How did our NZEPA fail to recognise that BNT162b2 [mRNA] was a GMO?
By technically limiting their scope of consideration. Important Australian court action, important Australian paper published, & a bit of a summary. Read on...
LONG READ, 5,600 WORDS. PLEASE LET ME KNOW IF CORRECTIONS ARE REQUIRED, AS I DRAFTED IT QUICKLY.
This post focuses on Australian developments, including a court action and a recently published paper The Canaries in the Human DNA Mine by prominent former barrister Julian Gillespie. The point of issues is that the BNT162b2 contain genetically modified organisms (GMO)s, and therefore a much greater scrutiny of risk should have been undertaken in accordance with legal obligations by the Australian regulators.
Central to the court action and Gillespies’ argument below is that there was always evidence that this technology, as a GMO pose a risk for genome integration (retroposition). In the Canaries paper, Gillespie make it clear that the potential for this mRNA technology to reverse transcribe had been known for decades, the WHO knew about the science of retroposition, and
The same holds for all medicine regulators throughout the world. Every one of them said nothing about retroposition at the time of the Pfizer and Moderna applications. (p.947)
Reviews and international organizations
often state that mRNA vaccines do not pose the risk for genome integration but do not cite any references in support of this idea… (nor do they) … reference the established knowledge on the biology of retroposition, seen, for instance, in peer-reviewed papers of Kaessmann et al. (2009), Casola et al. (2017), Cheetham et al. (2020), Zhang et al. (2021).’ (p.946)
In ignoring this science,
‘all of the regulators are doubling, tripling, and quadrupling their gamble that the science of retroposition is wrong in predicting catastrophic losses in the future of the human population.’
This post considers in parallel New Zealand Environmental Protection Authority (NZEPA) efforts to deny that the mRNA BNT162b2 gene therapy technology was a GMO in the first place, based on a technical picking apart of terms, (it couldn’t be deemed an organism), to therefore absolve the technology from legal requirements including risk assessment, under the Hazardous Substances and New Organisms Act 1996.
Most people might not know that the NZEPA’s Staff Assessment report was handed down on the same day that Provisional Consent to the Distribution of a New Medicine, BNT162b2 [mRNA] was granted, February 3, 2021.
By claiming the mRNA tech was not a GMO, NZEPA washed their hands from obligations to consider whether the adverse effects of the substance outweighed the positive effects. Pfizer benefitted, the company did not have to supply to the NZEPA information on the potential for any likely inseparable organisms; and all the possible adverse effects of the organism on the environment; and the affinities of the organism with other organisms in New Zealand.
But there is evidence that every booster increases the chance of integration of foreign DNA into human DNA, ‘transfection’, or transgenic modification. The synthetic mRNA is robust, it has a long half-life, which increases the potential for transgenesis, and the potential for adverse effects including diseases such as cancer.
As Gillespie takes pains to point out, the receiving environment that must be considered by regulatory authorities does not merely concern soil, air and water – but encompasses the human body. Perhaps if the NZEPA recognised that the BNT162b2 as a GMO, they would then have had to undertake a full assessment of risk to human bodies.
Gillespie makes the pertinent point, that A Human Right denied to One is a Human Right denied to All. Widespread mandates reveal that the signing on by countries to important human rights conventions may have in fact constituted mere tokenism, or ‘lip service’ by governments.
I’ve made repeated attempts to the New Zealand government to source reviews of the scientific literature as the pandemic progressed, to understand the state of risk, evidence on treatments, and evidence on the safety of the technology and safety and efficacy over time. My Official Information Act request is now with the Ombudsman. I do not believe any such reviews were undertaken. Safety and efficacy claims were based on corporate data and adverse event reports. Red flags and important considerations were broadly ignored or dismissed. Ethics and principles were set aside.
The regulatory approach is all too familiar. Technological positions that do not extend enquiry to consider biological and biochemical uncertainties including contradictory and challenging known risks described in the scientific literature. Far too much money is diverted to tech development, while too little money is diverted to broader biological enquiry to untangle how and where that tech might harm.
1. AUSTRALIAN COURT ACTION, JULY 2023
On the fourth of July, 2023 Katie Ashby-Koppens, of law firm PJ O’Brien and Associates, sent separate letters of demand to Pfizer, Moderna, the Australian Office of the Gene Technology Regulator and the Department of Health and Aged Care (who administers the Therapeutics Goods Administration (TGA)) letters of demand.
The firm demanded that the Therapeutics Goods Administration (TGA) and the Australian Office of the Gene Technology Regulator ‘immediately cause Pfizer and Moderna to cease dealing with the Covid-19 Products in Australia’; and that Pfizer and Moderna ‘immediately cease dealing with the Covid-19 Products in Australia’.
The firm asserts that the regulatory bodies, the TGA and OGTR/GTR have failed in their duty
a) Pfizer and Moderna have not obtained the necessary licences to deal with the Products as they constitute ‘genetically modified organisms’ (GMO) in Australia; and
b) the Products are contaminated with cell-substrate modDNA grossly in excess of acceptable levels.
While the drug companies have:
a) Not obtained the necessary licences to deal with ‘genetically modified organisms’ (GMO) in Australia; and
b) the Products are contaminated with cell-substrate deoxyribonucleic acid (DNA) grossly in excess of acceptable levels; and have
c) Failed certain of its sponsor obligations to the Therapeutic Goods Administration
The firm asserts that each of these matters give rise to breaches of the Gene Technology Act 2000 (GT Act) and Therapeutic Goods Act 1989 (TG Act).
2. IS THE TECHNOLOGY A GMO?
In The Canaries in the Human DNA Mine the ‘short answer is yes’. The reasoning is contained in pages 942-945 (see p.944 for the precise scientific explanation). Gillespie contradicts claims that modified RNA ‘does not enter the cell nucleus and does not interact or integrate with the genome’ on pages 946-950. Drawing from scientific reasoning by Associate Professor Domazet-Lošo:
. . all applied [genetic] engineering solutions [involved with the modRNAs] point that the vaccine mRNA molecules are, intentionally or unintentionally, designed to be integrated into genomes as easily as possible.
Interestingly, former barrister Gillespie states that
‘The guiding rule when answering the question is to abide by the legal definitions of a GMO, as they are the only definitions that count in a Court of Law.’
(As I discuss below in [4], New Zealand’s regulatory authority completely skirted around the definition of GMO in the HSNO Act, and instead resorted to the definitions of what makes an organism. The regulator appeared to consider that the boxes must be ticked for every definition, rather perhaps one or two definitions. The NZEPA certainly didn’t address the potential to enter the cell nucleus.)
Gillespie considers Australia’s definition, reasoning that:
the Australian criteria to be satisfied when looking at the Pfizer and Moderna products are whether any biological entity:
1. Is capable of transferring genetic material; and
2. The biological entity was modified by gene technology; and
3. The gene technology involved any techniques for the modification of genes or genetic material
Gillespie considers that the LNP-modRNA is a biological entity, and that it is capable of transferring genetic material. As the delivery mechanism the lipid nanoparticles (LNPs) assist in the delivery of the mRNA across the membrane of the human cells into the cytoplasm of cells.
(JB Note: I believe lipids can often go unrecognised by human biology, so make sense as a carrier. Also, we don’t need to establish exact mechanisms for regulatory authorities. For instance many psychiatric drugs have been approved without full knowledge of mechanistic action).
Spike mRNA has been detected in the nucleus of cells (Sattar et al. 2020); and scientists have demonstrated in vitro that the mRNA can be reverse transcribed into the liver cell lines (Alden et al 2022). As to the potential for heritability, Gillespie notes
Alden et al.. was further confirmed by the findings of Qin et al.., (2022) in mice that received LNP-modRNA. They not only acquired certain immune traits, but most importantly:
. . . mice pre-exposed to the mRNA-LNP platform can pass down the acquired immune traits to their offspring . . .
But you will say, this was only found in 2022.
Gillespie reasons that prior knowledge of the potential for these products to reverse transcribe has been
available to all global medicines regulators for quite some time, well in advance of the Pfizer and Moderna COVID-19 applications… That knowledge and information has been the highest reason for the existence of regulatory experts charged to detect and question whether a new biological entity such as the modRNAs should properly be regarded as GMOs.
3. BAYER KNEW, BUT DID MY NEIGHBOUR?
I believe the pharmaceutical industry broadly understood the mRNA technology contained GMO’s. During the rollout of Pfizer/BioNTech’s BNT162b2 I would call the vaccine a biotechnology or gene therapy and people would look at me critically and tell me I was incorrect. But, as Bayer head of pharmaceuticals Stefan Oelrich discussed in November 2021 (at 8.30), describing the life sciences as a ‘light in the darkness’:
‘ultimately the mRNA vaccines are an example for that cellular gene therapy. I always like to say if we had surveyed two years ago in the public, ‘Would you be willing to take a gene or cell therapy and inject it into your body we would have probably had a ninety-five percent refusal rate. I think this pandemic has opened many peoples’ eyes to innovation in the way that was maybe not possible before.’
How could a patented cellular gene therapy, containing the instructions for an altered viral protein, not be a genetically modified organism?
Did the New Zealand public have equal knowledge as the head of Bayer’s pharmaceutical division?
Debating the fact that the injection was a gene therapy would have been impossible in the legacy media, such was the financial and political investment by central government in deploying the technology.
4. NEW ZEALAND: IT DOESN’T REPLICATE SO IT ISN’T AN ORGANISM
Pfizer made a Section 26 application at a very late stage, on the 29th of January 2021, for approval of a biological entity based on SARS-CoV-2 spike (S) glycoprotein antigens encoded in RNA and formulated in lipid nanoparticles (LNPs).
Pfizer focussed on ‘organism’ and not ‘genetically modified organism’ and the New Zealand Environmental Protection Authority (NZEPA) did too.
The company informed the NZEPA that:
BNT162b2 consists of highly purified single-stranded messenger ribonucleic acid molecules (mRNAs) encapsulated in lipid nanoparticles (LNPs) in a buffer solution (see section 3 of the application). The only genetic material contained within BNT162b2 is the nucleoside-modified (N1-methylpseudouridine in place of uridine) mRNA which encodes a single gene, comprising a codon-optimised sequence based on the SARS-CoV-2 surface glycoprotein sequence (see GenBank QHD43416.1) and contains two proline mutations in place of lysine and valine codons. The translated region is flanked by a 5’ region to enhance translation and guide translocation and a 3’ region comprising a stabilisation element and a poly-adenosine (poly-(A)) tail to increase mRNA stability and enhance translational efficiency.
The mRNA, which is the active component of the vaccine, is unable to self-replicate, but is translated in the cell to produce the SARS-CoV-2 surface glycoprotein (the so-called “spike protein”), which generates an immune response in recipients.
It does not meet the definition of an organism (nor of a genetically modified organism) and therefore cannot be considered a new organism under section 26 of the Hazardous Substances and New Organisms (HSNO) Act 1996.
Pfizer’s point was purely technical because it did not fit the Act’s interpretation of ‘organism.’
I briefly discussed the NZEPA’s response in early 2022 report (see in original unedited form as a PDF or in chapter form on Substack):
While much of the processes of authorisation remain unclear, Pfizer approached the New Zealand Environmental Protection Authority (NZEPA) on the 29th of January 2021 (APP204176) seeking confirmation (a Section 26 Determination) 245 that Comirnaty COVID-19 Vaccine (BNT162b2 [mRNA]) did ‘not meet the definition of an organism (nor of a genetically modified organism) and therefore cannot be considered a new organism under section 26 of the Hazardous Substances and New Organisms (HSNO) Act 1996. Three days later a staff assessment report was produced by the NZEPA recommending that BNT162b2 does not meet the definition of an organism in the Act, and therefore it cannot be a new organism for the purpose of the Act. On February 11 the NZEPA decision-making committee, Kerry Laing and Julie Everett-Hincks, determined that BNT162b2 was not a new organism.
Just like that. In 2021’s toxic political atmosphere I wasn’t about to commence grilling individual scientists. Any scientist or doctor querying the vaccine rollout would be set upon by the legacy media. So I left it.
I remember reading separately that Pfizer was concerned that the Section 26 Determination was a potential barrier to release in New Zealand.
But it seemed that the NZEPA effortlessly sailed over it in four business days, even deliberating, perhaps, over the weekend to get it typed up in formalised report form by the 4th of February. I’m presuming the last minute application was either a last minute ruh roh – or a corporate strategy to get it done and dusted as quickly as possible.
What did the NZEPA do? They ignored the overall definition of genetically modified organism, then separately divided and conquered – individually looking at the definition for organism and for genetic element, then constructing them together.
It’s beyond belief. I personally believe their actions are misleading and deceptive.
New Zealand’s Hazardous Substances and New Organisms Act 1996 (HSNO Act) provides the definitions in the interpretation section:
genetically modified organism means, unless expressly provided otherwise by regulations, any organism in which any of the genes or other genetic material—
(a) have been modified by in vitro techniques; or
(b) are inherited or otherwise derived, through any number of replications, from any genes or other genetic material which has been modified by in vitro techniques
However, Pfizer expressly relied on the definition of ‘organism’.
organism—
(a) does not include a human being:
(ab) includes a human cell:
(b) includes a micro-organism:
(c) includes a genetic structure, other than a human cell, that is capable of replicating itself, whether that structure comprises all or only part of an entity, and whether it comprises all or only part of the total genetic structure of an entity:
(d) includes an entity (other than a human being) declared to be an organism for the purposes of the Biosecurity Act 1993:
(e) includes a reproductive cell or developmental stage of an organism
and:
genetic element, in relation to a new organism, means—
(a) heritable material; and
(b) any genes, nucleic acids, or other molecules from the organism that can, without human intervention, replicate in a biological system and transfer a character or trait to another organism or to subsequent generations of the organism
5. IT DOESN’T REPLICATE. IT CONTAINS A BLUEPRINT, IT ENCODES, TRANSLATES…
Pfizers’ claim is that the genetic structure does not self-replicate but rather translates or encodes a gene. It’s a sleight of hand. But their job is to get the product across regulatory barriers. Good on them.
The NZEPA then diligently responded in their Staff Assessment Report. They ignored the scientific literature on risk and instead focused on definitions in the Oxford English dictionary. The NZEPA did not address the interpretation of genetically modified organism, but dutifully followed Pfizer’s lead and segued to base their considerations around the interpretation of ‘organism’ and ‘genetic element’.
This is interesting, so although BNT162b2 specifical encodes a single gene – from a virus – this was not transparently alluded to by New Zealands’ biotechnology regulator. The NZEPA followed Pfizer’s lead and focussed on the drug as a template,
The spike protein is only produced in the cells of the vaccine recipient, and is not part of the structure of the BNT162b2 lipid nanoparticle. (p.6)
The officials strictly adhered to the company line, emphasising that the BNT162b2 mRNA would not reproduce.
The NZEPA picked apart the definition of organism to defer to the Oxford English dictionary. Bless. The definition of organism in the HSNO Act does not specify that organism must apply to all the definitions within the interpretation. However, I suspect this is how the NZEPA have interpreted it.
Even though it was a protein of a coronavirus, which kinda… made it a micro-organism, this direct relationship was not transparently outlined. Instead, it was the drug they narrowed their consideration to:
BNT162b2 can only serve as a template for the production of the spike protein in the cells of a recipient. The spike protein is only produced in the cells of the vaccine recipient, and is not part of the structure of the BNT162b2 lipid nanoparticle.
For the NZEPA, even if the spike protein is a protein of a virus, their concern is the medical injectable. Moreover, because it is announced by the corporation Pfizer that it does not allow its self-replication, the NZEPA judged that the category of organism didn’t technically apply, purely on the replication basis.
They were unconcerned that the template instructions coded for a gene of a viral organism. I.e. instructed the human body to make a foreign protein - like, oh gee, a GMO biotechnology. This is despite the fact that a genetic element included the potential to ‘replicate and… and transfer a character or trait to another organism or to subsequent generations of the organism.’
I’m repeating myself but the NZEPA’s technical issue appeared to exclusively concern the potential for the gene of the viral organism (i.e. the coded tech, the spike protein, once it was in the body) would then itself not replicate. From what I understand, in the minds of Kerry Laing and Julie Everett-Hincks, the first batch of uncontrolled release of a viral gene, a spike protein into the body did not fit the tech specs.
How is encoding, not replication? This is not discussed in their Staff Assessment Report.
6. IT’S ONLY THE DRUG, WHICH IS ONLY A TEMPLATE
The NZEPA didn’t conduct a literature review to evaluate the potential for the encoded mRNA product to transferred into the genome and become heritable. There might be instances in the literature demonstrating that synthetic mRNA biotechnologies might be replicable and heritable even when companies and patent holders are unaware of this.
They didn’t make an attempt to consider that the spike protein, inside the cell, would also enter the nucleus:
Thus, BNT162b2 can only serve as a template for the production of the spike protein in the cells of a recipient. The spike protein is only produced in the cells of the vaccine recipient, and is not part of the structure of the BNT162b2 lipid nanoparticle. (p.6)
The NZEPA have a long history of not undertaking methodological literature reviews that might contradict risk and policy positions. It’s not what they do. They reason based on the industry selected and supplied science they are given and stick at that.
Then the NZEPA, still failing to draw attention to the established definition of a genetically modified organism, went on to discuss whether the ‘active component’ of the BNT162b2, an mRNA molecule composed of natural and artificial nucleotide residues – could be a genetic element or structure.
Again, they ignored the issue of the fact that a genetic element could be a genetic element or structure, and from what I understand, exclusively focussed on the fact that the entire definition only worked if it was replicable. Their reasoning completely ignored any potential that the tech could be integrated into the genome, where the DNA could then be heritable.
Unlike the term “genetic element”, the term “genetic structure” mentioned in the section 2 definition of “organism” has no definition of its own. However, as with the definition of “genetic element”, definition (c) of “organism” states:
“includes a genetic structure, other than a human cell, that is capable of replicating itself…”. As with definition (b) of “genetic element”, the BNT162b2 mRNA, as a genetic structure encoding only the SARS-CoV-2 spike protein, does not have the capacity to replicate itself. Therefore, the Act’s definition (c) of “organism” does not apply to BNT162b2. (p.7)
NZEPA’s actions are to my mind, ethically immoral and unconstitutional. They made no effort to consider highly relevant issues, and discuss terms translate, or encode, and how these terms might be relevant and covered by the legislation. They simply adhered to the company line and the Oxford dictionary.
The NZEPA failed to consider the scientific evidence that demonstrated that it was highly possible that the spike protein could reverse-transcribed and integrated into the host genome (human cells) and affect the integrity of the genomic DNA (discussed below in [7] and [9]). This not only might have immediate effects, but the DNA be transferred to further generations. The NZEPA’s workaround here was to state:
As the genomes of many viral species including Coronaviruses are composed of RNA (Masters & Perlman 2013), the nucleotide sequence of BNT162b2 might be considered to be “heritable material”. However, as N1-methyl pseudouridine incorporated into BNT162b2 RNA is not a nucleotide that is found in nature, the in vitro-transcribed BNT162b2 mRNA molecule cannot be reproduced in a mammalian (including human) cell. Moreover, as discussed in the previous section, the BNT162b2 mRNA has no means to replicate itself, even if one takes into account the potential substitution of uridine for pseudouridine in a cell. For these reasons the BNT162b2 RNA neither meets the criteria of definition (a), nor definition (b) of “genetic element”, as defined in the Act. (page 7).
There was no literature review, just the statement that it couldn’t be transcribed somehow because it was a synthetic, laboratory altered protein.
NZEPA didn’t refer to or discuss the precautionary principle to think about the potential for harm from the product, the encoded product, or the unknown potential for a completely new drug to produce biological changes that could be heritable.
They turned into technical technocrats and got the approval over the line. The NZEPA handballed regulatory responsibility back to the Ministry of Health, the MAAC and Pharmac .
They’re failed to address more broadly, what the BNT162b2 makes the body do – produce a spike protein in a cell, and that repeated boosters increase potential for take-up in human DNA.
7. NEW ZEALAND’S TIMING
Notwithstanding that at that very same time, as I have written, the Medicines Assessment Advisory Committee (MAAC) were busy ignoring a bunch of relevant considerations. They sailed over so many red flags that their nice white business shirts must have been stained pink by the end of it all.
On February 2, 2021, the Medicines Assessment Advisory Committee (MAAC) unanimously recommended that a provisional consent be granted for a nine-month period, on that day Christopher James (Medsafe) granted provisional consent and the New Zealand Gazette published notification of provisional consent for use of the Pfizer Comirnaty BNT162b2 vaccine for people 12 years and older.
One day later, on February 3 2021, the Gazette notice was released authorising BNT162b2 for market release.
We can presume a lot of toing and froing was going on to have both departments, so very busy.
Why were the public not informed that they were receiving a biotechnology into their bodies, in New Zealand, with the findings of the Royal Commission on Genetic Modification, the Hazardous Substances and New Organisms Act 1996 and the Treaty of Waitangi (and the established Principles). All these elements were present to demand that officials considered information, even if it was controversial.
I’ve long suspected that New Zealand’s COVID-19 collaboration, the legacy and social media, the medical journals, the Ministry of Health, Department of Health, the lockdown Minister for Covid-19, Chris Hipkins, the Department of Prime Minister and Cabinet and the New Zealand Environmental Protection Authority did everything they could do to deny, divert, displace (i.e. substitution management of the issue) attention away from the uncomfortable knowledge that unethical and immoral steps were being taken to entice and demand that the New Zealand public to inject a biotechnology into their bodies.
The inconvenient issue of the mRNA gene technology as a biotechnology, has been set aside, dismissed, ignored – but the fact remains, it was a gene therapy, and our government did not sufficiently take account of the fact.
8. THE CANARIES IN THE HUMAN DNA MINE - & NOTES ON NZ
Returning to Australia. At the same time the court action commenced, former barrister Julian Gillespie LLB, BJuris published a paper in the International Journal of Vaccine Theory, Practice, and Research.
The paper draws attention to the decoupling of complex understanding of risk of biotechnology that is published in the peer reviewed literature, from notions of risk in vaccinology and medical regulation. This reflects a widely understood problem that over the past 40 years, basic science research has substantially shrunk, while applied science has become the poster child of funding committees. In technical, applied science environments, cultural perspectives easily dispense with complex (and ethical) ambiguities.
Decoupling the scientific literature from evidence on risk is very convenient for corporations who seek to make billions from risky technologies.
Gillespie draws attention to an unreconcilable antinomy, that four decades of scientific research demonstrates that biotechnologies are pervasively risky.
When new drugs constructed with the elements of our genes are introduced seemingly out of nowhere, and within months are scaled-up for a global population told “everything is fine, just take it, or else” . . . the failure to acknowledge over four decades of science speaking to the genetic risks associated with the drugs was never an oversight . . . It must have involved concerted planning and intentionality, a criminal avoidance of the real science at all costs. (p.950)
Gillespie outlines European legislation (Directives) in his reasoning, and
a 2020 EU law (Regulation 2020/1043) that was written in such a manner that any GMOs contained in COVID-19 drugs would remain undisclosed to the public.(p.929)
The two highly relevant Directives prioritise the protection of human life, (Directive 2001/18/EC and Directive 2009/41/EC); and the highest priority to in the 2001 law to apply the precautionary principle (p.930):
In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when:
— carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market within the Community,
— placing on the market genetically modified organisms as or in products within the Community.
The EU’s definition of organism is different from New Zealand’s. The 2001 Directive states that:
(1) “organism” means any biological entity capable of replication or of transferring genetic material;
(2) “genetically modified organism (GMO)” means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination;
Gillespie points out that the ‘environment’ specifically includes the human body.
Directive 2001 states that
‘ensure that all appropriate measures are taken to avoid adverse effects on human health . . . which might arise from the deliberate release or the placing on the market of GMOs’. (p.931)
Kiwis might also take note that New Zealand’s HSNO Act states that public health is a matter relevant to the Act (S.6), and:
S.4 Purpose of Act
The purpose of this Act is to protect the environment, and the health and safety of people and communities, by preventing or managing the adverse effects of hazardous substances and new organisms.
S.7 Precautionary approach
All persons exercising functions, powers, and duties under this Act including, but not limited to, functions, powers, and duties under sections 28A, 29, 32, 38, 45, and 48, shall take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those effects.
Gillespie also makes the point about EU legislation that is not in New Zealand legislation, that genes expressing resistance to antibiotics must be particularly taken into account. Gillespie then highlights the studies by Kevin McKernan et al Deep sequencing of the Moderna and Pfizer bivalent vaccines identifies contamination of expression vectors designed for plasmid amplification in bacteria. McKernan’s team found that the newer bivalent drugs were heavily contaminated with ‘billions of antibiotic resistant plasmids injected per person per shot’. Gillespie makes the point that if the bivalent techniques mirror the 2020 monovalents, might not the same contamination occur?
Gillespie spends considerable time pointing out the obligations of GMO sponsors in the 2001 Directive’s Annexes (p.932-934). This includes the requirement to consider indirect and cumulative long-term effects, including the potential for inducing disease in humans and other ‘allergenic or toxic effects.’ The altered susceptibility to pathogens, and even the potential to impact offspring. Broad consultation must occur.
Importantly, the EU notes that regulators require evaluation of the magnitude of the consequences of potential adverse events are evaluated, and that evaluation should assume an adverse event will occur.
The EU’s caution extends to requiring labelling stating that ‘This product contains genetically modified organisms.’ (p.936)
Fancy that.
9. PUNCHING HUMAN RIGHTS ON THE NOSE
Gillespie highlights that in 2020 the European Commission deliberately created legislation that suspended the right of the public to be informed. 2020 Regulation (2020/1043) - Notification Information for GMOs No Longer Required — The COVID-19 Drugs Exclusion (page 939).
While conventions of human rights were set aside:
10. GENOME INTEGRATION & RETROPOSITION
Oh my, (pp 946-947) the world – and the WHO have known since 1975 that genetic material from a virus could be transcribed into the genetic material of an infected organism, thus making it heritable. Integration into the host genome requires reverse transcriptase (ORF2), which we code using Long Interspersed Element-1 (L1) mRNA (L1 retroelements), known as L1 driven retroposition.
Gillespie draws on Associate Professor Domazet-Lošo author of mRNA Vaccines: Why Is the Biology of Retroposition Ignored? to explain and assert
‘The mechanism that leads to the formation of retrocopies in a human lineage is relatively well studied’ (p.946)
In many eukaryotes [organisms whose cells have a nucleus], the cellular mRNAs of various genes are endogenously reverse-transcribed and reintegrated into the genome, yielding their retrocopies . . . mRNA retroposition also occurs in somatic tissues [other tissue about the body]. . . . it is known to be common in cancer tissues and to occur during early development.(p.946)
There is ‘abundant science’ supporting this, and (expression and activity) ‘mobilization repeatedly occurs in the germline.’ (p.947)
Testes, spermatozoa, ovaries, oocytes and early embryos. In somatic tissues: liver, spleen, lungs, brain, adrenal glands, T cells and more.
The question then is the potential for the mRNA tech to achieve this?
The Alden paper demonstrates it is possible. (Of course, regulators making all relevant considerations and looking at the actual subject might have taken a precautionary approach before this time).
Gillespie emphasises that reverse-transcription was not a necessary precondition for categorising the mRNA tech as GMOs (in Australia and Europe).
The fact the LNP-modRNA complex enables entry into a cell (just into the cytoplasm) is sufficient. Due to the fact of this entry alone, all the legal obligations for performing a detailed GMO Environmental Risk Assessment arose. (p.948)
(Noting that genotoxicity and carcinogenicity studies were not required as these studies were not required for traditional vaccines. It’s just that the tech changed, and they used the old guidelines…)
Gillespie emphasises that once the Alden paper was released the mRNA products should have been suspended. Domazet-Lošo calculates that
‘the quantity of vaccine mRNA delivered in a single dose of BNT162b2 is large enough to theoretically reprogram the transcriptome [the full range of mRNA expressed by cells] of every single human cell that in principle can undergo retroposition.’ (p.948)
Gillespie asserts that Pfizer and Moderna know these numbers, and ‘given the research of Aldén et al. and that of Domazet-Lošo — these adverse health outcomes can only be the beginning.’ (p.949)
As Gillespie states, the TGA never held the companies to account, and the European Medicines Agency turned a blind eye.
Whether the NZEPA was incompetent or purposefully ignorant, remains to be seen.
What society can observe here is the setting aside of broader obligations of protection and precaution and the valorisation of narrow technical concepts.
Officials in New Zealand are unlikely to be broadly educated in constitutional and administrative law. They’re unlikely to have department heads who really want to bring up tricky issues of obligations to protect the public interest. Even thought the precautionary principle is embedded in their legislation, they’ve never published any document that might help officials apply the precautionary principles.
They detach themselves from broader obligations when they simply ignore broad biological and biochemical complexities. Complexity and ambiguity are pervasive dilemmas to address when environmental stressors interact with biological environments, yet they are set aside. The Ministry of Business, Innovation and Employment’s science policies perpetuate ignorance, as funding scopes for this sort of work are relatively no-existent. In New Zealand, there are scarce few experts who can speak across these complex ideas. New PhD students drill down and look at applied concepts. We have experts in very narrow areas.
But civil society and government will never recognise the short and long term, unanticipated and risk of technologies if we don’t fund that sort of science. That’s not happening now. We will have experts that can speak to these issues, but in highly competitive, precarious funding environments, they’re hardly likely to speak up and address political hot potatoes, and compromise their career and personal reputation.
As a final point, the issue of public law and relevant considerations extends beyond Crown law. The Treaty of Waitangi operates similarly to a contract. I’ve been told that in 1987 the New Zealand Court of Appeal established that the Crown must treat Māori in with the utmost good faith and that this requires full disclosure of all relevant considerations.
Hmmm. Did this occur?
Big thanks to Katie Ashby-Koppens, Julian Gillespie and the team in Australia for all their work. Ashby-Koppens is a kiwi, you can listen to her being interviewed on Reality Check Radio.
Other notes:
The HSNO Act was changed during three times in 2020 because of amendments to the Public Service Act (in August) and the Privacy Act (December 1) and through an COVID-19 unrelated Hazardous Substances and New Organisms (Schedules 1AA and 2A) Order 2020 (LI 2020/286) on December 3.
Interesting, one of the roles of the NZEPA is to
S.11(c) ‘promote awareness of the adverse effects of hazardous substances and new organisms on people or the environment and awareness of the prevention or safe management of those effects’
Have you ever heard the NZEPA critically discuss the potential for new organisms to cause adverse effects?
Me neither.