NZ Immunisation Safety Studies

Chris McCashin made this Official Information request to Health New Zealand

Health New Zealand did not have the information requested.

From: Chris McCashin

Dear Health New Zealand,

I am writing to request the following information under the Official Information Act 1982:

The gold standard safety reports associated with each vaccine currently included in the New Zealand childhood immunisation schedule. This should include, but not be limited to:

Results from randomized controlled trials (RCTs) conducted during the pre-licensure phase, including Phase 1, 2, and 3 studies.

Data from post-authorization surveillance, including both passive and active surveillance systems.

Results from any real-world evidence (RWE) studies conducted on these vaccines in New Zealand or internationally.

Information on any international collaborative studies that have been used to assess the safety of these vaccines.

Reports from regulatory bodies (such as Medsafe or international equivalents) that were used in the approval process for these vaccines.

Any additional safety studies or reports that Te Whatu Ora considers to be part of the gold standard for vaccine safety assessment for the childhood immunisation schedule vaccines.

Dates these vaccines were approved

Yours faithfully,
Chris

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From: hnzOIA

Tēnā koe, 

 

Thank you for contacting Health NZ, Te Whatu Ora. This is an automatic
reply to confirm that we have received your email.  Depending on the
nature of your request you may not receive a response for up to 20 working
days.  We will try to respond to your query as quickly as possible.

 

 

Ngā mihi

 

Health NZ, Te Whatu Ora.

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From: OIA Requests
Health New Zealand


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Link: [1]File-List
Link: [2]Preview
Link: [3]themeData
Link: [4]colorSchemeMapping

Kia ora Chris,

  

Thank you for your request for official information. The reference number
for your request is: H2024046260

 

"The gold standard safety reports associated with each vaccine currently
included in the New Zealand childhood immunisation schedule. This should
include, but not be limited to:
Results from randomized controlled trials (RCTs) conducted during the
pre-licensure phase, including Phase 1, 2, and 3 studies.
Data from post-authorization surveillance, including both passive and
active surveillance systems.
Results from any real-world evidence (RWE) studies conducted on these
vaccines in New Zealand or internationally.
Information on any international collaborative studies that have been used
to assess the safety of these vaccines.
Reports from regulatory bodies (such as Medsafe or international
equivalents) that were used in the approval process for these vaccines."
 
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: [5]http://www.ombudsman.parliament.nz/  

  

If you have any queries, please feel free to contact the OIA Services Team
on [6][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: [7][email address] or by calling 0800
802 602.

 

Ngā mihi

 

OIA Services Team 

[8]Ministry of Health information releases 

 

Link: [9]File-List
Link: [10]Preview
Link: [11]Edit-Time-Data
Link: [12]themeData
Link: [13]colorSchemeMapping

 

 
 

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References

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1. file:///C:/Users/kvirmani/AppData/Local/Packages/oice_16_974fa576_32c1d314_714/AC/Temp/msohtmlclip1/01/clip_filelist.xml
2. file:///C:/Users/kvirmani/AppData/Local/Packages/oice_16_974fa576_32c1d314_714/AC/Temp/msohtmlclip1/01/clip_preview.wmf
3. file:///C:/Users/kvirmani/AppData/Local/Packages/oice_16_974fa576_32c1d314_714/AC/Temp/msohtmlclip1/01/clip_themedata.thmx
4. file:///C:/Users/kvirmani/AppData/Local/Packages/oice_16_974fa576_32c1d314_714/AC/Temp/msohtmlclip1/01/clip_colorschememapping.xml
5. http://www.ombudsman.parliament.nz/
6. mailto:[email address]
7. mailto:[email address]
8. https://www.health.govt.nz/about-ministr...
9. file:///C:/Users/kvirmani/AppData/Local/Packages/oice_16_974fa576_32c1d314_714/AC/Temp/msohtmlclip1/01/clip_filelist.xml
10. file:///C:/Users/kvirmani/AppData/Local/Packages/oice_16_974fa576_32c1d314_714/AC/Temp/msohtmlclip1/01/clip_preview.wmf
11. file:///C:/Users/kvirmani/AppData/Local/Packages/oice_16_974fa576_32c1d314_714/AC/Temp/msohtmlclip1/01/clip_editdata.mso
12. file:///C:/Users/kvirmani/AppData/Local/Packages/oice_16_974fa576_32c1d314_714/AC/Temp/msohtmlclip1/01/clip_themedata.thmx
13. file:///C:/Users/kvirmani/AppData/Local/Packages/oice_16_974fa576_32c1d314_714/AC/Temp/msohtmlclip1/01/clip_colorschememapping.xml

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From: hnzOIA


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Kia ora Chris,
 
Thank you for your request for information. 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.
 
Ngâ mihi nui
Shane Sharma (he/him)
Advisor, Ministerial Services
Office of the Chief Executive
Spark Central, 44-48 Willis Street, Wellington| PO Box 5013, Wellington
6140
Health New Zealand – Te Whatu Ora
[3]www.TeWhatuOra.govt.nz
 
Statement of confidentiality: This email message and any accompanying
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received this message in error, please notify the sender immediately and
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References

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1. mailto:[Health New Zealand request email]
2. file:///tmp/
3. http://www.tewhatuora.govt.nz/

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From: OIA Requests
Health New Zealand


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Attachment H2024046260 Response Letter.pdf
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Kia ora Chris

 

Please see 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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2. https://covid19.govt.nz/

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From: Chris McCashin

Dear OIA Requests,

So just to confirm

Ministry of Health have no safety reports for any of the vaccines that are recommended in the childhood vaccine schedule?

So there are no studies that Ministry of Health hold that compare health outcomes in the vaccinated versus the unvaccinated for these diseases.

So you recommend them but can't tell me who would have better health outcomes if you compared vaccinated versus unvaccinated.

Following the next response you come back with I take it that I mark it that the Ministry of Health does not have any reports that show the "Health" outcomes of these products?

Do we need to change the name by what Ministry of Health go by?

Yours sincerely,

Chris McCashin

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From: OIA Requests
Health New Zealand


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Kia ora Chris

  

Thank you for your request for official information. The reference number
for your request is: H2024048020

  

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 

 

 

 

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

From: Chris McCashin <[5][FOI #27374 email]>
Sent: Tuesday, 23 July 2024 10:33
To: OIA Requests <[6][email address]>

Dear OIA Requests,

So just to confirm

Ministry of Health have no safety reports for any of the vaccines that are
recommended in the childhood vaccine schedule?

So there are no studies that Ministry of Health hold that compare health
outcomes in the vaccinated versus the unvaccinated for these diseases.

So you recommend them but can't tell me who would have better health
outcomes if you compared vaccinated versus unvaccinated.

Following the next response you come back with I take it that I mark it
that the Ministry of Health does not have any reports that show the
"Health" outcomes of these products?

Do we need to change the name by what Ministry of Health go by?

Yours sincerely,

Chris McCashin

 

****************************************************************************
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 #27374 email]
6. mailto:[email address]

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From: OIA Requests
Health New Zealand


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Tēnā koe Chris 

 

Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health – Manatū Hauora (the Ministry) on 31 July
2024. Please find a response to each part of your request below. 

 

'Ministry of Health have no safety reports for any of the vaccines that
are recommended in the childhood vaccine schedule? 

  

So there are no studies that Ministry of Health hold that compare health
outcomes in the vaccinated versus the unvaccinated for these diseases. 

  

So you recommend them but can't tell me who would have better health
outcomes if you compared vaccinated versus unvaccinated. 

  

Following the next response you come back with I take it that I mark it
that the Ministry of Health does not have any reports that show the
"Health" outcomes of these products? 

  

I interpret your request to ask for clinical trial information showing
efficacy and safety for vaccines on the childhood immunisation schedule.  

 

The Immunisation Handbook provides clinical guidelines for health
professionals on the safest and most effective use of vaccines in their
practice and includes summaries of the information requested. This is
publicly available here:
[1]www.tewhatuora.govt.nz/for-health-professionals/clinical-guidance/immunisation-handbook/. 

 

You can search for summary of clinical trial information for each vaccine
in the data sheet here:
[2]https://www.medsafe.govt.nz/Medicines/in...

 

Information related to Medsafe’s approval and review process for vaccines
in New Zealand is available here:
[3]www.medsafe.govt.nz/Medicines/regulatory-approval-process.asp. 

 

You can search for summaries of each vaccine’s approval and safety status
here: [4]www.medsafe.govt.nz/regulatory/DbSearch.asp. 

 

Do we need to change the name by what Ministry of Health go by?'

 

While it is permissible to seek information by asking questions under the
Act, a distinction must be drawn between questions which seek information
that is ‘held’, and questions which seek to elicit an opinion or
explanation. The primary purpose of the Act is to allow requesters to seek
information ‘held’ by agencies. It is not a mechanism for requesters to
seek an explanation or opinion from an agency. For this reason, I am
refusing this part of your request under section 18(g)(i) of the Act. 

 

If you wish to discuss any aspect of your request with us, including this
decision, please feel free to contact the OIA Services Team
on: [5][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: [6][email address] or by calling 0800
802 602. 

 

Nāku noa, nā 

 

OIA Services Team

Manatū Hauora | Ministry of Health

M[7]inistry of Health information releases 
U[8]nite against COVID-19 

 

****************************************************************************
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. https://www.tewhatuora.govt.nz/for-healt...
2. https://www.medsafe.govt.nz/Medicines/in....
3. http://www.medsafe.govt.nz/Medicines/reg...
4. http://www.medsafe.govt.nz/regulatory/Db...
5. mailto:[email address]
6. mailto:[email address]
7. https://www.health.govt.nz/about-ministr...
8. https://covid19.govt.nz/

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