Dear Ms Crawford

On behalf of Hon Dr Jonathan Coleman, Minister of Health, thank you for your email received 30 August 2017 requesting under the Official Information Act 1982:

The package inserts for Gardasil, published by the FDA and Medsafe NZ, list possible adverse events that may be experienced as a result of this vaccine.

FDA version: https://www.fda.gov/downloads/biologicsb...

Medsafe version: http://www.medsafe.govt.nz/profs/datashe...

However several events are missing from the New Zealand version. These are as follows:

Blood and lymphatic system disorders: Autoimmune hemolytic anemia.
Respiratory, thoracic and mediastinal disorders: Pulmonary embolus.
Gastrointestinal disorders: Pancreatitis.
Immune system disorders: Autoimmune diseases.
Nervous system disorders: motor neuron disease, paralysis, seizures.
Vascular disorders: Deep venous thrombosis General disorders and administration site conditions: DEATH

I'm sure you will agree that these are pretty serious omissions. The Parent Consent Form, used in the school based vaccination program, is a very watered down version of the package insert (with even less real information about side effects), so parents really have no idea of what risks their children might be facing.

Parent Consent Form: https://www.healthed.govt.nz/system/file...

Further information for parents: http://www.medsafe.govt.nz/consumers/cmi...

Are you aware of these anomalies?

Will you investigate the reasons for these adverse events to be kept hidden from the New Zealand public?

Will you make sure that the situation is put right?

You can expect a reply within 20 working days from the date of your email being received in this office. Please note that a working day is defined under the Act as “any day of the week other than a Saturday or Sunday, Good Friday, Easter Monday, Anzac Day, Labour Day, the Sovereign’s birthday, Waitangi Day and a day in the period commencing 25 December and ending 15 January the following year.

If a large amount of information has been requested or if further consultation is required to make a decision, we may need to extend this date (this is provided for in section 15A of the Act). We will advise you if such an extension is necessary.

Kind regards,

Melissa Buckle
Private Secretary (Admin) I Office of the Hon Dr Jonathan Coleman
Minister of Health, Minister for Sport and Recreation

-----Original Message-----
From: Virginia Crawford [mailto:[FOI #6492 email]]
Sent: Wednesday, 30 August 2017 10:31 a.m.
To: J Coleman (MIN)
Subject: Official Information request - Public Information about Gardasil

Dear Minister of Health,

The package inserts for Gardasil, published by the FDA and Medsafe NZ, list possible adverse events that may be experienced as a result of this vaccine.

FDA version: https://www.fda.gov/downloads/biologicsb...

Medsafe version: http://www.medsafe.govt.nz/profs/datashe...

However several events are missing from the New Zealand version. These are as follows:

Blood and lymphatic system disorders: Autoimmune hemolytic anemia.
Respiratory, thoracic and mediastinal disorders: Pulmonary embolus.
Gastrointestinal disorders: Pancreatitis.
Immune system disorders: Autoimmune diseases.
Nervous system disorders: motor neuron disease, paralysis, seizures.
Vascular disorders: Deep venous thrombosis General disorders and administration site conditions: DEATH

I'm sure you will agree that these are pretty serious omissions. The Parent Consent Form, used in the school based vaccination program, is a very watered down version of the package insert (with even less real information about side effects), so parents really have no idea of what risks their children might be facing.

Parent Consent Form: https://www.healthed.govt.nz/system/file...

Further information for parents: http://www.medsafe.govt.nz/consumers/cmi...

Are you aware of these anomalies?

Will you investigate the reasons for these adverse events to be kept hidden from the New Zealand public?

Will you make sure that the situation is put right?

Yours faithfully,

Virginia Crawford

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Hi Virginia,

Thanks for your email. We have your OIA response ready to be signed out and anticipate getting it to you early next week. We apologise for the delays in getting a response to you.

Kind regards,

Melissa Buckle
Private Secretary (Admin) I Office of the Hon Dr Jonathan Coleman
Minister of Health, Minister for Sport and Recreation

-----Original Message-----
From: Virginia Crawford [mailto:[FOI #6492 email]]
Sent: Thursday, 28 September 2017 10:06 p.m.
To: Melissa Buckle
Subject: RE: Official Information request - Public Information about Gardasil

Dear Melissa Buckle,

I have not yet received a response to my enquiry, although the time period for this has expired - could you please rectify this as soon as possible.

Yours sincerely,

Virginia Crawford

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

Dear Ms Crawford

On behalf of Hon Dr Jonathan Coleman, Minister of Health, thank you for your email received 30 August 2017 requesting under the Official Information Act 1982:

The package inserts for Gardasil, published by the FDA and Medsafe NZ, list possible adverse events that may be experienced as a result of this vaccine.

FDA version: https://www.fda.gov/downloads/biologicsb...

Medsafe version: http://www.medsafe.govt.nz/profs/datashe...

However several events are missing from the New Zealand version. These are as follows:

Blood and lymphatic system disorders: Autoimmune hemolytic anemia.
Respiratory, thoracic and mediastinal disorders: Pulmonary embolus.
Gastrointestinal disorders: Pancreatitis.
Immune system disorders: Autoimmune diseases.
Nervous system disorders: motor neuron disease, paralysis, seizures.
Vascular disorders: Deep venous thrombosis General disorders and administration site conditions: DEATH

I'm sure you will agree that these are pretty serious omissions. The Parent Consent Form, used in the school based vaccination program, is a very watered down version of the package insert (with even less real information about side effects), so parents really have no idea of what risks their children might be facing.

Parent Consent Form: https://www.healthed.govt.nz/system/file...

Further information for parents: http://www.medsafe.govt.nz/consumers/cmi...

Are you aware of these anomalies?

Will you investigate the reasons for these adverse events to be kept hidden from the New Zealand public?

Will you make sure that the situation is put right?

You can expect a reply within 20 working days from the date of your email being received in this office. Please note that a working day is defined under the Act as “any day of the week other than a Saturday or Sunday, Good Friday, Easter Monday, Anzac Day, Labour Day, the Sovereign’s birthday, Waitangi Day and a day in the period commencing 25 December and ending 15 January the following year.

If a large amount of information has been requested or if further consultation is required to make a decision, we may need to extend this date (this is provided for in section 15A of the Act). We will advise you if such an extension is necessary.

Kind regards,

Melissa Buckle
Private Secretary (Admin) I Office of the Hon Dr Jonathan Coleman Minister of Health, Minister for Sport and Recreation

-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #6492 email]

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

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

________________________________

hide quoted sections

Dear Ms Crawford,

Please find attached the response to your OIA request of 30 August 2017 regarding Gardasil.

Kind regards,

Melissa Buckle
Private Secretary (Admin) I Office of the Hon Dr Jonathan Coleman
Minister of Health, Minister for Sport and Recreation

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