Explosive revelations as a study conducted at FDA's own lab found residual DNA levels exceeded safety limits by 6 to 470 times. Experts say it's a 'smoking gun.'
I seem to recall in 2020 when the hope of delivering vaccines quickly was spoken of - the government said it was an opportunity to use the fast adaptability of a new form of vaccine which were BEING DEVELOPED
Here we have evidence of enthusiasm replacing experience and the beginning of the boost experiment on humanity ever and leading to the biggest pharmaceutical profits EVER
Cooler heads and more scientific method of eons should have prevailed
Why was there ever a 'vaccine solution' in the first place, against a disease the WHO admitted in the beginning wasn't a serious threat to most people?
In a WHO Q&A on coronaviruses (COVID-19) in March 2020, it was noted "Illness due to COVID-19 infection is generally mild, especially for children and young adults", which I quoted in my BMJ rapid response published on 25 March 2020: Is it ethical to impede access to natural immunity? The case of SARS-CoV2: https://www.bmj.com/content/368/bmj.m1089/rr-6
'COVID-19' was never the threat it was beat up to be...
So what was it all about? It was actually about creating a massive international vaccine market to exploit the people, and to capture people for a social credit system, via a 'vaccine passport'.
We so need to look back on all of this deliberately manufactured 'crisis'...who benefitted?
People such as Jane Halton, with her massive conflict of interest as Chair of CEPI, called for 'no jab, no play' for adults in May 2020, i.e. a vaccine mandate, but it seems she had no idea that the practitioners administering the injections have a legal, ethical and moral obligation to obtain voluntary informed consent for the intervention.
Valid consent cannot be obtained from people who are under duress, e.g. under a mandate with the threat of losing livelihood and participation in society if they refuse to comply.
The practitioners should never have gone along with this, the minute coercion and mandates were put on the table they should have refused to collaborate with this assault on personal autonomy and bodily integrity.
But in Australia they had already been bullied into the frame for years by AHPRA, with practitioners under threat of suspension if they said anything 'anti-vaccination'.
And they went along with the No Jab, No Pay law for coercive/incentivising vaccination of children in 2016. It should have been challenged then, but they went along with it. And here we are now in 'Covid' times, with the experience of 'No Jab, No Job'...'No Jab, No Life'...that was facilitated by the AHPRA Position Statement 9 March 2021, which effectively coerced the practitioners to support the then Morrison Government's COVID-19 vaccine rollout, see for example: Reckless disregard for voluntary informed consent - the AHPRA Position Statement 9 March 2021: https://elizabethhart.substack.com/p/reckless-disregard-for-voluntary
Interesting how this 'study' pops out just now. FDA trying to smooth over their very tarnished image? FDA and blob career bureaucrats already trying to craft a narrative to obfuscate, avoid blame from the surely to come, much more thorough investigations led by RFK and DOGE?
Lop of the heads, and at least two layers deep, of the FDA, CDC and other agencies. As a start.
I’m surprised the FDA allowed these student researchers to even publish the study…. Perhaps they thought no one would ever find it buried in a tiny journal.
The TGAs "misinformation" response is now shown to have been reckless and stupid. Instead of properly assessing a real issue they adopted a political response. And are now shown up for what they are.
This agency is compromised and this response and the idiotic decision to approve untested treatments for mass use means they need to be shut down and the entire management team be held accountable for their wrong and illogical actions.
Unfortunately Chris, as with all compromised institutions (including the ABC, the Academy, and multiple NGO's), the approach is to slander their critics and continue down their corrupt paths at "warp speed".
?“Otherwise, efforts to remove the residual DNA would result in an entirely new vaccine, requiring new trials and effectively restarting the process with an untested product.”?
The trials were conducted with product made by Process 1, which used PCR amplification to make "pure" mRNA to put into the LNPs. Then the products released to the public were made using Process 2, which is the one that made the vials the students were testing. The Process 2 product is the one should have required new trials!
In USA, the original trials and the FDA "EUA" process were a sham, as Sasha Latypova and Katherine Watt have written ample substacks about and as a few high level court cases have demonstrated. No clinical trials are needed under a DoD biological countermeasures program and no quality control is required and no liability accrues to the companies involved, because it is all under the purview of DoD and HHS. Not sure how that plays out in other countries, however, since they seemed to assume this was a legitimate medical product. As someone reported for EU, however, some countries there were simply following NATO directives and bypassing safety and quality controls.
As for removing the contamination etc and making yet more product for the public, why? There are perfectly good cheap early treatments well documented by now.
Yep, agree with all that. Not only did FDA accept process1/2 without question, they allowed buffer changes without trials, and now this. So many outrageous failures by this agency.
DYNAMITE Article ! Blows open the "cover up" that instigated and imposed by a now discredited FDA ! Keep shining that torch Doc into those dark corners of corruption !
I'm not sure that anyone has looked.....other vaccines are developed using recombinant technology but I don't know if the manufacturers have included SV40 promoters in their plasmids.
I find this interesting that students (high school) I think I read, at the FDA Whiteoaks campus were even assigned this project. I don’t know, something comes across as a step in a larger plan. Is it going to ultimately downplay the severity? I sound so skeptical don’t I? I just don’t trust anymore. This is an explosive failure that would have to be meticulously handled. The fallout from the public would be chaotic. Thank you Maryanne this is extremely interesting. I hope one day somebody that counts mines Kevin for a correct analysis of these shots.
The FDA can hide all it wants. These tests were conducted in their own labs, under the supervision of three senior FDA scientists, using FDA reagents, with sample’s obtained from reputable sources. Cannot deny it anymore.
Once again an illustration of the malfeasance undertaken by Big Pharma. But once again none of us reading this article, as the many similar articles that have been published on this matter in recent years, are at all surprised either.
Clearly, the scale of the abuse and malpractice adopted by Big Pharma across the plain of this "vaccine" is at such a level, that no-one, but no-one with any self consciousness, decency, integrity, or principles in relation to public health, can ever trust Big Pharma again. Also, when one realises the arrogance and total abrogation of responsibility towards public health adopted by the dogma within Big Pharma, the only resultant conclusion one can come to is to presume that such dogma has always been the protocol by which the pharmaceutical industry has ALWAYS treated the public.
Extrapolating further, one must conclude that every aspect of every "medication" and every "vaccine" that Big Pharma has ever produced must, in some manner, has been produced under the auspices of this protocol. Sadly, all one can conclude from such a thesis, is that there is NOTHING that one can trust that has come from the "mouths" of Big Pharma.
We know that the trials of every prospective new drug are only ever undertaken by the company looking to profit from the sale of this drug. Hence there is a concerning vested interest in the "successful" outcomes of these "trials".
We know that the value of peer reviewed commentaries, has, for a considerable period of time been questioned, due to the revolving door principle under which, those who are chosen to undertake these reviews are employed.
We know that the previously heralded and respected medical journals, that publish positive articles regarding the drugs coming online, have been financially captured by Big Pharma, for years, and hence the validity and authenticity of those articles comes into serious question.
We know that Big Pharma provide immense influence within medical undergraduate training establishments, such that those naive students are not aware of the manner by which they have been indoctrinated by the time they graduate, and effectively become Big Pharma dispensing automatons. (Having just written that, I now realise what the acronym FDA stands for - Farma Dispensing Automatons. Now it all makes sense!!😂)
We know that since 1986, (or there about,) in the US and in other countries since then, Big Pharma has been protected, by statute, from being sued in regards to detrimental side effects from their "vaccines".
So, we should not be at all surprised by the findings of some research undertaken by these students. My only concern regards the question as to where the laboratory within which these students worked, gets its funding from. If it is via Big Pharma, again it would be no surprise if this is the last meaningful study that is produced from this facility, before it is forced to close due a very rare and totally unforeseen occurrence of "Force Majeure!
The study was done at FDA’s White Oak facility in Maryland under the supervision of three FDA scientists. 65% of FDA’s budget for drug and biologics evaluation comes from big Pharma. 🙄
Mmm, well one imagines that there maybe some interesting telephone conversations between certain interested associated parties, in that case. I can't wait for the potential release of some very uncomfortable and damning information, around this area, once the Trump administration gets its feet under the table. Of course, that said, those feet might end up becoming buried under massive piles of shredded paper left under that "table"!
I'd forgot that FAKE MANTRA that Maryanne just referenced "mRNA was the "plug 'n play" technology that would revolutionise vaccination....
WHERE ARE WE TODAY with dealing with the Pandemic Transmission, Protection by vaccines and Treatment ....
So after the results reported in this article from the student research at FDA, we are now back at STAGE ONE 2020.... if TGA and FDA apply the standard they purport to apply on behalf of population safety - it means NEW trials and results with new APPROVED manufacture processes.
And VACCINES need to go back to traditional means immediately - no rain checks on this...
We might be very pleased that Robert Kennedy Jnr is in charge of US Health Policy....
Are we ready for new non mRNA vaccines....
ie Novavax etc even nasal vaccines as traditionally vaccines are not ALL muscular - think of sugar lump with polio vax!
And then there is the COMPLETE FAILURE to authorise good safe effective treatments. US and Australia have NOTHING for younger people who catch covid in the latest wave unless hospitalised...
Australia doesn't allow script medicines advertising although Pfizer got Ita Buttrose to do a little half advert on Facebook.... And I'd love to know what NEW trial evidence results led TGA in August 2024 to change Australian authorisation from provisional to full. Pfizer EPIC-HR does not provide evidence for younger people than 75yr olds unvaxed or those with compromising health issues. And Lagevrio is mutagenic and should be withdrawn.
BUT the push for full authorisation by FDA of Paxlovid in May 2023 from EUA previously, was so that Paxlovid TV ads could be done on TV during big games etc.. with a catchy jingle too. The full authority was based on EPIC-HR (High Risk over 75 and compromised health) and general wide use and effectiveness in the world population .... NO scientific evidence for general population ... go figure.. Young Americans for whom it didn't work, got rebound, got SAEs and spent $1500US for 5 days treatment were NOT happy.
AGAINST our rules this product marketed with the same name can be viewed in Australia without TGA RESTRICTED REPRESENTATIONS Infringment notice - ie TGA has done nothing to stop Australians seeing it on YouTube
All the people in the ad are younger - not one 75 yr old and it emblazens 86% efficacy
... with tiny printed saying
"In a clinical trial of unvaccinated patients, 9 out of 1039 taking PAXLOVID were hospitalized, and none died. 66 out of 1046 taking placebo were hospitalized and 12 died (from any cause)."
No mention of the EPIC-SR fail...
When non-australian ANITVIRAL DRUG treatment approvals came to Australia, we hear Minister Greg Hunt embellishing the science / evidence too with a BIG lie distributed to GPs and Health Professionals in "GP News" 20 January 2022 - official Royal Australian College of General Practitioners (RACGP) magazine..
"Speaking at a press conference following the announcement, Federal Health Minister Greg Hunt said the medicines will be available ‘subject to prescription by a general practice or in the hospital environment’ at no cost to the patient.
‘If it’s your GP that’s prescribing it, it will be available from a pharmacist,’ Minister Hunt said.
‘So simple and easy, subject to the gateway of a GP focusing on both the need, the efficacy and the safety elements.
‘This is about new hope and new protection.’
Both antivirals have been approved for use in patients aged 18 and over who develop mild-to-moderate COVID-19 and do not require initiation of oxygen but are deemed to be at increased risk of progression to hospitalisation or death.
To be effective, either treatment must be administered within five days of the onset of symptoms."
This is not the the population characteristics of the Pfizer Paxlovid TRIAL EPIC-HR on which FDA EUA approval was based and Mutual Agreements allowed TGA to give fast tracking too.
So what does Australia have left in our continuing Covid outbreaks.
Well there was an Australian antiviral nasal sprays which after 4 years of being challenged by TGA with things like the safety trial of blood tests every day for 7 days was insufficient in the opinion of the TGA clinical assessor who thought a 14 day trial would be more suitable. I have 429 FOI pages which show the delays and the entreaties to WITHDRAW the application. Eventually Starpharma has given up - at the end of the day the dollars associated with the application with no guarantee that it would be successful outweigh the community need for a simple effective prevention and treatment in first 5 days (BTW exactly the criteria with the AV drugs were unsuccessfully pursuing in normal population.
So we now wait.... Pfizer started phase 3 trials of PF-07817883 Ibuzatrelvir in December 2024 - 2 weeks ago. In August their fast track in their Pipeline was confirmed by FDA as a fast track so we can expect with Rolling Results a NOVEL drug (no name yet) for younger people and older ones too without the HIV drug pair of nirmatrelvir and ritonavir
This is a mess Maryanne and 20 million Aussies have nothing as treatment and we all need a different vaccine which is not planned.
I saw that Novavax withdrew its application for its updated (XXB.1.5) vaccine - I don't know why. It's almost as if the TGA is making it difficult for non-mRNA covid vaccines to make roots in Australia. hmmm.
That seems to be the case. They are determined not to have anything interfere with Pfizer mRNA AND PAXLOVID or PF-07817883 Ibuzatrelvir
You just wonder when Viraleze was all set for fast track or not escalation in the 12 month time limit of the MRFF covid response - someone at TGA was in total disagreement with Dept of Health encouraging a prevention treatment for COVID and decided to throw every obstacle. Up to July 2021 - have CE mark was easy step under mutual agreement of Europe and TGA - not automatic but common and the application for ARTG was in 23 July before changes to regulations occurred but the secretary (Skerritt) notified of non compulsory audit with documents to be provided by 16 September 21 after the 12 mth MRFF performance was due - on the basis that they had been issued with infringement on 2 July 2021 for RESTRICTED REPRESENTATIONS of Astodrimer sodium - the controls on that were so STIs sufferers could be referred to STI clinic by pharmacist under sched4 whilst use as HIV protection on condoms was unscheduled.
I really think there was a deal to get more mRNA VAX early in April with Morrison/Bourla and PF-07321332 Paxlovid had just completed phase1 and Pfizer knew is there was any other treatments then getting fda fasttrack might be stopped so they got questions asked at new post Brexit health in UK MHRA and country of origin Aust TGA.
The FOIs show absolutely no urgency in a pandemic and two diametrically opposed attitudes under the one (maybe 2) ministers. Dept of Health even awarded Viraleze a year later for distribution in the world but not Australia.
Starpharma awarded $1 million in matched funding by the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program to expedite development and commercialisation of VIRALEZE
Leaves Moderna looking safe and effective (not)! Hmm, all those new Moderna plants springing up globally, too.
Australia got one at Monash Univ opened only weeks ago
I seem to recall in 2020 when the hope of delivering vaccines quickly was spoken of - the government said it was an opportunity to use the fast adaptability of a new form of vaccine which were BEING DEVELOPED
Here we have evidence of enthusiasm replacing experience and the beginning of the boost experiment on humanity ever and leading to the biggest pharmaceutical profits EVER
Cooler heads and more scientific method of eons should have prevailed
How can we forget, the "plug 'n play" technology that would revolutionise vaccination.
But...
Why was there ever a 'vaccine solution' in the first place, against a disease the WHO admitted in the beginning wasn't a serious threat to most people?
In a WHO Q&A on coronaviruses (COVID-19) in March 2020, it was noted "Illness due to COVID-19 infection is generally mild, especially for children and young adults", which I quoted in my BMJ rapid response published on 25 March 2020: Is it ethical to impede access to natural immunity? The case of SARS-CoV2: https://www.bmj.com/content/368/bmj.m1089/rr-6
'COVID-19' was never the threat it was beat up to be...
So what was it all about? It was actually about creating a massive international vaccine market to exploit the people, and to capture people for a social credit system, via a 'vaccine passport'.
We so need to look back on all of this deliberately manufactured 'crisis'...who benefitted?
See for example my recent article: Jane Halton called for the COVID-19 vaccine mandate in May 2020: https://elizabethhart.substack.com/p/jane-halton-called-for-the-covid
It shifted from a public health response to a military response. Debbie Lerman is a talented writer who publishes on this https://substack.com/home/post/p-145471766
Thanks for the link to Debbie Lerman's work Maryanne, very, very interesting to think about now.
Likewise information from @DemocracyManifest https://democracymanifest.substack.com/ and Paula Jardine at TCW: https://www.conservativewoman.co.uk/author/paulajardine/
But do you know what the 'bad guys' forgot, or didn't even know?
"Informed consent should be obtained for every COVID-19 vaccination, as per usual consent procedures for other vaccinations." As advised by the Australian Government, see for example: https://vaccinationispolitical.net/wp-content/uploads/2022/11/mc22-018819-signed-highlighted-1.pdf
People such as Jane Halton, with her massive conflict of interest as Chair of CEPI, called for 'no jab, no play' for adults in May 2020, i.e. a vaccine mandate, but it seems she had no idea that the practitioners administering the injections have a legal, ethical and moral obligation to obtain voluntary informed consent for the intervention.
Valid consent cannot be obtained from people who are under duress, e.g. under a mandate with the threat of losing livelihood and participation in society if they refuse to comply.
The practitioners should never have gone along with this, the minute coercion and mandates were put on the table they should have refused to collaborate with this assault on personal autonomy and bodily integrity.
But in Australia they had already been bullied into the frame for years by AHPRA, with practitioners under threat of suspension if they said anything 'anti-vaccination'.
And they went along with the No Jab, No Pay law for coercive/incentivising vaccination of children in 2016. It should have been challenged then, but they went along with it. And here we are now in 'Covid' times, with the experience of 'No Jab, No Job'...'No Jab, No Life'...that was facilitated by the AHPRA Position Statement 9 March 2021, which effectively coerced the practitioners to support the then Morrison Government's COVID-19 vaccine rollout, see for example: Reckless disregard for voluntary informed consent - the AHPRA Position Statement 9 March 2021: https://elizabethhart.substack.com/p/reckless-disregard-for-voluntary
There is NO VALID CONSENT.
Who is going to bear the responsibility for this?
Interesting how this 'study' pops out just now. FDA trying to smooth over their very tarnished image? FDA and blob career bureaucrats already trying to craft a narrative to obfuscate, avoid blame from the surely to come, much more thorough investigations led by RFK and DOGE?
Lop of the heads, and at least two layers deep, of the FDA, CDC and other agencies. As a start.
I’m surprised the FDA allowed these student researchers to even publish the study…. Perhaps they thought no one would ever find it buried in a tiny journal.
This perplexes me too Maryanne . I don’t trust much anymore and wonder if there’s a devious reason.
Will the TGA
1/ Discount the study.
2/ Further increase the "safe" level of DNA contamination exponentially and with zero evidence.
3/ Put their heads in the sand and pretend there is nothing to see here.
I’d guess option 1 and 3….. discount the study and then go back to burying their heads in the sand. 🥴
Gareth
The TGAs "misinformation" response is now shown to have been reckless and stupid. Instead of properly assessing a real issue they adopted a political response. And are now shown up for what they are.
This agency is compromised and this response and the idiotic decision to approve untested treatments for mass use means they need to be shut down and the entire management team be held accountable for their wrong and illogical actions.
Unfortunately Chris, as with all compromised institutions (including the ABC, the Academy, and multiple NGO's), the approach is to slander their critics and continue down their corrupt paths at "warp speed".
?“Otherwise, efforts to remove the residual DNA would result in an entirely new vaccine, requiring new trials and effectively restarting the process with an untested product.”?
The trials were conducted with product made by Process 1, which used PCR amplification to make "pure" mRNA to put into the LNPs. Then the products released to the public were made using Process 2, which is the one that made the vials the students were testing. The Process 2 product is the one should have required new trials!
In USA, the original trials and the FDA "EUA" process were a sham, as Sasha Latypova and Katherine Watt have written ample substacks about and as a few high level court cases have demonstrated. No clinical trials are needed under a DoD biological countermeasures program and no quality control is required and no liability accrues to the companies involved, because it is all under the purview of DoD and HHS. Not sure how that plays out in other countries, however, since they seemed to assume this was a legitimate medical product. As someone reported for EU, however, some countries there were simply following NATO directives and bypassing safety and quality controls.
As for removing the contamination etc and making yet more product for the public, why? There are perfectly good cheap early treatments well documented by now.
Yep, agree with all that. Not only did FDA accept process1/2 without question, they allowed buffer changes without trials, and now this. So many outrageous failures by this agency.
DYNAMITE Article ! Blows open the "cover up" that instigated and imposed by a now discredited FDA ! Keep shining that torch Doc into those dark corners of corruption !
Thanks JB 🙌
Has this SV40 promoter been used in any modern vaccines besides mRNA?
I'm not sure that anyone has looked.....other vaccines are developed using recombinant technology but I don't know if the manufacturers have included SV40 promoters in their plasmids.
I find this interesting that students (high school) I think I read, at the FDA Whiteoaks campus were even assigned this project. I don’t know, something comes across as a step in a larger plan. Is it going to ultimately downplay the severity? I sound so skeptical don’t I? I just don’t trust anymore. This is an explosive failure that would have to be meticulously handled. The fallout from the public would be chaotic. Thank you Maryanne this is extremely interesting. I hope one day somebody that counts mines Kevin for a correct analysis of these shots.
The FDA can hide all it wants. These tests were conducted in their own labs, under the supervision of three senior FDA scientists, using FDA reagents, with sample’s obtained from reputable sources. Cannot deny it anymore.
True, it just boggles my mind.
Maybe those FDA officials were so naive to assume it would be squeaky clean
That’s too kind. This was deliberate negligence.
Once again an illustration of the malfeasance undertaken by Big Pharma. But once again none of us reading this article, as the many similar articles that have been published on this matter in recent years, are at all surprised either.
Clearly, the scale of the abuse and malpractice adopted by Big Pharma across the plain of this "vaccine" is at such a level, that no-one, but no-one with any self consciousness, decency, integrity, or principles in relation to public health, can ever trust Big Pharma again. Also, when one realises the arrogance and total abrogation of responsibility towards public health adopted by the dogma within Big Pharma, the only resultant conclusion one can come to is to presume that such dogma has always been the protocol by which the pharmaceutical industry has ALWAYS treated the public.
Extrapolating further, one must conclude that every aspect of every "medication" and every "vaccine" that Big Pharma has ever produced must, in some manner, has been produced under the auspices of this protocol. Sadly, all one can conclude from such a thesis, is that there is NOTHING that one can trust that has come from the "mouths" of Big Pharma.
We know that the trials of every prospective new drug are only ever undertaken by the company looking to profit from the sale of this drug. Hence there is a concerning vested interest in the "successful" outcomes of these "trials".
We know that the value of peer reviewed commentaries, has, for a considerable period of time been questioned, due to the revolving door principle under which, those who are chosen to undertake these reviews are employed.
We know that the previously heralded and respected medical journals, that publish positive articles regarding the drugs coming online, have been financially captured by Big Pharma, for years, and hence the validity and authenticity of those articles comes into serious question.
We know that Big Pharma provide immense influence within medical undergraduate training establishments, such that those naive students are not aware of the manner by which they have been indoctrinated by the time they graduate, and effectively become Big Pharma dispensing automatons. (Having just written that, I now realise what the acronym FDA stands for - Farma Dispensing Automatons. Now it all makes sense!!😂)
We know that since 1986, (or there about,) in the US and in other countries since then, Big Pharma has been protected, by statute, from being sued in regards to detrimental side effects from their "vaccines".
So, we should not be at all surprised by the findings of some research undertaken by these students. My only concern regards the question as to where the laboratory within which these students worked, gets its funding from. If it is via Big Pharma, again it would be no surprise if this is the last meaningful study that is produced from this facility, before it is forced to close due a very rare and totally unforeseen occurrence of "Force Majeure!
The study was done at FDA’s White Oak facility in Maryland under the supervision of three FDA scientists. 65% of FDA’s budget for drug and biologics evaluation comes from big Pharma. 🙄
Mmm, well one imagines that there maybe some interesting telephone conversations between certain interested associated parties, in that case. I can't wait for the potential release of some very uncomfortable and damning information, around this area, once the Trump administration gets its feet under the table. Of course, that said, those feet might end up becoming buried under massive piles of shredded paper left under that "table"!
Curiouser and curiouser. Students discovered this contamination and there is no outcry?
Three FDA scientists supervised the students in a student program at the FDA…. Doing the work the agency should be doing. 🥴
Words fail me.
I'd forgot that FAKE MANTRA that Maryanne just referenced "mRNA was the "plug 'n play" technology that would revolutionise vaccination....
WHERE ARE WE TODAY with dealing with the Pandemic Transmission, Protection by vaccines and Treatment ....
So after the results reported in this article from the student research at FDA, we are now back at STAGE ONE 2020.... if TGA and FDA apply the standard they purport to apply on behalf of population safety - it means NEW trials and results with new APPROVED manufacture processes.
And VACCINES need to go back to traditional means immediately - no rain checks on this...
We might be very pleased that Robert Kennedy Jnr is in charge of US Health Policy....
Are we ready for new non mRNA vaccines....
ie Novavax etc even nasal vaccines as traditionally vaccines are not ALL muscular - think of sugar lump with polio vax!
And then there is the COMPLETE FAILURE to authorise good safe effective treatments. US and Australia have NOTHING for younger people who catch covid in the latest wave unless hospitalised...
Australia doesn't allow script medicines advertising although Pfizer got Ita Buttrose to do a little half advert on Facebook.... And I'd love to know what NEW trial evidence results led TGA in August 2024 to change Australian authorisation from provisional to full. Pfizer EPIC-HR does not provide evidence for younger people than 75yr olds unvaxed or those with compromising health issues. And Lagevrio is mutagenic and should be withdrawn.
BUT the push for full authorisation by FDA of Paxlovid in May 2023 from EUA previously, was so that Paxlovid TV ads could be done on TV during big games etc.. with a catchy jingle too. The full authority was based on EPIC-HR (High Risk over 75 and compromised health) and general wide use and effectiveness in the world population .... NO scientific evidence for general population ... go figure.. Young Americans for whom it didn't work, got rebound, got SAEs and spent $1500US for 5 days treatment were NOT happy.
If you want to see Pfizer's ad - Suggest you look at https://www.youtube.com/watch?v=Z_5Xxk00gM0
AGAINST our rules this product marketed with the same name can be viewed in Australia without TGA RESTRICTED REPRESENTATIONS Infringment notice - ie TGA has done nothing to stop Australians seeing it on YouTube
All the people in the ad are younger - not one 75 yr old and it emblazens 86% efficacy
... with tiny printed saying
"In a clinical trial of unvaccinated patients, 9 out of 1039 taking PAXLOVID were hospitalized, and none died. 66 out of 1046 taking placebo were hospitalized and 12 died (from any cause)."
No mention of the EPIC-SR fail...
When non-australian ANITVIRAL DRUG treatment approvals came to Australia, we hear Minister Greg Hunt embellishing the science / evidence too with a BIG lie distributed to GPs and Health Professionals in "GP News" 20 January 2022 - official Royal Australian College of General Practitioners (RACGP) magazine..
https://www1.racgp.org.au/newsgp/clinical/gps-will-soon-be-able-to-prescribe-two-new-oral-tr
"Speaking at a press conference following the announcement, Federal Health Minister Greg Hunt said the medicines will be available ‘subject to prescription by a general practice or in the hospital environment’ at no cost to the patient.
‘If it’s your GP that’s prescribing it, it will be available from a pharmacist,’ Minister Hunt said.
‘So simple and easy, subject to the gateway of a GP focusing on both the need, the efficacy and the safety elements.
‘This is about new hope and new protection.’
Both antivirals have been approved for use in patients aged 18 and over who develop mild-to-moderate COVID-19 and do not require initiation of oxygen but are deemed to be at increased risk of progression to hospitalisation or death.
To be effective, either treatment must be administered within five days of the onset of symptoms."
This is not the the population characteristics of the Pfizer Paxlovid TRIAL EPIC-HR on which FDA EUA approval was based and Mutual Agreements allowed TGA to give fast tracking too.
So what does Australia have left in our continuing Covid outbreaks.
Well there was an Australian antiviral nasal sprays which after 4 years of being challenged by TGA with things like the safety trial of blood tests every day for 7 days was insufficient in the opinion of the TGA clinical assessor who thought a 14 day trial would be more suitable. I have 429 FOI pages which show the delays and the entreaties to WITHDRAW the application. Eventually Starpharma has given up - at the end of the day the dollars associated with the application with no guarantee that it would be successful outweigh the community need for a simple effective prevention and treatment in first 5 days (BTW exactly the criteria with the AV drugs were unsuccessfully pursuing in normal population.
So we now wait.... Pfizer started phase 3 trials of PF-07817883 Ibuzatrelvir in December 2024 - 2 weeks ago. In August their fast track in their Pipeline was confirmed by FDA as a fast track so we can expect with Rolling Results a NOVEL drug (no name yet) for younger people and older ones too without the HIV drug pair of nirmatrelvir and ritonavir
This is a mess Maryanne and 20 million Aussies have nothing as treatment and we all need a different vaccine which is not planned.
I saw that Novavax withdrew its application for its updated (XXB.1.5) vaccine - I don't know why. It's almost as if the TGA is making it difficult for non-mRNA covid vaccines to make roots in Australia. hmmm.
That seems to be the case. They are determined not to have anything interfere with Pfizer mRNA AND PAXLOVID or PF-07817883 Ibuzatrelvir
You just wonder when Viraleze was all set for fast track or not escalation in the 12 month time limit of the MRFF covid response - someone at TGA was in total disagreement with Dept of Health encouraging a prevention treatment for COVID and decided to throw every obstacle. Up to July 2021 - have CE mark was easy step under mutual agreement of Europe and TGA - not automatic but common and the application for ARTG was in 23 July before changes to regulations occurred but the secretary (Skerritt) notified of non compulsory audit with documents to be provided by 16 September 21 after the 12 mth MRFF performance was due - on the basis that they had been issued with infringement on 2 July 2021 for RESTRICTED REPRESENTATIONS of Astodrimer sodium - the controls on that were so STIs sufferers could be referred to STI clinic by pharmacist under sched4 whilst use as HIV protection on condoms was unscheduled.
I really think there was a deal to get more mRNA VAX early in April with Morrison/Bourla and PF-07321332 Paxlovid had just completed phase1 and Pfizer knew is there was any other treatments then getting fda fasttrack might be stopped so they got questions asked at new post Brexit health in UK MHRA and country of origin Aust TGA.
The FOIs show absolutely no urgency in a pandemic and two diametrically opposed attitudes under the one (maybe 2) ministers. Dept of Health even awarded Viraleze a year later for distribution in the world but not Australia.
Starpharma awarded $1 million in matched funding by the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program to expedite development and commercialisation of VIRALEZE
Winner “Most significant commercial outcome”
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.
And the MSM says nothing. Like they are gagged
With TNI they may well have been.
It’s totally bizarre