Kia ora

  

Thank you for your request for official information. The reference number
for your request is: H2023021279

  

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 

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Kia ora J
Please find attached a partial transfer of 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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 Kia ora J,

Thank you for your request under the Official Information Act 1982 (the
Act) to Manatū Hauora (the Ministry of Health) on 3 March 2023. Please
find a response to each part of your request below: 

 

a) Medsafe safe and effective reports and statements prior to March 31,
2021. Please provide copies of briefings, submissions, aide memoire or
advice where Medsafe states that the Comirnaty BNT162b2 product is safe
and effective prior to March 31, 2021. 
 

b) Please supply risk-benefit notes and reports produced by Medsafe for
presentation to the 109th Meeting of the Medicines Assessment Advisory
Committee (MAAC). 

 

c) Re: Benefit-risk reports produced after provisional consent granted,
and during the staged rollout. Please supply report numbers and dates of
all benefit-risk reports published by the Ministry of Health after
provisional consent was granted, to support the staged rollout to Tiers 2,
3 and 4 of the population as per the COVID-19 Vaccine and Immunisation
Programme (and the Sequencing Framework)(1) and ensure that the response
was proportionate to health risk, that respected individuals and was not
undertaken in an arbitrary manner. 

 

Medsafe considers the benefits and risks of medicines before recommending
whether they can be approved for use in New Zealand, however Medsafe does
not hold reports and statements or briefings, submissions, aide memoires
specifically stating that the Pfizer COVID-19 vaccine (Comirnaty) is “safe
and effective”. Therefore, this part of your request is refused under
section 18(e) of the Act, as the information requested does not exist.  

 

Please refer to the Medsafe website and following published response for
publicly available information regarding the risk-benefit notes and
reports produced by Medsafe:
[1]www.health.govt.nz/system/files/documents/information-release/h202106950-_response.pdf  

A benefit/risk analysis was undertaken by Medsafe prior to the Comirnaty
vaccine being granted provisional consent for use in New Zealand. The
assessment has been released in the above published response. Please refer
to document 10 on page 94.  

 

Following provisional consent being granted, there have been ongoing
measures to monitor the safety of COVID-19 vaccines. More information is
available at: [2]www.medsafe.govt.nz/COVID-19/safety-monitoring.asp.   

 

d) Re: Staged rollout of the COVID-19 Vaccine and Immunisation Programme
and the Sequencing Framework. Please supply a list of all briefings,
submissions, aide memoire, or advice provided by the Ministry to the Hon
Chris Hipkins and Director General Ashley Bloomfield, from 1 October
2020-1 January 2021 including the dates and title of each document.
Information required is in relation to scheduling of the staged rollout to
all of the COVID-19 Vaccine and Immunisation Programme and the Sequencing
Framework overseen by Hipkins and Bloomfield.(2) 

 

On 16 March 2023 this part of your request was transferred to Te Whatu
Ora - Health New Zealand) under section 14(b)(i) of the Act. You can
expect a response from Te Whatu Ora in due course. 

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: [email address] or by calling 0800 802
602. 

Ngā mihi 

OIA Services Team

Manatū Hauora | Ministry of Health

M[3]inistry of Health information releases 
U[4]nite against COVID-19 

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Kia ora,
 
Thank you for your request under the Official Information Act 1982 (the
Act) for:

"d) Re: Staged rollout of the COVID-19 Vaccine and Immunisation Programme
and the
Sequencing Framework. Please supply a list of all briefings, submissions,
aide memoire,
or advice provided by the Ministry to the Hon Chris Hipkins and Director
General Ashley
Bloomfield, from 1 October 2020-1 January 2021 including the dates and
title of each
document. Information required is in relation to scheduling of the staged
rollout to all of the
COVID-19 Vaccine and Immunisation Programme and the Sequencing Framework
overseen by Hipkins and Bloomfield."
 
Pursuant to section 15(1)(a) of the Act, Te Whatu Ora, Health New Zealand
is writing to advise you that a decision has been made on your request;
however, it will take us some time to prepare the information for release,
as it is currently being administratively processed and will be provided
to you shortly. We apologise for the delay, and endeavor to send you the
information by 21 April 2023. 
 
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: [1][email address] or by calling 0800
802 602. 
 
Ngâ mihi
 
Te Whatu Ora Ministerial Team
 
Ministerial Services

Te Whatu Ora – Health New Zealand
TeWhatuOra.govt.nz
 
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mailto:[email address]

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Kia ora 
 
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
 
Ministerial Services

Te Whatu Ora – Health New Zealand
TeWhatuOra.govt.nz
 
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Statement of confidentiality: This e-mail message and any accompanying
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