"COVID-19 vaccines are NOT fully approved by the TGA"
My email to Professor Brendan Murphy, three weeks after his ABC 7.30 interview in February 2021
In a recent article, I explain why I have submitted a formal notification to Ahpra regarding Professor Brendan Murphy’s public statements on the ABC’s 7.30 program on 3 February 2021, see:
The concerns outlined in that notification were not formed retrospectively. They were articulated at the time.
On 24 February 2021 - three weeks after the broadcast of his interview with Leigh Sales - I wrote directly to Professor Murphy raising the distinction between provisional approval and full registration under the Therapeutic Goods Administration framework.
At the time, the TGA’s published statements made clear that both the Pfizer and AstraZeneca vaccines had been granted provisional approval, under a time-limited pathway requiring Pfizer and AstraZeneca to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
The Pfizer and AstraZeneca vaccines were not fully registered on the Australian Register of Therapeutic Goods on the basis of a complete clinical data package.
That regulatory distinction formed the basis of the concerns expressed in my email to Professor Murphy, reproduced below exactly as sent.
The email was copied to members of the COVID-19 Vaccines and Treatments for Australia – Science and Industry Technical Advisory Group (chaired by Professor Murphy) and was subsequently forwarded to other senior officials, including David Anderson (then Managing Director of the ABC), Prime Minister Scott Morrison, and Health Minister Greg Hunt.
No substantive response was received from any party.
In the interests of transparency, the email is published here in full, and is also accessible via this link: https://vaccinationispolitical.net/wp-content/uploads/2021/02/covid-19-vaccines-are-not-fully-approved-by-the-tga.pdf
Email to Professor Brendan Murphy, sent on 24 February 2021:
From: Elizabeth Hart <elizmhart@gmail.com>
Date: Wed, Feb 24, 2021 at 9:20 PM
Subject: COVID-19 vaccines are NOT fully approved by the TGA
To: <Brendan.Murphy@health.gov.au>
Cc: <covid19vaccinerfi@health.gov.au>, <christopher.blyth@uwa.edu.au>, Allen Cheng <Allen.Cheng@monash.edu>, <chief.scientist@chiefscientist.gov.au>, Marshall, Larry (Executive, Black Mountain) <larry.marshall@csiro.au>, <a.wilson@sydney.edu.au>, <sue.macleman@mtpconnect.org.au>, <mark.sullivan@medicinesdevelopment.com>, ATAGI Secretariat <atagi.secretariat@health.gov.au>, PBAC <pbac@health.gov.au>
For the attention of:
Professor Brendan Murphy
Secretary of the Australian Department of Health
Chair of the COVID-19 Vaccines and Treatments for Australia - Science and Industry Technical Advisory Group
Professor Murphy
You recently assured Australians that the Pfizer and AstraZeneca vaccine products have “gone through the normal, full range of regulatory approvals for our vaccines...we have been able to do the full, safe, regulatory approval...we have not cut any corners” and “...we decided that to get the confidence of the people in Australia, because we had no community transmission, we were not going to do anything other than our full normal registration process”, during an interview with Leigh Sales on the ABC’s 7.30 program on 3 February 2021. (See copy of transcript attached.)
Your statements were in response to Leigh Sales’ questions “...what is your message to any Australian who might be legitimately worried thinking, “This has happened all pretty quickly. I’m sort of worried. Is it going to be safe to have a vaccine? What is your official advice on that?” (My emphasis.)
Professor Murphy, I suggest your ‘official advice’ on this matter is misleading because in fact both the Pfizer and and AstraZeneca vaccine products have only been given ‘provisional’ approval by the TGA. This has not been made clear to the Australian public.
The TGA provisional approval statement for both the Pfizer COMIRNATY[1] and COVID-19 Vaccine AstraZeneca[2] vaccine products states: (See copies attached.)
“Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for (Pfizer/AstraZeneca) to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post market assessment. (Pfizer COMIRNATY/COVID-19 Vaccine AstraZeneca) has been shown to prevent COVID-19 however it is not yet known whether it prevents transmission or asymptomatic disease.” (My emphasis.)
Professor Murphy, I again suggest you have misled Australians about the TGA approval for the Pfizer and AstraZeneca vaccine products.
These vaccine products have not been fully approved, and it is not yet known whether they prevent transmission or asymptomatic disease.
The Pfizer and AstraZeneca vaccine products are provisionally approved for two years, and the TGA will be relying on manufacturer supplied data to judge the longer term efficacy and safety from ongoing clinical trials and post-market assessment. ‘Post-market assessment’ indicates people being vaccinated in the community are now part of the clinical trials assessing these vaccine products - are people being informed they are part of a vaccine clinical trial? Are these people giving their consent to being involved in a vaccine clinical trial with these provisionally approved vaccine products?
It’s on the record I have brought this matter to your attention Professor Murphy, as witnessed by other members of the COVID-19 Vaccines and Treatments for Australia - Science and Industry Technical Advisory Group copied on this email.
This email will be forwarded to Prime Minister Scott Morrison, Health Minister Greg Hunt and other parties.
Sincerely
Elizabeth Hart
Independent person investigating the over-use of vaccine products and conflicts of interest in vaccination policy
References:
1. TGA provisionally approves Pfizer COVID-19 vaccine. 25 January 2021.
2. TGA provisionally approves AstraZeneca’s COVID-19 vaccine. 16 February 2021.
Attachments:
If the same test was applied to Murphy and HCSCC Commissioner Grant Davies as has been applied to the rest of us, they’d be banned from any form of employment in the health sector for life! I can’t recommend Chamomile tea to soothe a sore tummy or honey and lemon tea for a sore throat without risking a Prohibition Order, but these criminals can do whatever they want and get away with it!
Thank you Elizabeth, mRNA is not a "vaccine", it is a synthetic gene therapy treatment. (then) Senator Gerard Rennick raised the matter some time back (in senate estimates I think) when he questioned Dr Raj Bhula, from The Office of The Gene Therapy Regulator (OTGR). As a result of his questioning, she accepted that Pfizzer and Moderna are "dealing with GMO`s without a licence" (a serious criminal offence).
Katie Ashby Koppens and retired barrister, Julian Gillespie took this matter to court (DR Julian Fidge vs Pfizer & Anor). Unfortunately, a compromised judge (that represented pfizzer on at least 4 occasions, also had extended family with substantial interests in the pharmaceutical industry and potentially stood to make financial gain by this matter being overturned) Helen Rofe claimed Dr Fidge did not have standing in this matter and promptly threw it out of court. Now the only way to see justice is to enact section 72(ii) of the constitution. This will never happen because our corrupt politicians are also suppressing the truth from ever seeing daylight. The Federal Police Commissioner was informed and did nothing, the GG did nothing and the DPP did nothing. I am sure everybody is aware of the coverups and denials in the TGA as well. The corruption to hide these crimes against humanity is comprehensive.