but I sure as hell made sure I gave them every bit of information I had without bias either way.

              My choice was to not get the mRNA shot and it had consequences too. That was my choice to make, and my consequences to bear. I don't see the problem with that, and I especially don't see why scolds and bullies are still going full Karen just because I refused to die when told to. You got your opportunity to be genuinely awful to others for two years straight and now the party is over. Move on.

              Ultimately people pretending we don't know that vaccines work and are exceptionally safe and that other treatments work when they've been disproven cost lives.

              People pretending that less than three year old mRNA treatments are equivalent to sixty year old antigen vaccines are either ignorant or wilful deceivers.

              We both know that mRNA treatments are still being used under experimental authorisation, that a bunch of them have only received certification for political reasons (because the five and ten year safety studies can't exist), and that a bunch of the treatments have already failed and will never be certified.

              If this is to be a matter of trust then how have you not failed in that? If it is not to be a matter of trust then I'll go back to my own research.

              This isn't a matter of belief, it's a matter of reality vs your belief.

              I think it is more about the fact that I'm going to do what I choose for the reasons that satisfy me and you can't do a damn thing about it but be a bully and claim a higher authority.

              I will make up my own mind, thank you very much. Inclusive of the opportunity to be wrong and bear the cost thereof.

              • -1

                @cfuse:

                Which you didn't bother to read.

                You clearly didn't.

                How did you manage to turn 38 papers into 10 citations without reading or cherry picking?

                These are literally all 10 of the 10 studies cited.

                Why don't we discuss the sex and race differences in IQ scores and distributions

                We do? It's not that complicated to understand. Especially if you've ever done an IQ test and notice they're rife with cultural references.

                We already know the error rates for scientific study and they're massive. Most of what we 'know' to be true today is wrong.

                Wrong. Most of what YOU 'know' is wrong.

                I fail to see how my mistakes are your problem

                And yet apparently what you think are mine are your problem.

                Medication side effects are quantifiable and we have a system for doing so. Vaxzevria is no longer approved in Australia for that reason

                It was withdrawn by AstraZeneca because there are better options available and it was no longer commercially viable. Shocking. But yes, we do have an exceptional system for finding such extremely rare but severe side effects.

                I refused to die when told to.

                Melodramatic much?

                You got your opportunity to be genuinely awful to others for two years straight and now the party is over. Move on.

                And yet here we are, with people on this topic proving they continue to be genuinely awful to others.

                People pretending that less than three year old mRNA treatments are equivalent to sixty year old antigen vaccines are either ignorant or wilful deceivers.

                There's decades of mRNA research. This didn't happen overnight. Antigen vaccines are constantly revised. You're right, I would have guessed the newer vaccines would have had more unknowns, but after over a billion doses it's obvious they're safer.

                We both know that mRNA treatments are still being used under experimental authorisation,

                ? What's this weird terminology you're making up. In the US they were originally under emergency authorization, they went through all the normal processes in Australia. People are outright lying when saying they went though anything but the full safety trials all other vaccines go through in Australia. All vaccines are studied for side effects during the entire time they're available. By your measure all medications are always 'experimental'. Which is a massive distortion of reality.

                If it is not to be a matter of trust then I'll go back to my own research.

                Try and do it somewhat objectively. You're the one that will feel the worst consequences if you continue to ignore the people who actually know the topics they're researching, instead of mis-representing industry terms they don't understand.

                I think it is more about the fact that I'm going to do what I choose for the reasons that satisfy me and you can't do a damn thing about it but be a bully and claim a higher authority.

                This has never not been the case. Such a victim complex.

                • @JumperC:

                  People are outright lying when saying they went though anything but the full safety trials all other vaccines go through in Australia.

                  The injections were submitted through the TGA's provisional approval pathway.

                  This means it was released into the general population with interim data provided by the sponsor.

                  It is not the same as the traditional approval process.

                  Since then, in the USA, there have been efforts through FOI requests to get access to data submitted to the FDA as part of the emergency use authorisation. It took a court to decide to force the FDA to hand over the millions of pages of data, albeit on a staggered schedule, a certain number of pages per month.

                  Naomi Klein's Daily Clout site has researchers looking over the releases, as has the organisation PHMPT. The documents are available on phmpt.org

                  Post marketing authorization vaccine safety data has always been riddled with problems. The systems are mostly passive reporting. Before the last 3 years, very few people, even within the professional healthcare community, knew the DAEN even existed, let alone how to report a case. The government & health authorities, to my knowledge, have never run a large public awareness campaign to make sure people knew about it or how to report.

                  Basically, the government doesn't want to know about problems. It pays lip service to adverse events, because it is focused on getting as large an uptake of vaccines as possible. The TGA list about 20 "probable" deaths in Australia to these novel injections, which is absolutely laughable (tragically) to anyone who has their eyes open.

                  • -1

                    @mrdean: All new medicines go through the provisional approval pathway in Australia for up to their first 6 years. People are confusing that with the US that had an 'emergency' pathway. Provisional approval is NORMAL for new medicines, it wasn't some special thing for the Covid vaccine.

                    This means it was released into the general population with interim data provided by the sponsor.

                    This is how all new medicines are approved.

                    It is not the same as the traditional approval process.

                    It is EXACTLY the traditional approval process for any new medicine. The only way to not be provisionally approved first is to be already approved for use. There's no normal further trials before provisional approval. The point of provisional approval is ADDITIONAL not reduced scrutiny, the non provisional approval process provides less scrutiny, because it's a medication that was previously approved. This is the complete opposite of emergency approval.

                    blah blah blah

                    Before the last 3 years, very few people, even within the professional healthcare community, knew the DAEN even existed

                    Bullshit. It's literally a requirement that you submit suspected vaccine adverse effects to retain your registration. If you fail you can be deregistered. What's new is people misrepresenting what it actually is.

                    Basically, the government doesn't want to know about problems.

                    Sure, that's why they spend all the money maintaining ATAGI / the TGA / DAEN etc.

                    The TGA list about 20 "probable" deaths in Australia to these novel injections, which is absolutely laughable (tragically) to anyone who has their eyes open.

                    By 'eyes open' you mean 'people who attribute any post vaccine death to the vaccine'. As if all the other things people used to die from stopped happening and it was ALL the vaccine. Basically the anti-vax sheeple.

                    DAEN / VAERS are only half the story, to verify if the vaccine actually causes those effects they compare them to the typical incidence in the unvaccinated population. You can have very high numbers but if they're statistically no different to normal, that means there's no ACTUAL measurable effect. But people are too simple to realise what the data is, a collection of ALL medical conditions someone had within 6 weeks of being vaccinated that couldn't definitively be traced to another source. So people look at the totals, with no concept of how many people normally have those effects just by being human.

                    Since then, in the USA, there have been efforts through FOI requests to get access to data submitted to the FDA as part of the emergency use authorisation. It took a court to decide to force the FDA to hand over the millions of pages of data, albeit on a staggered schedule, a certain number of pages per month.

                    Yeah, I wonder why they don't want to give over personal details of trial participants without checking them for identifying notes to a rabbid sandy hook type crowd.

                    Naomi Klein

                    Surprise, someone with a book to sell (and it's Naomi Wolf not Naomi Klein, though both have books to sell!). It's amazing that people seem to hold in their mind public servants paid either way are part of some grand conspiracy, but those with the book to sell whose entire income is dependent on their agenda being anti-establishment are the selflessly honest ones. There's plenty of bad things the pharmaceutical industry does, this one isn't it. Chasing documents from initial trails is kind of worthless now we have results from billions of doses. Even if it somehow found something nefarious, it doesn't really change anything.

                    • @JumperC:

                      All new medicines go through the provisional approval pathway in Australia for up to their first 6 years. People are confusing that with the US that had an 'emergency' pathway. Provisional approval is NORMAL for new medicines, it wasn't some special thing for the Covid vaccine.

                      https://www.tga.gov.au/resources/resource/guidance/provision…

                      "The Therapeutic Goods Regulations were amended in July 2021 to support the timely availability of new COVID-19 vaccines and treatments."

                      • -1

                        @mrdean: Yes, did you read the amendment? It's the same pathway.

                        The amendment is a change to 2below:

                        This is the amendment:

                        https://www.legislation.gov.au/Details/F2021L01032

                        And other than some vaping changes, the specific part for Covid is here: at 2 (b):

                        http://classic.austlii.edu.au/au/legis/cth/consol_reg/tgr199…

                        Which provide an exemption for subsection 22D(2)

                        Which if you trace it down, is a waiver of the application fee.

                        This is a great example of people seeing something that looks suspicious but is entirely innocuous, because you're predisposed to seeing what you want to see.

                        Yes, big Pharma did convince the government to legislate and waive their application fee. Shocker.

                        • @JumperC:

                          Yes, did you read the amendment? It's the same pathway.

                          The pathways are described here:

                          https://www.tga.gov.au/resources/resource/guidance/provision…

                          Are you saying all new medicines are approved or registered on the basis of preliminary clinical data, as it says on that page in the section titled "provisional registration process"?

                          There are also these two tga pages:

                          https://www.tga.gov.au/how-we-regulate/supply-therapeutic-go…
                          https://www.tga.gov.au/provisional-approval-pathway-prescrip…

                          "As part of the Government's response to the Review of Medicines and Medical Devices Regulation (MMDR review), we are implementing a pathway for the provisional registration of prescription medicines. Approval through the provisional pathway will be on the basis of preliminary clinical data where there is the potential for a substantial benefit to Australian patients"

                          It appears to me that the provisional registration pathway has been in existence since approximately 2018.

                          • -2

                            @mrdean:

                            Are you saying all new medicines are approved or registered on the basis of preliminary clinical data, as it says on that page in the section titled "provisional registration process"?

                            There's only two ways to get data, trials or real world use. Thus all instances of new medicines leaving trials and entering real world use have to use trial data. The alternative is medicines that are being re-registered or have use data from elsewhere in the world.

                            If you look through the 'standard pathway' it's for medicines that have already had real world use. The difference is that provisional review (and priority review) both take a lot more resources at the TGA to review, they're more intensive, and thus cost more to do. They don't have the luxury of waiting for other agencies overseas to approve first, so they have to provide extra scrutiny. Whereas normally they just sit on the application for a year (or 3 months less for 'priority') and wait for someone else to do the work.

                            It's a brutally efficient use of taxpayer dollars, but not exactly ideal when there is evidence proving medicines are safe and effective, to just delay looking at them for a year. I'm sure we'd all have loved another year of lockdowns….. Normally the priority pathway involves the applicant paying a higher fee, which is why it was waived in this instance.

                            The TGA also needs to be sure that the risk of the medication is much lower than the risk of not approving the medication. Basically the provisional pathway is faster, but has more, not less scrutiny from the TGA, it also expires in a short period.

                            From your links:

                            Despite being based on preliminary data, a higher level of scrutiny and deliberation may be required to understand uncertainties and weigh up the benefits and risks of earlier availability of these medicines, resulting in a similar evaluation time.

                            For example, the medicine must be a major advance over any similar medicines that are already approved for supply.

                            Fast track pathways can be used for both new medicines and new uses for already approved medicines.

                            So basically 'major advances' go through the priority / provisional path way. Things that are slight alterations of existing medicines for existing uses go through the standard pathway. Basically, they don't want to put in the extra effort for a priority / provisional approval for medicines that don't change much.

                            Think of the standard pathway as the 'low benefit' / 'low scrutiny' / 'low effort' / 'low speed' pathway.

                            • -2

                              @JumperC:

                              The TGA also needs to be sure that the risk of the medication is much lower than the risk of not approving the medication. Basically the provisional pathway is faster, but has more, not less scrutiny from the TGA, it also expires in a short period.

                              So, basically, there are multiple pathways to the approval & registration of drugs.

                              Is it not obvious that with the amount of data that has come out from the FDA FOI requests, that regardless of how many workers at the TGA were put on to help with the registration & approval process for the provisional pathway, even with the early & limited data sets, that in effect it does not mean there was more "scrutiny" placed on these novel injections.

                              There is, within the corporate world, a well known trick; flood the regulators with pages of documents, knowing at the other end, political pressure in the form of ministerial pushing of "results", not to mention the media campaigns of fear, will end in the desired result.

                              As far as I'm aware, the FDA had already granted the authorization for the novel injections use, the TGA has contact with them & other major supposed regulators like the EMA. They state this within their own documents & every time I watched them being questioned by senators during estimates committee meeting. They are not registering or approving drugs & medicines in isolation. In fact, it seems to me & others, that they just follow others lead.

                              • -1

                                @mrdean: At this point you’re trying to convince people gravity is just a theory. I’ll leave you to your own campaign of ignorant fear.

                                You people really lost me when quoting websites run by people who claim Apple invented a vaccine that allows time travel as somehow ‘proof’.

                                • @JumperC:

                                  At this point you’re trying to convince

                                  Do you consider yourself rational & logical?

                                  If so, why are antibodies considered protective for all so called viruses that are supposedly protected by vaccines, but are considered indicative of illness when it comes to hiv?

                                  Do you know what the conventional answer is to this apparent contradiction?

                                  • -3

                                    @mrdean:

                                    If so, why are antibodies considered protective for all so called viruses that are supposedly protected by vaccines, but are considered indicative

                                    Dude… This was taught in like yr 9 science/biology.
                                    You just proved you are absolutely clueless.

                                    • @Ughhh:

                                      Dude… This was taught in like yr 9 science/biology.
                                      You just proved you are absolutely clueless.

                                      How about you take the time to explain it to me like I'm a high school student rather than being dismissive, patronizing & insulting?

                                      • -3

                                        @mrdean: Come on, we both know that's a waste a time. Plenty of people have explained things to you. You never made the post with an open mind. Nor ever thought of the possibility that you may be wrong on a subject you probably have no educational or professional background in to analyse and interpret data.

                                        All the school teachers are brainwashed and controlled by the Gov and NASA anyway right 🥴🤯

                                        As you and your friends would say, Do yOuR oWn rESeaRcH.

                                        • @Ughhh:

                                          Come on, we both know that's a waste a time. Plenty of people have explained things to you. You never made the post with an open mind. Nor ever thought of the possibility that you may be wrong on a subject you probably have no educational or professional background in to analyse and interpret data.

                                          Oh my dear Ughhh…..onwards to more assertions & patronizing comments. Where did you learn the art of reading minds? Why not just simply engage in a dialogue. You made the assertion that the answers to my question regarding antibodies & their apparent contradiction were something that every year 9 student knows.

                                          How about laying it out for us. I want to be educated. I am constantly learning new things & different ways of looking at the world. But I also have tonnes of questions.

                • @JumperC:

                  These are literally all 10 of the 10 studies cited.

                  1. Go here: https://www.covid19treatmentguidelines.nih.gov/therapies/mis…

                  2. Click on the grey tab marked Clinical Data below the heading Ivermectin and to the right of the tab marked Drug Info.

                  3. Click on the plus symbol on the right of the grey bar with the heading References on it.

                  4. There you are.

                  If you won't do the most basic work involved in a discussion then I'm not wasting any more of my time on you (and that's saying something, given how much of it I have).

                  • @cfuse: Yeah, I copied all the rom the table above it. See the heading on that page as to why.

                    https://www.covid19treatmentguidelines.nih.gov/tables/iverme…

                    So what I copied is literally right there on the page you directed me to, the very first 10 lots of clinical data in the table above the references.

                    The first link in your table was excluded from the table because it was a study of TEN people ! Seriously TEN people. If ever there was junk science, that's it.

                    • @JumperC:

                      The first link in your table was excluded from the table because it was a study of TEN people ! Seriously TEN people. If ever there was junk science, that's it.

                      If you are referring to the Spoorthi & Sasank trial, there were 100 patients in it, not 10. The ivermectin & doxycycline protocol was used in those with mild to moderate illness.

      • -4

        20x less deaths with the vaccine while there’s zero clinical difference from ivermectin vs a placebo. Proven time and again. The only place they’ve been able to get ivermectin to kill Covid is in a dish in the lab at a dose that would kill a horse.

        The vaccines are among the most tested medicines out there. Anyone with a tenth of a brain would be sceptical of the snake oil salesman selling their time to talk about disproven treatments you’re pushing without bothering to apply the slightest bit of scepticism to.

        The probes with people doing their own research is people are morons and can’t read the research they’re doing correctly and so pretend things that sound right to them are actually ‘research’.

        This is the same bunch who fly through windscreens because it’s illegal not to wear a seatbelt. ‘Dig in’ indeed.

      • -2

        Medically these treatments are virtually untested, as evidenced by their emergency medical authorisation use. 'Safe' medications can easily take a decade to make it through all the hoops of a TGA approval.

        This is what you get when you conflate your American information with Australia and turn it into misinformation.

        There was no 'emergency medical authorisation use' in Australia. The vaccines all made it through all the normal hoops to get normal TGA approval. The US vaccines have also subsequently made it through normal approval (they are the ones that had the emergency use authorization, due to, you know the million people dying from Covid while the vaccine even with emergency use had already proven death rate couldn't be anything like that). Because we didn't have Covid outbreaks of huge scale there wasn't a reason to short cut any approvals. As is normal with all vaccines they're monitored extremely closely after release for things that wouldn't show up in trials. Hence the discovery of the one in a million AZ TTS.

        I don't know why people who say 'do your own research' seem to consistently prove they're very very bad at research. You might as well do your own open heart surgery.

    • +2

      Vaccine efficacy is simply a formula used in trials.

      https://en.wikipedia.org/wiki/Vaccine_efficacy

      Imagine a trial with 2 groups, 10 in each, one group gets the vaccine, the other doesn't.
      1 in the medicine group gets sick, 5 in the other doesn't. The efficicy is 80% according to the formula.

      That's all it means, applying it to the general population is misleading. From memory there were about 18000 in each group (scattered over many different clinical trial locations) in the original trials & the numbers used to calculate the vaccines efficacy was less than 150.

      • And since the trials we’ve had hundreds of millions if not billions vaccinated.

        • +1

          This is a fact. Not sure why it has been downvoted. Disconnect from reality?

          • +1

            @try2bhelpful: https://www.youtube.com/watch?v=Gkh6N-ZL3_k&t=2s

            Norman Fenton illustrating vaccine efficacy reporting in real world situations, using a spreadsheet. It appears the delay of either 2-3 weeks before classing someone as "vaccinated" is used to create a high efficacy for the shots. But you can see how it tapers off dramatically in the ensuing weeks.

            Interesting to note how Fenton has been treated in the media & on various skeptic sites.

            • -4

              @mrdean: Not going to bother funding whatever that guy is selling. 6 months later regardless of if it stops you getting it, the chance of death is 20x higher if unvaccinated. We’re a long way from ancient data from within 2-3 weeks. If you wanted better data you’d look at places like Australia where most people were vaccinated when COVID wasn’t widespread. Vaccines aren’t effective immediately, that’s not manipulative that’s reality. Only a moron would try and twist that.

              • -1

                @JumperC: There is no benefit to getting the COVID vaccines, why isn't it so difficult for you to comprehend natural immunity versus a so called "vaccine" that is supposedly required every 6 months? In some definitions they had to literally change the definition of vaccination because the Pfizer jab does not provide immunity, it does not stop transmission (because it does not provide immunity). It's pretty much marketed now as to Reduce severity of COVID. Fail IMO.

                Why are you so adamant that everyone should get the experimental COVID "vaccines"?
                You don't even understand how they actually work. And you clearly don't understand actual risk versus relative risk.

                • -3

                  @reactor-au: False.

                  Who said I’m adamant everyone should get them.

                  You’re simply lying, both about what I said and their effectiveness which is well and truly proven. You clearly don’t understand the actual risk vs relative risk. You clearly don’t have the most basic idea of how they work.

                  If you think there’s anything experimental about something with billions of doses as datapoints, you need your head examined.

                  • +1

                    @JumperC: Ok so if it is so safe and effective, according to you anyway, then who do say shouldn't get it and why not?

                    100 in 100,000 people driving blue cars get a speeding ticket; absolute risk 0.1%
                    200 in 100,000 people driving red cars get a speeding ticket; absolute risk 0.2%
                    Relative risk of getting a ticket by driving a red car instead of a blue car; 100%
                    Increase in absolute risk; 0.1%
                    Difference in absolute risk versus relative risk; 99.9%
                    So you can see why Pfizer would happily tout relative risk instead of absolute risk.

                    There are not billions of doses of data points, Pfizer did not track the data of billions of people, the trial was <50,000 and <25,000 received the drug.
                    They do not know what the long-term impact is (unless they have time machine and have been to the future).

                    The nano particles go everywhere, to every organ, and every cell that produces spike protein promotes inflammation.
                    The nano particles have been found present >6 months post vaccination.

                    • @reactor-au:

                      They do not know what the long-term impact is (unless they have time machine and have been to the future).

                      The US government had a pretty good idea what to look out for back in October 2020, 2 months before the rollout:

                      https://totalityofevidence.com/wp-content/uploads/2022/09/FD…

                      One of many questions to ask……why was there such a push in the media, & by health authorities to deny links to the injections for all those adverse outcomes listed on that jpg slide? We were told they were exceedingly "rare" adverse events, & yet that list is pretty spot on isn't it?

                      • +1

                        @mrdean: Yes those are the known/disclosed risks, things like cancer and reproductive issues are very long term, we won't know for years still. Which is crazy because Pfizer is already reinventing influenza vaccines based on their mRNA platform. Count me out, I'll take my chance with the viruses thanks.

                        • @reactor-au:

                          Count me out, I'll take my chance with the viruses thanks.

                          If the corporations get the future they want, no one will be able to opt out.

  • +1

    hahah what a waste of $$$

    the panic exceeded all sense of logic and this is just another element

    https://www.news.com.au/finance/economy/australian-economy/n…

    • -7

      The cost to the UK and USA with the loss of lives would’ve dwarfed this money. The high vaccination rate has allowed the RAT to not be so necessary. This means people aren’t dying, in droves, from the disease.

  • -5

    So this post turned out to be an anti vaxxers opportunity to spread BS, not a genuine ambivalent post as per the title and the claims made by OP in their opening thread post..
    These ppl will be the first to rock up in emergency if Dr Craig Kelly's Ivermectin joke backfires in their social media addicted bean bags.
    I think we need a community Ivermectin vaccination drive.Just to see who's right.
    It's funny how many of the covid zombie cohort who bag all the actions taken to protect the community, are happy to work form home innit?

  • -6

    There must be plenty of moon units out there self medicating with Ivermectin. It's now much harder to get it where it is normally sold or the price has exploded compared to pre covid. I hope there is a register somewhere because the downstream health effects shoud be user pays.

    • -2

      Wow. 2 and counting, already. Lots of cows with ticks via this selfish self poisoning behaviour. Craig Kelly,is that you?

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