Consideration of risk to 2 million people following post-marketing report required to be forwarded to officials (as a Gazette condition)
J Bruning made this Official Information request to Ministry of Health
The request was refused by Ministry of Health.
From: J Bruning
Dear Ministry of Health,
As the Ministry is aware, the Pfizer/BioNTech February 28, 2021 post-marketing report revealed 1223 deaths and thousands of adverse events. This level of harm was unprecedented in the history of public release of a vaccine onto the global market.
Pfizer was legally required to provide post-marketing reports within 5 working days of post-marketing reports being produced.
https://gazette.govt.nz/assets/pdf-cache...
The government signed the second Pfizer/BioNTech vaccine agreement one week later, on March 8, 2021.
https://covid19.govt.nz/news-and-data/la...
There is a temporal association with the release of the FDA post-marketing report and the rapid signing of the second Pfizer agreement for 8.5 million doses.
However, it would be expected that the post-marketing report provided by Pfizer to the FDA would have been captured by the Gazette condition.
https://phmpt.org/wp-content/uploads/202...
We assume the disclosure of such massive adverse events would have triggered a risk-benefit calculation, particularly for the healthy groups that were not at risk of hospitalisation and death.
The public deserve to understand and consider the discussions between officials over this time so that they may assess the following issues: (a) Did Pfizer fail to disclose this post-marketing findings; and (b) Did officials knew about the death load and heavy adverse event profiles in the post-marketing report and were they dismissed or recognised as relevant considerations in the decision-making of officials.
Please supply urgently, between 27 February 2021 and 9 March 2021 the following information:
[a] All discussions via WhatsApp, Signal, Messenger, private email, Parliamentary or political party email by officials, including Ministers and the Director General of Health discussing Pfizer, BioNTech, the post-marketing report, FDA, deaths and adverse events.
[b] All reports, releases, memos, advice discussing and/or reviewing the implications of, contents, evidence in the post-marketing report supplied as a requirement in the Gazette conditions, and taking all steps to reasonably consider the harm profile to the population who were not at risk of hospitalisation or death from COVID-19 (required by Health Act, Part3A, s.92, Overarching Principles). This includes the risk to pregnant women, young people and children.
https://www.legislation.govt.nz/act/publ...
This cohort [group 4], 2 million people, were targeted by the Minister for COVID-19 to be injected from July 2021. General civil society would be required to be injected to work, to access services and public facilities. Therefore, it would be expected that a risk-benefit analyses for these individuals would be undertaken so as to protect public health, as required by the overarching legislation.
https://covid19.govt.nz/news-and-data/la...
[c] All discussions via WhatsApp, Signal, Messenger, private email, Parliamentary or political party email sent by officials, including Ministers and the Director General of Health planning and discussing the signing of the second agreement.
Yours faithfully,
J Bruning
From: OIA Requests
Kia ora
Thank you for your request for official information. The reference number
for your request is: H2023021708
As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngā mihi
OIA Services Team
M[2]inistry of Health information releases
U[3]nite against COVID-19
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References
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1. http://www.ombudsman.parliament.nz/
2. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/
From: OIA Requests
Kia ora J Bruning,
Please see attached letter regarding your request for official
information.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
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References
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1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: J Bruning
Dear Elisabeth Brunt,
As per:
Email: [email address]
Ref: H2023021708
Partial Transfer of request for official information, you have stated that this information requested:
“Please supply urgently, between 27 February 2021 and 9 March 2021 the following information: [a] All discussions via WhatsApp, Signal, Messenger, private email, Parliamentary or political party email by officials, including Ministers and the Director General of Health discussing Pfizer, BioNTech, the post-marketing report, FDA, deaths and adverse events
Is held with Te Whatu Ora.
There is no rationale for why Te Whatu Ora should hold this information.
I reject this transfer as firstly, the institution was not established during the period relating to the question, and secondly, this question directly concerns how the Ministry with responsibility for policy, and responsibility for the protection of the health of the population of New Zealand might deal with unwelcome information that might disadvantage the predetermined staged rollout of the gene therapy NBT162b2 to Tiers 2, 3 and 4 of the population as per the COVID-19 Vaccine and Immunisation Programme (and the Sequencing Framework).
Therefore, discussion of post-marketing reports should be of no direct concern of Te Whatu Ora and this part of the information request should not be transferred.
Therefore, I reject this transfer of information as it is unjustifiable and it signals an absence of transparency that it contradicts the promises made under the Open Government Partnership (OGP), an international agreement by governments to create greater transparency, increase civic participation.
Please supply this information as per the original request.
Sincerely
J Bruning
NOTES
Te Whatu Ora was established July 1 2022, and the Interim Health New Zealand was established in September 2021.
Te Whatu Ora manages all health services, including hospital and specialist services, and primary and community care
See: https://www.futureofhealth.govt.nz/healt...
It is the Ministry of Health has historically held responsibility for policy development and this continues with the reforms.
Health system reforms have aimed to ‘refocus the role of the Ministry of Health as the chief steward of the health system and the lead advisor to Government on matters relating to health’
See: https://dpmc.govt.nz/sites/default/files...
From: OIA Requests
Kia ora J Bruning
The Act places a duty on all agencies to consider if another agency that
is also subject to the Act (or the local government equivalent) might hold
the information and transfer it to them. This happens every single day,
with the Ministry, for example transferring to MBIE (about MIQ
facilities), Justice (about coronial matters), to ESR (about COVID
testing) or to one of our relevant Ministers (e.g., for Cabinet-related
material) and receiving transfers from a range of agencies. Likewise, Te
Whatu Ora (Health New Zealand) and the districts, both individually or
collectively often transfer to the Ministry if we hold the information
(e.g., hospital infrastructure plans).
As we noted in the transfer email, if you have concerns about the
Ministry’s decision to transfer the request, you have the right under
section 28 you have the right to seek a review of the Ministry’s decisions
from the Ombudsman.
Ngâ mihi
OIA Services Team
Manatû Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
--------------------------------------------------------------------------
From: J Bruning <[FOI #22085 email]>
Sent: Thursday, 30 March 2023 11:23
To: OIA Requests <[email address]>
Subject: Re: Partial transfer of your request for official information
(ref: H2023021708) CRM:0114317
Dear Elisabeth Brunt,
As per:
Email: [FOI #22085 email]
Ref: H2023021708
Partial Transfer of request for official information, you have stated that
this information requested:
“Please supply urgently, between 27 February 2021 and 9 March 2021 the
following information: [a] All discussions via WhatsApp, Signal,
Messenger, private email, Parliamentary or political party email by
officials, including Ministers and the Director General of Health
discussing Pfizer, BioNTech, the post-marketing report, FDA, deaths and
adverse events
Is held with Te Whatu Ora.
There is no rationale for why Te Whatu Ora should hold this information.
I reject this transfer as firstly, the institution was not established
during the period relating to the question, and secondly, this question
directly concerns how the Ministry with responsibility for policy, and
responsibility for the protection of the health of the population of New
Zealand might deal with unwelcome information that might disadvantage the
predetermined staged rollout of the gene therapy NBT162b2 to Tiers 2, 3
and 4 of the population as per the COVID-19 Vaccine and Immunisation
Programme (and the Sequencing Framework).
Therefore, discussion of post-marketing reports should be of no direct
concern of Te Whatu Ora and this part of the information request should
not be transferred.
Therefore, I reject this transfer of information as it is unjustifiable
and it signals an absence of transparency that it contradicts the promises
made under the Open Government Partnership (OGP), an international
agreement by governments to create greater transparency, increase civic
participation.
Please supply this information as per the original request.
Sincerely
J Bruning
NOTES
Te Whatu Ora was established July 1 2022, and the Interim Health New
Zealand was established in September 2021.
Te Whatu Ora manages all health services, including hospital and
specialist services, and primary and community care
See:
[3]https://scanmail.trustwave.com/?c=15517&...
It is the Ministry of Health has historically held responsibility for
policy development and this continues with the reforms.
Health system reforms have aimed to ‘refocus the role of the Ministry of
Health as the chief steward of the health system and the lead advisor to
Government on matters relating to health’
See:
[4]https://scanmail.trustwave.com/?c=15517&...
show quoted sections
From: hnzOIA
Tēnā koe,
Thank you for contacting Te Whatu Ora, Health NZ. This is an automatic
reply to confirm that we have received your email. Depending on the
nature of your request you may not receive a response for up to 20 working
days. We will try to respond to your query as quickly as possible.
s information that is identified to be of general public interest, the
response may also be published on our website. If we e response to your
OIA request, all personal information, including your name and contact
details will be removed.
Ngā mihi
Te Whatu Ora, Health NZ.
show quoted sections
From: hnzOIA
Kia ora J Brunning
Thank you for your request for official information, received on 29 March
2023 for:
“Please supply urgently, between 27 February 2021 and 9 March 2021 the
following
information:
[a] All discussions via WhatsApp, Signal, Messenger, private email,
Parliamentary or
political party email by officials, including Ministers and the Director
General of Health
discussing Pfizer, BioNTech, the post-marketing report, FDA, deaths and
adverse events."
In order to provide you with the information requested, could you please
specify the information you are seeking in order for us to collate the
information in a manner that is feasibly retrievable.
Please note, under section 15 of the Official Information Act 1982, any
clarification or amendments made to a request within seven days after the
date it is received, that request may be treated as a new request and the
time limit for the response restarts.
We look forward to receiving your response.
Ngâ mihi nui
Ministerial Services
Government, Partnerships and Risk
Spark Central, 44-48 Willis Street, Wellington| PO Box 5013, Wellington
6140
Te Whatu Ora – Health New Zealand
[1]www.TeWhatuOra.govt.nz
show quoted sections
References
Visible links
1. http://www.tewhatuora.govt.nz/
From: J Bruning
Dear hnzOIA,
This request concerns discussion of post-marketing reports relating to the Pfizer BNT162b2 product.
Post-marketing is the key search term.
Thank you
Yours sincerely,
J Bruning
From: hnzOIA
Kia ora J Brunning
Thank you for your request for official information request for the
following:
“Please supply urgently, between 27 February 2021 and 9 March 2021 the
following information:
[a] All discussions via WhatsApp, Signal, Messenger, private email,
Parliamentary or
political party email by officials, including Ministers and the Director
General of Health
discussing Pfizer, BioNTech, the post-marketing report, FDA, deaths and
adverse events."
As the request currently stands, it would require substantial collation
due to the hundreds of employees and potentially thousands of messages. We
invite you to narrow the request down to either one organisation or one
application (i.e., emails) over a short period of time (i.e., a month).
Anything more than that would be unmanageable. Please note that your
request may be refused under 18(f) of the Act if your request remains due
to substantial collation of information which may take the business unit
away from their operational duties.
Please note, under section 15 of the Official Information Act 1982, any
clarification or amendments made to a request within seven days after the
date it is received, that request may be treated as a new request and the
time limit for the response restarts.
We look forward to receiving your response.
Ngâ mihi nui
Ministerial Services
Government, Partnerships and Risk
Spark Central, 44-48 Willis Street, Wellington| PO Box 5013, Wellington
6140
Te Whatu Ora – Health New Zealand
[1]www.TeWhatuOra.govt.nz
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References
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1. http://www.tewhatuora.govt.nz/
From: OIA Requests
Kia ora J Bruning,
Please see attached the response to your request for official information
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: hnzOIA
Kia ora J Brunning,
Thank you for your request for information on 29 March 2023. Please find
attached our response to your request.
If you have any questions, please get in touch at
[1][email address].
If you are not happy with this response, you have the right to make a
complaint to the Ombudsman. Information about how to do this is available
at [2]www.ombudsman.parliament.nz or by phoning 0800 802 602.
Ngā mihi,
Te Whatu Ora Ministerial Team
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References
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1. mailto:[email address]
2. file:///tmp/foiextract20230417-24703-18k4vln#
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