Are mRNA vaccines against covid-19 genetically modified organisms (GMOs)?
By Swedish MP Elsa Widding
In Australia, evidence is presented that the vaccines against covid-19 are genetically modified organisms (GMOs).
See case number: VID510/2023 and Dr. Julian Fidge v Pfizer Australia Pty Ltd and Moderna Pty Ltd Dr Fidge is an Australian physician and trained pharmacist.
The case has been brought under the Australian Gene Technology Act 2000.
Section 10 of the Genetic Engineering Act in Australia defines what a genetically modified organism (GMO) is:
'Every biological entity'."
Genetically modified organisms that can transfer genetic material.
An organism that has been modified by genetic engineering
The first part of the definition of genetically modified organisms, GM O , is fulfilled by the fact that an organism is a biological entity "capable of transferring genetic material".
Pfizer's and Moderna's covid products contain LNP-modRNA complexes. ModRNA is genetic material and thus these complexes meet the requirements to be called "any biological entity" under the Genetic Engineering Act.
The second part of the G MO definition in Australia is met by the physical mode of transport of the LNP-modRNA complexes.
The lipid nanoparticles (LNP) encapsulate modified RNA that is distributed throughout the body (thus NOT staying in the arm as the pharmaceutical industry and the media conveyed to the public in Sweden). LNP has a chemical composition that transports the synthetically modified RNA into cells (LNP is transported to all organs of the body including the brain). In this way, genetic material is physically transferred from the syringe to the body's cells.
The third part of the G M O definition is – an organism that has been modified by genetic engineering. The genetic engineering part requires showing: a technique for modifying genes or other genetic material.
Pfizer and Moderna admit to modifying genes to create modified RNA (modRNA) for their products. It was made abundantly clear that Pfizer and Moderna use modified nucleosides for modRNA when the Covid-19 products were approved. For example, in the TGA's Australian approval for Pfizer, the TGA notes:
Pfizer-BioNTech's covid-19 vaccine, BNT162b2 mRNA (trade name Comirnaty), consists of a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike glycoprotein (S) of SARS-CoV-2. Pfizer and Moderna create their modified nucleosides in the lab using recombinant techniques (the genetic sequence).
This also fulfills the genetic engineering part of the legal definition of genetically modified organisms. This means that Pfizer's and Moderna's covid-19 products meet the Australian legal definitions to be properly called GMOs.
Under the Australian Genetic Engineering Act, anyone who 'handles' a GMO in Australia must be regulated by a GMO licence. Unlike Astra Zeneca, Pfizer and Moderna failed to apply for GMO licenses in Australia. Handling genetically modified organisms in Australia without a GMO license is a serious offense under section 32 of the Gene Technology Act 2000.
In fact, the head of Australia's Office of the Gene Technology Regulator, or OGTR, recently admitted to an Australian Senate committee that both Pfizer's and Moderna's products are GMOs.
No Australian was told by the OGTR or TGA that they were being asked to receive genetically modified organisms or GMOs when they received a covid-19 injection . However, this should not just be a GMO legal issue in Australia.
In the UK GMOs are dealt with under the Environmental Protection Act 1990 and in particular section 106 of Part VI. UK legal definitions of what are considered genetically modified organisms are almost identical to the legal definitions in Australia. As in Australia, the UK requires new GMOs to undergo a comprehensive risk assessment.
Even after a comprehensive risk assessment, the UK Secretary of State still needs to give his consent before a genetically modified organism can be brought into the UK. Both Pfizer and Moderna applied for marketing authorization under the Human Medicines Regulations 2012 which exempted them from having to undergo a GMO risk assessment for their Covid-19 products. Because of this exemption, none of the companies had to mention in the product information that their products contain genetically modified organisms, even though they meet the legal definitions (see attached product information).
It is claimed that Australia, Europe, South Africa and the USA have almost identical legislation regarding genetically modified organisms. How then is it that modified RNA is not considered GMO in Sweden? Is there any clear opinion on the matter?