Pfizer adheres to NZ Regulations for Medicines, this includes ‘Gene Therapy’. NZ is focusing on its Gene Technology Regulations to facilitate Research *Development * Manufacture of New Therapies. Pfizer compliancy is bound by NZ Regulations for the Pharmaceutical Industry that covers all aspects of Medicines, including emerging fields eg:- Gene Therapy. With NZ Govt updating its Regulations to make it easier for the Medical Professions, Scientists to develop Gene Therapies including Gene Technology.

NZ Govt moving from a Restrictive System to one that facilitates Research and Access to Treatments. Pfizer’s role is well known as being focused on Gene Therapy Research and Development internationally. Pfizer trials on Gene Therapy would need Medsafe approval for local trials in NZ. Late 2024 early 2025 NZ Govt began over-hauling its Gene Therapy Regulations to replace the 30yr Hazardous Substance and New Organism (HSNO) Act

The new Gene Technology Bill is modeled on Australia’s Gene Technology Act. A new Regulator will be established with the Environmental Protection Authority (EPA) to oversee the field. This will allow for Fast Tracking of Gene Therapies. Hence Pfizer’s most prominent activity to Gene Technology in NZ has been to supply MrNA COVID 19 Jabs, which have received Provisional Approval by MedSafe…(MedSafe is NZs Medicines Regulator)

Alexion is an AstraZeneca subsidiary that acquired a portfolio of pre-clinical Gene Therapies from Pfizer in a Global deal. NZ Researchers are currently conducting clinical trials on Gene Therapies. NZs growing involvement in this field (even prior to the latest Legislative changes). NZs  Worlds First Trials – the Clinical Research Center using CRISPA in NZ. The Malaghan Institute of Medical Research running NZs first CART-Cell Trial- Genetically modifying a patients Immune Cells

Auckland University led Trials on Gene Therapies. Research collaboration in NZ Clinical Research Centers- Universities- Hospitals are already collaborating to accelerate Genetic Research and Advanced treatments using Gene Therapies for companies like Pfizer a Path to Gene Therapies in NZ. Gene Therapies include modification of Plants etc., This is backed majorly by the National and ACT Party. Reported to be a permissive approach to Gene Modification of Risks & Benefits.

Gene Technology involves Plants * Animals  * Humans * Micro-organisms = DNA. Also described as Genetic Engineering or Genetic Modification. GMOs  are organisms that have undergone the process or inherited modification of Genes. Gene Technology from a Technical perspective can involve *Modification * Removal & Multiplication * Relocation of a Gene within an organism- or the Transfer of a Gene from one Species to another

The Genetic Modification of Crops to increase production is reported to improve resistance to environmental conditions (Adaption to Climate Change referring to the Agricultural Industry)  The Gene Technology 1996- 2024 Approach- Gene Technology releasing GMOs into the Environment is heavily restricted under Law- although heavily restricted its still possible with Regulations approval

The primary barrier of using Gene Technology and GMOs in the Hazardous Substances & New Organisms Act 1996. Amendments were made in 2000 to incorporate recommendations made by the Royal Commission on Genetic Modification which meant very little changed as far as the Law is concerned. The Law at this present time before new legislation kicks in is:-

A GMO may not be imported * manufactured * developed * field tested or released into the environment other than in accordance with an approval. The  current ACT does not provide a wholesale ban on the release of GMOs outside a Lab setting in NZ. Although it does make it subject to EPA approval. The using GMOs inside Labs  are strictly regulated. GMOs can only be implemented into a developed or tested within a containments facility (A Controlled Lab) approved by the Ministry Of Primary Industries (MPI)

Operated in accordance with MPI and EPA Standards and other legal barriers such as approval from authorities in NZ. The Bio-Security Act 1993 prohibits Importation * Release * Propagation of GMOs that are not approved for Important by the current legislation (HSNO ACT). This is enforced at the Border by MPI

Between the HSNO Act and other Environmental Legislations this has been an area of tension in NZ, as a result Court decisions and some Local Authorities consider they have the power under the Resource Management Act (RMA) 1991 to regulate the use and release GMOs through Policy Statements and Plans. There are Bio-Security hurdles as to the use of Gene Technologies, therapeutic products that are GMOs which are regulated by Medsafe under the Medicine Act 1981. The Human Tissues Act 2008 which contains general prohibition on Trading in Human Tissue * Cells * Blood * Bone Marrow and other Body Parts

Australia’s Hybrid Approach is likely to be adopted in NZ. RMA Restrictions removed and the HSNO Act amended. NZ Regulators will utilize overseas regulations as to its activities. Automatic authorization will be granted for Human Medicine – Regulations for the New Gene Technology is expected to be in place by the end of 2025.. The NZ Omnibus Bill seeks to use Gene Technology in NZ by establishing a new Regulatory regime (Gene Technology Bill 2024)

AstraZeneca- Pfizer $1 Billion Gene Therapy deal with Astrenica’s subsidiary Alexion- a portfolio of pre-clinical Gene Therapy and Technologies from Pfizers deal. Alexions Global Pre-clinical Research is conducted globally. Eg 2019 collaboration with NZ Pharma focusing on discovery, research up to pre clinical stage trials. The Global Pre-clinical Candidate in 2024 is called ZP1000468 developed by Alexion and NZ Pharma prepared for Clinical Trials.

Watch for the partnership announcements as to future collaboration that could lead to new clinical trials in NZ. Alexion has had interactions with NZ Pharmaceutical Regulatory body Pharmac for its approved medicines. 2019 Alexion announced collaboration with Danish BioTech company..NZ to lead certain therapies. NOTE:- Local Clinical Trial Websites.. Research Networks * PCRN * Momentum Clinical Research * Clinical Trials NZ

NZ Gene Therapy Law aims to create opportunities for companies like Pfizer by modernizing regulations similar to Australian Gene Technology Regime. However there are Risk when it comes to Gene Therapies. And Australia does refer to those risks and the consequence involved. Concerns about integrating Vectors. Leading to severe health problems. Long term follow-ups are crucial. There are many uncertainties. Risks and Uncertainties

WakeUpNZ.. RESARCHER: Cassie

Risks include Social & Ethical Issues. The High Cost of Patented GMO Seeds. Marginalizing Rural Farming Communities. Loss of Traditional practices of seed saving and exchange among farmers to keep costs down. Reduced Food Sovereignty in New Zealand. Risks to our Domestic Market also a potential risk to Exports and NZs Economy * Exportation of Crops * Horticultural * Dairy Products . Ignores the right for Farmers and Consumers to make their own choices not to be put at risk from the likelihood of ‘Cross Seed Pollination Flow’. The  GMO seed flow to Non-GMO Crops and Organic Farms, Human and Animal Health Risks. Contaminations and Toxins. Corporate Capture of Food Systems.

 A few  Multicorporations having dominant power over Seed Patents.  Market Concentration where a wave of Mega Mergers eventuate in agrochemicals this includes Giants such as  *Bayer (Which acquired Monsanto.  * Corteva a spinoff of (DowDupont)….. *Sygenta (Owned by ChemChina).

Dominant Bio-Tech Companies where Farmers are dependent on them for multiply products. Farmers that purchase these patented seeds also must buy the matching herbicide from the same corporation (Seeds and Chemicals). The High Costs because of the Corporate nature of GMO Farming. And the Risk of Cross pollination of crops. Some GMO Crops have been developed with ‘Terminator Technology’ this means the seeds are sterile after one growing season.. locking farmers into the cycle of seed dependency and the power of price manipulation. (Unfair Competition)  Reducing Farmers profit margin. The risks, threat from the passing of the Gene Technology Bill (2024) is huge.

Dangers of gene technology include potential health risks like unforeseen allergic reactions or toxins from new genetic combinations, and agricultural risks such as the development of herbicide-resistant “superweeds,” gene flow to wild relatives, and impacts on non-target species. There are also concerns about a lack of adequate regulation and labeling, the potential for large corporations to dominate the food supplies..Time and time again I have read reports documenting that its ‘CRUCIAL’ there is Long-Term Monitoring of Gene Therapy. And how there is a potential to harm Human, Animal & Plant Life for a variety of concerning reasons.

(https://www.ncbi.nlm.nih.gov/books/NBK424534/ ) (Unintended effects associated with the genetic-engineering process (for example, DNA changes resulting from plant tissue culture).

Human Health Effects of Genetically Engineered Crops. Some of the evidence available to the committee came from documents that were part of the U.S. regulatory process for GE crops conducted by the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA). Other evidence came from studies published by regulatory agencies in other countries or by companies, nongovernmental organizations (NGOs), and academic institutions. The committee also sought evidence from the public and from the speakers at its public meetings and webinars.¹.. ”The Risk of GE crops is that the genetic-engineering process could cause “unnatural” changes in a plant’s own naturally occurring proteins or metabolic pathways and result in the unexpected production of toxins or allergens in food”.

Unintended effects of the targeted genetic changes on other characteristics of the food (for example, the intended presence of or increase in one compound in plant cells could result in changes in plant metabolism that affect the abundance of other compounds).  (Genetically Engineered Crops: Experiences and Prospects

United Nations – Playing with Genes..The Good, the Bad, and the Ugly. Moreover, there can be unintended health consequences of genetically modified crop production, including increased risks of contamination and loss of biodiversity. The downside risks can be even uglier. Genetic modifications can potentially lead to the production of “designer babies” and super-humans and fundamentally alter the human species. Genomic research can be weaponized to target and harm specific population groups. The legal, ethical and moral boundaries of using genetic technologies are increasingly unclear, creating opportunities for their misuse and abuse (https://policy.desa.un.org/sites/default/files/inline-images/eapd2023/publication/FTQ_May_2019.pdf)

WakeUpNZ

RESEARCHER: Cassie

The Potential  Risk of Gene Therapies  includes :- Potential for Allergic Reactions * Inflammation * Unknown Long Health Effects – Consequences * Concerns around the risks of Integrating Vectors. Hene Therapies can lead to Severe Health Problems. Long Term follow-up is Crucial

1)Long Term Risks of Integrating Vectors Gene Therapies include:- Insertional Mutagenesis leading to Secondary Malignancies * Immune Related Reactions * Persistent Infections. Although newer Vectors have been developed it is still reported that its crucial, essential for long term monitoring  * Insertional Mutagenesis: Integrating vectors can insert in or near genes that regulate cell growth, potentially causing uncontrolled cell growth and secondary cancers, as seen in early leukemia cases from some retroviral therapy trials

1a) Gene Disruptions: Integration can sometimes disrupt essential Genes or regulatory elements, leading to impaired Gene function  *Gene Editing Tools like CRISPA-Cas 9 can cause unintended modifications, such as Large Deletions or Chromosomal Rearrangements

2)There Are Also Immune Related Risks such as Autoimmune Reactions: where the body’s Immune System may recognize the Vector or the new Therapeutic Protein as Foreign thus triggering an Immune Response that can lead to Autoimmune like conditions also an

2a)Immune Suppression or Over-stimulation is a risk- where Immune Responses can be Unpredictable. In some cases the Immune Response can reduce the Therapy’s effectiveness or cause Systemic Inflammation

2b) Hypersensitivity can happen when introducing new Proteins from Gene Therapies, this can lead to hypersensitivity or, in rare cases, anaphylaxis.

3a)Viral/Bacterial Vector Risks: May include a ‘Persistent Infection as some Viral or Bacterial Vectors can cause persistent, long term infections, particularly in immune-compromised individuals.

3b)Re-Activation problems may occur as Vectors with a potential for Latency can Re-activate later thus leading to ‘Delayed Adverse Events’

3c) The Random Nature of Vector Integration can lead to other Genetic Errors beyond Oncogenesis, with unpredictable Long Term Consequences

4)Why is Long Term Monitoring Crucial? Because Permanent Changes can happen by Integrating Gene Therapies which are designed to provide Long Term or Permanent Therapeutic effects.. which is why the potential for unpredictable- delayed risks like Malignancy is a real concern…

5)Due to the potential for Serious Delayed Adverse Events – Long Term Follow-up is required to Monitor for these Risks  *Ongoing Research is critical for better understanding of these risks for developing much safer therapies. There are still many uncertainties.

6) Long-term gene control: For lifelong therapies, controlling the expression level of the integrated gene is critical, but this can be difficult to manage consistently over a patient’s lifetime.

7) Non-Integrating Vectors (Adeno- Associated Viral Vectors): AAV vectors deliver their genes as small, circular DNA molecules called episomes that stay in the cell nucleus – however:-

8)Pre-Existing Immunity can happen because AAV is common in the wild, many people have pre-existing antibodies that can neutralize the Vector, rendering the Therapy ineffective or causing Toxic Immune reactions. Acute Immunotoxicity is a risk although less immunogenic than some other Vectors, high dose Systemic AVV Therapy has been linked to Severe and sometimes Fatel Immunotoxicities eg :- Liver * Kidney and Heart Failure..* These adverse reactions are due to strong immune responses that can be difficult to predict or treat.

9)Dorsal Root Ganglion (DRG Toxicity): Some AAV serotypes can cause neurotoxicity in the peripheral nervous system, particularly when delivered intrathecally (into the spinal fluid).

10)Integration Risks: AAV Vectors can integrate into the Host at low frequency. Animal studies have occasionally linked this to the development of hepatocellular carcinoma, though this risk appears to be largely theoretical in human clinical settings.. There can be a risk of Transient Expression because Episomal DNA is not passed during Cell Division, the therapeutic effect can be diluted over time, particularly in tissues with high cell turnover.

11)The Long-Term Considerations For All Vectors:-

11a) Autoimmune reactions: The expression of a new protein by the vector could be misinterpreted as foreign by the immune system, potentially leading to autoimmune-like disorders.

11b) Infection and latency: Vector components from herpes viruses can have potential for latency and reactivation

11c) Patient monitoring: The long-term nature of these therapies necessitates long-term follow-up for treated patients to ensure safety, durability, and effectiveness. The FDA may require multi-year or multi-decade monitoring, especially for products with high integration activity or those intended for permanent effects.

12)WHAT IS A VECTOR IN GENE THERAPY?:  A Vector in Gene Therapy is a Delivery Vehicle used to Transport Therapeutic Genetic Material into a Patients Cells. The goal is to correct a defective gene, add a new one, or manipulate gene expression to treat or prevent a disease.

13)How do Vectors Work? Vectors are engineered to overcome the natural cellular barriers that prevent foreign genetic material from entering a cell. They act like tiny envelopes or packages, carrying their genetic payload to the target cells. Upon arrival, the vector unloads its cargo, which is then replicated and/or expressed to produce the desired therapeutic effect.

13a) What Types of Vectors are there?…. Vectors are broadly categorized into two main types: viral and non-viral…

13b) There are Viral Vectors:- These are modified viruses, stripped of their disease-causing genes and engineered to carry therapeutic genes instead. Viruses are highly effective as vectors because they have naturally evolved efficient mechanisms for infecting cells and delivering their genetic material. Common types include

13c) Lentiviruses and Retroviruses: Derived from viruses like HIV, these vectors are notable for their ability to integrate the therapeutic gene permanently into the host cell’s genome, allowing for long-term gene expression. Lentiviruses can target both dividing and non-dividing cells.

14)Adeno-Associated Viruses (AAVs) ..These are used widely because they are non-pathogenic (not known to cause disease) and have a low risk of triggering a strong immune response. They typically deliver genes as separate, non-integrating DNA molecules (episomes), which can lead to durable expression in long-lived, non-dividing cells.

15) Adenoviruses: Based on the common cold virus, these vectors can carry a large genetic payload and deliver genes to a wide variety of cells. The genetic material is not integrated into the host genome, leading to temporary expression.

16) Non-viral Vectors: These are artificial or synthetic delivery systems that avoid the potential safety issues associated with viruses. While often safer, they can be less efficient at delivering genes than viral vectors. Non-viral vectors include….

16a) Lipid Nanoparticles (LNPs): These are tiny, synthetic fat-like particles that can encapsulate genetic material like DNA or mRNA. This approach was famously used for the delivery of mRNA in COVID-19 vaccines.

16b) Physical methods: Techniques like electroporation and the “gene gun” use physical force, such as electrical pulses or pressure, to create temporary openings in the cell membrane, allowing genetic material to enter.

16c) Polymer-based vectors: Positively charged polymers can bind to negatively charged DNA, forming a complex that protects the genetic cargo and helps it enter the cell

17)What Is The Purpose of Using Vectors? Vectors are necessary for several key reasons in gene therapy. Vectors are used for Protection * Targeting *Overcoming barriers. For instance…..

17a)  (1)They protect the delicate genetic material from being degraded by the body’s enzymes before it can reach its target. (2) They can be engineered to Target specific Cell Types thus increasing the therapy’s precision and reducing potential side effects on healthy cells.  (3) When it comes to ‘Overcoming barriers they help the Genetic Cargo Cellular Barriers, such as the Cell Membrane and Nuclear Envelope to reach its Site of Action

18)CONCLUSION:  The Main Dangers Of Gene Therapy: Are a harmful immune response, the potential for causing cancer, and unintended side effects from gene delivery. While gene therapy holds immense promise for treating diseases, these risks underscore the need for careful vector design, patient screening, and long-term monitoring.

19)Several 2025 reports and events indicate that gene therapy, while making significant progress, continues to carry potential risks. Issues such as acute toxicities, adverse immune responses, and the complexities of long-term follow-up and manufacturing have been highlighted in clinical trial updates, regulatory guidance, and market analysis throughout the year.

20)Recent Clinical Trials have  underscored that severe, acute adverse events remain a risk for certain gene therapy products.. For Example- n 2025, regulatory and public attention focused on Sarepta Therapeutics’ approved Duchenne muscular dystrophy gene therapy, Elevidys. In July 2025, the FDA requested the suspension of all Elevidys distribution and placed a clinical hold on related trials after a third patient died, likely due to acute liver failure.

20a)Because of Vector-related issues: The fatal events for Elevidys were associated with the AAVrh74 vector, prompting the FDA to suspend its platform designation for that vector. This indicates that even with standardized vectors, severe and sometimes fatal toxicities can arise

20b)It was Highlighted in several 2025 Reports that Managing the Patients Immune Response to Viral Vector remains a Challenge…A presentation at the American Society of Gene and Cell Therapy (ASGCT) 2025 conference discussed a gene therapy for osteoarthritis. It noted that patients with pre-existing antibodies to the AAV vector showed less improvement than those without, demonstrating how prior immunity can limit treatment effectiveness.

20c)In a June 2025 Article Researchers noted that severe inflammatory reactions to viral proteins, which can lead to organ damage, remain a concern.  * Because gene therapies are often intended to produce permanent or long-lasting changes, the need for long-term monitoring is ongoing and complex.

21)Delayed Adverse Events – (A FDA Draft Guidance Document from January 2025).. emphasizes that patients in gene therapy trials may be at risk for undesirable outcomes that appear as delayed adverse events. Depending on the product, the guidance recommends monitoring subjects for up to 15 years.

22)Reference has been made to new Disease Patterns: At the World Federation of Neurology congress in October 2025, Professor Mary Reilly noted that as patients live longer, novel disease patterns may emerge, emphasizing the need to study the natural history of treated diseases.

23)The Evolving Regulatory Environment:- Regulatory bodies like the FDA are continually adapting their standards to balance innovation with patient safety, indicating that the landscape is not yet settled.

  24) Call for Stricter Standards: Throughout 2025, the FDA  has signaled stricter evidentiary standards for gene therapy approvals. The agency has been willing to extend review timelines to gather more long-term durability data before giving final approval

25)September and October 205 the FDA released a new draft guidance documents for Clinical Trials covering innovative trial designs for rare diseases and post-approval safety data collection for gene therapies. This shows an ongoing effort to address the unique challenges of gene therapy, rather than viewing the safety issues as fully resolved.

26)There is a Commercial and Investment Risk:

26a)Risk perception: A 2025 report from the consulting firm McKesson found that two-thirds of oncologists still view cell and gene therapies (CGTs) as “largely unproven,” and 66% say their patients see CGTs as “too experimental or risky”.

26 b)Cost and reimbursement: Insurers in 2025 have continued to demand more evidence to justify reimbursement for gene therapies, which, along with recent safety incidents, has contributed to a downturn in investment in the sector

WakeUpNZ

RESEARCHER: Cassie

Most people who are engaged in underground organizations try not to have their involvement known publicly,” said Stéphane Dujarric, spokesperson of United Nations Secretary-General Antonio Guterres, when asked why the UN employed for decades a Hamas terror chief who oversaw 2,000 teachers at UNRWA, the United Nations Relief and Works Agency.1 Yet this report reveals that the opposite is true: Hamas terror chiefs held top positions within UNRWA’s educational system despite publicly and repeatedly flaunting their support for and ties to Hamas and terrorism. UNRWA knew — and did nothing.

The UN agency that raises more than $1 billion annually from Western states with the promise to educate Palestinian children with values such as peace, tolerance, and universal human rights, instead has handed them over to the very operatives who recruit child soldiers, glorify suicide bombers, and preach the annihilation of a UN member state. By knowingly employing Hamas terrorist leaders as school principals and teachers, and by allowing terror chiefs to head the unions that oversee thousands of their teachers, UNRWA didn’t just tolerate extremism — the Western-funded UN agency institutionalized it, turning classrooms into incubators of hate.

Over its 75 years of existence, UNRWA has churned out thousands of jihadi terrorists. Some of the most infamous include the perpetrators of the 1972 Munich Massacre, or Mohammed Deif, the now-deceased commander of Hamas’s Al-Qassam Brigades, one of the masterminds of the October 7th atrocities in Israel. This in itself should raise alarm bells for any donor that supports UNRWA out of genuine humanitarian concerns.

UN humanitarian agency has a track record for producing so many terrorists? This report tells the story of how Hamas took over the UNRWA staff unions that oversee thousands of teachers and school principals, and hijacked the agency’s entire education system. As we established in our previous report, The Unholy Alliance: UNRWA, Hamas, and Islamic Jihad,

Following the scandal over a 3,000-member UNRWA staff Telegram chat group that cheered the October 7th atrocities, exposed by UN Watch in January 2024, the UN created an “independent review” headed by former French foreign minister Catherine Colonna “to assess whether UNRWA is doing everything within its power to ensure neutrality and respond to allegations of serious neutrality breaches when they are made.”

March 2023: Senior Hamas member and former UNRWA Gaza Staff Union leader Issam Al-Daalis facilitated UNRWA’s hiring of Hamas government teachers who had resigned in order to work for UNRWA.  October 2024 to March 2025: UNRWA suspended five of Sharif’s associates in the UNRWA Lebanon Teachers’ Union. This prompted the usual fierce opposition and protests from UNRWA staff. Despite clear and compelling evidence of their ties to and support for terrorism, it took nearly a year for UNRWA to fire them

Hamas took over UNRWA’s education system in Gaza. The report reveals UNRWA’s repeated capitulation to coordinated extortion tactics by Hamas and the UNRWA Gaza Staff Union, focusing on UNRWA’s longtime employment of Suhail Al-Hindi and his UNRWA-Hamas associates in Gaza

LET THE TRUTH BE TOLD…HOW THIS UN AGENCY INDOCRINATE MANIPULATED CHILDRED MINDS COLLABORATING WITH HAMAS LED TERRORIST ORGANIZATION…And we have Pro PFLP Solidarity Groups in NZ that support these horrors.

WakeUpNZ

RESEARCHER: Cassie

LINK (https://unwatch.org/wp-content/uploads/2025/09/Schools-in-the-Grip-of-Terror-UNRWA-Report.pdf ) 220 Pages