GENE THERAPY ‘ PFIZER’- ASTRAZENICA- THE NZ NEW GENE THERAPY BILL 2024…

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

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GENE THERAPY ‘ PFIZER’- ASTRAZENICA- THE NZ NEW GENE THERAPY BILL 2024…

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

...

CDC ARE ENCOURAGING COVID19 TO BE TEACHABLE IN SCHOOLS

How schools can support COVID-19 vaccine confidence
• Encourage teachers and staff to share their COVID-19 vaccination stories on social media and/or through school. Seeing adults they trust getting the COVID-19 vaccine can spur students to talk with their families and also put their minds at ease about vaccination.
• Invite students to wear their COVID-19 vaccination stickers to school.
• Recruit a set of teachers to host a school-wide art or writing contest about COVID-19.
• Display age-appropriate COVID-19 vaccine educational posters around the school building and in classrooms.
• MAKE COVID19 A TEACHABLE MOMENT-Discuss lessons about COVID19 and vaxes, incorporate into school subjects.
School districts can do their part in promoting well child visits as an opportunity to address any other special health and development needs — especially any that arose during the pandemic such as behavior and mental health concerns. See Resources for Encouraging Routine Childhood Vaccinations for more information.

https://www.cdc.gov/vaccines/covid-19/planning/school-located-clinics/how-schools-can-support.html

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DOES A DEATH CULT EXIST UNDER THE VEIL OF COVID19?

In November The Defender wrote to the New Zealand Ministry of Health (MOH) to ask some important questions about the practice of euthanasia and assisted suicide in New Zealand.

In light of the serious deficiencies in the End of Life Choice Act (EOLCA), and concerns that have been raised by healthcare professionals, we felt it was crucial to put some urgent questions to the MOH.

In our Official Information Act (OIA) request we asked the following question:
“Could a patient who is severely hospitalised with Covid-19 potential
ly be eligible for assisted suicide or euthanasia under the Act if a health practitioner viewed their prognosis as less than 6 months?”
There were several reasons why The Defender wanted to seek clarity from the MOH about this issue. One of those being the vague interpretation of what determines , qualifies as a ‘terminal illness’

Firstly, New Zealand is currently described as being in a precarious position when it comes to COVID-19 and hospital resources. In light of this, it would not be hard to envisage a situation in which a speedy and sizeable rise in COVID-19 hospitalisations could result in pressure to utilise euthanasia and assisted suicide as tools to resolve such a serious crisis.

Overseas commentators have raised the prospect of these kind of unethical motivations since early in this pandemic.

The Defender News Media have created a petition to Parliament calling to have David Seymour’s Euthanasia Act to be amended urgently (End Of Life Choice)
Ever since Seymour’s Bill (End Of Life Choice) was introduced to parliament I have had serious concerns about the dangerous concepts that exist within it. I view the word ‘Choice’ used within the title of the Act as being a psychological drawcard. Everyone’s loves a choice.

When members of Parliament voted as to this euthanasia Bill last year, under the veil of COVID19 it was not a party political vote, it was an individual vote. One of heart, emotions etc., I believe the facts as to the serious risks that could eventuate were not taken into consideration. And how many people would unnecessarily seek to prematurely end their lives due to serious circumstances that no health professional could ever know about. That no political act could regulate.

In my rumble video I explain in greater depth what I deem to be the dangerous concepts of Seymour’s Euthanasia, Assisted Suicide Act that became law last month (November 2021).

I also express my concern as to whether we the citizens of New Zealand under residing under an institutionalized state death cult, that has been introduced under the veil of COVID19.

PLEASE CLICK ON THE ARROW WITHIN THE IMAGE WHICH WILL TAKE YOU TO MY RUMBLE VIDEO WHERE I AIR MY SERIOUS CONCERNS AND THAT OF OTHERS.

IF YOU HAVE NOT SIGNED UP TO MY WEBSITE YET PLEASE DO SO NOW, THANK YOU.

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A ONE HEALTH APPROACH ‘SURVEILLANCE’ IN NEW ZEALAND SOONER THAN YOU THINK ‘CONTROL ALL LIVING BEINGS’

Otago University Prof David Murdoch spoke about the concept of the One Health Approach, saying this is going to be sooner than you think, this One Health  Approach to Disease surveillance. Describing this as an integrated, unifying approach for people, animals and eco-systems.

An ecosystem is a geographic area where plants, animals, and other organisms, as well as weather and landscape, work together to form a bubble of life. This is how the academics, government explain eco-systems to a child “An ecosystem is made up of the interaction of all living organisms (like animals, plants, and bugs) in an area with all of the non-living organisms (like water, dirt, rocks, and the sun).

Academics, Governments, NGO and corporate ventures etc., are using a ‘One Health Approach to ward of any future threats (ANY). So, academics are saying ““Increased urbanization, overcrowded living conditions, increased global migration, and the increasing push of humans into animal habitat has created an environment that promotes the transmission of infections and made the COVID-19 pandemic possible.”. BUT  this is what they are promoting the future slums of called Smart Cities. C40 Cities with mass migration entrenched into urbanization. (Reference Mayor Migration Declarations- Mayors Migration Council- Mayors Mitigation with C40 Cities).  Auckland has won a C40 Award for their acceleration and promotion of the 100 city C40 City Network under Phil Goff which was resigned before the new mayor took over. (Wayne Brown).

C40 Cities network Dietary Plan-Plant Based Foods targeting farmers within highly populated areas. No Farmers No Food.. ah well eat tree’s and beetle bugs this is barking up the wrong tree so to speak.

Professor David Murdoch says “COVID-19 has thrust into focus the impact of humanity’s changing relationship with the environment”. In other words the ‘One Health Approach’. NO SURPRISES HERE:- Prof David Murdoch Otago University Flagship Research Council of New Zealand  funded by ..Gavi, the Vaccine Alliance- Bill & Melinda Gates Foundation – Ministry of Business, Innovation and Employment

The Lancet One Health Commission called for transdisciplinary collaboration promoting and generating solutions to complex health challenges. COVID19 Pandemic recognizes the fundamental connectedness of humans, animals and the whole eco system.   CRISIS  CRISIS   CRISIS   CONTROL EVERYTHING

Of course, if you do not oppose the concept of a One Health Approach this equates to ‘Silence is Consent’

RESEARCHED BY Carol Sakey

https://www.otago.ac.nz/hekitenga/2020/otago742802.html

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