Lack of data regarding pharmacodynamics, pharmacokinetics, etc
Virginia Crawford made this Official Information request to Ministry of Health
The request was refused by Ministry of Health.
From: Virginia Crawford
Dear Ministry of Health,
Given that the Pfizer trial protocols state that none of the following are being evaluated:
pharmacodynamics
pharmacokinetics
genetics
biomarkers
what steps (with specific details) have been taken by Medsafe to investigate these issues?
If none, please explain the rationale for not doing so.
Yours faithfully,
Virginia Crawford
From: OIA Requests
Kia ora Virginia,
Thank you for your request for official information received on 5 July
2021 for:
"Given that the Pfizer trial protocols state that none of the following
are being evaluated:
pharmacodynamics
pharmacokinetics
genetics
biomarkers
what steps (with specific details) have been taken by Medsafe to
investigate these issues?
If none, please explain the rationale for not doing so. "
The Ministry's reference number for your request is: H202108112.
As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 2 August 2021, being 20
working days after the day your request was received.
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Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
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From: OIA Requests
Kia ora Virginia
Thank you for your request for official information.
Medsafe did a comprehensive evaluation on the Comirnaty vaccine. The link below outlines what Medsafe looks at and it means Medsafe look at pharmacodynamics, pharmacokinetics, genetics (if relevant): https://www.medsafe.govt.nz/Consumers/Sa....
All applications are to be provided according to the Common Technical Dossier (CTD) format that ensures that all aspects of the medicine are covered. CTD is used internationally.
I trust this information fulfils your request. Under section 28(3) of the Act, you have the right to ask to the Ombudsman to review any decisions under this request.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
-----Original Message-----
From: Virginia Crawford <[FOI #15974 email]>
Sent: Monday, 5 July 2021 3:18 pm
To: OIA Requests <[email address]>
Subject: Official Information request - Lack of data regarding pharmacodynamics, pharmacokinetics, etc
Dear Ministry of Health,
Given that the Pfizer trial protocols state that none of the following are being evaluated:
pharmacodynamics
pharmacokinetics
genetics
biomarkers
what steps (with specific details) have been taken by Medsafe to investigate these issues?
If none, please explain the rationale for not doing so.
Yours faithfully,
Virginia Crawford
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From: Virginia Crawford
Dear OIA Requests,
No, I am afraid you have not fulfilled my request. All you have done is refer me to a page which gives a generalised description of the measures you employ when assessing a vaccine.
Please answer the specific question asked and if you have not carried out an independent investigation of the issues mentioned, then kindly explain why not.
Yours sincerely,
Virginia Crawford
victor left an annotation ()
8 entries in the xlsm file.
Age Group: 0 - 9
Female: 7
Male: 1
Why are these aged babies infants children being injected with pfizer comirnaty?
From: OIA Requests
Kia ora Virginia
Medsafe evaluated preclinical and clinical study reports that included pharmacokinetic and pharmacodynamic analyses submitted with the new medicine application. However, it is not clear what is intended by the terms “genetics” and “biomarkers” in your original request.
If you would like to see more information relevant to the Medsafe evaluation process specific to COVID-19 vaccines, please refer to the following link: www.medsafe.govt.nz/COVID-19/vaccine-app....
You might also like to view the European Medicines Agency’s public assessment report which is publicly available and outlines that authority’s assessment of the same data that Medsafe evaluated: https://www.ema.europa.eu/en/medicines/h....
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
-----Original Message-----
From: Virginia Crawford <[FOI #15974 email]>
Sent: Tuesday, 6 July 2021 2:51 pm
To: OIA Requests <[email address]>
Subject: RE: Official Information request - Lack of data regarding pharmacodynamics, pharmacokinetics, etc (H202108112)
Dear OIA Requests,
No, I am afraid you have not fulfilled my request. All you have done is refer me to a page which gives a generalised description of the measures you employ when assessing a vaccine.
Please answer the specific question asked and if you have not carried out an independent investigation of the issues mentioned, then kindly explain why not.
Yours sincerely,
Virginia Crawford
-----Original Message-----
Kia ora Virginia
Thank you for your request for official information.
Medsafe did a comprehensive evaluation on the Comirnaty vaccine. The link below outlines what Medsafe looks at and it means Medsafe look at pharmacodynamics, pharmacokinetics, genetics (if relevant): https://www.medsafe.govt.nz/Consumers/Sa....
All applications are to be provided according to the Common Technical Dossier (CTD) format that ensures that all aspects of the medicine are covered. CTD is used internationally.
I trust this information fulfils your request. Under section 28(3) of the Act, you have the right to ask to the Ombudsman to review any decisions under this request.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #15974 email]
Disclaimer: This message and any reply that you make will be published on the internet. Our privacy and copyright policies:
https://scanmail.trustwave.com/?c=15517&...
If you find this service useful as an Official Information officer, please ask your web manager to link to us from your organisation's OIA or LGOIMA page.
-------------------------------------------------------------------
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legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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From: Virginia Crawford
Dear OIA Requests,
I do not believe this is correct. And by the way, genetics and biomarkers were specifically mentioned in the Pfizer document I read.
My question to you was whether your agency had carried out an independent investigation of these issues, as Pfizer indicated clearly that they were not evaluated.
Once again, you are evading the question. Did your agency carry out a specific investigation or not?
Yours sincerely,
Virginia Crawford
From: OIA Requests
Kia ora Virginia
The Ministry of Health has nothing further to add. If you are unsatisfied with the Ministry's response, you have the right to approach the Ombudsman.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
-----Original Message-----
From: Virginia Crawford <[FOI #15974 email]>
Sent: Tuesday, 13 July 2021 11:01 am
To: OIA Requests <[email address]>
Subject: RE: Official Information request - Lack of data regarding pharmacodynamics, pharmacokinetics, etc (H202108112)
Dear OIA Requests,
I do not believe this is correct. And by the way, genetics and biomarkers were specifically mentioned in the Pfizer document I read.
My question to you was whether your agency had carried out an independent investigation of these issues, as Pfizer indicated clearly that they were not evaluated.
Once again, you are evading the question. Did your agency carry out a specific investigation or not?
Yours sincerely,
Virginia Crawford
-----Original Message-----
Kia ora Virginia
Medsafe evaluated preclinical and clinical study reports that included pharmacokinetic and pharmacodynamic analyses submitted with the new medicine application. However, it is not clear what is intended by the terms “genetics” and “biomarkers” in your original request.
If you would like to see more information relevant to the Medsafe evaluation process specific to COVID-19 vaccines, please refer to the following link: www.medsafe.govt.nz/COVID-19/vaccine-app....
You might also like to view the European Medicines Agency’s public assessment report which is publicly available and outlines that authority’s assessment of the same data that Medsafe evaluated: https://scanmail.trustwave.com/?c=15517&...
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #15974 email]
Disclaimer: This message and any reply that you make will be published on the internet. Our privacy and copyright policies:
https://scanmail.trustwave.com/?c=15517&...
If you find this service useful as an Official Information officer, please ask your web manager to link to us from your organisation's OIA or LGOIMA page.
-------------------------------------------------------------------
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
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by the Ministry of Health's Content and Virus Filtering Gateway
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victor left an annotation ()
Hi Virginia
Medafe reviewed only sponsor provided data. Sponsor is Pfizer Biontech (Pfizer Nz)
Pfizer biontech had 100% control from clinical trial design to through every data element to the manuscripts presented for regulatory process.
Medsafe like Tga Australia data reviewed consists of only pfizer biontech owned and controlled documents.
Link to this