Cessations of safety reports for Comirnaty by Medsafe

Erika Whittome made this Official Information request to Ministry of Health

Response to this request is long overdue. By law Ministry of Health should have responded by now (details and exceptions). The requester can complain to the Ombudsman.

From: Erika Whittome

Dear Ministry of Health,
The last safety report for Comirnaty is dated 30 Nov 2022 and contains a total of 184 reported deaths post vaccination for this medicine
https://www.medsafe.govt.nz/COVID-19/saf...

There have been no subsequent safety reports and today is the 6 of Jun 2023. Kindly share the decision for ceasing to publish these and share all emails, correspondences, memos, meeting minutes etc for the cessation of these safety reports.

Yours faithfully,

Erika Whittome

Link to this

From: OIA Requests


Attachment image.png
89K Download


Kia ora
  
Thank you for your request for official information. The reference number
for your request is: H2023028694
  
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 related to this request, please do not hesitate to
get in touch. 
 
Ngā mihi 

OIA Services Team 
M[2]inistry of Health information releases 
U[3]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. http://www.ombudsman.parliament.nz/
2. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/

hide quoted sections

Link to this

From: OIA Requests


Attachment Outlook tbqlmnxp.png
80K Download

Attachment H2023028694 Response.pdf
130K Download View as HTML


Kia ora Erika
Please find attached a letter regarding your request for information

Ngā mihi 

  

OIA Services Team

Manatū Hauora | Ministry of Health

M[1]inistry of Health information releases 
U[2]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.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/

hide quoted sections

Link to this

From: Erika Whittome

Dear OIA Requests,

Your reply says:

The vaccine safety reports were produced in conjunction with the national COVID-19 immunisation programme. Since the pandemic immunisation response has started reverting back to the non-pandemic immunisation programme, so has the safety reporting. Therefore, no further reports will be produced and published. The data will be moved to the Suspected Medicine

I requested the information around the decision to cease these reports, not where the adverse event data has been moved to. Kindly answer the question.

If there was a decision to revert back to something and adopt a different safety reporting mechanism, then that is a decision for a change. Again answer the question and share the details for this decision: when, by whom, meeting minutes etc.

Yours sincerely,

Erika Whittome

Link to this

From: OIA Requests


Attachment image.png
80K Download


Kia ora Erika
  
Thank you for your request for official information. The reference number
for your request is: H2023030040
  
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
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases 
U[5]nite against COVID-19
 
 

------------------- Original Message -------------------
From: Erika Whittome <[FOI #23407 email]>;
Received: Tue Aug 01 2023 19:00:14 GMT+1200 (New Zealand Standard Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Re: Your request for information, ref: H2023028694

Dear OIA Requests,

Your reply says:

The vaccine safety reports were produced in conjunction with the national
COVID-19 immunisation programme. Since the pandemic immunisation response
has started reverting back to the non-pandemic immunisation programme, so
has the safety reporting. Therefore, no further reports will be produced
and published. The data will be moved to the Suspected Medicine

I requested the information around the decision to cease these reports,
not where the adverse event data has been moved to. Kindly answer the
question.

If there was a decision to revert back to something and adopt a different
safety reporting mechanism, then that is a decision for a change. Again
answer the question and share the details for this decision: when, by
whom, meeting minutes etc. 

Yours sincerely,

Erika Whittome

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

Kia ora Erika
 Please find attached a letter regarding your request for information

 Ngā mihi 

   

 OIA Services Team

 Manatū Hauora | Ministry of Health

 M[1]inistry of Health information releases 
 U[2]nite against COVID-19 
 
References

 Visible links
 1. [6]https://www.health.govt.nz/about-ministr...
 2.
[7]https://aus01.safelinks.protection.outlo...

-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #23407 email]

Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[8]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.

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

****************************************************************************
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. https://covid19.govt.nz/
6. https://www.health.govt.nz/about-ministr...
7. https://covid19.govt.nz/
8. https://fyi.org.nz/help/officers

hide quoted sections

Link to this

From: OIA Requests


Attachment Outlook oh0fxc5j.png
80K Download

Attachment H2023030040 Response.pdf
196K Download View as HTML


Kia ora Erika
Please find attached a letter regarding your request for information

Ngā mihi 

  

OIA Services Team

Manatū Hauora | Ministry of Health

M[1]inistry of Health information releases 
U[2]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.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/

hide quoted sections

Link to this

M Bell left an annotation ()

Chris James provides a syllogism on the reasoning to stop the reporting as follows:

“Since the pandemic immunisation response has started reverting back to the non-pandemic immunisation programme, so has the safety reporting. Therefore, no further reports will be produced and published.”

Of course this reasoning does not follow and appears completely arbitrary.
How is “reverting back to...” even connected to “no further reports” unless it is demonstrated the decision was based on something, and that something would surely have a document trail.

The requestor recognizes this and asks for the information that was not provided, Chris James replies “nothing further to add” and then goes on to state that asking again may be vexatious and grounds for refusal.

Therefore seems 2 alternative conclusions at this point.
A) medsafe is arbitrary in decision making
or
B) medsafe is engaging in obfuscation by refusing to answer the OIAR

Link to this

Things to do with this request

Anyone:
Ministry of Health only: