It took 18 months for TGA to release on FOI request. The request was by Nancy ? who got first a very very redacted version after 6 months and then the version that was released in December 2022 coincided with FDA letters to Pfizer and Moderna requiring listing of cases of myocarditis and pericarditis serious adverse effects.
We have to wonder why Scott Morrison in Feb 2021 declared there were no adverse effects from the mRNA vaccines when the report below was a month old…
BUT in dec 2022 the in-vivo animal report showed an ape died and there were serious adverse effects on organs.
Thank you Maryanne for always being on top of things. Thank you for this. It seems that people could be walking down the street oozing contaminated DNA, LNP’s SV40 etc and still it would be met with nothing to see here, move along. I am proud of the tenacious efforts to reveal the truth and get these shots off the market. The majority of the population are clueless to the dangers and keep getting the “next” one. The first roll out had no informed consent despite Pfizer’s 38 pages of adverse effects of special interest dated February/21. I got my shot 2 months later. It infuriates me that powerful people thought it was acceptable to pull the wool over people’s eyes. I saw a clip maybe 3 years ago of the head or CEO of Bayer talking to an audience and smugly made a comment about “if people knew these shots were gene therapy they wouldn’t have gotten them.” Sounds like the insiders knew. I’m now open to the possibility that all of this mess starting with covid was a plan to get around the regulatory systems put in place to protect the public through EUA. I believe there is much more that went on behind our backs to advance the mRNA technology. It’s like we were the trials.
We’ve all observed the most bizarre behaviour of our health agencies. An absolute refusal to acknowledge shot injuries or deaths. A refusal even to investigate. In Brianne Dressen’s book “worth a shot” the NIH conducted a study on 21 or 22 of the vaccine injured, they even payed for their flights. The NIH did all kinds of testing including taking spinal fluid. It was under the guise of helping the vaccine injured but were told to stay silent about it. Then suddenly it was all dropped with no explanation. So, we know the NIH knows and they have lots of blood samples, spinal fluid samples and gawd knows what else. There’s too many weird things going on and where there’s smoke there’s fire. I have so much gratitude for all the people including you Maryanne, for attempting to get to the bottom of this. I hope if RFK gets confirmed we will get some answers to the multitude of questions we have. My fear is that powerful people will do what it takes to ensure he doesn’t get confirmed.
The lack of integrity and intellectual dishonesty in the human species is rampant, and disappointing. There is no gene editing tool to fix this deficit.
Revoking approval seems appropriate - they haven’t followed established scientific method and risk real danger to the population - let’s hope this citizens petition is succeeds. I’m certainly workers about my family of child bearing age
The whole process has not benefited the people
Why did novel experimental mRNA achieve so much with such poorly evaluated evidence
The MANTRA IS VACCINES AND EXPENSIVE PROFITABLE TREATMENTS - really shortsighted and silly. Funding guaranteed
We mustn’t muddy the waters with preventatives and stopping transmission or cheap treatments.
I think what occurred was a deal with WHO and big govt US (Fauci/Trump?) EU (Ursula Von der Leyen) Aust(Morrison) UK (Johnson) - the agreement that if Pfizer and Moderna (the obligatory oligopolistic competitor cos we don’t do monopolies in democracies!! ) spent big and quick on guaranteed market vaccines. WHO and BIG GOVT would delimit the TREATMENT approvals preserving marketed are for NOVEL AV DRUGS by Pfizer and Merck as injectables or monoclonal antibodies were unsuitable for the community. Merck was makers of out of patent cheap ivermectin and that would compete with novel Paxlovid so had be stopped as was hydroxychloroquine.
I’m very suspicious of Morrison in secret second health minister portfolio and Broula overnight meeting 8 April 2021. What did Morrison deal to get extra and earlier Comirnaty. Bourla was progressing to PF-07321332 Paxlovid combined phase2/3 trial beginning July 2021 in unvaxed vulnerable EPIC-HR
WHO & BIG GOVT stopped every existing cheap antiviral treatment which wasn’t patent protected ie ivermectin hydroxychloroquine - simple to criticise drugs where they can roll out a litany of issues and SERs but antiviral nasal sprays were not absorbed -not dangerous. Also they were cheap enough to be preventive and stop community transmission and research was showing the Covid vaccines weren’t even as good as our 8-10 month flu jabs.
How easy would it have been for antiviral nasal sprays to upset the back channel agreement for BIG PHARMA novel profitable drugs
So Australian Starpharma’s Astodrimer sodium antiviral nasal spray Viraleze and Canadas SaNOtize had got going too quickly. Viraleze had EU EMA approval by Nov 2020, mass production in Feb 2021 and UK marketing commencing March 2021
So WHO/BIG GOVT conspired to use every trick
Nasal sprays had zero SERs unlike AZ vax where they could claim blood clotting in young females. By April 2021 Viraleze was UK Pandemic best selling product ever in Lloyd’s pharmacy 1800 branches. Those not yet eligible for vaccines were protecting themselves with nasal sprays and masks and clean air. Nasal sprays were too effective, people might not vaccinate…
So BIG PHARMA used the Brexit change FROM EUROPE EMA to UK regulator to question Europe approval with inactivated SARS-CoV-2 claims on Viraleze package. Resulting in crucially timed 8mths wait June 2021-March 2022 before approved repackaging…
Meantime in Australia - the country of origin Viraleze was not approved yet. With EU EMA - MD Class1 it should have straight through TGA authorisation under regulations 2020-2021 If MD class 2 / 3 then CE mark and MRA (mutual recognition agreement between Europe /Australia and others) were usually used for expedited approval and it was a guaranteed approval.
There were probably arguments between Dept of Health giving MRFF and TGA responsible for ARTG where TGA was trying to control VACCINES/drug TREATMENTS to make it $$$$ worthwhile for big pharma. The argument was likely over how antiviral nasal spray Viraleze could easily replace vaccines for reluctant people not wanting to be Guinea pigs to try untested (or the vocal antivaxers) and the expensive treatment which Pfizer were probably by June 2021 seeing highly effective in unvaccinated but behind closed doors they were aware of vaccinated and younger people issues. So clamp down on other drugs with lapsed patents and antiviral nasal sprays before their success could be widely publicised and destroy the gameplay of Big Pharma lobbyists and WHO/Big Govt.
So 10mths into 12mth grant period the headlines shocked Starpharma with irrational infringement noticed with ban / fine. Big publicity about the infringement.
The scenario let down 20million out of 25m Australians who have nothing to protect or treat Covid.
Who made big profits ? … in 1 year $5billion left our shores for Pfizer BioNTech (German partners). Foreign expenditure that could have been foreign income.
And as we all know COVID is not over.
Many cases in Hospitals and Aged Care continue
Vaccines only last about 3 or 4 months
Paxlovid only high efficacy in unvaccinated.
1 in 5 gets some form of long covid.
There are other respiratory viruses that could impact many people.
Private scripts for antiviral drugs are over $1000 and not given with informed consent to vaccinated people.
The mRNA vaccines need to keep changing as new variants arise - Most unable to have 4 monthly repeats and many worried about impact of vaccines longterm and repeat COVID.
When in 2024 Astodrimer sodium as nasal spray was finally entered in poison standard sched2, the TGA delegate required that no mention of covid treatment be made as it would put people off going to the doctor and getting “OTHER” treatments… what those other treatments were is a mystery. Australians waiting to buy in pharmacies thought it just weeks away. A TGA letter received in July 2024 even foreshadowed a mid September decision…
But vaccine maker, Pfizer, had moves afoot.
With big “fail” issues of Paxlovid ie rebound, not working with young or vaccinated who were paying $US1500 for private scripts after seeing TV ad marketing miracle treatment - Pfizer needed to move to develop another NOVEL Paxlovid replacement av drug. Targeting something cheaper for all age groups from about 18 - would it be a similar cost to diet drug Ozempic. PF-07817883 Ibuzatrelvir doesn’t include the HIV antiviral drug with its SAEs but is still 12 hourly.
In Pfizer pipeline for fast track 2023/2024 - by Aug 2024 Ibuzatrelvir is now listed by FDA as fast track. Pfizer reported to stock market and in media that phase2b had good results in Sept 2024. Fasttrack means FDA can approve EUA on rolling results. Phase3 started mid Dec 2024. A condition of EUA is no alternative - so every trick again to stop antiviral nasal sprays like Viraleze which inconveniently has proven efficacy v placebo published with Peer review in Sept 2024. BTW Pfizer Bourla said in May 2024 that Pfizer’s working quickly and regulators working quickly. Now TGA is secretive- they do not publicise what is to be escalated. In Jan2022 boss John Skerritt just announced Paxlovid and Lagevrio exempt from poison sched approval process and instant ARTG medicines and PBS lay down mazare!
So Viraleze must be stopped and every hurdle is placed - insist viraleze with no pharmacological effect is a medicine not Medical Device class 1, Starpharma applied for ARTG under wrong category. The CV of the clinical expert isn’t acceptable because is a retired physician without experience in infectious diseases; and so on. Application must go back to start …. Also on safety they only tested blood for 7 days not 14 so another trial would be needed More time delays.. If medicine needs 2000-3000 participants to make any covid claims. The fact it is a safe barrier doesn’t hold any sway with TGA. 5 years into the pandemic with many not wanting what could be dangerous vaccine, we are still not allowed to protect ourselves daily with a simple antiviral nasal sprays.
It took 18 months for TGA to release on FOI request. The request was by Nancy ? who got first a very very redacted version after 6 months and then the version that was released in December 2022 coincided with FDA letters to Pfizer and Moderna requiring listing of cases of myocarditis and pericarditis serious adverse effects.
We have to wonder why Scott Morrison in Feb 2021 declared there were no adverse effects from the mRNA vaccines when the report below was a month old…
BUT in dec 2022 the in-vivo animal report showed an ape died and there were serious adverse effects on organs.
Nonclinical Evaluation Report BNT162b2 [mRNA] COVID-19 vaccine (COMIRNATY"™)
Submission No: PM-2020-05461-1-2
Sponsor: Pfizer Australia Pty Ltd
January 2021
TGA
There has been little choice of vaccines for informed consent for Australians as we went All the way with FDA
LET’S hope the law catches up for the sake of the people
Maryanne,
One day the dam will burst on these terrible treatments. Hopefully soon.
A very important article. Thanks!
Thank you Maryanne for always being on top of things. Thank you for this. It seems that people could be walking down the street oozing contaminated DNA, LNP’s SV40 etc and still it would be met with nothing to see here, move along. I am proud of the tenacious efforts to reveal the truth and get these shots off the market. The majority of the population are clueless to the dangers and keep getting the “next” one. The first roll out had no informed consent despite Pfizer’s 38 pages of adverse effects of special interest dated February/21. I got my shot 2 months later. It infuriates me that powerful people thought it was acceptable to pull the wool over people’s eyes. I saw a clip maybe 3 years ago of the head or CEO of Bayer talking to an audience and smugly made a comment about “if people knew these shots were gene therapy they wouldn’t have gotten them.” Sounds like the insiders knew. I’m now open to the possibility that all of this mess starting with covid was a plan to get around the regulatory systems put in place to protect the public through EUA. I believe there is much more that went on behind our backs to advance the mRNA technology. It’s like we were the trials.
We’ve all observed the most bizarre behaviour of our health agencies. An absolute refusal to acknowledge shot injuries or deaths. A refusal even to investigate. In Brianne Dressen’s book “worth a shot” the NIH conducted a study on 21 or 22 of the vaccine injured, they even payed for their flights. The NIH did all kinds of testing including taking spinal fluid. It was under the guise of helping the vaccine injured but were told to stay silent about it. Then suddenly it was all dropped with no explanation. So, we know the NIH knows and they have lots of blood samples, spinal fluid samples and gawd knows what else. There’s too many weird things going on and where there’s smoke there’s fire. I have so much gratitude for all the people including you Maryanne, for attempting to get to the bottom of this. I hope if RFK gets confirmed we will get some answers to the multitude of questions we have. My fear is that powerful people will do what it takes to ensure he doesn’t get confirmed.
Thanks Vivien, I have sent it to RFK Jr, so hoping he manages to see it. 🤞
The lack of integrity and intellectual dishonesty in the human species is rampant, and disappointing. There is no gene editing tool to fix this deficit.
I do hope and pray it succeeds. 🙏
Didn't we just read about WHO efforts to combat "substandard medical products"? Here is their chance to shine.
I'm not sure WHO can 'shine'. Maybe rub a little tarnish off, but that's about it.
Revoking approval seems appropriate - they haven’t followed established scientific method and risk real danger to the population - let’s hope this citizens petition is succeeds. I’m certainly workers about my family of child bearing age
The whole process has not benefited the people
Why did novel experimental mRNA achieve so much with such poorly evaluated evidence
The MANTRA IS VACCINES AND EXPENSIVE PROFITABLE TREATMENTS - really shortsighted and silly. Funding guaranteed
We mustn’t muddy the waters with preventatives and stopping transmission or cheap treatments.
I think what occurred was a deal with WHO and big govt US (Fauci/Trump?) EU (Ursula Von der Leyen) Aust(Morrison) UK (Johnson) - the agreement that if Pfizer and Moderna (the obligatory oligopolistic competitor cos we don’t do monopolies in democracies!! ) spent big and quick on guaranteed market vaccines. WHO and BIG GOVT would delimit the TREATMENT approvals preserving marketed are for NOVEL AV DRUGS by Pfizer and Merck as injectables or monoclonal antibodies were unsuitable for the community. Merck was makers of out of patent cheap ivermectin and that would compete with novel Paxlovid so had be stopped as was hydroxychloroquine.
I’m very suspicious of Morrison in secret second health minister portfolio and Broula overnight meeting 8 April 2021. What did Morrison deal to get extra and earlier Comirnaty. Bourla was progressing to PF-07321332 Paxlovid combined phase2/3 trial beginning July 2021 in unvaxed vulnerable EPIC-HR
WHO & BIG GOVT stopped every existing cheap antiviral treatment which wasn’t patent protected ie ivermectin hydroxychloroquine - simple to criticise drugs where they can roll out a litany of issues and SERs but antiviral nasal sprays were not absorbed -not dangerous. Also they were cheap enough to be preventive and stop community transmission and research was showing the Covid vaccines weren’t even as good as our 8-10 month flu jabs.
How easy would it have been for antiviral nasal sprays to upset the back channel agreement for BIG PHARMA novel profitable drugs
So Australian Starpharma’s Astodrimer sodium antiviral nasal spray Viraleze and Canadas SaNOtize had got going too quickly. Viraleze had EU EMA approval by Nov 2020, mass production in Feb 2021 and UK marketing commencing March 2021
So WHO/BIG GOVT conspired to use every trick
Nasal sprays had zero SERs unlike AZ vax where they could claim blood clotting in young females. By April 2021 Viraleze was UK Pandemic best selling product ever in Lloyd’s pharmacy 1800 branches. Those not yet eligible for vaccines were protecting themselves with nasal sprays and masks and clean air. Nasal sprays were too effective, people might not vaccinate…
So BIG PHARMA used the Brexit change FROM EUROPE EMA to UK regulator to question Europe approval with inactivated SARS-CoV-2 claims on Viraleze package. Resulting in crucially timed 8mths wait June 2021-March 2022 before approved repackaging…
Meantime in Australia - the country of origin Viraleze was not approved yet. With EU EMA - MD Class1 it should have straight through TGA authorisation under regulations 2020-2021 If MD class 2 / 3 then CE mark and MRA (mutual recognition agreement between Europe /Australia and others) were usually used for expedited approval and it was a guaranteed approval.
With Viraleze having been awarded a $1m grant under MRFF https://biotechdispatch.com.au/news/starpharma-wins-recognition-for-development-of-covid-19-antivira#:~:text=Starpharma%20was%20selected%20by%20an,development%20and%20commercialisation%20of%20VIRALEZE.
This did not fit the WHO /BIG GOVT storyline…
There were probably arguments between Dept of Health giving MRFF and TGA responsible for ARTG where TGA was trying to control VACCINES/drug TREATMENTS to make it $$$$ worthwhile for big pharma. The argument was likely over how antiviral nasal spray Viraleze could easily replace vaccines for reluctant people not wanting to be Guinea pigs to try untested (or the vocal antivaxers) and the expensive treatment which Pfizer were probably by June 2021 seeing highly effective in unvaccinated but behind closed doors they were aware of vaccinated and younger people issues. So clamp down on other drugs with lapsed patents and antiviral nasal sprays before their success could be widely publicised and destroy the gameplay of Big Pharma lobbyists and WHO/Big Govt.
So 10mths into 12mth grant period the headlines shocked Starpharma with irrational infringement noticed with ban / fine. Big publicity about the infringement.
The scenario let down 20million out of 25m Australians who have nothing to protect or treat Covid.
Who made big profits ? … in 1 year $5billion left our shores for Pfizer BioNTech (German partners). Foreign expenditure that could have been foreign income.
And as we all know COVID is not over.
Many cases in Hospitals and Aged Care continue
Vaccines only last about 3 or 4 months
Paxlovid only high efficacy in unvaccinated.
1 in 5 gets some form of long covid.
There are other respiratory viruses that could impact many people.
Private scripts for antiviral drugs are over $1000 and not given with informed consent to vaccinated people.
The mRNA vaccines need to keep changing as new variants arise - Most unable to have 4 monthly repeats and many worried about impact of vaccines longterm and repeat COVID.
When in 2024 Astodrimer sodium as nasal spray was finally entered in poison standard sched2, the TGA delegate required that no mention of covid treatment be made as it would put people off going to the doctor and getting “OTHER” treatments… what those other treatments were is a mystery. Australians waiting to buy in pharmacies thought it just weeks away. A TGA letter received in July 2024 even foreshadowed a mid September decision…
But vaccine maker, Pfizer, had moves afoot.
With big “fail” issues of Paxlovid ie rebound, not working with young or vaccinated who were paying $US1500 for private scripts after seeing TV ad marketing miracle treatment - Pfizer needed to move to develop another NOVEL Paxlovid replacement av drug. Targeting something cheaper for all age groups from about 18 - would it be a similar cost to diet drug Ozempic. PF-07817883 Ibuzatrelvir doesn’t include the HIV antiviral drug with its SAEs but is still 12 hourly.
In Pfizer pipeline for fast track 2023/2024 - by Aug 2024 Ibuzatrelvir is now listed by FDA as fast track. Pfizer reported to stock market and in media that phase2b had good results in Sept 2024. Fasttrack means FDA can approve EUA on rolling results. Phase3 started mid Dec 2024. A condition of EUA is no alternative - so every trick again to stop antiviral nasal sprays like Viraleze which inconveniently has proven efficacy v placebo published with Peer review in Sept 2024. BTW Pfizer Bourla said in May 2024 that Pfizer’s working quickly and regulators working quickly. Now TGA is secretive- they do not publicise what is to be escalated. In Jan2022 boss John Skerritt just announced Paxlovid and Lagevrio exempt from poison sched approval process and instant ARTG medicines and PBS lay down mazare!
So Viraleze must be stopped and every hurdle is placed - insist viraleze with no pharmacological effect is a medicine not Medical Device class 1, Starpharma applied for ARTG under wrong category. The CV of the clinical expert isn’t acceptable because is a retired physician without experience in infectious diseases; and so on. Application must go back to start …. Also on safety they only tested blood for 7 days not 14 so another trial would be needed More time delays.. If medicine needs 2000-3000 participants to make any covid claims. The fact it is a safe barrier doesn’t hold any sway with TGA. 5 years into the pandemic with many not wanting what could be dangerous vaccine, we are still not allowed to protect ourselves daily with a simple antiviral nasal sprays.