Promulgation of the Nonclinical Evaluation Report from Pfizer, January 2021
Erika Whittome made this Official Information request to Ministry of Health
Response to this request is long overdue. By law Ministry of Health should have responded by now (details and exceptions). The requester can complain to the Ombudsman.
From: Erika Whittome
Dear Ministry of Health,
There is a report from the Comirnaty manufacturer, Pfizer called:
Nonclinical Evaluation Report
BNT162b2 [mRNA] COVID-19 vaccine
(COMIRNATYTM)
Submission No: PM-2020-05461-1-2
https://www.tga.gov.au/sites/default/fil...
Date January 2021
Please confirm whether Pfizer or any other entity has provided information consistent with the information, concerns and data contained in the above report to any New Zealand health or government agency. If so please confirm which agency and on what date these concerns were addressed.
This is an excerpt from the report's summary (page 4) with a concern of long term immunity:
BNT162b2 (V9) was found to be immunogenic in non-clinical studies in mice, rats and rhesus macaques. BNT162b2 (V9) induced humoral and cellular immune responses in mice and monkeys. However, antibodies and T cells in monkeys declined quickly after 5 weeks after the second dose of BNT162b2 (V9) raising long term immunity concerns.
Yours faithfully,
Erika Whittome
From: OIA Requests
Kia ora Erika
Thank you for your request for official information. The reference number
for your request is: H2023025284
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From: OIA Requests
Kia ora Erika,
Please find attached a response to your request for official information.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
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From: Erika Whittome
Dear OIA Requests,
You have not answered my question on the promulgation of the report . You have deferred me to another OIA which just supplies a copy of the report ie
https://www.health.govt.nz/system/files/...
Kindly answer this OIA regarding the promulgation of this Pfizer clinical report.
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora
Thank you for your request for official information. The reference number
for your request is: H2023026889
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/
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are relevant to your request, please do not hesitate to contact us so that
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review any decisions made under this request. The Ombudsman may be
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802 602.
Ngā mihi
OIA Services Team
M[4]inistry of Health information releases
U[5]nite against COVID-19
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From: OIA Requests
Kia ora Erika,
Please find attached the response for 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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From: Erika Whittome
Dear OIA Requests,
Would you kindly extend your definition of promulgation to the following:
the act of publicly teaching or setting forth an idea, doctrine
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Thank you for your response. Manatū Hauora (the Ministry of Health) stands
by its decision and has nothing further to add. Under section 28(3) of the
Act, you have the right to ask the Ombudsman to review any decisions made
under your requests. The Ombudsman may be contacted by email at:
[email address] or by calling 0800 802 602.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
--------------------------------------------------------------------------
From: Erika Whittome <[FOI #22791 email]>
Sent: Wednesday, 5 July 2023 21:36
To: OIA Requests <[email address]>
Subject: Re: Response to your official information act request, ref:
H2023026889 CRM:0114758
Dear OIA Requests,
Would you kindly extend your definition of promulgation to the following:
the act of publicly teaching or setting forth an idea, doctrine
Yours sincerely,
Erika Whittome
-----Original Message-----
Kia ora Erika,
Please find attached the response for 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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Erika Whittome left an annotation ()
Another OIA h202106950 reveals the Ministry of Health did get a copy of this Non-clinical report in 2021.
https://www.health.govt.nz/system/files/...
Document 12 (page 111) contains the non-clinical report, however in h202106950, Pages 6- 57 withheld under section 9(2)(b)(ii) of the Act .
This demonstrates Medsafe, and agency of the Ministry of Health was sharing and reading this report.
I am making a complaint to the Ombudsman today regarding this request for information not being answered.
Link to this