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 -------------------
From: Erika Whittome <[FOI #26209 email]>;
Received: Sun Mar 24 2024 06:59:06 GMT+1300 (New Zealand Daylight Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Comirnaty Obligatjon #54 in the
provisional approval notice

Dear Ministry of Health,
The New Zealand gazette has many obligations published February 2021
[5]https://aus01.safelinks.protection.outlo...

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
 
 
 
-----Original Message-----
From: Erika Whittome <[email address]>
Sent: Sunday, 24 March 2024 7:27 am
To: OIA Requests <[email address]>
Subject: Official Information request - Decision to use E2B “clinical
safety data management” for immunization data

Dear Ministry of Health,
I refer you to OIA response H2024036547 dated 21 March which Chris James
says :

The COVID-19 vaccination database was a temporary database built to manage
the increase in reporting through the COVID-19 vaccine rollout and link to
the Covid Immunisation Register (CIR). As it was a temporary database, it
had limited scope and restricted capabilities for recording non-essential
information for pharmacovigilance. As for all reports to CARM the reporter
chooses what information to report and individuals may choose not to
disclose certain information for confidentiality reasons, leading to gaps
in the database. Both the temporary pharmacovigilance database and the CIR
have now been decommissioned.
The data from the now-decommissioned pharmacovigilance database has been
transferred to an E2B compatible database (Database to Database
transmission). The E2B fields are publicly available here:
[6]https://aus01.safelinks.protection.outlo...
reports-icsrs-data-elements-message-specification-implementation-guide-scientific-guideline.

It appears from Mr James’ response is that  all the immunization  and
pharmocovilligance data is now going into a format for “clinical”  data .
E2B is  for  “Clinical Safety Data Management”
Which is in Page 2 of
[7]https://aus01.safelinks.protection.outlo...

1 When did the Medafe quit using Salesforce to store adverse event reports
?
2 How much were the annual licensing fees for Salesforce for medsafe or
the ministry of health for this safety monitor report from safesforce?
3 Did the  ministry of health join or apply to join ICH? (
[8]https://aus01.safelinks.protection.outlo...)
If so, please share the minutes for this decision to join?
4 Please share the procurement documents for agreeing to deploy an E2B
system for immunization and safety data?
5  Please share the annual software licensing costs for this new E2B
syatem.
6 Please share which vendor has supplied it?
7 Is this E2B data housed on NZ soil in NZ data centers?  If not,  where
please?

8 How is the functionality of the E2B data format for “clinical safety
data management”  appropriate for the New Zealand population who are not
in a clinical setting at all?
9 Please supply the RFP for this procurement of a new system to store
immunization and safety/pharmocovilligance  data .

Yours faithfully,

Erika Whittome

 

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References

Visible links
1. http://www.ombudsman.parliament.nz/
2. mailto:[email address]
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://gazette.govt.nz/notice/id/2021-g...
6. http://www.ema.europa.eu/en/ich-e2b-r3-e...
7. https://www.ema.europa.eu/en/documents/s...
8. https://www.ich.org/

hide quoted sections

 

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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2. https://www.facebook.com/minhealthnz/
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4. https://www.youtube.com/minhealthnz
5. https://www.linkedin.com/company/ministr...

hide quoted sections

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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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.
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immediately and delete this message.
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References

Visible links
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2. https://covid19.govt.nz/

hide quoted sections

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 
 

-----Original Message-----
From: Erika Whittome [5][FOI #26209 email]
Sent: Tuesday, 23 April 2024 1:58 pm
To: OIA Requests [6][email address]
Subject: Re: Response to your request for official information, ref:
H2024038268 CRM:0121928

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

 

 

 

****************************************************************************
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.
****************************************************************************

References

Visible links
1. http://www.ombudsman.parliament.nz/
2. mailto:[email address]
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. mailto:[FOI #26209 email]
6. mailto:[email address]

hide quoted sections

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 
 
 
 
-----Original Message-----
From: Erika Whittome [5][FOI #26209 email]
Sent: Friday, 3 May 2024 4:56 am
To: OIA Requests [6][email address]
Subject: Re: Acknowledgement of your request for official information 

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

 

****************************************************************************
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.
****************************************************************************

References

Visible links
1. http://www.ombudsman.parliament.nz/
2. mailto:[email address]
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. mailto:[FOI #26209 email]
6. mailto:[email address]

hide quoted sections

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

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

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]https://aus01.safelinks.protection.outlo...
   
 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 
  

-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #26209 email]

Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[4]https://aus01.safelinks.protection.outlo...

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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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. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/
4. https://fyi.org.nz/help/officers

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