133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
21 January 2022
Chuck Schooner
By email:
[email address]
[email address]
[FYI request #17783 email]
[email address]
Ref:
H202117069
H202117155
Tēnā koe Chuck
Response to your request for official information
Thank you for your request of 3 December 2021 under the Of icial Information Act 1982 (the
Act) for information about the vaccination of young people with the Pfizer Comirnaty vaccine.
Your request was transferred by the Office of the Minister for COVID-19 Response to the
Ministry of Health (the Ministry) for response.
On 6 December 2021, you made a further request about batch sampling of the Comirnaty
vaccine, and on 8 and 10 December 2021, you asked for information related to the publication
in the United States of the
Cumulative Analysis of Post-Authorization Adverse Event Reports of
PF-07302048 (BNT162B2) Received Through 28-Feb-2021 document (hereafter the
Cumulative Analysis Report).
Given all these requests involve COVID-19 vaccines, the Ministry has decided to consolidate
them into one response to reduce the administrative burden. Rather than repeat your requests
in full, they are attached as Appendix 1.
Much of your requests are not requests for official information. While the Act allows people to
ask for information from Ministers, government agencies and Crown entities, there is no
obligation under the Act for agencies to create new information, compile information they do not
hold, provide, or prove an opinion, or respond to inflammatory statements or hypothetical
questions. Much of this request seems designed to engage in the debate with the Ministry about
the Government’s COVID-19 vaccination and immunisation programme. The Act does not
support requests where statements are put to agency for comment, couched as a request for
official information. Within this category fall several statements including your references to
Medsafe deciding “to inflict this poison on the next generation,” “who will ultimately be
responsible for potentially inflicting anyone of the following il nesses on children and why they
believe this is okay,” comments purportedly made to a hearing in the United States, decisions
made in Japan or swine flu in the 1970s. Therefore, these parts of your request are refused
under section 18(g) on the grounds that the information is not held. Please also note that the
inflammatory language you have used in your requests might result in future requests being
refused as vexatious under section 18(h).
Turning to your request for information about the vaccination of young people with the
Comirnaty vaccine. Asking for “all documentation” brings within scope significant numbers of
emails and is therefore likely to be refused under section 18(f) on the grounds that it would
involve substantial collation. However, a narrower request on the same subject is processed by
the Ministry and is due to be published at:
https:/ fyi.org.nz/request/17871-evidence-used-in-
determining-whether-to-vaccinate-children-5-11 Therefore this part of your request is refused
under section 18(d) of the Act on the grounds that the information requested wil soon be
publicly available. There is further information about vaccination of young people at:
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.
Turning to those parts of your requests which provides a lengthy list of adverse events following
immunisation (AEFI) lifted from the Cumulative Analysis Report. The Ministry and Medsafe have
received several requests for information related to the Cumulative Analysis Report and its
publication in the United States. A comprehensive response that explains its genesis and
relevance in New Zealand, and addresses your questions has been published at:
www.health.govt.nz/system/files/documents/information-release/h202117570_response_0.pdf
This response also provides a comprehensive answer to your questions related to adverse
events following immunisation (AEFI). Therefore, this part of your request is refused under
section 18(d) because a response to the matters you have raised is publicly available.
Turning to questions about treatment with Remdesivir (and about treatment of COVID-19 in
general) it is important to note that neither the Ministry nor Medsafe treats patients. Treatment is
the responsibility of general practitioners and health professionals working in district health
boards (DHBs). If you want further information about treatment protocols, the contact details for
all DHBs are at available at:
www.health.govt.nz/new-zealand-health-system/key-health-sector-
organisations-and-people/district-health-boards/district-health-board-websites.
Remdesivir has not been approved by Medsafe as it is prescribed under section 25 of the
Medicines Act 1981. There is more information about the funding and use of Remdesivir at:
https:/ pharmac.govt.nz/news-and-resources/consultations-and-decisions/decision-2021-09-16-
remdesivir-to-treat-covid-19/. You may want to contact Pharmac directly for more information
at
: https://pharmac.govt.nz/about/contact/
Turning to your questions about quality controls and sampling of the Pfizer Comirnaty vaccine, I
can advise that the quantitative formulation is submitted to Medsafe and reviewed as part of the
evaluation process. The qualitative formulation is published in the Datasheet, and on Medsafe’s
website, and is a complete reflection of the vaccine ingredients. Information regarding the
vaccine approval process can be found at:
www.medsafe.govt.nz/COVID-19/vaccine-approval-
process.asp.
The vaccine is manufactured and tested according to the requirements of Good Manufacturing
Practice and the relevant sites are regularly inspected by regulators (for example, the United
States Food and Drug Administration) to ensure that the quality meets these requirements. As
part of Medsafe’s evaluation process, the sponsor (Pfizer) must supply evidence of current
Good Manufacturing Practice for manufacturing and testing sites. The sites of manufacture and
testing are published at:
www.medsafe.govt.nz/regulatory/ProductDetail.asp?ID=21938.
In addition, before being delivered to New Zealand, batches of the Pfizer vaccines are tested by
a testing laboratory, independent of Pfizer. This independent testing has regulatory oversight,
for example by way of European Union Of icial Control Authority Batch Release certification.
The Gazet e notice that outlines these requirements is available at:
www.medsafe.govt.nz/COVID-19/Comirnaty-Gazette-Oct-2021.pdf.
As the Ministry has previously told you, the Pfizer Comirnaty vaccine is not gene therapy and
does not interact with a person’s DNA or genes. There is more information about this at:
www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-
vaccines/covid-19-how-vaccine-works. Please be advised that repeatedly asking the same or
Page 2 of 7
similar questions in future could result in such requests being refused under section 18(h) as
frivolous or vexatious.
You have also asked about aspects of the contract or official agreement or supply agreement of
the first COVID-19 vaccine purchase agreement signed by the New Zealand Government with
the vaccine provider Pfizer and BioNTech. This is withheld in full under section 9(2)(b)(i ) of the
Act as its release would likely unreasonably prejudice the commercial position of the person
who supplied the information. However, I can confirm there are no clauses prohibiting testing of
the contents of the vials as you have suggested.
Under section 28(3) of the Act, you have the right to ask the Ombudsman to review any
decisions made under this request. The Ombudsman may be contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests.
Nāku noa, nā
Jan Torres
Acting Manager, OIA Services
Office of the Director-General
Page 3 of 7
Appendix 1
Request on 3 December 2021:
You are recently on record as saying they are assessing if this vaccine should be given to 7-11
year olds.
Please provide all documentation confirming that the vaccine is safe for 7-11 year olds.
Please specifically provide a cost-benefit analysis to support jabs for this age group.
At an FDA panel hearing an expert doctor stated that the Pfizer vaccine "failed any reasonable
risk-benefit calculus in connection with children. He went on to state that vaccinating this age
group you are assigning innocent kids and uninformed parents to a fate that wil undoubtedly
rob some of them of their lives".
Please provide a generic email that I can send this Pfizer document too so that Medsafe are
fully informed when they decide to inflict this poison on the next generation.
Can you please state who wil ultimately be responsible for potentially inflicting anyone of the
following il nesses on children and why they believe this is okay? The list below is partial only
directly from a Pfizer document.
1p36 deletion syndrome;2-Hydroxyglutaric aciduria;5'nucleotidase increased;Acoustic
neuritis;Acquired C1 inhibitor deficiency;Acquired epidermolysis bullosa;Acquired epileptic
aphasia;Acute cutaneous lupus erythematosus;Acute disseminated encephalomyelitis;Acute
encephalitis with refractory, repetitive partial seizures;Acute febrile neutrophilic
dermatosis;Acute flaccid myelitis;Acute haemorrhagic leukoencephalitis;Acute haemorrhagic
oedema of infancy;Acute kidney injury;Acute macular outer retinopathy;Acute motor axonal
neuropathy;Acute motor-sensory axonal neuropathy;Acute myocardial infarction;Acute
respiratory distress syndrome;Acute respiratory failure;Addison's disease;Administration site
thrombosis;Administration site vasculitis;Adrenal thrombosis;Adverse event following
immunisation;Ageusia;Agranulocytosis;Air
embolism;Alanine aminotransferase abnormal;Alanine aminotransferase increased;Alcoholic
seizure;Al ergic bronchopulmonary mycosis;Al ergic oedema;Al oimmune hepatitis;Alopecia
areata;Alpers disease;Alveolar proteinosis;Ammonia abnormal;Ammonia increased;Amniotic
cavity infection;Amygdalohippocampectomy;Amyloid
arthropathy;Amyloidosis;Amyloidosis senile;Anaphylactic reaction;Anaphylactic
shock;Anaphylactic transfusion reaction;Anaphylactoid reaction;Anaphylactoid
shock;Anaphylactoid syndrome of pregnancy;Angioedema;Angiopathic neuropathy;Ankylosing
spondylitis;Anosmia;Antiacetylcholine receptor antibody positive;Anti-actin antibody
positive;Anti-aquaporin-4 antibody positive;Anti-basal ganglia antibody positive;Anti-cyclic
citrullinated peptide antibody positive;Anti-epithelial antibody positive;Anti-erythrocyte antibody
positive;Anti-exosome complex antibody positive;AntiGAD antibody negative;Anti-GAD antibody
positive;Anti-ganglioside antibody positive;Antigliadin antibody positive;Anti-glomerular
basement membrane antibody positive;Anti-glomerular basement membrane disease;Anti-
glycyl-tRNA synthetase antibody positive;Anti-HLA antibody test positive;Anti-IA2 antibody
positive;Anti-insulin antibody increased;Anti-insulin antibody positive;Anti-insulin receptor
antibody increased;Anti nsulin receptor antibody positive;Anti-interferon antibody negative;Anti-
interferon antibody positive;Anti-islet cell antibody positive;Antimitochondrial antibody
positive;Anti-muscle specific kinase antibody positive;Anti-myelin-associated glycoprotein
antibodies positive;Anti-myelin-associated glycoprotein associated
polyneuropathy;Antimyocardial antibody positive;Anti-neuronal antibody positive;Antineutrophil
cytoplasmic antibody increased;Antineutrophil cytoplasmic antibody positive;Anti-neutrophil
cytoplasmic antibody positive vasculitis;Anti-NMDA antibody positive;Antinuclear antibody
increased;Antinuclear antibody positive;Antiphospholipid antibodies positive;Antiphospholipid
syndrome;Anti-platelet antibody positive;Anti-prothro Can you confirm if you wil ultimately be
responsible for the roll out in kids?
Page 4 of 7
And if you are wil you take any responsibility for potentially giving children anyone of the
following il nesses from a recently released Pfizer document. 1p36 deletion syndrome;2-
Hydroxyglutaric aciduria;5'nucleotidase increased;Acoustic neuritis;Acquired C1 inhibitor
deficiency;Acquired epidermolysis bullosa;Acquired epileptic aphasia;Acute cutaneous lupus
erythematosus;Acute disseminated encephalomyelitis;Acute encephalitis with refractory,
repetitive partial seizures;Acute febrile neutrophilic dermatosis;Acute flaccid myelitis;Acute
haemorrhagic leukoencephalitis;Acute haemorrhagic oedema of infancy;Acute kidney
injury;Acute macular outer retinopathy;Acute motor axonal neuropathy;Acute motor-sensory
axonal neuropathy;Acute myocardial infarction;Acute respiratory distress syndrome;Acute
respiratory failure;Addison's disease;Administration site thrombosis;Administration site
vasculitis;Adrenal thrombosis;Adverse event following
immunisation;Ageusia;Agranulocytosis;Air
embolism;Alanine aminotransferase abnormal;Alanine aminotransferase increased;Alcoholic
seizure;Al ergic bronchopulmonary mycosis;Al ergic oedema;Al oimmune hepatitis;Alopecia
areata;Alpers disease;Alveolar proteinosis;Ammonia abnormal;Ammonia increased;Amniotic
cavity infection;Amygdalohippocampectomy;Amyloid
arthropathy;Amyloidosis;Amyloidosis senile;Anaphylactic reaction;Anaphylactic
shock;Anaphylactic transfusion reaction;Anaphylactoid reaction;Anaphylactoid
shock;Anaphylactoid syndrome of pregnancy;Angioedema;Angiopathic neuropathy;Ankylosing
spondylitis;Anosmia;Antiacetylcholine receptor antibody positive;Anti-actin antibody
positive;Anti-aquaporin-4 antibody positive;Anti-basal ganglia antibody positive;Anti-cyclic
citrullinated peptide antibody positive;Anti-epithelial antibody positive;Anti-erythrocyte antibody
positive;Anti-exosome complex antibody positive;AntiGAD antibody negative;Anti-GAD antibody
positive;Anti-ganglioside antibody positive;Antigliadin antibody positive;Anti-glomerular
basement membrane antibody positive;Anti-glomerular basement membrane disease;Anti-
glycyl-tRNA synthetase antibody positive;Anti-HLA antibody test positive;Anti-IA2 antibody
positive;Anti-insulin antibody increased;Anti-insulin antibody positive;Anti-insulin receptor
antibody increased;Anti nsulin receptor antibody positive;Anti-interferon antibody negative;Anti-
interferon antibody positive;Anti-islet cell antibody positive;Antimitochondrial antibody
positive;Anti-muscle specific kinase antibody positive;Anti-myelin-associated glycoprotein
antibodies positive;Anti-myelin-associated glycoprotein associated
polyneuropathy;Antimyocardial antibody positive;Anti-neuronal antibody positive;Antineutrophil
cytoplasmic antibody increased;Antineutrophil cytoplasmic antibody positive;Anti-neutrophil
cytoplasmic antibody positive vasculitis;Anti-NMDA antibody positive;Antinuclear antibody
increased;Antinuclear antibody positive;Antiphospholipid antibodies positive;Antiphospholipid
syndrome;Anti-platelet antibody positive;Anti-prothro.
Request on 6 December 2021
Latest statistics shows that a large amount of the New Zealand population has been vaccinated.
A lot of them have been vaccinated safely yet there are now 126,679 adverse reports that have
been reported including the below very serious side effects.
- strokes
- at least one death
- cardiac arrest
- myocarditis & pericarditis
- haemmorrage
Despite all of these very serious side effects the Ministry of Health, and I say this in gest given
statistics can you please state if
- Medsafe has done any batch sampling of the Pfizer vaccines to assess consistency?
- If not, why not?
- Does the Pfizer document preclude any and all testing of the contents in the vial? This is a yes
no answer and does not require any sensitive information being disclosed
Page 5 of 7
- Are Medsafe aware that in Japan 1.6m doses of the vaccine were discarded due to
contamination - how does Medsafe determine if any of the Pfizer vaccines are contaminated?
- What quality controls are completed by Medsafe to ensure the vaccine doses are consistent
and not contaminated?
- Would very serious side effects in some versus no side effects in others raise any flags at
Medsafe and how would that be investigated?
- Are there clauses in the Pfizer contract that preclude any investigation of the vials at all? Yes
or No
- In the 1970's 1/3 of the American population were vaccinated against swine flu - there were 26
suspicious deaths and then the vaccine was stopped. Pfizers cumulative analysis report
recently released under Of icial Information by the FDA confirms that over 1,200 people died in
the first 90 days of the Pfizer roll out directly from the vaccine (and to date thousands more
globally). What has changed from the 70's versus now? Given it is now categorically known
from Pfizers own documentation that this vaccine/gene therapy can kil you could any criminal
charges be laid against the persons approving this vaccine if they were knowingly aware of the
Pfizer cumulative analysis report?
Request on 8 December 2021
On receipt of a trove of Pfizer documents released by the FDA.
Please state if Pfizer provided the following document to Medsafe for their safety assessment.
5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS
OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
If so, when did Medsafe receive this document. If not, why was this document not provided
given the date. Now that Medsafe is aware of the document and the vaccine has caused death
and 10 pages of other serious side effects can you honestly say proper due diligence was
completed.
Request on 10 December 2021
Please state if the following report was used in the assessment to approve the Pfizer/Biontech
vaccine when Medsafe first approved this gene therapy/vaccine.
5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT
REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
If the report was not available can you please state if Medsafe requested any real time safety
reports from Pfizer in advance of approving this gene therapy.
By the time Medsafe approved this gene therapy the vaccine had been widely used globally and
so there would be real time statistics. If not, did you rely on Pfizer trial information only?
Medsafe then approved the gene therapy for two more years and stated Pfizer had met a
number of safety conditions following their provisional approval. Please provide all
reports/evidence that Pfizer provided Medsafe that prove that they met their safety conditions
that were part of the first gazette notice.
The above report was dated early 2021 - please state if Pfizer had provided this to Medsafe at
all when they have completed any of their due diligence in assessing this gene therapy.
Please state if on the release of the documents by the FDA has Medsafe requested all of the
Pfizer documents that have been released - please provide a list of all the Pfizer documents that
Medsafe have relied upon in approving this gene therapy.
Page 6 of 7
This document is now available and if you approve this in children who wil ultimately be
responsible for il nesses in children? Medsafe or Ministry of Health.
Were Medsafe responsible for approving Remdesivir as a Covid-19 treatment.
Is Medsafe/Ministry of Health using Remdesivir as a Covid-19 treatment?
What studies were used to say Remdesivir was safe?
An Ebola study using Remdesivir showed that it was pulled from use in a 12 month trial after six
months because it kil ed 54% of the trial subjects it used.
The Remdesiver study also showed that patients were having the following side effects
- 10 day treatment of Covid-19 showed 23% had serious adverse events were organ
dysfunction syndrome, septic shock, acute kidney failure and kidney failure.
Please state how many Covid patients have been treated with Remdesiver in New Zealand and
how many of them had the above side effects and died. It appears Remdesiver will kill you. Did
Medsafe do any due diligence for Remdesiver as it wil likely poison patients.
Page 7 of 7
