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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THE ARSES THAT RESIDE IN THE STINKY TOILET BOWL PERSISTENTLY CRAP ON KIWIHEADS

The severe erosion of Human Rights, Freedoms as laid out in The Universal Declaration of Human Rights which was introduced worldwide on 10th December 1948.
Human Dignity is the fundamental core of all Human Rights regardless of age, status, gender, ethnicity… Human Dignity is one of the most important things to the human spirit. The importance of respecting a persons human dignity is also tied into respecting an individuals bodily integrity.
Bodily integrity is the inviolability of the physical body and emphasizes the importance of personal autonomy, self-ownership, and self-determination of human beings over their own bodies.

The right to a private life protects your dignity and autonomy (your right to be independent and make your own decisions about your life). … the right to personal autonomy and physical and psychological integrity (this right means you must not to be physically or psychologically interfered with)

A right to refusal of human treatments, vaccines etc., is part of human bodily integrity. A Human Right.
The Declaration of Human Rights has been severely violated, the UN/ WEF are key players when it comes to violating Human Rights and promoting discrimination. The official partnership agreement between the UN and World Economic Forum, a public-private corporate imperial governance of the world will persistently, continuously insist on the destruction of freedoms, human rights, the right to choose one’s own destiny.

Wealth before Health, Wealth before Human Rights, Freedoms, Wealth before Autonomy, Wealth before traditions and cultures, Wealth to determine every part of your life…. A one script for all, everyone, everywhere, every age… from the cradle to the grave… a universal plan to dictate how each person thinks, behaves… like cattle to the slaughter.. the end of Human Dignity.. the fundamental core of all Human Rights.

WAKE UP NEW ZEALAND.

Please click on the arrow in the image above which will link you to further information in my rumble video. Thank you.

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WEALTH BEFORE HEALTH- REFERS TO THE NZ GOVERNMENTS ‘AI’ PARTNERSHIP PROJECT WITH THE WORLD ECONOMIC FORUM

An AI dictated future, a future in which our every move, our every word, our every relationship is trackable, traceable and data-mineable by unprecedented collaborations between government and tech giants.

It’s a future in which our every move, our every word, our every relationship is trackable, traceable and data-mineable by unprecedented collaborations between government and tech giants.

In Australia for instance, , there is a certain amount of disillusionment creeping into the e health debate (tele-medicine and tele-health). This is because long-standing issues relating to privacy, access to records, the competency of some bureaucracies charged with overseeing projects and questions about the adequacy

Telemedicine and telehealth standards are established by the same state-specific regulatory institutions that establish standards for in-person clinical treatment. … But despite federal adjustments to telehealth oversight, many aspects of telehealth regulation are still determined on a state-by-state level

Since providers can’t physically examine patients during virtual medical appointments, it’s harder to carry out a standard of care

There are various limitations to telehealth- Telemedicine visits are not a complete substitute for in-person visits; nor they are feasible for all patients or clinical situations. For example, technology does not always work smoothly, and technical difficulties may interfere with delivery of care
Panic, fear, anxiousness has swept away many peoples ability to use logical thought processes. For some a learned helpless to comply with isolation, distancing themselves from human contact from others.

Many people have been swept away by a tidal wave of panic, and this warmed-over dystopia have become acceptable of this AI acceleration into their lives, just taking it all for granted without thinking about the serious consequences., the huge impacts of a global AI totalitarianism that controls peoples lives, that stops them from seeking human comfort instead turning to an AI decision making algorithm.

This is NOT NORMAL, and the so called NEW NORMAL should never be acceptable to the Human Race.

Mass surveillance can be the killer of the human race, this application of deep learning. Isolation and the lack of human contact.

Please click on the arrow above in the image which will link you to my Rumble Video with more important information on ‘Telehealth’ which the New Zealand Government is promoting in their white paper project in their partnership with the World Economic Forum.

Please sign up to my website if you have not done so already, thank you.

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NZ GOVERNMENT PLAYS HUGE ROLE IN GLOBAL DIGITAL DICATORSHIP

Behind the closed doors of the political toilet bowl of Wellington the New Zealand Government is reaping its global glory as it promotes, makes plans and policies partnering with Google AI and the World Economic Forum and its UN official partnership with the UN.
International laws to control the planet, people and profit. The wealthy 0.01% of wealthy multistakeholder capitalist corporations, big tech, big pharma, Bayers-Monsanto GE seeds, Lab manufactured foods. A system, digital framework on a one global metric system that includes the now COVID19 restrictions right into year 2030.

The destruction of the world economy through COVID19 controls, restrictions – a window of opportunity to redesign your life, your diet the way you think, behave – live. The Government calls this ‘Unlocking New Zealand’s Digital Potential’. More censorship, more surveillance, trading privacy for security. A global Digital transformation…leave no-one behind, everyone, everywhere at every age. From the cradle to the grave.
Everyone monitored, controlled by a Communist Chinese Social Credit System, rewards and punishments. Comply – don’t comply you lose your freedoms. Using the bludgeoning of fear to control the people. (Fear is a liar).

Legal Fictions are rife through data in and data out, global metric systems, data modelling biases, predictions. Real Science is under attack. Real history is under attack. The citizens of New Zealand are under attack. Free Speech is under attack.

To learn more about this please go to my Rumble Video link in the image above, Thank you.

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MEDSAFE QUESTIONS AND ANSWERS AS TO SAFETY POST COVID19 JABS

How will Medsafe assess the short and long-term efficacy and/or safety of a COVID-19 vaccine?

Medsafe will apply its usual assessment criteria for the evaluation of any COVID-19 vaccine submissions. We will use international regulatory guidance in general, and advice specific to COVID-19 vaccines.

Efficacy is determined by the results of clinical trial(s) and studies on the types of immune response generated by the vaccine.
Safety data will be available from the clinical trials. As for all medicines, additional safety information will be gathered from long-term follow-up of clinical trial participants and safety monitoring.

Most information provided to Medsafe as part of a medicine application is confidential to the pharmaceutical company. However, some detail such as the qualitative product formulation, site of manufacture, and the data sheet will be published on Medsafe website when the vaccine is approved
How long will the vaccines work?

At this stage, we do not know how long a vaccine might work for.

Where can I find the clinical, safety, and quality data that Medsafe evaluated to approve COVID-19 vaccines?
Information submitted to and held by Medsafe as part of the approval process is confidential to the respective pharmaceutical companies
Provisional consent allows conditions to be imposed on the vaccine, restricting its use by healthcare professionals according to the data available at the time of approval. Provisional consent was included in the Medicines Act to allow New Zealand patients to have early access to medicines with a significant unmet clinical need.

What happens when the provisional consent for a COVID-19 vaccine expires?
Provisional consent was granted to all three currently approved COVID-19 vaccines for a period of nine months. Prior to expiry of this period, provisional consent may be renewed for a further period of up to two years, full consent may be granted, or the consent may not be renewed.
Medsafe has renewed the provisional consent for Comirnaty for a period of two years and the renewed consent is valid until 3 November 2023.
COVID-19 Vaccine Safety – Questions and Answers PUBLISHED 27TH November 2021 MEDSAFE WEBSITE https://www.medsafe.govt.nz/COVID-19/q-and-a-vaccine-safety.asp

PLEASE NOTE:-Should I be getting a COVID-19 vaccine while I am pregnant?
Currently, the Comirnaty (Pfizer) vaccine is the only COVID-19 vaccine available in New Zealand. There is limited data with the use of Comirnaty in pregnant women. Animal studies have not indicated direct or indirect harmful effects in pregnancy, development of the fetus or the newborn.

WHAT ADVERSE EVENTS AFTER JABS ARE- doctors, nurses, DHB staff, pharmacists required to report to the Centre for Adverse Reactions Monitoring (CARM)?
There is no legal requirement for healthcare professionals to report adverse events following immunisation (AEFIs). However, we encourage healthcare professionals to report all AEFIs

ARE ADVERSE EVENTS OCCCURRING within a specified period after vaccination required to be reported to CARM?
There is no time limit for reporting adverse events.
Are adverse events listed by the vaccine manufacturer in the package inserts and data sheets required to be reported to CARM?
There is no legal requirement to report adverse events.

DOES THE JAB AFFECT FERTILITY:- Animal studies for the Comirnaty vaccine did not show any effect on fertility.

ARE THE COVID JABS SAFE FOR CHILDREN?..The Comirnaty vaccine is indicated for use in individuals aged 12 years and older. Clinical trials to assess safety and efficacy in children are ongoing.

WHAT MEDSAFE STUDIES HAVE MEDSAFE DONE.. to ensure the vaccine is safe for general use?
Medsafe does not conduct studies. Medsafe reviews the data submitted by the pharmaceutical company, including clinical trial data. See above for more information on the types of data that is required.

WHAT ARE THE ACCEPTABLE NUMBER OF SIDE EFFECTS? We encourage healthcare professionals and consumers to report any suspected side effect to a COVID-19 vaccine. For this reason, and because so many people will be receiving a vaccine, we expect many side effects to be reported.
Receiving large numbers of reports also indicates that the reporting system is working and easy to use.

Research and Data on vaccinating young people. https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-health-advice/covid-19-vaccine-and-children-information-parents-and-caregivers (US Wide- over 17 million 12-15yr ods in the US)

Immunization Advisory Centre. https://covid.immune.org.nz/faq/myocarditis-and-covid-19-vaccine-new-zealand
Myocarditis and the COVID-19 vaccine in New Zealand
An increased risk of heart inflammation (myocarditis, pericarditis, or both) has been observed in people who have received mRNA COVID-19 vaccines in overseas studies, particularly in males under 30 years of age after the second vaccine dose.
After treatment, many patients live long, full lives free from the effects of myocarditis. For others, however, ongoing cardiovascular medication or even a heart transplant may be needed

Covid-19: Vaccinations for children aged 5 to 11 due to begin …
https://www.stuff.co.nz › … · Whakamāoritia tēnei whārangi
1 Haki 2021 — Vaccinations for children aged 5 to 11 years are expected to start before the end of January reportef Covid-19 Response Minister Chris Hipkins PLEASE NOTE WHAT MEDSAFE REPORTS AS TO SAFETY FOR CHILDREN POST COVID JABS- Do not state Safe or Not. Do not respond to safety post jab question as a Yes or No.

Covid-19: Pfizer vaccine approved for children aged 5-11…
Medsafe has granted provisional approval for the Pfizer COVID-19 vaccine for children aged 5 to 11 years old.
Pfizer has plans to trial the vaccine in children aged 6 months to 5 years, and Moderna has ongoing trials to test the safety and efficacy of vaccines in children under 12 years old.
Pfizer revealed that there were very few serious adverse events and no deaths during the phase 2 and 3 trials of children aged 5–12 years. He also explained that the side effects were similar to those that adults experience

October 29, 2021 https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age

WHAT IS EMERGENCY USE AUTHORIZATION ? An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.
Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.

https://www.medsafe.govt.nz/COVID-19/q-and-a-vaccine-approval.asp

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