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Comirnaty Obligatjon #54 in the provisional approval notice

Erika Whittome made this Official Information request to Ministry of Health

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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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Attachment Official Information request Digital security settings to address anti vaccine sentiment in Tertiary and Education.txt
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Attachment E Whittome prioritisation request.pdf
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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

Visible links
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...

Link to this

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

Visible links
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

Link to this

From: OIA Requests


Attachment image.png
89K Download


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 
 

show quoted sections

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

Link to this

From: OIA Requests


Attachment image.png
89K Download


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


Attachment Outlook iqkodl0j.png
80K Download


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
80K Download


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/

Link to this

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