Post-marketing report, were the DPMC & Cabinet informed and involved in the second Pfizer contract? (dose quantities for injection into healthy people)
J Bruning made this Official Information request to Department of the Prime Minister and Cabinet
Response to this request is long overdue. By law Department of the Prime Minister and Cabinet should have responded by now (details and exceptions). The requester can complain to the Ombudsman.
From: J Bruning
Dear Department of the Prime Minister and Cabinet,
As the Cabinet should be 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.
https://phmpt.org/wp-content/uploads/202...
It would be expected that upon receipt of this devasting information, that the relevant Ministers, - of Health, of the COVID-19 Response would advise Cabinet before any action would be taken to purchase quantities of the Pfizer/BioNTech BNT162b2 gene therapy product.
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...
It would be presumed by the public that Cabinet and Cabinet officials had knowledge of these relevant considerations.
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 consider 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 DPMC and Cabinet officials discussing Pfizer, BioNTech, the post-marketing report, FDA, deaths and adverse events.
[b] All reports, releases, memos, advice received by DPMC including Cabinet officials and Ministers 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 DPMC officials and Cabinet officials, including Ministers planning and discussing the signing of the second agreement.
Yours faithfully,
J Bruning
From: Information [DPMC]
Department of the Prime Minister and Cabinet
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From: Information [DPMC]
Department of the Prime Minister and Cabinet
[IN-CONFIDENCE]
Kia ora,
Thank you for your request under the Official Information Act 1982 (OIA)
received on 13 March 2023, copied below. We will respond to your request
within the statutory timeframes set out in the Act. If we are unable to
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Ngā mihi,
Ministerial Coordinator
Ministerial Services
Strategy, Governance and Engagement
Department of the Prime Minister and Cabinet
E [2][DPMC request email]
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-----Original Message-----
From: J Bruning <[FOI #22086 email]>
Sent: Monday, 13 March 2023 2:17 pm
To: Information [DPMC] <[DPMC request email]>
Subject: Official Information request - Post-marketing report, were the
DPMC & Cabinet informed and involved in the second Pfizer contract? (dose
quantities for injection into healthy people)
[You don't often get email from
[3][FOI #22086 email]. Learn why this is
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Dear Department of the Prime Minister and Cabinet,
As the Cabinet should be 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.
[5]https://aus01.safelinks.protection.outlo...
It would be expected that upon receipt of this devasting information, that
the relevant Ministers, - of Health, of the COVID-19 Response would advise
Cabinet before any action would be taken to purchase quantities of the
Pfizer/BioNTech BNT162b2 gene therapy product.
Pfizer was legally required to provide post-marketing reports within 5
working days of post-marketing reports being produced.
[6]https://aus01.safelinks.protection.outlo...
The government signed the second Pfizer/BioNTech vaccine agreement one
week later, on March 8, 2021.
[7]https://aus01.safelinks.protection.outlo...
It would be presumed by the public that Cabinet and Cabinet officials had
knowledge of these relevant considerations.
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.
[8]https://aus01.safelinks.protection.outlo...
We consider 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 DPMC and Cabinet officials
discussing Pfizer, BioNTech, the post-marketing report, FDA, deaths and
adverse events.
[b] All reports, releases, memos, advice received by DPMC including
Cabinet officials and Ministers 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.
[9]https://aus01.safelinks.protection.outlo...
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.
[10]https://aus01.safelinks.protection.outlo...
[c] All discussions via WhatsApp, Signal, Messenger, private email,
Parliamentary or political party email sent by DPMC officials and Cabinet
officials, including Ministers planning and discussing the signing of the
second agreement.
Yours faithfully,
J Bruning
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From: Information [DPMC]
Department of the Prime Minister and Cabinet
[UNCLASSIFIED]
Kia ora,
Please see the attached letter regarding your recent OIA request.
Ngā mihi,
Ministerial Coordinator
Ministerial Services
Strategy, Governance and Engagement
Department of the Prime Minister and Cabinet
E [1][DPMC request email]
The information contained in this email message is for the attention of
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communication of the Department of the Prime Minister and Cabinet. If you
are not the intended recipient you must not disclose, copy or distribute
this message or the information in it. If you have received this message
in error, please destroy the email and notify the sender immediately.
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are not the intended recipient you must not disclose, copy or distribute
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From: J Bruning
Dear Clare,
I specifically made this request of the DPMC to understand the consideration process by officials and Ministers which includes those in the DPMC.
The government have not been forthcoming in releasing this information.
The response by DPMC rejecting my request for information between 27 February 2021 and 9 March 2021continues this arguably disingenuous and evasive process. The DPMC were heavily involved with decision-making. You stated:
'The information you have requested is more closely connected with the functions of the Ministry of Health (MoH). We would normally transfer your request to the MoH under section 14(b)(ii) of the Act. However, since you have made a similar request to that agency, we are referring you to their response instead.'
Yet I note the Cabinet Manual 2017:
Officials ‘should inform Ministers promptly of matters of significance within their portfolio responsibilities, particularly where these matters may be controversial or may become the subject of public debate.’
‘Ministers should put before their colleagues the sorts of issues on which they themselves would wish to be consulted. Ministers should keep their colleagues informed about matters of public interest, importance, or controversy. Where there is uncertainty about the type of consideration needed, Ministers should seek advice from the Prime Minister or the Secretary of the Cabinet. Similarly, departments should seek advice from the office of the portfolio Minister, or from the Cabinet Office’
‘Ministers are expected to consult relevant ministerial colleagues before submitting papers that deal with significant or potentially controversial matters, or that affect other Ministers’ portfolio interests.’
https://dpmc.govt.nz/sites/default/files...
It would be expected such information would be discussed if it were understood.
The COVID-19 rollout was a whole of government project.
The DPMC was a key co-ordinating data/information centre over this period and the post-marketing data would have been considered as part of the response as it was cogently relevant to the rollout.
The public understood this: Ardern’s ‘Cabinet colleagues technically make these decisions collectively but generally what the prime minister says goes.’ https://www.stuff.co.nz/national/politic...
Minister Hipkins was working closely with Prime Minister Ardern, for example, communicating the information on December 17 2020 that vaccines were purchased for the entire population.
From July 1 2020, the COVID-19 All-of-Government Response Group was established as a business unit of the Department of the Prime Minister and Cabinet. It was responsible for data analytics, monitoring, reporting and insights - including coordinated reporting to provide a tested, robust and consistent source of information https://dpmc.govt.nz/news/new-covid-19-b...
It is in the public interest that the public understand the extent to which government officials and Ministers were aware of the excessive injury and death rate that was signalled in Pfizer’s February Post-marketing report through to Feb 28 2021.
https://phmpt.org/wp-content/uploads/202...
Or whether Pfizer had not yet disclosed this information to the government, in contravention of the Gazette Notice, if such facts were known.
It is evident that this information would have severely compromised public trust in a novel, experimental, mandated gene therapy.
Therefore, I require this information, as per this OIA request OIA-2022/23-0660 - beyond the Ministry of Health confines, as the DPMC also had exceptional powers – but extensive responsibility to protect health in 2021.
Sincerely
J Bruning.
Yours sincerely,
J Bruning
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