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

INFORMATION FOR THOSE THAT SAY THE NUREMBERG TRIALS (NUREMBERG CODE) NO LONGER RELATE TO HUMAN RIGHTS VIOLATIONS TODAY:-

REFERENCES ARE MADE TO THE: United Nations A/64/272 General Assembly Distr.: General 10 August 2009
Sixty-fourth session Item 71 (b) of the provisional agenda

Promotion and protection of human rights: human rights questions, including alternative approaches for improving the effective enjoyment of human rights and fundamental freedoms

This report discusses the need for laws and international instruments to take into account the vulnerability of certain individuals whose rights are compromised owing to deeply rooted power imbalances and structural inequalities, presenting particular responsibilities to States and health-care providers to protect the human dignity and autonomy of all persons.
In the recommendations, the Special Rapporteur urges: –
(a) States to meet their obligations to safeguard informed consent through legislative, political and administrative mechanisms;
(b) Health-care providers to be cognizant that, according to their duty to act in the best interests of the patient, they are key players in protecting informed consent
(c) National and international bodies to emphasize the importance of informed consent as a fundamental aspect of the right to health in relevant policy and practice.

The concept of consent has evolved for centuries to arrive at its current meaning. In the aftermath of the Nuremberg Trials, increased international recognition of patients’ rights developed in the twentieth century, defining the responsibility of health-care providers and States responsibilities to the patient.

In 1947, the Nuremberg Code asserted that the voluntary consent of the human subject to medical research is necessary under all circumstances. The Declaration of Helsinki (1964) further developed the Code principles and tied them to the ethical duties of physicians, as outlined in the Declaration of Geneva (1948)

In 1994, the World Health Organization Amsterdam Declaration on Patients’ Rights required informed consent as a prerequisite for any medical intervention, guaranteeing also the right to refuse or halt medical interventions.
Informed consent is not mere acceptance of a medical intervention, but a voluntary and sufficiently informed decision, protecting the right of the patient to be involved in medical decision-making, and assigning associated duties and obligations to health-care providers. Its ethical and legal normative justifications stem from its promotion of patient autonomy, self-determination, bodily integrity and well-being. Important components of informed consent are discussed below-

Respect for legal capacity Competency to consent is a status known as legal capacity generally determined by the ability to comprehend, retain, believe and weigh information provided in arriving at a decision. Legal capacity is presumed in adult persons and renders them the right to consent to, refuse or choose an alternative medical intervention.

Scientists have admitted that man made global warming is a massive hoax. The Norwegian Nobel Committee rescinded the Peace Prize it awarded in 2007 to former US vice president Al Gore and the United Nations Intergovernmental Panel on Climate Change, amid overwhelming evidence that global warming is an elaborate hoax cooked up by Mr. Gore.

A press release from the committee that quotes a chagrined Rajendra Pachauri, who is the UN IPCC climate panels chair, claimed he was a victim of a “cunning deception spanning over many years”
Saying “he was deeply ashamed for having unwittingly perpetrated such a massive fraud on the governments of the world”.
Reports have shown that data from data satellites and radiosondes, surface temperature readings, borehole analysis, measurements of rising seas, melting glaciers and permafrost…..pheno-logical data and proxy reconstructions of paelo-climatic conditions were fabricated out of thin air by my former friend, who is Al Gore …

After Al Gore Noble Peace Prize & IPCC (UN) was revoked, the Nobel Peace Prize Committee awarded the prize money to the 31,000 people who signed the Oregan Petition, the peace prize money was shared between each signatory of the petition. ($1.53 million)
Al Gore owned up to hus duping of the scientific community. In a blog on his website, the explained the so called ‘genesis of his scheme’. It went like this .. “now that the jig is up (he’d been found out to be a liar) ..
”Now that the jig is up, as long as I can remember, my goal is life has been to destroy free-market capitalism, to replace it with global totalitarian social.. but it seemed that tradition methods such as guerrilla warfare were proving unsuccessful.,
then one day in 1988, I was strolling through the halls of my giant mansion when it hit me:- carbon dioxide… by striking at the molecule that lies at the heart of industrial civilization I could bring the whole system to its knees and usher in a workers paradise.”
He goes on to say “The rest just sort of fell into place….“ I wrote a book, held some Congressional hearings, made a movie, dashed off a few pseudonymous journal articles on radiative forcing…. and the next thing you know, I was on TV with Dave Matthews and Ludacris where I convinced people to purchase carbon offsets”.. He said “ I would have gotten away with it if it were not for that darn petition”

The New York Times quoted ‘NASA climate scientists James Hanen, an very outspoken advocate of limiting gas emissions saying that Al Gore ruse sucked him in “hook, line and sinker”. Not all scientists of course were fooled by Gore, but many have remained silent…
One scientist stated :- It is our hope that, whenever future generations find themselves swayed by the notion that one can derive generalizations about the physical world by gathering measurable data and subjecting it to logical analysis, they will recall the humbling and extraordinary events of today, April Fools Day, 2009.

Some severely character assassinated, lost their reputation through a litany of lies about them, others have been silenced by money or been threatened in some way or another. There are trillions of dollars being made and will continue to be made by global eco geographical multistakeholder capitalist corporations through global greening. The Green Mask, the mask that hides the ugly face of Marxism, socialism, communism.

The mask that hides the truth behind the World Economic Forums official strategic agreement with the United Nations. On the 13th June 2019, prior to COVID19. The Global Public Private Corporate Governance. As the WEF and UN collaborate on every part of how you live, eat, whether you work or not, welfare and income, no doubt a universal income… digital controls through the money markets.
When WEF’s Directorship board meet, Al Gore, Black Rock and a couple of members of Bidens, Obama’s, Clinton team are on board… also Jac Ma the richest man in China… And a couple of leading executives from the International Monetary Fund (IMF) and of course Klaus Schwab himself, founder of the WEF and chairman. All to accelerate UN Agenda 2030.

The collaboration of Vaccine Passes, certificates with digital wallets, a cashless society.. where political policing will know your behaviours, the way you think, who you meet, where you go etc., In NZ before the select committee the Digital ID Framework Trust Bill. (Ignore the word TRUST).
All your individual id in one place…. How convenient. For the government that rules from the top down that has seriously violated all our human rights. Trust the government, when even your driver licensing info is shared with 3rd parties. And of course what about cyber attacks, hacks.
Many of you may not have heard of the Oregon Petition, a political petition that was designed to educate the public about scientific results, the consensus of climate change research. This petition urged the US Government to reject the man made hoax- the Kyoto man made global warming protocol of 1997 and the policies that have followed.

The petition reads:- We urge the United States government to reject the global warming agreement that was written in Kyoto, Japan in December, 1997, and any other similar proposals. The proposed limits on greenhouse gases would harm the environment, hinder the advance of science and technology, and damage the health and welfare of mankind.

There is no convincing scientific evidence that human release of carbon dioxide, methane, or other greenhouse gases is causing or will, in the foreseeable future, cause catastrophic heating of the Earth’s atmosphere and disruption of the Earth’s climate.

Moreover, there is substantial scientific evidence that increases in atmospheric carbon dioxide produce many beneficial effects upon the natural plant and animal environments of the Earth.

Back to Al Gore,s court case where this British Judge ruled Al Gores doco “An Inconvenient Truth’ that was distributed around the world.. ruled that Al Gore’s Doco was not to be shown in UK Schools unless accompanied by materials explaining the films inaccuracies”. Gores doco was determined as biased, the law suit alleged. Gores doco was to go to 3,500 secondary schools in the UK as part of a ‘Sustainable schools year of action’. The Education Secretary at the time, Alan Johnson said “that influencing the opinions of children is crucial to developing a long term public view of the environment’
4.Yes that’s what they do, influence the minds of the young through the education system,.. dumbing education down.
Gore’s doco was described at the court by one person who opposed it as “just over half of the film is scientific material, 30% pure politics and 20% much, much.. used to soften up the viewer to persuasion”.

This barrister said “ scientifically the majority of the arguments advanced are false, or falsely exaggerated on the basis of the governments own evidence. The key flaw to Gores film is partisan, aimed at influencing rather than informing, it lacks balance.. that the government set out to disseminate .. what we say, this is about advancing political political propaganda into schools…
This very same political propaganda that is being taught in New Zealand schools.
That’s what happens, when the truth is spoken that does not fit the geo-eco political narratives.. truth tellers are called conspiracy theorists from the propaganda machine

Al Gore has authored several eco-political books…he is the co-founder and chairman of Generation Investment Management. He is also a senior partner at Kleiner Perkins Caufield & Byers, and a member of Apple, Inc.’s board of directors, and spends much of his time as chairman of ‘The Climate Reality Project’ .. Never let a good crisis go to waste. Ardern and her political cronies in the toilet bowl of Wellington are not.
Gore was elected to the U.S. House of Representatives in 1976, 1978, 1980 and 1982 and the U.S. Senate in 1984 and 1990. He was inaugurated as the forty-fifth Vice President of the United States on January 20, 1993, and served eight years.

During the Administration, Gore was a central member of President Clinton’s economic team. He served as President of the Senate, a Cabinet member, a member of the National Security Council and as the leader of a wide range of Administration initiatives
In New Zealand the Government has influenced, brainwashed our children through the education system as to UN Agenda 2030. Climate Alarmism, The seas will rise so high, the planet is on fire.. now brainwashed and indoctrinated they are taught to make placards and go on School Climate Strike. Don’t blame the young, in fact blame every political cronie in the cesspit of Wellington for mentally abusing our children through the school system. Dumbing education down.

Official mental health services in the UK have documented that the teaching of climate alarmism through education .. this is affecting many children’s mental health, they have now officially called this a mental issue ..namely ‘Eco Alarmism’

The UN recently proclaimed “A code Red for Climate Change”. A code Red of how populations worldwide are being hammered, severely disempowered by those that promote this climate alarm globally, that fills our childrens heads with fear. Code Red be aware of the UN/WEF Public-Private Corporate Governance.. the global – national geo-eco-political power play, the stench of greed of the 1% of the whole of the worlds population, those that are represented by the WEF… as they in collaboration with Ardern and all those political cronies in the toilet bowl of Wellington have eroded your freedoms and human rights as they all are part and parcel of this evil global corruption of causing severe havock to peoples lives worldwide.
And they could never have achieved this cruel evilness without an introduction of a global crisis, to shut the worlds economy down, to indoctrinate, brainwash – influence a new normal society with a new normal economy…without the COVID19 Global Crisis none of this insanity, erosion of freedoms, human rights could have happened.

Ardern entered UN Agenda 2030 in NZ Governments policy decision making. 17 out of 17 global development goals (17 SDG’s) include Climate Alarmism. 14 of 17 include ‘The UN Global Strategy of Vaccines.. (2011-2019). Then the UN Global Strategy of Vaccines introduced in 2019 prior to COVID19.. IA 2030.
The Decade of Vaccines 2020-2030. Documented by the UN- LEAVE NO-ONE BEHIND..EVERYONE, EVERYWHERE AT EVERY AGE. A LIFETIME OF VACCINES.. FROM THE CRADLE TO THE GRAVE…WHO (UN) REPORT- HESITANCY TO VACCINES= DEMAND THEM. TARGET THOSE THAT HAVE VACCINE HESITANCY. USE PSYCHO BABBLE- USE CHARM…KINDNESS….
NEW VACCINES.. 95% UPTAKE AT LEAST FOR NEW VACCINES. Teach children as young as 10 years old about the importance of Vaccines through the education system. All included in UN Agenda 2030 Global Development Goals.

Ardern was a guest speaker at a Bill & Melinda Gates event during which she boasted having entered UN Agenda 2030 17 SDG’a into NZ Policies, she added quite proudly “other nations may take her lead”.

Article 21 Health- Informed Consent
Prepared by the International Disability Caucus

The Working Group text for article 21 deals with informed consent in paragraphs (j) and (k):-
Ensure that health and rehabilitation services provided to persons with disabilities, and the sharing of their personal health or rehabilitation information, occur only after the person concerned has given their free and informed consent, and that health and rehabilitation professionals inform persons with disabilities of their relevant rights;

Prevent unwanted medical and related interventions and corrective surgeries from being imposed on persons with disabilities.

A footnote in the Working Group text suggested a definition for informed consent:- “Informed decisions can be made only with knowledge of the purpose and nature, the consequences, and the risks of the treatment and rehabilitation supplied in plain language and other accessible formats”.

1. Informed consent is an aspect of the right to health:- The right to the highest attainable standard of health (art. 12 ICESCR) states:-
The right to health contains both freedoms and entitlements. The freedoms include the right to control one’s health and body, including sexual and reproductive freedom, and the right to be free from interference, such as the right to be free from torture, non-consensual medical treatment and experimentation.

Thus, health is not a public good to be pursued independent of the will of each individual, but requires respect for the will of the individual person with respect to his or her own well-being. This is reinforced by the requirement that health services be culturally acceptable to individuals and communities

2. Informed consent must be guaranteed to persons with disabilities on an equal basis with others.. prohibits discrimination in the exercise and enjoyment of the right to health, including on the ground of disability. The freedoms contained in the right to health, as well as the entitlements, are subject to non-discrimination.

The General Comment unfortunately perpetuates discrimination based on disability, by permitting exceptions to be made to the obligation to refrain from coercive medical practices, in the context of “treatment of mental illness or the prevention and control of communicable diseases” such as HIV/AIDS. Such exceptions fail to respect the rights and dignity of persons with psychosocial disabilities and persons living with HIV/AIDS and should not be repeated in this Convention.

Self-determination of persons with disabilities as starting point for informed consent:-
The proposed Supplement to the Standard Rules on the Equalization of Opportunities for Persons with Disabilities, addressing the failure of governments to respect the autonomy of persons with disabilities on an equal basis with others, provides as follows:-

States should recognize that persons with disabilities have the same right to self-determination as other citizens, including the right to accept or refuse treatment. … States should also ensure that medical facilities and personnel inform people with disabilities of their right to self-determination, including the requirement of informed consent, the right to refuse treatment and the right not to comply with forced admission to institutional facilities. States should also prevent unwanted medical and related interventions and/or corrective surgeries from being imposed on persons with disabilities.

The Supplement was developed by the Special Rapporteur on Disability in consultation with a panel of experts formed by international disability organizations, as part of mandated activity to monitor the Standard Rules. These provisions enjoy the support of the disability community and should be considered as a best practice in the establishment of human rights standards. Any exceptions or limitations to the exercise of informed consent by persons with disabilities will be a step backwards.

Legal capacity (capacity to act) underlies the right to informed consent:-
Legal capacity (capacity to act) is a necessary prerequisite for exercise of the right of informed consent by any individual. Without legal capacity, a person remains vulnerable to decisions by other people that may be unacceptable to the individual, and to a process of decision-making that disrespects self-determination and human dignity. In the health context, persons with disabilities face increased vulnerability to unacceptable services due to prejudice about our capabilities, needs, and worth as human beings. For this reason a recognition of legal capacity on an equal basis with others, with supported decision-making as an entitlement that must not undermine legal capacity, is necessary to ensure that informed consent is meaningful for all people with disabilities.

Article 9 addresses legal capacity as a transversal matter in the Convention, relevant to exercise of all rights and freedoms. In article 21, it is sufficient to establish a right to informed consent, without any exceptions or limitations, and leave the resolution of legal capacity to article 9.

5. Access to information

The provision of all health related information is to be timely, meaningful and accessible formats, modes, means and language, including sign language. This is crucially important for people with sensory, intellectual and other disabilities.

The extent to which this provision is implemented will directly determine the extent to which people with sensory, intellectual and other disabilities will be able to –

* access affordable health care without discrimination, clause 2(a);
* access the same range and standards of health services as others, clause 2(b);
* give informed consent to treatment, clause 2(e);
* access their health and medical records, clause 2(f);
* select treatment options, clause 2(g);
* access information to maximise personal health, clause 2(l).

“Informed decisions can be made only with knowledge of the purpose and nature, the consequences, and the risks of the treatment and rehabilitation supplied in plain language and other accessible formats”.’