Informed Consent #24 - Missing Information in Risk Management Plan for Comirnaty

Annie Weston made this Official Information request to Andrew Little

The request was refused by Andrew Little.

From: Annie Weston

Dear Andrew Little,

Regarding the Risk Management Plan for Comirnaty:

https://www.medsafe.govt.nz/COVID-19/Com...

The plan refers to Table 1: List of important risks and missing information.

Missing Information:

-Use in pregnancy and while breast feeding
-Use in immunocompromised patients
-Use in frail patients with co-morbidities (eg, chronic obstructive pulmonary disease [COPD], diabetes, chronic neurological disease, cardiovascular disorders)
-Use in patients with autoimmune or inflammatory disorders
-Interaction with other vaccines
-Long-term safety data

Please can you advise when the “missing information” will be available to the public.

You have a year of real world data to inform you.

Yours faithfully,

Annie Weston

Link to this

From: A Little Office (MIN)
Andrew Little

Tçnâ koe

 

 

Thank you for contacting the office of Hon Andrew Little MP, Minister of
Health, Minister for Treaty of Waitangi Negotiations, Minister Responsible
for the NZSIS, Minister Responsible for the GCSB and Minister Responsible
for Pike River Re-entry.

 

Minister Little receives a significant volume of correspondence:

 

·       If your message is for Minister Little’s advice, or if you have
copied your email to another Minister and/or Member of Parliament with
more appropriate portfolio responsibilities, then this will be noted,

·       If you have invited Minister Little to an event then a member of
staff may contact you for more information if the Minister’s attendance
might be possible,

·       If you have made a request for official information then this will
be managed in accordance with the provisions of the Official Information
Act 1982, which may include transfer to a more relevant Minister or
agency,

·       If you have made a request under the Privacy Act then this will be
managed in accordance with the principles of the Privacy Act 1993, which
may include transfer to a more relevant Minister or agency,

·       If you are a journalist then your request will be triaged by a
press secretary,

·       To find out more about Minister Little read his [1]biography or
recent [2]statements.

 

Ngâ mihi

 

Office of Hon Andrew Little MP
Reception +64 4 817 8707 | Ministerial Email [Andrew Little request email] |
Web [3]beehive.govt.nz | Postal Freepost Parliament, Private Bag 18 041,
Parliament Buildings, Wellington 6160, New Zealand

 

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References

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1. https://www.beehive.govt.nz/minister/bio...
2. https://www.beehive.govt.nz/minister/hon...
3. https://www.beehive.govt.nz/minister/hon...

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From: Steph Harding


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Attachment FW Official Information request Informed Consent 25 Miscarriage and stillbirth rates in rat study.txt
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Kia ora Annie
On behalf of Hon Andrew Little, Minister of Health, thank you for your
Official Information request of 10 December 2021.

 

You requested:

             " Missing Information:

·       Use in pregnancy and while breast feeding -Use in
immunocompromised patients -Use in frail patients with co-morbidities (eg,
chronic obstructive pulmonary disease [COPD], diabetes, chronic
neurological disease, cardiovascular disorders) -Use in patients with
autoimmune or inflammatory disorders -Interaction with other vaccines
-Long-term safety data

·       Please can you advise when the “missing information” will be
available to the public.” 

The information requested appears to be more closely associated with the
functions and responsibilities of the Ministry of Health. Accordingly I am
transferring your request to the Ministry of Health under section
14(b)(ii) of the Official Information Act 1982.

 

I have been advised that you have made the same request to the Ministry of
Health, as such, a transfer of your request under section 14 of the Act
will not be necessary. You can expect a response from the Ministry of
Health in due course.

You have the right, under section 28 of the Act, to ask the Ombudsman to
review this decision to transfer your request for information.

 

Ngā mihi nui

 

Steph Harding
Private Secretary (Health)

 

Office of Hon Andrew Little MP, Minister of Health, Lead Coordination
Minister for the Government’s Response to The Royal Commission’s Report
into the Terrorist Attack on the Christchurch Mosques, Minister for Treaty
of Waitangi Negotiations, Minister Responsible for the NZSIS, Minister
Responsible for the GCSB, Minister Responsible for Pike River Re-entry
Reception +64 4 817 8707 | Ministerial Email
[1][Andrew Little request email] | Web [2]beehive.govt.nz | Postal Freepost
Parliament, Private Bag 18 041, Parliament Buildings, Wellington 6160, New
Zealand

[3]https://xink.io/wp-content/themes/Xink/a...

Please note information about meetings related to the Ministers’
portfolios will be proactively released (this does not include personal or
constituency matters). For each meeting in scope, the summary would list:
date, time (start and finish), brief description, location, who the
meeting was with, and the portfolio. If you attend a meeting with the
Minister on behalf of an organisation, the name of the organisation will
be released. If you are a senior staff member at an organisation, or meet
with the Minister in your personal capacity, your name may also be
released. The location of the meeting will be released, unless it is a
private residence. The proactive release will be consistent with the
provisions in the Official Information Act, including privacy
considerations. Under the Privacy Act 1993 you have the right to ask for a
copy of any personal information we hold about you, and to ask for it to
be corrected if you think it is wrong. If you’d like to ask for a copy of
your information, or to have it corrected, or are concerned about the
release of your information in the meeting disclosure, please contact the
sender. You can read more about the proactive release policy at
[8]https://www.dia.govt.nz/Proactive-Releas...

Authorised by Hon Andrew Little MP, Parliament Buildings, Wellington 6160,
New Zealand

 

 

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From: Steph Harding


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Kia ora Annie
On behalf of Hon Andrew Little, Minister of Health, thank you for your
Official Information request of 10 December 2021.

 

You requested:

             "What were the miscarriage and stillbirth rates among the
rats that were studied?” 

The information requested appears to be more closely associated with the
functions and responsibilities of the Ministry of Health. Accordingly I am
transferring your request to the Ministry of Health under section
14(b)(ii) of the Official Information Act 1982.

 

I have been advised that you have made the same request to the Ministry of
Health, as such, a transfer of your request under section 14 of the Act
will not be necessary. You can expect a response from the Ministry of
Health in due course.

You have the right, under section 28 of the Act, to ask the Ombudsman to
review this decision to transfer your request for information.

 

Ngā mihi nui

 

Steph Harding
Private Secretary (Health)

 

Office of Hon Andrew Little MP, Minister of Health, Lead Coordination
Minister for the Government’s Response to The Royal Commission’s Report
into the Terrorist Attack on the Christchurch Mosques, Minister for Treaty
of Waitangi Negotiations, Minister Responsible for the NZSIS, Minister
Responsible for the GCSB, Minister Responsible for Pike River Re-entry
Reception +64 4 817 8707 | Ministerial Email
[1][Andrew Little request email] | Web [2]beehive.govt.nz | Postal Freepost
Parliament, Private Bag 18 041, Parliament Buildings, Wellington 6160, New
Zealand

[3]https://xink.io/wp-content/themes/Xink/a...

Please note information about meetings related to the Ministers’
portfolios will be proactively released (this does not include personal or
constituency matters). For each meeting in scope, the summary would list:
date, time (start and finish), brief description, location, who the
meeting was with, and the portfolio. If you attend a meeting with the
Minister on behalf of an organisation, the name of the organisation will
be released. If you are a senior staff member at an organisation, or meet
with the Minister in your personal capacity, your name may also be
released. The location of the meeting will be released, unless it is a
private residence. The proactive release will be consistent with the
provisions in the Official Information Act, including privacy
considerations. Under the Privacy Act 1993 you have the right to ask for a
copy of any personal information we hold about you, and to ask for it to
be corrected if you think it is wrong. If you’d like to ask for a copy of
your information, or to have it corrected, or are concerned about the
release of your information in the meeting disclosure, please contact the
sender. You can read more about the proactive release policy at
[8]https://www.dia.govt.nz/Proactive-Releas...

Authorised by Hon Andrew Little MP, Parliament Buildings, Wellington 6160,
New Zealand

 

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From: OIA Requests


Attachment H202117251 Weston FINAL.pdf
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Kia ora Annie
Please find a request from the Ministry of Health to rescope your
consolidated requests. 

  

Ngā mihi 

 

OIA Services 

Office of the Director-General | Ministry of Health  

  

E: [1][email address]  

  

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1. mailto:[email address]

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From: OIA Requests


Attachment H202117251 Annie Weston FINAL.pdf
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Kia ora Annie
Please find attached a response to your request for official information.

 

Ngâ mihi 

 

OIA Services 

Office of the Director-General | Ministry of Health  

  

E: [1][email address]  

 

Do your bit to keep New Zealand COVID free; get vaccinated; wear a mask;
practice good hygiene (includes washing your hands often and coughing into
your elbow), sign using the NZ COVID Tracer app, if you’re unwell stay
home and get tested. 

 

  

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Anyone:
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