Comirnaty Obligatjon #54 in the provisional approval notice

Erika Whittome made this Official Information request to Ministry of Health

Ministry of Health did not have the information requested.

From: Erika Whittome

Dear Ministry of Health,
The New Zealand gazette has many obligations published February 2021 https://gazette.govt.nz/notice/id/2021-g...

Would you please supply the information in this obligation #54 for the provisionally approved product, Comirnaty. I will copy and paste the condition:

54. Provide any reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, efficacy in population subgroups and results from post-marketing studies, within five working days of these being produced.

Yours faithfully,

Erika Whittome

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From: OIA Requests


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Kia ora Erika,
  
Thank you for your request for official information. The reference number
for your request is: H2024038268
  
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, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account. 

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: [3][email address] or by calling 0800
802 602.

Ngā mihi 
 
OIA Services Team 
[4]Ministry of Health information releases 

 
 

------------------- Original Message

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From: OIA Requests


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Kia ora Erika

 

 

Please find attached a letter from the Ministry of Health regarding your
requests for information.

 

In addition to the requests noted in the letter, the Ministry asks that
you also consider the OIA you’ve recently submitted on 9 April 2024. A
copy of which is attached for ease of reference.

 

If you have any queries, please feel free to get in touch. We look forward
to your response.

 

 

Ngâ mihi

 

OIA Services Team

[1]Manatû Hauora information releases

 
[2][IMG] [3][IMG] [4][IMG] [5][IMG]

 

 

 

 

 

 

 

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References

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1. https://www.health.govt.nz/about-ministr...
2. https://www.facebook.com/minhealthnz/
3. https://twitter.com/minhealthnz
4. https://www.youtube.com/minhealthnz
5. https://www.linkedin.com/company/ministr...

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From: Erika Whittome

Dear OIA Requests,
It is unfortunate that there is no existing documentation or publications relating to the information I request in this OIA. However this does not diminish the importance or the actions of the MoH and the information around their actions spending public money. I will copy and past from the Official Information Act:

The purposes of this Act are, consistently with the principle of the Executive Government’s responsibility to Parliament,—
(a)to increase progressively the availability of official information to the people of New Zealand in order—
(i)to enable their more effective participation in the making and administration of laws and policies; and
(ii)to promote the accountability of Ministers of the Crown and officials,—
and thereby to enhance respect for the law and to promote the good government of New Zealand:
(b) to provide for proper access by each person to official information relating to that person:
(c)to protect official information to the extent consistent with the public interest and the preservation of personal privacy.

Yours sincerely,

Erika Whittome

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From: OIA Requests


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Attachment H2024038268 Response Letter.pdf
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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 
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/

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From: Erika Whittome

Dear OIA Requests,

There is no answer to these questions asked:

Please share the procurement documents for agreeing to deploy an E2B system for immunization and safety data?
Please supply the RFP for this procurement of a new system to store immunization and safety/pharmocovilligance
How much were the annual licensing fees for Salesforce for medsafe or the ministry of health for this safety monitor report from safesforce?
Please share the annual software licensing costs for this new E2B system.
Please share which vendor has supplied it?

A complaint made to the Ombudsman.
Yours sincerely,

Erika Whittome

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From: OIA Requests


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Kia ora Erika,
  
Thank you for your request for official information. The reference number
for your request is: H2024040163 
  
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, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account. 

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: [3][email address] or by calling 0800
802 602.

Ngā mihi 
 
OIA Services Team 
[4]Ministry of Health information releases 
 

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Link to this

From: Erika Whittome

Dear OIA Requests,
Please disregard my last update.
The information I requested has not been supplied, ie
The New Zealand gazette has many obligations published February 2021
Would you please supply the information in this obligation #54 for the provisionally
approved product, Comirnaty. I will copy and paste the condition:
54. Provide any reports on efficacy including asymptomatic infection in the vaccinated
group, vaccine failure, immunogenicity, efficacy in population subgroups and results from
post-marketing studies, within five working days of these being produced

It is unclear how the conditions were clearly set out, and then the conditions can just disappear.

Yours sincerely,

Erika Whittome

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From: OIA Requests


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Kia ora Erika,
  
Thank you for your request for official information. The reference number
for your request is: H2024040733
  
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, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account. 

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: [3][email address] or by calling 0800
802 602.

Ngā mihi 
 
OIA Services Team 
[4]Ministry of Health information releases 
 
 
 

show quoted sections

Link to this

From: OIA Requests


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Kia ora Erika,

Thank you for your follow up request.

The Ministry of Health stands by its previous response to you (H204038268
refer) 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 this request. The Ombudsman may be
contacted by email at: [1][email address] or by calling 0800
802 602.

Ngā mihi 

  

OIA Services Team

Manatū Hauora | Ministry of Health

M[2]inistry of Health information releases 
U[3]nite against COVID-19 

--------------------------------------------------------------------------

From: Erika Whittome <[FOI #26209 email]>
Sent: Friday, 3 May 2024 04:56
To: OIA Requests <[email address]>
Subject: Re: Acknowledgement of your request for official information ref:
H2024040163 CRM:0114903
 
Dear OIA Requests,
Please disregard my last update.
The information I requested has not been supplied, ie
The New Zealand gazette has many obligations published February 2021
Would you please supply the information in this obligation #54 for the
provisionally
approved product, Comirnaty. I will copy and paste the condition:
54. Provide any reports on efficacy including asymptomatic infection in
the vaccinated
group, vaccine failure, immunogenicity, efficacy in population subgroups
and results from
post-marketing studies, within five working days of these being produced

It is unclear how the conditions were clearly set out, and then the
conditions can just disappear.

Yours sincerely,

Erika Whittome

show quoted sections

Link to this

From: OIA Requests


Attachment Outlook ezaudlrc.png
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Kia ora Erika,

 

Thank you for your follow up request on 23 April 2024. You requested:

 

Please share the procurement documents for agreeing to deploy an E2B
system for  immunization and safety data?

Please supply the RFP for this procurement of a new system to store
immunization and  safety/pharmocovilligance How much were the annual
licensing fees for Salesforce for medsafe or the ministry of health for
this safety monitor report from safesforce?

Please share the annual software licensing costs for this new E2B system.

Please share which vendor has supplied it?

 

The Ministry of Health - Manatû Hauora stands by its previous response to
you (H2024038268) and has nothing further to add.

 

For further information about the E2B system please contact Health New
Zealand – Te Whatu Ora at: [1][email address]

 

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: [2][email address] or by calling 0800
802 602. 

 

Ngâ mihi 

  

 

OIA Services Team

Manatû Hauora | Ministry of Health

M[3]inistry of Health information releases 
U[4]nite against COVID-19 

 

show quoted sections

References

Visible links
1. mailto:[email address]
2. mailto:[email address]
3. https://www.health.govt.nz/about-ministr...
4. https://covid19.govt.nz/

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From: hnzOIA


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Tēnā koe Erika

Thank you for your email received by Health NZ | Te Whatu Ora (Health NZ)
as a transfer from the Ministry of Health on 7 January 2026, asking for
the following information under the Official Information Act 1982 (the
OIA):

"Please share the procurement documents for agreeing to deploy an E2B
system for immunization and safety data?
Please supply the RFP for this procurement of a new system to store
immunization and safety/pharmocovilligance
How much were the annual licensing fees for Salesforce for medsafe or the
ministry of health for this safety monitor report from safesforce?
Please share the annual software licensing costs for this new E2B system.
Please share which vendor has supplied it?"

This email is to let you know that Health NZ needs more time to make a
decision on your request.

The OIA requires that we advise you of our decision on your request no
later than 20 working days after the day we received your request.
Unfortunately, it will not be possible to meet that time limit and we are
therefore writing to notify you of an extension of the time to make our
decision, to 6 March 2026.

This extension is required because the consultations necessary to make a
decision on the request are such that a proper response cannot reasonably
be made within the original time limit.

If you have any questions, please contact us
at [1][email address

If you are not happy with this extension, 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

 
 

Emmie

Government Services
Health New Zealand | Te Whatu Ora

 

 

Statement of confidentiality: This email 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

References

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1. mailto:[email address]
mailto:[email address]
2. http://www.ombudsman.parliament.nz/
http://www.ombudsman.parliament.nz/

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From: hnzOIA


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Kia ora Erika, 
 
Thank you for your request for information transferred to Health New
Zealand | Te Whatu Ora from the Ministry of Health on 7 January
2026. 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, 
 
 

Emmie

Government Services
Health New Zealand | Te Whatu Ora

 

 

Statement of confidentiality: This email 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

References

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1. mailto:[email address]
2. file:///tmp/

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From: Erika Whittome

Dear hnzOIA,
I have not received the requested information.
Would you please supply the information in this obligation #54 for the provisionally approved product, Comirnaty. I will copy and paste the condition:

54. Provide any reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, efficacy in population subgroups and results from post-marketing studies, within five working days of these being produced.

By not providing this study, not only are you not being transparent in line with the Official Information Act 1982, but you are also violating the basic scientific method which is to make data public....especially because this medicine was used as a public health measure.

Yours sincerely,

Erika Whittome

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From: hnzOIA


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Kia ora, Erika,
 
Thank you for your request of 2 April 2026 for the following information:
 

“Dear hnzOIA,
I have not received the requested information.
Would you please supply the information in this obligation #54 for the
provisionally approved product, Comirnaty. I will copy and paste the
condition:

54. Provide any reports on efficacy including asymptomatic infection in
the vaccinated group, vaccine failure, immunogenicity, efficacy in
population subgroups and results from post-marketing studies, within five
working days of these being produced.

By not providing this study, not only are you not being transparent in
line with the Official Information Act 1982, but you are also violating
the basic scientific method which is to make data public....especially
because this medicine was used as a public health measure.

Yours sincerely,
Erika Whittome”

 
Your request asks for information which is more closely aligned with the
functions of Ministry of Health.  
For this reason, Health New Zealand has decided to transfer your request
in full to Ministry of Health under section 14(b)(ii) of the Official
Information Act (OIA) and you can expect a response from them in due
course.
 
Under section 28(3) of the OIA you have the right to ask the Ombudsman
to review any decisions made under this request. 
The Ombudsman may be contacted
by email at: [1][email address] or by calling 0800 802 602. 
If you have any queries related to this request, please do not hesitate to
get in touch.  
 
Ngā mihi  
 
 

Michael

Government Services (OIA)
[2][email address]
Health New Zealand | Te Whatu Ora

Statement of confidentiality: This email 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

References

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2. mailto:[email address]

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Kia ora Erika,

  

Thank you for your request under the Official Information Act 1982 (the
Act), received by the Ministry of Health - Manatū Hauora on 14 April 2026.
You requested:

 

"Would you please supply the information in this obligation #54 for the
provisionally approved product, Comirnaty. I will copy and paste the
condition:

 

54. Provide any reports on efficacy including asymptomatic infection in
the vaccinated group, vaccine failure, immunogenicity, efficacy in
population subgroups and results from post-marketing studies, within five
working days of these being produced. "

 

The reference number for your request is H2026081414. We will endeavour to
respond to your request as soon as possible and in any event no later than
13 May 2026 being 20 working days after the day your request was received.
If we are unable to respond to your request by then, we will notify you of
an extension of that timeframe.

 

If you have any queries regarding your request, please feel free to
contact the OIA Services Team on [1][email address]. If any
additional factors come to light which are relevant to your request,
please do not hesitate to contact us so that these can be taken into
account. 

 

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: [2][email address] or by calling 0800
802 602.

 

 

Ngā mihi, 
 
OIA Services Team

Ministry of Health | Manatū Hauora

 

M[3]inistry of Health information releases

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References

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1. mailto:[email address]
mailto:[email address]
2. mailto:[email address]
mailto:[email address]
3. https://www.health.govt.nz/about-ministr...
https://www.health.govt.nz/about-ministr...

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From: OIA Requests


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Kia ora,  
 
Please find attached the response for your request for official
information. 
Ngā mihi,

OIA Services Team

Ministry of Health | Manatū Hauora

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