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Provisional approval for 'Comirnaty' Pfizer Covid-19 mRNA Vaccine

Matt Shepherd made this Official Information request to Ministry of Health

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From: Matt Shepherd

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'?

To Clarify, I want to know the SPECIFIC number value that represents the "limited number of patients who can receive treatment with this medicine while it is under the status of 'provisionally approved'"

Yours faithfully,

Matt Shepherd

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Kia ora Matt,

 

Thank you for your email. This part of the Medicines Act 1981 is being
updated, further information can be found here:

[1]https://www.beehive.govt.nz/release/tech....

 

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: [2][email address] or by calling 0800
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Ngā mihi 

OIA Services Team 

  

[3]Ministry of Health information releases 

[4]Unite against COVID-19 

 

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From: Matt Shepherd <[FOI #17252 email]>
Sent: Monday, 18 October 2021 18:39
To: OIA Requests <[email address]>
Subject: Official Information request - Provisional approval for
'Comirnaty' Pfizer Covid-19 mRNA Vaccine

 

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'?

To Clarify, I want to know the SPECIFIC number value that represents the
"limited number of patients who can receive treatment with this medicine
while it is under the status of 'provisionally approved'"

Yours faithfully,

Matt Shepherd

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Paul Jones left an annotation ()

Note that the the Ministry lost the court case that challenged the provisional approval of pfizer under the "limited number" usage. Their response was to change the law 24 hours later and grant retroactive approval.

See an overview here https://www.nzherald.co.nz/nz/covid-19-c...

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