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
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.
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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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From: Steph Harding
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
-----Original Message-----
From: Annie Weston
[[9]mailto:[FOI #17901 email]]
Sent: Friday, 10 December 2021 11:03 AM
To: A Little Office (MIN) <[10][Andrew Little request email]>
Subject: Official Information request - Informed Consent #24 - Missing
Information in Risk Management Plan for Comirnaty
Dear Andrew Little,
Regarding the Risk Management Plan for Comirnaty:
[11]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
-------------------------------------------------------------------
This is an Official Information request made via the FYI website.
Please use this email address for all replies to this request:
[12][FOI #17901 email]
Is [13][Andrew Little request email] the wrong address for Official
Information requests to Andrew Little? If so, please contact us using this
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[14]https://fyi.org.nz/change_request/new?bo...
Disclaimer: This message and any reply that you make will be published on
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References
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7. https://www.beehive.govt.nz/minister/hon...
8. https://www.dia.govt.nz/Proactive-Releas...
9. mailto:[FOI #17901 email]
10. mailto:[Andrew Little request email]
11. https://www.medsafe.govt.nz/COVID-19/Com...
12. mailto:[FOI #17901 email]
13. mailto:[Andrew Little request email]
14. https://fyi.org.nz/change_request/new?bo...
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hide quoted sections
From: Steph Harding
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
-----Original Message-----
From: Annie Weston
[[9]mailto:[email address]]
Sent: Friday, 10 December 2021 11:19 AM
To: A Little Office (MIN) <[10][Andrew Little request email]>
Subject: Official Information request - Informed Consent #25 - Miscarriage
and stillbirth rates in rat study
Dear Andrew Little,
In Medsafe’s data sheet for Pfizer’s vaccine it mentions the below under:
4.6 Fertility, pregnancy and lactation
Fertility
“In a combined fertility and developmental toxicity study, female rats
were intramuscularly administered COMIRNATY prior to mating and during
gestation (4 full human doses of 30 μg each, spanning between pre-mating
day 21 and gestation day 20). SARS-CoV-2 neutralising antibodies were
present in maternal animals from prior to mating to the end of the study
on postnatal day 21 as well as in fetuses and offspring. There were no
vaccine related effects on female fertility and pregnancy rate.”
Pregnancy
“Animal studies do not indicate direct or indirect harmful effects with
respect to pregnancy, embryo/fetal development, parturition or post-natal
development.”
[11]https://www.medsafe.govt.nz/profs/Datash...
Question please:
What were the miscarriage and stillbirth rates among the rats that were
studied?
Yours faithfully,
Annie Weston
-------------------------------------------------------------------
This is an Official Information request made via the FYI website.
Please use this email address for all replies to this request:
[12][email address]
Is [13][Andrew Little request email] the wrong address for Official
Information requests to Andrew Little? If so, please contact us using this
form:
[14]https://fyi.org.nz/change_request/new?bo...
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[15]https://fyi.org.nz/help/officers
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.
-------------------------------------------------------------------
--------------------------------------------------------------------------
References
Visible links
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2. https://www.beehive.govt.nz/minister/hon...
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6. https://nz.linkedin.com/in/andrewlittlemp
7. https://www.beehive.govt.nz/minister/hon...
8. https://www.dia.govt.nz/Proactive-Releas...
9. mailto:[email address]
10. mailto:[Andrew Little request email]
11. https://www.medsafe.govt.nz/profs/Datash...
12. mailto:[email address]
13. mailto:[Andrew Little request email]
14. https://fyi.org.nz/change_request/new?bo...
15. https://fyi.org.nz/help/officers
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From: OIA Requests
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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From: OIA Requests
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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