133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
17 February 2023
Chris McCashin
By email: [FYI request #21667 email]
Ref:
H2023020017
Tēnā koe Chris
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Hauora
(the Ministry of Health) on 9 February 2023.You requested:
“The current Pfizer Covid-19 vaccine has "provisional' approval until 3 November 2023 -
Yes - No?
There have been four confirmed deaths from the Covid-19 vaccine - Yes - No?
Despite these deaths the current risk management plan does not identify death as a risk -
Yes - No?
The current risk management plan notes there is missing information in pregnancy and breastfeeding - despite this missing information the vaccine was recommended by agencies
for pregnant woman? Yes - No?
There have been reports of spontaneous abortion and miscarriage to CARM following
administration - Yes - No?
The four deaths caused by the Covid-19 vaccine have never been discussed / considered
by Medicines Adverse Reactions Committee Meeting (MARC)? Yes - No? To put into
perspective numerous other Medicines that have caused death have, but not the Covid-19
causality deaths following review of all the meeting minutes as far as I can tell since the roll
out.The initial meeting discussing the Covid-19 vaccine quoted by Medsafe that "safety
specification for this product is currently inadequate and does not accurately reflect known
risks". Despite this information Medsafe allowed this vaccine to be mandated with reliance
on "robust post-market" information gathering being of the utmost importance. Knowing that "robust post-market" information was required the regulator Medsafe / Health
authorities vaccinated the control group? Yes – No Therefore there are no data points that can be relied on by the regulator? Yes – No
There are "15 deaths that could not be assessed due to insufficient information". Despite
being a first world country our regulator can approve a medicine but does not then have the
ability / tools to determine if the person died of the vaccine. Yes – No
New Zealand suffered 18% excess mortality the year this vaccine was rolled out - Yes - No
There is not one person in any and all of the regulatory authorities that has the ability to
determine if fifteen people (some of these very young) died from a medication that is known
to cause death. Doctors, Health Professionals, Medsafe, Ashley Bloomfield, Pfizer
representatives, Minister of Health, Coroner, internet searches. So just to confirm -
Medsafe can approve a medicine but then don't have the ability to determine if that
medicine that they approved killed that person? Yes - No Can yo also please provide all of the Post Marketing studies provided to Medsafe by Pfizer. If these are not available can you provide dates these reports were received. Is Medsafe aware that FDA, CDC and tried to bury trial information and post-marketing
Pfizer reports for 75 years - does Medsafe have any inclination as to why this might be?
Maybe it is reflective of our current dataset?”
While the Act allows New Zealanders to ask for information from Ministers and government
agencies, there is no requirement for agencies to create new information, compile information
they do not hold or provide or prove an opinion. Your questions and the statements that support
them appear designed to engage in a debate about the Government’s COVID-19 vaccination
programme, rather than a request for official information. The Act does not support requests
where an opinion, comment, argument, or hypothetical statement is put to the Ministry for
response, couched as a request for information. Most of your request is therefore refused under
section 18(g) on the grounds that it is not held by Manatū Hauora. Moreover, please be advised
that using the Act in this manner could be construed as vexatious and result in such requests
being refused under section 18(h) of the Act.
You may be interested in the following information relating to your request:
• Information on Approval status of COVID-19 vaccines applications received by Medsafe is
publicly available here:
www.medsafe.govt.nz/COVID-19/status-of-
applications.asp#Comirnaty12.
• The summary of reported deaths information here
: www.medsafe.govt.nz/COVID-
19/safety-report-46.asp#death.
• The risk management plan (RPM) is publicly available here:
www.medsafe.govt.nz/COVID-19/Comirnaty-RMP.pdf.
• COVID-19 vaccine information for people who are pregnant, and breastfeeding is publicly
available her
e: www.health.govt.nz/covid-19-novel-coronavirus/covid-19-vaccines/covid-
19-vaccine-pregnancy-and-breastfeeding.
• A summary of reports is published in the safety report publicly available here:
www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp.
• Te Whatu Ora has published information regarding excess mortality in 2020, 2021 and
2022 here:
https://fyi.org.nz/request/20946/response/79785/attach/4/H2022015313%20Response%2
0Letter.pdf.
• All deaths suspected to be caused by a COVID-19 vaccine are presented to MARC.
• It is the coroner who determines cause of death.
Studies provided to Medsafe by Pfizer and information about those studies are withheld in full
under section 9(2)(b)(ii) of the Act where its release would likely unreasonably prejudice the
commercial position of the person who supplied the information.
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.
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Please note that this response, with your personal details removed, may be published on the
Manatū Hauora website at:
www.health.govt.nz/about-ministry/information-releases/responses-
official-information-act-requests. Nāku noa, nā
Chris James
Group Manager
Medsafe
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