Genetically modified organisms

Are the Covid-19 drugs produced by Pfizer and Moderna GMOs or genetically modified organisms? An Australian Federal Court case has evidence to say they are GMOs Case File Number: VID510/2023 Dr Julian Fidge v. Pfizer Australia Pty Ltd & Moderna Pty Ltd Dr Fidge is an Australian medical doctor and trained pharmacist. The case has been brought under the Australian Gene Technology Act 2000 Section 10 of Gene Technology Act defines what a Genetically Modified Organism (GMO) is. First, an Organism is: ‘any biological entity’ ‘capable of transferring genetic material’ The Pfizer and Moderna Covid products contain LNP-modRNA complexes These complexes satisfy being called ‘any biological entity’ under the law The modRNA is genetic material The Lipid Nanoparticles or LNPs encapsulate the modRNA and together bio-distribute and transfer the LNP-modRNA complexes throughout the human body The LNPs then transfect and transfer the modRNA cargo across cell membranes to deliver the modRNA inside cells By moving the modRNA about the body and then into cells, the LNP-modRNA complexes physically transfer genetic material after injection So the Organism part of the GMO definition is satisfied by the physical mode of transport of the LNP-modRNA complexes The next part of the GMO legal definition is – a Genetically Modified Organism is: an organism that has been modified by gene technology The Gene Technology part requires showing: any technique for the modification of genes or other genetic material. Pfizer and Moderna admit they modify genes to create modified RNA or modRNA for their products The MHRA, EMA, FDA, and TGA when approving the Covid-19 products recognised Pfizer and Moderna use modified nucleosides for the modRNA In the TGA Australian approval for Pfizer for example, the TGA notes: The Pfizer-BioNTech COVID-19 vaccine, BNT162b2 mRNA (tradename Comirnaty), comprises a nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Pfizer and Moderna create their modified nucleosides in the lab using recombinant techniques So the Gene Technology part of the GMO legal definition is also satisfied This means the Pfizer and Moderna Covid-19 products satisfy the Australian legal definitions for being properly called GMOs Under the Australian Gene Technology Act anyone who ‘deals’ with a GMO in Australia must be regulated under a GMO licence Pfizer and Moderna failed to apply for GMO licences in Australia Dealing with GMOs in Australia without a GMO licence is a serious criminal offense under Section 32 of the Gene Technology Act 2000 In fact the boss of Australia’s Office of the Gene Technology Regulator, or OGTR, recently admitted to an Australian Senate Committee that both the Pfizer and Moderna products are GMOs No Australian was told by the OGTR or the TGA that they were being asked to receive Genetically Modified Organisms or GMOs when getting a Covid-19 injection This is not just an Australian GMO legal issue In the United Kingdom Genetically Modified Organisms are dealt with under the Environmental Protection Act 1990 and specifically Section 106 under Part VI The United Kingdom legal definitions for what is regarded as a GMO is almost identical to the Australian legal definitions we just looked at Like in Australia, the United Kingdom requires new GMOs to be subjected to an extensive Risk Assessment Even after an extensive Risk Assessment the United Kingdom Secretary of State still has to provide a Consent before a GMO can be introduced into the United Kingdom The MHRA knew United Kingdom GMO legal definitions applied to Pfizer and Moderna because it is their job to know and they have GMO experts But both Pfizer and Moderna applied for marketing approvals under the Human Medicines Regulations 2012 which exempted them from having to undergo a GMO Risk Assessment for their Covid-19 products And because of that exemption neither company had to mention on the Product Information that their products contain GMOs even though they satisfy the legal definitions