Purchase of Pfizer Comirnaty JN.1 and Comirnaty Omicron XBB.1.5
John Armstrong made this Official Information request to Ministry of Health
This request has an unknown status. We're waiting for John Armstrong to read recent responses and update the status.
From: John Armstrong
Dear Ministry of Health,
I refer to the Government Gazette notice 2025-go4763, dated 28 August 2025, as per link https://gazette.govt.nz/notice/id/2025-g... "Consent to the Distribution of New Medicines"
1/ Could you please supply details of quantities / doses purchased and price per respective dose for the following:
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL dose
Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL dose
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL dose
Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL dose
Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 3mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 10mcg/0.2mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 3mcg/0.2mL dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, plastic)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL dose
2/ Can you please confirm whether these products were issued provisional consent under Emergency Use Authorisation? If not then please supply details of new Authorisation.
3/ What timeframe applies to the distribution of these products eg, when does the purchase agreement expire or become due for review?
4/ Could you please supply the full list of ingredients and relevant safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these products?
Yours faithfully,
John Armstrong
From: OIA Requests
Kia ora John
Thank you for your request under the Official Information Act 1982 (the
Act), received by the Ministry of Health on 29 July 2025. You requested:
1/ Could you please supply details of quantities / doses purchased and
price per respective dose for the following:
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, plastic)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
2/ Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
3/ What timeframe applies to the distribution of these products eg, when
does the purchase agreement expire or become due for review?
4/ Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these
products?
The reference number for your request is H2025071983. As required under
the Act, the Ministry will endeavour to respond to your request no later
than 20 working days after the day your request was
received: [1]http://www.ombudsman.parliament.nz/
If you have any queries related to this request, please do not hesitate to
get in touch ([2][email address]).
Ngā mihi
OIA Services Team
[3]Ministry of Health information releases
show quoted sections
References
Visible links
1. http://www.ombudsman.parliament.nz/
2. mailto:[email address]
3. https://www.health.govt.nz/about-ministr...
From: OIA Requests
Kia ora John,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health-Manatū Hauora on 29 August. You requested:
"1/ Could you please supply details of quantities / doses purchased and
price per respective dose for the following:
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, plastic)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
2/ Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
3/ What timeframe applies to the distribution of these products eg, when
does the purchase agreement expire or become due for review?
4/ Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these
products? "
The Ministry does not hold any information relating to a majority of your
request; however, we have been advised that this information is more held
by Pharmac. For this reason, the Ministry has decided
to partially transfer your request to Pharmac under section 14(b)(ii) of
the Act.
You can expect a response from their agency in due course. They can be
contacted at: [1][email address].
Please note the Ministry will respond to the below questions in due
course:
"2/ Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
4/ Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these
products? "
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
802 602.
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
M[3]inistry of Health information releases
--------------------------------------------------------------------------
From: John Armstrong <[FOI #32155 email]>
Sent: Friday, 29 August 2025 09:23
To: OIA Requests <[email address]>
Subject: Official Information request - Purchase of Pfizer Comirnaty JN.1
and Comirnaty Omicron XBB.1.5
Dear Ministry of Health,
I refer to the Government Gazette notice 2025-go4763, dated 28 August
2025, as per link
[4]https://aus01.safelinks.protection.outlo...
"Consent to the Distribution of New Medicines"
1/ Could you please supply details of quantities / doses purchased and
price per respective dose for the following:
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, plastic)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
2/ Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
3/ What timeframe applies to the distribution of these products eg, when
does the purchase agreement expire or become due for review?
4/ Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these
products?
Yours faithfully,
John Armstrong
-------------------------------------------------------------------
This is an Official Information request made via the FYI website.
Please use this email address for all replies to this request:
[FOI #32155 email]
Is [Ministry of Health request email] the wrong address for Official Information requests
to Ministry of Health? If so, please contact us using this form:
[5]https://aus01.safelinks.protection.outlo...
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[6]https://aus01.safelinks.protection.outlo...
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.
show quoted sections
From: Web Enquiry
Kia ora John
This is an acknowledgement of your OIA request which Pharmac received on 2
September 2025. The reference number for your request is: 2025-26-056
Please note Pharmac will be responding to part 1& 3 of your request, and
the remainder is to be responded to you by the Ministry of Health.
You should receive a response from us on or before 30 September 2025. This
is within the 20 working day limit set out in the Official Information
Act.
Please contact us if you have any questions.
Ngā mihi,
Government Services | Pharmac
___________________________________________________________________
Pharmac - Te Pātaka Whaioranga | Level 9, 40 Mercer Street, Wellington
[1]www.pharmac.govt.nz
________________
From: OIA Requests <[email address]>
Sent: Tuesday, 2 September 2025 9:24 am
To: John Armstrong <[FOI #32155 email]>
Subject: Partial transfer of your request for official information, ref:
H2025071983
Kia ora John,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health-Manatū Hauora on 29 August. You requested:
"1/ Could you please supply details of quantities / doses purchased and
price per respective dose for the following:
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, plastic)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
2/ Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
3/ What timeframe applies to the distribution of these products eg, when
does the purchase agreement expire or become due for review?
4/ Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these
products? "
The Ministry does not hold any information relating to a majority of your
request; however, we have been advised that this information is more held
by Pharmac. For this reason, the Ministry has decided
to partially transfer your request to Pharmac under section 14(b)(ii) of
the Act.
You can expect a response from their agency in due course. They can be
contacted at: [2][email address].
Please note the Ministry will respond to the below questions in due
course:
"2/ Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
4/ Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these
products? "
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: [3][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
M[4]inistry of Health information releases
------------------------------------------------------------------------
From: John Armstrong <[5][FOI #32155 email]>
Sent: Friday, 29 August 2025 09:23
To: OIA Requests <[6][email address]>
Subject: Official Information request - Purchase of Pfizer Comirnaty JN.1
and Comirnaty Omicron XBB.1.5
Dear Ministry of Health,
I refer to the Government Gazette notice 2025-go4763, dated 28 August
2025, as per link
[7]https://aus01.safelinks.protection.outlo...
"Consent to the Distribution of New Medicines"
1/ Could you please supply details of quantities / doses purchased and
price per respective dose for the following:
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, plastic)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
2/ Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
3/ What timeframe applies to the distribution of these products eg, when
does the purchase agreement expire or become due for review?
4/ Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these
products?
Yours faithfully,
John Armstrong
-------------------------------------------------------------------
This is an Official Information request made via the FYI website.
Please use this email address for all replies to this request:
[8][FOI #32155 email]
Is [9][Ministry of Health request email] the wrong address for Official Information
requests to Ministry of Health? If so, please contact us using this form:
[10]https://aus01.safelinks.protection.outlo...
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[11]https://aus01.safelinks.protection.outlo...
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.
show quoted sections
From: OIA Requests
Kia ora John
Thank you for your request for official information, received on 29 August
2025 for:
“2. Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
4. Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5. Can you please supply the risk assessments / review conducted for these
products:
* Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
* Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
* Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to
3mcg/0.3mL dose
* Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to
30mcg/0.3mL dose
* Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
* Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to
10mcg/0.2mL dose
* Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to
30mcg/0.3mL dose
* Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to
30mcg/0.3mL dose
* Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to
30mcg/0.3mL dose
* Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
* Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
* Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
3mcg/0.3mL dose
* Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to
30mcg/0.3mL dose
* Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to
30mcg/0.3mL dose
* Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to
10mcg/0.2mL dose
* Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to
3mcg/0.2mL dose
* Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to
30mcg/0.3mL dose
* Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe,
plastic)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to
30mcg/0.3mL dose "
We are contacting you in accordance with section 18B of the Official
Information Act 1982 (the Act) as the highlighted section of your request
above (question 5), as it is currently worded, is for a very large volume
of information. Your request may be refused under section 18(f) of the Act
as the information requested cannot be made available without substantial
collation or research.
In order to provide you with information sooner and in order to work
within a more manageable request, are you happy to refine your request a
single product or application? Please note, the evaluation reports that
fall within scope of this request, if released, will likely be heavily
redacted to withhold commercially sensitive/confidential information.
Please respond by 22 September so that we can consider your refinement in
our response to your request.
We look forward to receiving your response.
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
M[1]inistry of Health information releases
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
From: John Armstrong
Dear OIA Requests,
Thanks for your response received. I am willing to refine question 5 as follows:
5. Can you please supply the risk assessments / review conducted for these
products:
A/ Comirnaty JN.1 and,
B/ Comirnaty Omicron XBB1.5
Yours sincerely,
John Armstrong
From: OIA Requests
Kia ora John
Thank you for your prompt response. Unfortunately, your refined request
encompasses a significant amount of information within scope. Are you
happy to refine question 5 of your request to one of the following product
applications?
Application ID 127294
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Application ID 127798
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Application ID 129264
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, plastic)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Application ID 130870
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Please respond by 22 September so that we can consider your refinement
in our response to your request.
We look forward to receiving your response.
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
M[1]inistry of Health information releases
show quoted sections
Please use this email address for all replies to this request:
[FOI #32155 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[3]https://aus01.safelinks.protection.outlo...
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.
-------------------------------------------------------------------
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://www.health.govt.nz/about-ministr...
3. https://fyi.org.nz/help/officers
From: John Armstrong
Dear OIA Requests,
As per your request for refinement, could you please supply information as in original request for:
Application ID 130870
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Yours sincerely,
John Armstrong
From: Web Enquiry
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Kia ora John
Please find attached a response to your request for official information.
Ngā mihi,
Government Services | Pharmac
___________________________________________________________________
Pharmac - Te Pātaka Whaioranga | Level 9, 40 Mercer Street, Wellington
[1]www.pharmac.govt.nz
________________
From: Web Enquiry <[email address]>
Sent: Tuesday, 2 September 2025 4:01 pm
To: John Armstrong <[FOI #32155 email]>
Subject: Acknowledgment of your request for official information -
2025-26-056
Kia ora John
This is an acknowledgement of your OIA request which Pharmac received on 2
September 2025. The reference number for your request is: 2025-26-056
Please note Pharmac will be responding to part 1& 3 of your request, and
the remainder is to be responded to you by the Ministry of Health.
You should receive a response from us on or before 30 September 2025. This
is within the 20 working day limit set out in the Official Information
Act.
Please contact us if you have any questions.
Ngā mihi,
Government Services | Pharmac
___________________________________________________________________
Pharmac - Te Pātaka Whaioranga | Level 9, 40 Mercer Street, Wellington
[2]www.pharmac.govt.nz
________________
From: OIA Requests <[3][email address]>
Sent: Tuesday, 2 September 2025 9:24 am
To: John Armstrong <[4][FOI #32155 email]>
Subject: Partial transfer of your request for official information, ref:
H2025071983
Kia ora John,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health-Manatū Hauora on 29 August. You requested:
"1/ Could you please supply details of quantities / doses purchased and
price per respective dose for the following:
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, plastic)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
2/ Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
3/ What timeframe applies to the distribution of these products eg, when
does the purchase agreement expire or become due for review?
4/ Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these
products? "
The Ministry does not hold any information relating to a majority of your
request; however, we have been advised that this information is more held
by Pharmac. For this reason, the Ministry has decided
to partially transfer your request to Pharmac under section 14(b)(ii) of
the Act.
You can expect a response from their agency in due course. They can be
contacted at: [5][email address].
Please note the Ministry will respond to the below questions in due
course:
"2/ Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
4/ Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these
products? "
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: [6][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
M[7]inistry of Health information releases
------------------------------------------------------------------------
From: John Armstrong <[8][FOI #32155 email]>
Sent: Friday, 29 August 2025 09:23
To: OIA Requests <[9][email address]>
Subject: Official Information request - Purchase of Pfizer Comirnaty JN.1
and Comirnaty Omicron XBB.1.5
Dear Ministry of Health,
I refer to the Government Gazette notice 2025-go4763, dated 28 August
2025, as per link
[10]https://aus01.safelinks.protection.outlo...
"Consent to the Distribution of New Medicines"
1/ Could you please supply details of quantities / doses purchased and
price per respective dose for the following:
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL
dose
Product: Comirnaty JN.1
Active Ingredient: Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty JN.1 (single dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty JN.1 (multi dose vial)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, plastic)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty JN.1 (pre-filled syringe, glass)
Active Ingredient: Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to
10mcg/0.3mL dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.033mg/mL equivalent to 3mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (single dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (multi dose vial)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 10mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 3mcg/0.2mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
Product: Comirnaty Omicron XBB.1.5 (pre-filled syringe, plastic)
Active Ingredient: Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL
dose
2/ Can you please confirm whether these products were issued provisional
consent under Emergency Use Authorisation? If not then please supply
details of new Authorisation.
3/ What timeframe applies to the distribution of these products eg, when
does the purchase agreement expire or become due for review?
4/ Could you please supply the full list of ingredients and relevant
safety data sheets for each product?
5/ Can you please supply the risk assessments / review conducted for these
products?
Yours faithfully,
John Armstrong
-------------------------------------------------------------------
This is an Official Information request made via the FYI website.
Please use this email address for all replies to this request:
[11][FOI #32155 email]
Is [12][Ministry of Health request email] the wrong address for Official Information
requests to Ministry of Health? If so, please contact us using this form:
[13]https://aus01.safelinks.protection.outlo...
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[14]https://aus01.safelinks.protection.outlo...
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.
show quoted sections
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Minutes from the 113th meeting of the Medicines Assessment Advisory Committee (MAAC)
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