Provisional approval for COVID-19 vaccine
Greg Keen made this Official Information request to Ministry of Health
Response to this request is long overdue. By law Ministry of Health should have responded by now (details and exceptions). The requester can complain to the Ombudsman.
From: Greg Keen
Dear Ministry of Health,
The Comirnaty COVID-19 mRNA Pfizer vaccine is listed on the Medsafe website as having current approval under Section 23 of the Medicines Act.
Section 23 of the Medicines Act allows for the Minister to give provisional consent to the sale or supply or use of a new medicine where he is of the opinion that it is desirable that the medicine be sold, supplied, or used on a restricted basis for the treatment of a limited number of patients.
As Section 23 of the Medicines Act does not allow for this new vaccine to be used by the entire population of New Zealand, please provide the following information:
What is the limited number of patients who can receive treatment with this medicine while it is under the status of 'provisionally approved'?
Yours faithfully,
Greg Keen
From: OIA Requests
Kia ora
Thank you for your request for official information received 25 March 2021
for:
" The Comirnaty COVID-19 mRNA Pfizer vaccine is listed on the
Medsafe website as having current approval under Section 23 of the
Medicines Act.
Section 23 of the Medicines Act allows for the Minister to give
provisional consent to the sale or supply or use of a new medicine where
he is of the opinion that it is desirable that the medicine be sold,
supplied, or used on a restricted basis for the treatment of a limited
number of patients.
As Section 23 of the Medicines Act does not allow for this new vaccine to
be used by the entire population of New Zealand, please provide the
following information:
What is the limited number of patients who can receive treatment with this
medicine while it is under the status of 'provisionally approved'?
The Ministry's reference number for your request is: H202103598.
As required under the Official Information Act 1982 we will endeavour to
respond to your request no later than 26 April 2021, being 20 working days
after the day your request was received.
If we are unable to respond to your request within this time frame, we
will notify you of an extension of that time frame.
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
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From: OIA Requests
Kia ora Greg,
Please ignore the date for response in our previous email to you, this was
incorrect.
Please be advised the Ministry will endeavour to respond to your request
no later than 27 April 2021, being 20 working days after the day your
request was received.
Kind regards,
Megan
OIA Services
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From: OIA Requests <[email address]>
Sent: Thursday, 25 March 2021 15:42
To: [FYI request #14993 email]
<[FYI request #14993 email]>
Cc: OIA Requests <[email address]>
Subject: Acknowledgement of your request for official information (ref:
H202103598)
Kia ora
Thank you for your request for official information received 25 March 2021
for:
" The Comirnaty COVID-19 mRNA Pfizer vaccine is listed on the
Medsafe website as having current approval under Section 23 of the
Medicines Act.
Section 23 of the Medicines Act allows for the Minister to give
provisional consent to the sale or supply or use of a new medicine where
he is of the opinion that it is desirable that the medicine be sold,
supplied, or used on a restricted basis for the treatment of a limited
number of patients.
As Section 23 of the Medicines Act does not allow for this new vaccine to
be used by the entire population of New Zealand, please provide the
following information:
What is the limited number of patients who can receive treatment with this
medicine while it is under the status of 'provisionally approved'?
The Ministry's reference number for your request is: H202103598.
As required under the Official Information Act 1982 we will endeavour to
respond to your request no later than 26 April 2021, being 20 working days
after the day your request was received.
If we are unable to respond to your request within this time frame, we
will notify you of an extension of that time frame.
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
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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Ministry of Health
Kia ora
Thank you for your request for official information, received on 25 March
2021 for information pertaining to the COVID-19 vaccination rollout within
New Zealand.
The Ministry of Health has decided to extend the period of time available
to respond to your request under section 15A of the Official Information
Act 1982 (the Act) as further consultation is required.
You can now expect a response to your request on, or before, 3 May 2021.
You have the right, under section 28 of the Act, to ask the Ombudsman to
review my decision to extend the time available to respond to your
request.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
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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From: Greg Keen
Dear Ministry of Health,
Please provide details of the 'further consultation' which is delaying the release of the information requested, including details of why a proper response to the request could not reasonably be made within the original time limit.
Yours faithfully,
Greg Keen
From: OIA Requests
Kia ora Greg
Thanks for your email, it was necessary in this case for the Ministry to
consult with an external agency, hence the extension required.
Have a lovely day,
OIA Services
Office of the Director-General
Ministry of Health
E: [email address]
L1 North, Yellow, 113 Molesworth St, Wellington
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From: Greg Keen <[FYI request #14993 email]>
Sent: Wednesday, 28 April 2021 11:38
To: OIA Requests <[email address]>
Subject: Re: Extension of time for responding to request, ref: H202103598
Dear Ministry of Health,
Please provide details of the 'further consultation' which is delaying the
release of the information requested, including details of why a proper
response to the request could not reasonably be made within the original
time limit.
Yours faithfully,
Greg Keen
-----Original Message-----
Kia ora
Thank you for your request for official information, received on 25 March
2021 for information pertaining to the COVID-19 vaccination rollout
within
New Zealand.
The Ministry of Health has decided to extend the period of time available
to respond to your request under section 15A of the Official Information
Act 1982 (the Act) as further consultation is required.
You can now expect a response to your request on, or before, 3 May 2021.
You have the right, under section 28 of the Act, to ask the Ombudsman to
review my decision to extend the time available to respond to your
request.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
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[FYI request #14993 email]
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If you have received this message in error, please notify the sender
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Ministry of Health
Kia ora Greg
Please find attached the response to your request for official
information.
Nga mihi,
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
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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From: Greg Keen
Dear Ministry of Health,
Thank you for your reply. Unfortunately the information supplied by Medsafe does not fulfill my request.
I have requested an actual number of patients who can receive this medicine while it has provisional consent, which has been applied under Section 23 of the Medicines Act. Section 23 does not specify that a medicine with provisional consent can be used by anyone over the age of 16, it specifies that it can be used only on a restricted basis by a limited number of patients.
Please provide a numeric value indicating the maximum number of patients who can use this medicine while it has provisional consent, in accordance with Section 23 of the Medicines Act.
Yours faithfully,
Greg Keen
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