Kia ora Jan,  

  

Thank you for your request for official information. The Ministry's
reference number for your request is: H2022009783.  

  

As required under the Official Information Act 1982, the Ministry 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 

 
------------------- Original Message -------------------
From: Jan Magee <[FOI #20185 email]>;
Received: Tue Aug 09 2022 12:45:41 GMT+1200 (New Zealand Standard Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Approval of Ethics Committee re
COVID vaccine trial

Dear Ministry of Health,

Can you please advise the dates the Director General of Health or the
Health Research Council approved the ethics committee that subsequently
went on to approve the Covid 19 vaccine trial

Could you please provide the evidence confirming how they were satisfied
that the trial was not to be conducted principally for the benefit of the
manufacturer or distributor of the medicine or item being trialled

Thanking you in advance

Yours faithfully,

Jan Magee

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Kia ora,  

Thank you for your request for official information received on 9 August
2022 for:

“Can you please advise the dates the Director General of Health or the
Health Research Council approved the ethics committee that subsequently
went on to approve the Covid 19 vaccine trial

Could you please provide the evidence confirming how they were satisfied
that the trial was not to be conducted principally for the benefit of the
manufacturer or distributor of the medicine or item being trialledWe are
contacting you to clarify part of your request.

Please clarify which COVID-19 vaccine you are referring to.

We look forward to receiving your response. Please respond to this
clarification email by COB Friday 19 August 2022.

 

 

Ngâ mihi,

OIA Services
Government and Executive Services
Manatû Hauora

 

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If you have received this message in error, please notify the sender
immediately and delete this message.
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Tēnā koe Jan, 

 

Thank you for your request under the Official Information Act 1982 (the
Act) to Manatū Hauora (Ministry of Health) on 9 August 2022 for
information regarding the Pfizer COVID-19 vaccine. You requested:  

 

“Can you please advise the dates the Director General of Health or the
Health Research Council approved the ethics committee that subsequently
went on to approve the Covid 19 vaccine trial 

 

Could you please provide the evidence confirming how they were satisfied
that the trial was not to be conducted principally for the benefit of the
manufacturer or distributor of the medicine or item being trialled” 

 

On 16 August 2022, you were contacted by Manatū Hauora to clarify your
request and you clarified you are interested in:  

 

“the Covid 19 vaccine by Pfizer which was the initial vaccine provided” 

 

The Pfizer-BioNTech vaccine did not undergo a clinical trial in New
Zealand as it received approval from Medsafe. Approval from a Health and
Disability Ethics Committee (HDEC) was not required and the HDECs were not
involved in the process. Therefore, your request for information is
refused under section 18(e) of the Act, as the information requested does
not exist. 

 

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. 

Ngā mihi 

  

OIA Services Team 

M[2]inistry of Health information releases 
U[3]nite against COVID-19 

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distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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References

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