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

...

Health Blog Posts View all Categories

IS THERE A DANGER LURKING IN THOSE NEW ZEALAND PCR TESTS?

Through social media I cam across a post that referred to a dangerous chemical namely Ethylene Oxide being used in PCR tests as a sterilization agent. This caused me some serious concern, therefore I decided to dig a bit deeper into this chemical namely Ethylene Oxide.

The FDA Is Taking Steps to Move Beyond Ethylene Oxide “Gas” Sterilization. There has been calls to replace Ethylene Oxide because of cancer risks

There’s outrage from exposed communities has federal regulators and device makers seriously rethinking a question that’s been hanging over the sterilization industry for decades: Can ethylene oxide be replaced?

Ethylene oxide is a widely used chemical made in the U.S. by some of the industry’s global giants, including Dow Chemical, Huntsman, Shell and Union Carbide. The main ingredient in automobile antifreeze.

FDA reported they will l continue in its efforts to reduce over-reliance on ethylene oxide for medical device sterilization. Supply issues can lead to shortages of medical devices—and can pose a threat to public health by delaying or disrupting critical care for patients. Mitigating product supply issues and working to prevent patient harm from device shortages are important to the FDA.

November 2019 it was reported that regulators from public health agencies, medical device manufacturers and expert physicians gathered at a 2 day meeting to discuss, address challenges with ethylene oxide, a carcinogenic gas used to sterilize more than 50% of medical devices.

The topic of focus of those at the gathering was “What’s the potential impact of reducing, eliminating or replacing ethylene oxide sterilization on the medical device supply chain, and what can FDA do to prevent shortages of critical devices used by hospitals and other healthcare providers across the country”?

Back in 2019, it was documented that 20 billion to 25 billion devices are sterilized in 2018 using ethylene oxide. FDA issued a warning in October 2019 that without adequate availability of Ethylene Oxide a national shortage of devices will occur.

Clinical Oncology News in the US, May 2nd 2020’s article read ‘Sterilization has beena problem for months- then COVID19 hit’
For months, officials had been warning of a looming shortage in the supply of a gas used in the sterilization of medical equipment (Ethylene Oxide). That the system had now taken another hit and was stressed due to COVID19.

One of the most adopted sterilization processes uses ethylene oxide (EO), a highly reactive, toxic and flammable gas capable of sterilizing at ambient temperature, preserving those medical devices which cannot be exposed to moisture or high temperatures — like the ones made of polymers, plastics or those containing electronic components.

The EO sterilization is assumed to play an important role in the battle against COVID-19, but, due to its intrinsic hazardous nature and carcinogenic effect on human beings, very high attention must be paid on possible residual levels
This position is supported by the Centres for Disease Control and Prevention (CDC) which states, “Ethylene oxide is not recommended as a crisis strategy for cleaning filtering facepiece respirators as it may be harmful to the wearer.”

In this scenario, it becomes even more critical to rely on efficient and sensitive testing methods to ensure no residual EO is present on PPE and medical devices in general.

Ethylene Oxide is absorbed by many materials, for this reason, following sterilization the item must undergo aeration to remove any residual. Guidelines have been promoted regarding allowable EO limits for devices that depend on how the device is used, how often, and how long in order to pose a minimal risk to patients in normal product use

Additionally, during the EO sterilization process, it is also possible the formation of 2-chloroethanol (or ethylene chlorohydrin, ECH)2, which is classified as a hazardous substance very toxic by inhalation and skin absorption.
Ethylene Oxide is used for various medical devices including PCR tests to insert deeply into peoples nasal cavaties

Please go to the link in the image above which takes you to my Rumble video for more information on this serious subject.

...

MEDFSAFE WEBSITE QUESTIONS AND ANSWERS TO SAFETY OF COVID 19 VACCINE (HUMAN EXPERIMENTS)

QUESTIONS AND ANSWERS ON MEDSAFE WEBSITE- https://www.medsafe.govt.nz/COVID-19/q-and-a-vaccine-safety.asp

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 (NOTE: DOES NOT DOCUMENT HUMAN STUDIES)

What adverse effects (or events) after vaccination 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. Consumers can also report any reactions they experience to medicines and vaccines.
(NOTE: NO LEGAL REQUIREMENTS TO REPORT ADVERSE EFFECTS)

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. However, we encourage reporting of adverse events listed in the package inserts as well as any event that may be related to vaccination. ( NOTE: NO LEGAL REQUIREMENT )

If a patient has previously had an adverse event to a vaccine, can they receive a COVID-19 vaccine? (NOTE: AGAIN NO DIRECT ANSWER OF YES OR NO).

If a patient has previously had an adverse event to a vaccine, can they receive a COVID-19 vaccine?
Healthcare professionals should refer to the data sheet for information on contraindications to specific vaccines. These are published on our website.
(NOTE : AGAIN DOES NOT ANSWER YES OR NO )

Are the vaccines dangerous for people with previous COVID-19 infection?
The Cominarty clinical trials included people with previous COVID-19 infection. There are no known safety issues for people with previous infection. (NOTE: DOES NOT GIVE ANSWER YES OR NO)

Are the vaccines 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. (NOTE: AGAIN NO YES OR NO ANSWER.. BUT TRIALS ARE STILL ONGOING… AS ARE THE HUMAN EXPERIMENTS ON OUR CHILDREN)

Are the vaccines safe for people with immunodeficiency or autoimmune conditions?
Refer to the vaccine’s Data Sheet or Consumer Medicine Information (CMI). (NOTE: STILL NO..YES OR NO ANSWERS)

What 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. (NOTE:- THEY DO NOT DO THEIR OWN TRIALS… NOTHING IS TRANSPARANT)

What is an 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.
Note that the cause of death is investigated and determined by the coroner, not by CARM or Medsafe. See the Coronial Services website (NOTE: DO NOT GIVE AN ANSWER AS TO ACCEPTABLE NUMBER OF SIDE EFFECTS..HOWEVER THEY WILL SEE AND THERE HAVE BEEN MANY MORE SERIOUS SIDE EFFECTS AND MORTALITIES)
ALSO PLEASE NOTE 5 -6 YEARS BACKLOG WITH INVESTIGATIONS IN CORONERIAL SERVICES.

...

COVID19 HEALTH AND RESPONSE ACT AMENDMENT (2) 2021

The COVID-19 Public Health Response Act was enacted in May 2020, at a very early point in Aotearoa New Zealand’s response to the COVID-19 pandemic. At the time, nobody knew how long we would be dealing with the pandemic and there were still a lot of unknowns about the virus. This bill aims to update that Act to better reflect developing knowledge of how long the public health response may be necessary, to address the reliance of MIQ on the general law and operational decisions, and to ensure that the empowering and enforcement provisions are suitable for preventing and managing the risk of the outbreak and spread of COVID-19.

What does this bill mean?

Provisions in the bill will make many changes to the existing COVID-19 Public Health Response Act. The legislation:

Extends the time the Act is in effect until May 2023

Increases the maximum fines and fees for infringements (with fees of up to $4000 and fines of up to $12,000 for individuals), and enables new regulations to set a sliding scale of infringement offences

Refines the powers of COVID-19 orders, including by broadening their purpose, incorporating material by reference, and improving delegations
allows for the creation of COVID-19 orders for requisitioning testing consumables and requiring labs doing COVID-19 testing to do so for the national public health response, with appropriate compensation and a disputes appeal process

Expressly recognises the ability of the chief executive of the agency responsible for MIQ (currently the Ministry of Business, Innovation, and Employment) to impose room restrictions on people undertaking isolation or quarantine. For example, the chief executive may allow or disallow people from taking their daily exercise if they deem it necessary to ensure the health and safety of MIQ workers.

The bill also makes several changes to how Managed Isolation and Quarantine (MIQ) works.

It creates a process for making complaints about MIQ, enables the chief executive of the responsible agency to make rules for the day-to-day operation of MIQ facilities
Makes people automatically liable for MIQ charges unless they are exempt, enables MIQ to collect contact details from people undertaking isolation or quarantine to support invoicing for MIQ charges. Shifts provisions regarding the allocation and prioritisation of spaces in MIQ from COVID-19 orders to primary legislation.

The Bill does not change any existing safeguards in the original Act, including the requirements for the House to pass resolutions to continue the Act on a periodic basis, the prerequisites for COVID-19 orders, or the requirement that all COVID-19 orders be consistent with the New Zealand Bill of Rights Act 1990.

Who might this bill affect?
The legislation will have an impact on everyone in Aotearoa New Zealand, but may particularly affect:

People seeking to return to NZ
Essential workers
People who provide COVID-19 tests and testing services
The Ministry of Business, Innovation, and Employment

PLEASE NOTE: NOTHING HAS STOPPED NEW RESIDENCY IN NEW ZEALAND … THE GOVERNMENT IMMIGRATION ‘PATH’ PROGRAM… 165,000 NEW NEW ZEALAND RESIDENCIES BY JULY 2022.

...

A 1991 BLUEPRINT FOR A PRE-PLANNED GLOBAL REVOLUTION FOR THE 21ST CENTURY

The pre-planned blueprint of the 21st Century was introduced by the Club of Rome in 1991. Just before the UN introduced UN Agenda 21 with its millennium goals, a global strategy of transformation that included people, planet and profit for the wealthy few.

Agenda 21 ended in 2015 when UN Agenda 2030 replaced it, this included 17 Global Development Goals. 17 out of 17 of these global development goals included climate alarmism (using weapons of fear to bludgeon minds worldwide, including our children’s minds.

14 of those 17 global development goals include vaccines. To leave no-one behind, everyone, everywhere at every age from the cradle to the grave. For 95% of the population in developed countries to participate in new vaccination, human experiments.. now and in the future. 2020- 2030 the Global Strategy of Vaccines.. Leave No-one behind. The Decade of Vaccines.

Target vaccine hesitancy, fill the population gaps, target hesitancy to vaccines..demand vaccines (World Health Org., UN). A global transformation of people and planet.

The Club of Rome has other related clubs, the Club of Vienna and the Club of Madrid. Helen Clark is a member of the Club of Madrid. Clarke received an email that was also cc’d to James Shaw in 2019 from the Club of Rome…

Dear Helen Clark, as a member of the Club Of Rome (Madrid), I omitted to include in a hyerlinked email to the main Club of Rome members on the 27/05/2019 the following. As our former PM we believe this is important for you to know, that the Club Of Rome’s Emergency Plan is flawed..is based on theory-refuting high forecast inaccuracy (84%-97%). The IPCC’s dismissal/omission of natural climate change risks relevant to the 21st century that the UN IPCC contrived in (Art 2) that dictated key-risk assessment, its unsafe alteration to ice age boundaries which dis-orients governments to the significance of today’s climate change.
Please note that this email was also cc’d to 60 government ministers (MPs) including those politicians of the opposition.. The Maori Party, Greens, Act and National. Yes they are all in this together.

The elephants have never left the room as John Key, Winston Peters and Helen Clark are also key manipulators, influencers in this evil transformation of human lives through a Global Strategy namely UN Agenda 2030.

Under the veil of COVID19 massive weapons of fear are intruding into personal lives, destroying family relationships, friendships as Ardern’s government, all those political cronies in the cesspit of Wellington are playing their parts, to control New Zealanders lives in every aspect possible.

The Club of Rome, the Malthusian Agenda of Population Control, the 1991 blueprint for a global revolution in the 21st century, transformation of people, planet to reward the wealthy few. A Private-Public Global Corporate Governance. The World Economic Forum that represents the Multistakeholder Capitalist Corporations to replace small businesses and the farming communities worldwide. Introducing fake meat grown in labs, chemicals, crops of Monsanto-Bayer. They call this healthier for the population as they promote Coca-cola and fast food companies. Lesson human contact, work from home. Human contact is necessary is part of human nature. The desensitizing of human life itself by ungodly, immoral global forces.

For further information on this very serious topic of our lives in their hands please go to the link in the image above.
If you have not joined up to my website could you please do so now, as I am expecting to be de- platformed from Facebook very soon as a consequence of the information I have researched and sharing with as many people as possible. Please share this link with other like minded people.

...