Altered composition of Comirnaty BNT162b2
Catherine Jamieson made this Official Information request to Ministry of Health
The request was partially successful.
From: Catherine Jamieson
Dear Ministry of Health,
Prior to the December 2022 Medsafe consents granted in respect of bivalents containing Famtozinameran and Riltozinameran, has the product composition of Comirnaty BNT162b2 entering New Zealand (other than that for use in the under 12s) altered at any time from the original product imported into New Zealand in the first delivery in early 2021?
If so what was(were) the date(s) any product of altered composition was imported into NZ, and date(s) first used on consumers. By composition category please supply batch numbers, the sites those batches were distributed to for administration and on what dates.
Please also supply any reports, emails or other correspondence pertaining to :-
i. any altered product composition; or
ii. expectation or otherwise that New Zealand authorities would receive advice of any altered product composition
including, but not limited to, to Tozinameran.
Yours faithfully,
Catherine Jamieson
From: OIA Requests
Kia ora Catherine
Thank you for your request for official information. The reference number
for your request is: H2023030117
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, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account.
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
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases
U[5]nite against COVID-19
------------------- Original Message -------------------
From: Catherine Jamieson <[FYI request #23680 email]>;
Received: Thu Aug 03 2023 09:31:13 GMT+1200 (New Zealand Standard Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Altered composition of Comirnaty
BNT162b2
Dear Ministry of Health,
Prior to the December 2022 Medsafe consents granted in respect of
bivalents containing Famtozinameran and Riltozinameran, has the product
composition of Comirnaty BNT162b2 entering New Zealand (other than that
for use in the under 12s) altered at any time from the original product
imported into New Zealand in the first delivery in early 2021?
If so what was(were) the date(s) any product of altered composition was
imported into NZ, and date(s) first used on consumers. By composition
category please supply batch numbers, the sites those batches were
distributed to for administration and on what dates.
Please also supply any reports, emails or other correspondence pertaining
to :-
i. any altered product composition; or
ii. expectation or otherwise that New Zealand authorities would
receive advice of any altered product composition
including, but not limited to, to Tozinameran.
Yours faithfully,
Catherine Jamieson
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From: OIA Requests
Kia ora Catherine,
Please find attached a letter regarding your request for 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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From: Catherine Jamieson
Dear OIA Requests,
I request that Chris James, Group Manager, Medsafe, revisit request for information H2023030117 pursuant to the Official Information Act.
This request has not been satisfactorily answered. The request was not restricted to Comirnaty 0.5mg/ml products and asked for information on alterations to product composition with no regard to a qualitative descriptor.
For clarity the questions contained in H2023030117 relate to all COMIRNATY® and Pfizer BioNTech Covid-19 products imported into New Zealand (other than that for use in the under 12 year age group) prior to the 21 December 2022 approval of the bivalent COMIRNATY® products.
Yours faithfully,
Catherine Jamieson
From: OIA Requests
Kia ora Catherine,
Thank you for your email. Below is some further information relating to
Comirnaty (Pfizer/BioNTech) vaccine.
Information on the approval of each of the COVID-19 vaccines, including
the Comirnaty vaccines can be found on the Medsafe website at:
[1]https://www.medsafe.govt.nz/COVID-19/sta...(4)%20of%20the%20Medicines%20Act,valid%20until%2029%20April%202024.&text=Approved%20indication-,Active%20immunisation%20to%20prevent%20COVID-19%20caused%20by%20SARS-CoV,in%20accordance%20with%20official%20recommendations.
Additionally, the qualitative formulations for any medicine can found on
Medsafe website. For all Comirnaty vaccines, the qualitative formulation
has not changed since they were first approved by Medsafe.
[2]https://www.medsafe.govt.nz/regulatory/d....
Details regarding quantitative formulations are withheld under
9(2)(b)(ii), as I have considered the countervailing public interest in
releasing information and consider that it does not outweigh the need to
withhold at this time.
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
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases
U[5]nite against COVID-19
------------------------------------------------------------------------
From: Catherine Jamieson
<[6][FOI #23680 email]>
Sent: Tuesday, 29 August 2023 00:22
To: OIA Requests <[7][email address]>
Subject: Re: Response to your official information act request –
H2023030117 CRM:0113304
Dear OIA Requests,
I request that Chris James, Group Manager, Medsafe, revisit request for
information H2023030117 pursuant to the Official Information Act.
This request has not been satisfactorily answered. The request was not
restricted to Comirnaty 0.5mg/ml products and asked for information on
alterations to product composition with no regard to a qualitative
descriptor.
For clarity the questions contained in H2023030117 relate to all
COMIRNATY® and Pfizer BioNTech Covid-19 products imported into New Zealand
(other than that for use in the under 12 year age group) prior to the 21
December 2022 approval of the bivalent COMIRNATY® products.
Yours faithfully,
Catherine Jamieson
-----Original Message-----
Kia ora Catherine,
Please find attached a letter regarding your request for information.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
Ministry of Health information releases
Unite against COVID-19
References
Visible links
1. [8]https://www.health.govt.nz/about-ministr...
2.
[9]https://aus01.safelinks.protection.outlo...
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[10][FOI #23680 email]
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.
-------------------------------------------------------------------
****************************************************************************
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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References
Visible links
1. https://www.medsafe.govt.nz/COVID-19/sta...(4)%20of%20the%20Medicines%20Act,valid%20until%2029%20April%202024.&text=Approved%20indication-,Active%20immunisation%20to%20prevent%20COVID-19%20caused%20by%20SARS-CoV,in%20accordance%20with%20official%20recommendations
2. https://www.medsafe.govt.nz/regulatory/d...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/
6. mailto:[FOI #23680 email]
7. mailto:[email address]
8. https://www.health.govt.nz/about-ministr...
9. https://covid19.govt.nz/
10. mailto:[FOI #23680 email]
11. https://fyi.org.nz/help/officers
hide quoted sections
M Bell left an annotation ()
Ministry of Health quote: “Details regarding quantitative formulations are withheld under 9(2)(b)(ii), as I have considered the countervailing public interest in releasing information and consider that it does not outweigh the need to withhold at this time.”
The ombudsman produced a report on the topic of whether to withhold information because of commercial interest, see link below...
https://www.ombudsman.parliament.nz/reso...
Following through the procedure of determining whether 9(2)(b)(ii) applies (appendix A of the document) the only way I can see that the release of this information could prejudice Pfizer is if the information actually confirms that they HAVE been changing the recipe and that there is a commercial arrangement to conceal this fact.
Furthermore there is actually considerable public interest in the answer to the question did the composition change in different batch numbers after approval, and on that basis alone this information should be released in full.
From: Catherine Jamieson
Dear OIA Requests,
Most of my request does not relate to 'details regarding quantitative formulations', can be answered without referring to any detail and therefore not likely to unreasonably prejudice a commercial position.
As per August 2019 Ombudsman Commercial Information report mentioned in an annotation to this request string, a mere assertion of prejudice is not sufficient and agencies need to be able to explain how release of the information at issue would be likely unreasonably to prejudice a commercial position.
An excerpt from page 19:-
‘If an agency is a regulator, it may hold commercially sensitive information about the quality of a product or the practices of an organisation. There are strong public interest arguments in allowing access to information that will help protect the public from unsafe products or practices.’
If there was more than one product composition for COMIRNATY® and Pfizer BioNTech Covid-19 products distributed and administered for the 12+ age group prior to 21 December 2022 approval of the bivalent products, there is a strong public interest argument in allowing access to the requested information. What follows below is an excerpt example of such transparency from the United States:-
https://web.archive.org/web/202110300005...
‘Pfizer-BioNTech COVID-19 vaccines for individuals 12 years of age and older contain 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered:
• potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose OR
• tromethamine, tromethamine hydrochloride, and sucrose ‘
For simplicity most questions in my initial request are relabelled below. Q1 can be answered with a yes or no answer. Q2 and Q3 ask solely for dates and a separation of batch numbers into categories that can be differentiated from one another using a heading that provides no detail with regard to quantitative formulation. Q4 can be answered without reference to details regarding quantitative formulations.
1. Prior to the December 2022 Medsafe consents granted in respect of bivalents containing Famtozinameran and Riltozinameran, has the product composition of Comirnaty BNT162b2 entering New Zealand (other than that for use in the under 12s) altered at any time from the original product imported into New Zealand in the first delivery in early 2021?
2.If so what was(were) the date(s) any product of altered composition was imported into NZ, and date(s) first used on consumers?
3. By composition category please supply batch numbers, the sites those batches were distributed to for administration and on what dates.
4 Please also supply any reports, emails or other correspondence pertaining expectation or otherwise that New Zealand authorities would receive advice of any altered product composition including, but not limited to, to Tozinameran.
Please also confirm the name and/or job title and agency of the person referring to themselves as 'I' in the 31 August response who considers that the public interest of a response does not outweigh the need to withhold at this time.
Yours faithfully,
Catherine Jamieson
From: OIA Requests
Kia ora Catherine
Thank you for your request for official information. The reference number
for your request is: H2023031399
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, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account.
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
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases
U[5]nite against COVID-19
------------------- Original Message -------------------
From: Catherine Jamieson <[FOI #23680 email]>;
Received: Sat Sep 02 2023 10:51:49 GMT+1200 (New Zealand Standard Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Re: Response to your official information act request –
H2023030117 CRM:0113304
Dear OIA Requests,
Most of my request does not relate to 'details regarding quantitative
formulations', can be answered without referring to any detail and
therefore not likely to unreasonably prejudice a commercial position.
As per August 2019 Ombudsman Commercial Information report mentioned in an
annotation to this request string, a mere assertion of prejudice is not
sufficient and agencies need to be able to explain how release of the
information at issue would be likely unreasonably to prejudice a
commercial position.
An excerpt from page 19:-
‘If an agency is a regulator, it may hold commercially sensitive
information about the quality of a product or the practices of an
organisation. There are strong public interest arguments in allowing
access to information that will help protect the public from unsafe
products or practices.’
If there was more than one product composition for COMIRNATY® and Pfizer
BioNTech Covid-19 products distributed and administered for the 12+ age
group prior to 21 December 2022 approval of the bivalent products, there
is a strong public interest argument in allowing access to the requested
information. What follows below is an excerpt example of such
transparency from the United States:-
[6]https://aus01.safelinks.protection.outlo...
‘Pfizer-BioNTech COVID-19 vaccines for individuals 12 years of age and
older contain 1 of the following sets of additional ingredients; ask the
vaccination provider which version is being administered:
• potassium chloride, monobasic potassium phosphate, sodium
chloride, dibasic sodium phosphate dihydrate, and sucrose OR
• tromethamine, tromethamine hydrochloride, and sucrose ‘
For simplicity most questions in my initial request are relabelled below.
Q1 can be answered with a yes or no answer. Q2 and Q3 ask solely for dates
and a separation of batch numbers into categories that can be
differentiated from one another using a heading that provides no detail
with regard to quantitative formulation. Q4 can be answered without
reference to details regarding quantitative formulations.
1. Prior to the December 2022 Medsafe consents granted in respect of
bivalents containing Famtozinameran and Riltozinameran, has the product
composition of Comirnaty BNT162b2 entering New Zealand (other than that
for use in the under 12s) altered at any time from the original product
imported into New Zealand in the first delivery in early 2021?
2.If so what was(were) the date(s) any product of altered composition was
imported into NZ, and date(s) first used on consumers?
3. By composition category please supply batch numbers, the sites those
batches were distributed to for administration and on what dates.
4 Please also supply any reports, emails or other correspondence
pertaining expectation or otherwise that New Zealand authorities would
receive advice of any altered product composition including, but not
limited to, to Tozinameran.
Please also confirm the name and/or job title and agency of the person
referring to themselves as 'I' in the 31 August response who considers
that the public interest of a response does not outweigh the need to
withhold at this time.
Yours faithfully,
Catherine Jamieson
-----Original Message-----
Kia ora Catherine,
Thank you for your email. Below is some further information relating to
Comirnaty (Pfizer/BioNTech) vaccine.
Information on the approval of each of the COVID-19 vaccines, including
the Comirnaty vaccines can be found on the Medsafe website at:
[1][7]https://www.medsafe.govt.nz/COVID-19/sta...(4)%20of%20the%20Medicines%20Act,valid%20until%2029%20April%202024.&text=Approved%20indication-,Active%20immunisation%20to%20prevent%20COVID-19%20caused%20by%20SARS-CoV,in%20accordance%20with%20official%20recommendations.
Additionally, the qualitative formulations for any medicine can found on
Medsafe website. For all Comirnaty vaccines, the qualitative formulation
has not changed since they were first approved by Medsafe.
[2][8]https://www.medsafe.govt.nz/regulatory/d....
Details regarding quantitative formulations are withheld under
9(2)(b)(ii), as I have considered the countervailing public interest in
releasing information and consider that it does not outweigh the need to
withhold at this time.
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
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases U[5]nite against COVID-19
------------------------------------------------------------------------
From: Catherine Jamieson
<[6][FOI #23680 email]>
Sent: Tuesday, 29 August 2023 00:22
To: OIA Requests <[7][email address]>
Subject: Re: Response to your official information act request –
H2023030117 CRM:0113304
Dear OIA Requests,
I request that Chris James, Group Manager, Medsafe, revisit request for
information H2023030117 pursuant to the Official Information Act.
This request has not been satisfactorily answered. The request was not
restricted to Comirnaty 0.5mg/ml products and asked for information on
alterations to product composition with no regard to a qualitative
descriptor.
For clarity the questions contained in H2023030117 relate to all
COMIRNATY® and Pfizer BioNTech Covid-19 products imported into New
Zealand (other than that for use in the under 12 year age group) prior to
the 21 December 2022 approval of the bivalent COMIRNATY® products.
Yours faithfully,
Catherine Jamieson
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[9][FOI #23680 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[10]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.
-------------------------------------------------------------------
****************************************************************************
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legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
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If you have received this message in error, please notify the sender
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Visible links
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2. mailto:[email address]
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/
6. https://web.archive.org/web/202110300005...
7. https://www.medsafe.govt.nz/COVID-19/sta...(4)%20of%20the%20Medicines%20Act,valid%20until%2029%20April%202024.&text=Approved%20indication-,Active%20immunisation%20to%20prevent%20COVID-19%20caused%20by%20SARS-CoV,in%20accordance%20with%20official%20recommendations
8. https://www.medsafe.govt.nz/regulatory/d...
9. mailto:[FOI #23680 email]
10. https://fyi.org.nz/help/officers
hide quoted sections
Athina Andonatou left an annotation ()
Very interested in this response once a direct answer to your initial questions are answered.
c a left an annotation ()
Hi Catherine, There is definitely a huge amount of public interest in these answers. I am waiting to see the response. In the meantime pg. 13 of this document raises some questions for me: https://www.health.govt.nz/system/files/... it came from here: https://www.health.govt.nz/our-work/dise...
From: OIA Requests
Kia ora Catherine,
Please find attached a letter regarding the partial transfer of your
request for 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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legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
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From: hnzOIA
Tēnā koe,
Thank you for contacting Te Whatu Ora, Health NZ. This is an automatic
reply to confirm that we have received your email. Depending on the
nature of your request you may not receive a response for up to 20 working
days. We will try to respond to your query as quickly as possible.
Ngā mihi
Te Whatu Ora, Health NZ.
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hide quoted sections
S McEwan left an annotation ()
I too am interested in the answers to Catherine's questions; as I expect would be many of the people who have been injected with them. This is certainly of public interest and should have been released long ago in the interests of transparency.
S McEwan left an annotation ()
I too am interested in the answers to Catherine's questions; as I expect would be many of the people who have been injected with the comirnity products. This is certainly of public interest and should have been released long ago in the interests of transparency.
From: OIA Requests
Tçnâ koe Catherine,
Thank you for your follow up request under the Official Information Act
1982 (the Act) to Manatû Hauora (the Ministry of Health) on 2 September
2023 clarifying your request for information regarding the product
composition of Comirnaty vaccines.
As you were advised on 28 September 2023, parts 2 and 3 of your request
have been 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 for these
parts of your request in due course. I will respond to the remaining parts
of your request below.
“1. Prior to the December 2022 Medsafe consents granted in respect of
bivalents containing Famtozinameran and Riltozinameran, has the product
composition of Comirnaty BNT162b2 entering New Zealand (other than that
for use in the under 12s) altered at any time from the original product
imported into New Zealand in the first delivery in early 2021?”
A number of presentations of Pfizer’s Comirnaty vaccine have been used in
New Zealand. A summary of these vaccines is available on Medsafe’s website
at: [1]www.medsafe.govt.nz/COVID-19/status-of-applications.asp. On this
website you will be able to access datasheets for each presentation,
including the qualitative formulation.
The initial presentation of the vaccine approved used a phosphate
buffering system, however more recent presentations of the vaccine use a
tris buffering system.
“4. Please also supply any reports, emails or other correspondence
pertaining expectation or otherwise that New Zealand authorities would
receive advice of any altered product composition including, but not
limited to, to Tozinameran.”
Please refer to our previous response to you on 24 August 2023 (ref:
H2023030117) for information regarding the process for notifying changes
to the formulation of medicines in New Zealand.
“Please also confirm the name and/or job title and agency of the person
referring to themselves as 'I' in the 31 August response who considers
that the public interest of a response does not outweigh the need to
withhold at this time.”
Responses and decisions made under your request for official information
are attributable to Manatû Hauora as a whole. If you wish to discuss any
aspect of your request with us, please feel free to contact the OIA
Services Team on [2][email address].
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.
Ngâ mihi
OIA Services Team
M[4]inistry of Health information releases
U[5]nite against COVID-19
****************************************************************************
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.
****************************************************************************
References
Visible links
1. https://www.medsafe.govt.nz/COVID-19/sta....
2. mailto:[email address]
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/
hide quoted sections
From: hnzOIA
Tēnā koe Catherine
Thank you for your email asking for the following information under the
Official Information Act 1982 (the Act):
“2. If so what was(were) the date(s) any product of altered composition
was imported into NZ, and date(s) first used on consumers?
3. By composition category please supply batch numbers, the sites those
batches were distributed to for administration and on what dates.”
This email is to let you know that Te Whatu Ora needs more time to make a
decision on your request.
The Act requires that we advise you of our decision on your request no
later than 20 working days after the day we received your request.
Unfortunately, it will not be possible to meet that time limit and we are
therefore writing to notify you of an extension of the time to make our
decision, to 20 November 2023, if not earlier.
This extension is required because the consultations and volume of
information are such that a proper response cannot reasonably be made
within the original time limit.
If you have any questions, please contact us at [1][email address]
If you are not happy with this extension, you have the right to make a
complaint to the Ombudsman. Information about how to do this is available
at www.ombudsman.parliament.nz or by phoning 0800 802 602.
Ngā mihi nui
Shane Sharma (he/him)
Advisor, Ministerial Services
Government, Partnerships and Risk
īmēra: [2][email address]
Spark Central, 44-48 Willis Street, Wellington| PO Box 5013, Wellington
6140
Te Whatu Ora – Health New Zealand
[3]www.TeWhatuOra.govt.nz
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From: Chris McIlroy
Tēnā koe Catherine
Te Whatu Ora is writing to advise you that, pursuant to section 15(1)(a)
of the Act, a decision has been made on your request; however, we are
unable to provide you the information prepared for release today.
We apologise for any possible delay, and endeavour to send you the
information as soon as possible.
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.
Nāku iti noa, nā
Chris McIlroy
Senior Ministerial Advisor
Government Services
Office of the Chief Executive
Te Whatu Ora – Health New Zealand
------------------- Original Message -------------------
From: HNZ OIA <[email address]>;
Received: Fri Oct 27 2023 09:41:15 GMT+1300 (New Zealand Daylight Time)
To: Catherine Jamieson <[FYI request #23680 email]>;
Subject: Te Whatu Ora needs more time to make a decision on your request
HNZ00030152 CRM:0129428
Tēnā koe Catherine
Thank you for your email asking for the following information under the
Official Information Act 1982 (the Act):
“2. If so what was(were) the date(s) any product of altered composition
was imported into NZ, and date(s) first used on consumers?
3. By composition category please supply batch numbers, the sites those
batches were distributed to for administration and on what dates.”
This email is to let you know that Te Whatu Ora needs more time to make a
decision on your request.
The Act requires that we advise you of our decision on your request no
later than 20 working days after the day we received your request.
Unfortunately, it will not be possible to meet that time limit and we are
therefore writing to notify you of an extension of the time to make our
decision, to 20 November 2023, if not earlier.
This extension is required because the consultations and volume of
information are such that a proper response cannot reasonably be made
within the original time limit.
If you have any questions, please contact us at [2][email address]
If you are not happy with this extension, you have the right to make a
complaint to the Ombudsman. Information about how to do this is available
at www.ombudsman.parliament.nz or by phoning 0800 802 602.
Ngā mihi nui
Shane Sharma (he/him)
Advisor, Ministerial Services
Government, Partnerships and Risk
īmēra: [3][email address]
Spark Central, 44-48 Willis Street, Wellington| PO Box 5013, Wellington
6140
Te Whatu Ora – Health New Zealand
[4]www.TeWhatuOra.govt.nz
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From: Catherine Jamieson
Dear Chris McIlroy,
Thank you for you correspondence of November 20 2023.
Can you please let me know when I can expect the information prepared for release to be provided.
Yours sincerely,
Catherine Jamieson
From: hnzOIA
HNZ00030152 Jamieson OIA response letter FINAL.pdf
268K
Download
View as HTML
Appendix A Dispatch Data up to 03 November 2023 Pfizer vaccines.xlsx
1.6M
Download
View as HTML
Kia ora Catherine
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.
Ngā mihi,
Te Whatu Ora Ministerial Team
****************************************************************************
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From: Catherine Jamieson
Dear hnzOIA,
Thank you for the material. Unfortunately it is incomplete as there were no batch numbers included. My question was :
'By composition category please supply batch numbers, the sites those batches were distributed to for administration and on what dates.'
Please reissue the response with a column included for batch numbers.
Yours sincerely,
Catherine Jamieson
From: hnzOIA
Kia ora Catherine
Apologies for this oversight and for the further delay.
Please find attached the response reissued with a column for batch
numbers.
Ngâ mihi
Adam
Adam McFerran ([1]he/him)
Kaitohutohu Matua | Senior Advisor, Ministerial Services
Office of the Chief Executive
Follow us on [2]LinkedIn | [3]Facebook | [4]Instagram
Te Whatu Ora – Health New Zealand
------------------- Original Message -------------------
From: Catherine Jamieson <[FOI #23680 email]>;
Received: Fri Dec 15 2023 14:51:03 GMT+1300 (New Zealand Daylight Time)
To: hnzOIA <[email address]>; HNZ OIA <[email address]>;
Subject: Re: HNZ00030152 Response to your request CRM:0410080
Dear hnzOIA,
Thank you for the material. Unfortunately it is incomplete as there were
no batch numbers included. My question was :
'By composition category please supply batch numbers, the sites those
batches were distributed to for administration and on what dates.'
Please reissue the response with a column included for batch numbers.
Yours sincerely,
Catherine Jamieson
-----Original Message-----
Kia ora Catherine
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]https://aus01.safelinks.protection.outlo...
or by phoning 0800 802 602.
Ngâ mihi,
Te Whatu Ora Ministerial Team
References
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2. [6]file:///tmp/foiextract20231215-34-ir0t99#
-------------------------------------------------------------------
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Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[7]https://aus01.safelinks.protection.outlo...
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From: Catherine Jamieson
Dear hnzOIA,
Thank you for your reply of 18 January.
The Medsafe product detail for the purple cap (Tozinameran 0.5 mg/mL equivalent to 30 µg/0.3mL dose) product is below.
https://www.medsafe.govt.nz/regulatory/P...
The reply given does not make any differentiation for the composition change reflected in this Product Detail. If the modified purple cap product was distributed within NZ please modify the file to reflect what was asked in the original question .
'...what was(were) the date(s) any product of altered composition was imported into NZ, and date(s) first used on consumers. By composition category please supply batch numbers, the sites those batches were distributed to for administration and on what dates.'
Yours sincerely,
Catherine Jamieson
From: Catherine Jamieson
Dear hnzOIA,
I have several queries and requests regarding the information provided in HNZ00030152.
Please clarify whether the distribution information provided regarding batch SDYX4 is correct - that 7350 doses were distributed within the South Island. OIA response HNZ00032271 declares that none of the 81,900 doses were dispatched but rather discarded.
I understand that a seperate database was utilised prior to the CIR inventory portal becoming fully functional and some distribution data were recorded in a separate database?
1. Please include distribution data as per the original request for batches
- EP2163, EP9605, ER7449, ET3045, ET9096
2. Please include any distribution data additional to that already provided for the following batches (or distribution data in respect of any other batches additional to those mentioned in this request that may not have been supplied in HNZ00030152 table) to provide a complete response to the initial request.
EX2405, FA5833, FC3558, FC5029, FD0927, FD9234, FE2090, FE3064, FE8163, FF2382, FF4206, FG0050, FG3716
Yours sincerely,
Catherine Jamieson
From: hnzOIA
Tēnā koe,
Thank you for contacting Te Whatu Ora, Health NZ. This is an automatic
reply to confirm that we have received your email. Depending on the
nature of your request you may not receive a response for up to 20 working
days. We will try to respond to your query as quickly as possible.
Ngā mihi
Te Whatu Ora, Health NZ.
****************************************************************************
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hide quoted sections
Athina Andonatou left an annotation ()
Still watching and waiting with interest for a clear reply to your reasonable requests. Stay at it and thank you for your persistence and tenacity.
Diana Martyn left an annotation ()
Thankyou Catherine for your persistence. Look forward to some answers.
From: hnzOIA
Tēnā koe Catherine
Thank you for your email of 13 February 2024, asking for the following
information under the Official Information Act 1982 (the Act):
"I have several queries and requests regarding the information provided in
HNZ00030152.
Please clarify whether the distribution information provided regarding
batch SDYX4 is correct - that 7350 doses were distributed within the South
Island. OIA response HNZ00032271 declares that none of the 81,900 doses
were dispatched but rather discarded.
I understand that a seperate database was utilised prior to the CIR
inventory portal becoming fully functional and some distribution data were
recorded in a separate database?
1. Please include distribution data as per the original request for
batches
- EP2163, EP9605, ER7449, ET3045, ET9096
2. Please include any distribution data additional to that already
provided for the following batches (or distribution data in respect of any
other batches additional to those mentioned in this request that may not
have been supplied in HNZ00030152 table) to provide a complete response to
the initial request.
EX2405, FA5833, FC3558, FC5029, FD0927, FD9234, FE2090, FE3064, FE8163,
FF2382, FF4206, FG0050, FG3716"
This email is to let you know that Health NZ | Te Whatu Ora needs more
time to make a decision on your request.
The Act requires that we advise you of our decision on your request no
later than 20 working days after the day we received your request.
Unfortunately, it will not be possible to meet that time limit and we are
therefore writing to notify you of an extension of the time to make our
decision, to 2 April 2024.
This extension is required because the volume of information is such that
it is necessary to make a decision on your request are such that a proper
response cannot reasonably be made within the original time limit.
If you have any questions, please contact us at [1][email address]
If you are not happy with this extension, you have the right to make a
complaint to the Ombudsman. Information about how to do this is available
at www.ombudsman.parliament.nz or by phoning 0800 802 602.
Nāku iti noa, nā
Vicky
Government Services
Office of the Chief Executive
Health New Zealand | Te Whatu Ora
****************************************************************************
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From: hnzOIA
Kia ora Catherine,
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.
Ngā mihi,
Health NZ | Te Whatu Ora Ministerial Team
Government Services
Office of the Chief Executive
Health New Zealand | Te Whatu Ora
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From: Catherine Jamieson
Dear hnzOIA,
Can you please provide an update as to when I will receive reply to my request of February 10 2024.
Yours sincerely,
Catherine Jamieson
From: hnzOIA
Hi Catherine
We have been unable to locate your request sent on the 10th of February
2024
Can you please provide the email/request that was sent to us on the 10th
of February.
Ngā mihi
Office of the CE
Health New Zealand | Te Whatu Ora
------------------- Original Message -------------------
From: Catherine Jamieson <[FOI #23680 email]>;
Received: Wed Apr 03 2024 22:30:12 GMT+1300 (New Zealand Daylight Time)
To: hnzOIA <[email address]>; HNZ OIA
<[email address]>;
Subject: Re: Response to your request for information HNZ00037995
CRM:0304709
Dear hnzOIA,
Can you please provide an update as to when I will receive reply to my
request of February 10 2024.
Yours sincerely,
Catherine Jamieson
-----Original Message-----
Kia ora Catherine,
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]https://aus01.safelinks.protection.outlo...
or by phoning 0800 802 602.
Ngā mihi,
Health NZ | Te Whatu Ora Ministerial Team
Government Services
Office of the Chief Executive
Health New Zealand | Te Whatu Ora
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From: Catherine Jamieson
Dear hnzOIA,
This is the request sent 10 February. It can be seen scrolling up the fyi.org.nz string of messages.
'Dear hnzOIA,
Thank you for your reply of 18 January.
The Medsafe product detail for the purple cap (Tozinameran 0.5 mg/mL equivalent to 30 µg/0.3mL dose) product is below.
https://www.medsafe.govt.nz/regulatory/P...
The reply given does not make any differentiation for the composition change reflected in this Product Detail. If the modified purple cap product was distributed within NZ please modify the file to reflect what was asked in the original question .
'...what was(were) the date(s) any product of altered composition was imported into NZ, and date(s) first used on consumers. By composition category please supply batch numbers, the sites those batches were distributed to for administration and on what dates.'
Yours sincerely,
Catherine Jamieson
From: Catherine Jamieson
Dear hnzOIA,
I refer to response dated March 28 where it was stated 'we are unable to provide receiving data'.
Please provide reference to the section/part of the Official Information Act under which my request is being denied.
Under the Public Records Act shouldn't there be stored records to be retrieved and queried to provide receiving data for these batches? Can you do that please or if not, please provide the reason why not.
For clarity I am requiring receiving location data that was not supplied in HNZ00030152, namely:-
1. Please include distribution data as per the original request for batches - EP2163, EP9605, ER7449, ET3045, ET9096
2. Please include any distribution data additional to that already provided for the following batches (or distribution data in respect of any other batches additional to those mentioned in this request that may not have been supplied in HNZ00030152 table) to provide a complete response to the initial request. EX2405, FA5833, FC3558, FC5029, FD0927, FD9234, FE2090, FE3064, FE8163, FF2382, FF4206, FG0050, FG3716
Yours sincerely,
Catherine Jamieson
From: hnzOIA
Kia ora Catherine,
Thank you for your email of 10 February 2024. We apologise for the delay
in responding.
The purple cap used in New Zealand was Covid Adult Pfizer Original. It was
replaced by 2 adult vaccines: Covid Adult Pfizer 30mcg Monovalent, Covid
Adult Pfizer 15/15mcg Bivalent. Health New Zealand | Te Whatu Ora can
confirm this has been captured in the spreadsheet previously provided.
We hope this provides clarity but if you have any questions, you can
contact us at [1][email address].
Ngā mihi nui
Adam McFerran ([2]he/him)
Government Services
[3][email address]
Health New Zealand | Te Whatu Ora
-----Original Message-----
From: Catherine Jamieson
<[4][FOI #23680 email]>
Sent: Saturday, 10 February 2024 8:01 am
To: hnzOIA <[5][email address]>
Subject: Re: HNZ00030152 Response to your request CRM:0410080
Dear hnzOIA,
Thank you for your reply of 18 January.
The Medsafe product detail for the purple cap (Tozinameran 0.5 mg/mL
equivalent to 30 µg/0.3mL dose) product is below.
[6]https://www.medsafe.govt.nz/regulatory/P...
The reply given does not make any differentiation for the composition
change reflected in this Product Detail. If the modified purple cap
product was distributed within NZ please modify the file to reflect what
was asked in the original question .
'...what was(were) the date(s) any product of altered composition was
imported into NZ, and date(s) first used on consumers. By composition
category please supply batch numbers, the sites those batches were
distributed to for administration and on what dates.'
Yours sincerely,
Catherine Jamieson
-----Original Message-----
Kia ora Catherine
Apologies for this oversight and for the further delay.
Please find attached the response reissued with a column for batch
numbers.
Ngâ mihi
Adam
Adam McFerran ([1]he/him)
Kaitohutohu Matua | Senior Advisor, Ministerial Services Office of the
Chief Executive Follow us on [2]LinkedIn | [3]Facebook |
[4]Instagram Te Whatu Ora – Health New Zealand
-------------------------------------------------------------------
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[7][FOI #23680 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[8]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.
-------------------------------------------------------------------
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6. https://www.medsafe.govt.nz/regulatory/P...
7. mailto:[FOI #23680 email]
8. https://fyi.org.nz/help/officers
hide quoted sections
From: Catherine Jamieson
Dear hnzOIA,
Please acknowledge my message of 10 April in this thread and advise when I can expect a reply.
The MoH reply of April 16 still does not answer the question. For clarity, there was an amendment to the product detail for the Tozinameran 30mcg product with PBS buffer where a new excipient was available from December 2021.
https://www.medsafe.govt.nz/regulatory/P...
Please notify which batch numbers contained the initial excipient formation and which batch numbers contained the excipient available from December 2021.
Yours sincerely,
Catherine Jamieson
From: hnzOIA
Tēnā koe Catherine,
Thank you for your email of 8 April 2024, asking for the following
information under the Official Information Act 1982 (the Act):
'Please provide reference to the section/part of the Official Information
Act under which my request is being denied.
Under the Public Records Act shouldn't there be stored records to be
retrieved and queried to provide receiving data for these batches? Can you
do that please or if not, please provide the reason why not.
For clarity I am requiring receiving location data that was not supplied
in HNZ00030152, namely:-
1. Please include distribution data as per the original request for
batches - EP2163, EP9605, ER7449, ET3045, ET9096
2. Please include any distribution data additional to that already
provided for the following batches (or distribution data in respect of any
other batches additional to those mentioned in this request that may not
have been supplied in HNZ00030152 table) to provide a complete response to
the initial request. EX2405, FA5833, FC3558, FC5029, FD0927, FD9234,
FE2090, FE3064, FE8163, FF2382, FF4206, FG0050, FG3716
The Medsafe product detail for the purple cap (Tozinameran 0.5 mg/mL
equivalent to 30 µg/0.3mL dose) product is below.
[1]https://aus01.safelinks.protection.outlo...
The reply given does not make any differentiation for the composition
change reflected in this Product Detail. If the modified purple cap
product was distributed within NZ please modify the file to reflect what
was asked in the original question .
'...what was(were) the date(s) any product of altered composition was
imported into NZ, and date(s) first used on consumers. By composition
category please supply batch numbers, the sites those batches were
distributed to for administration and on what dates.'
This email is to let you know that Health New Zealand | Te Whatu Ora needs
more time to make a decision on your request.
The Act requires that we advise you of our decision on your request no
later than 20 working days after the day we received your request.
Unfortunately, it will not be possible to meet that time limit and we are
therefore writing to notify you of an extension of the time to make our
decision, to 21 May 2024.
This extension is required because the consultations necessary to make a
decision on your request are such that a proper response cannot reasonably
be made within the original time limit.
We are working hard to provide a response to you sooner than the extended
timeframe.
If you have any questions, please contact us
at [2][email address].
If you are not happy with this extension, you have the right to make a
complaint to the Ombudsman. Information about how to do this is available
at [3]www.ombudsman.parliament.nz or by phoning 0800 802 602.
Nāku iti noa, nā
Government Services
[4][email address]
Health New Zealand | Te Whatu Ora
Statement of confidentiality: This email message and any accompanying
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References
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4. mailto:[email address]
From: hnzOIA
Kia ora Catherine,
Thank you for your request for information regarding. 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.
Ngā mihi,
Health New Zealand | Te Whatu Ora Ministerial Team
Government Services
Office of the Chief Executive
Health New Zealand | Te Whatu Ora
Statement of confidentiality: This email message and any accompanying
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From: Catherine Jamieson
Dear Ministry of Health,
On 28 Sept 2023 my original request was transferred to Health New Zealand Te Whatu Ora. To date I am still pursuing answers to my original questions although I have narrowed in more specifically where omissions in the responses to my initial request have been identified.
Today Health New Zealand have informed via HNZ00043798 that they are not able to respond to this request as they do not hold this information. Therefore I am returning to the Ministry of Health for answers.
Firstly I am requiring receiving location data that was not supplied in HNZ00030152, namely:-
1. Please include distribution data as per the original request for batches - EP2163, EP9605, ER7449, ET3045, ET9096
2. Please include any distribution data additional to that already provided for the following batches (and distribution data in respect of any other batches additional to those mentioned in this request that may not have been supplied in HNZ00030152 table) to provide a complete response to the initial request. EX2405, FA5833, FC3558, FC5029, FD0927, FD9234, FE2090, FE3064, FE8163, FF2382, FF4206, FG0050, FG3716
Secondly the Medsafe product detail for the purple cap (Tozinameran 0.5 mg/mL equivalent to 30 μg/0.3mL dose) product is below.
https://www.medsafe.govt.nz/regulatory/P...
There was an amendment to the product detail for the Tozinameran 30mcg product with PBS buffer where a new excipient was available from December 2021.
https://www.medsafe.govt.nz/regulatory/P...
Please notify which batch numbers contained the initial excipient formation and which batch numbers contained the excipient available from December 2021.
Yours faithfully,
Catherine Jamieson
From: OIA Requests
Kia ora Catherine,
Thank you for your request for official information. The reference number
for your request is: H2024041515
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, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account.
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
[4]Ministry of Health information releases
-------
From: Catherine Jamieson
<[FOI #23680 email]>;
Received: Wed May 15 2024 14:24:30 GMT+1200 (New Zealand Standard Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Re: Official Information request - Altered composition of
Comirnaty BNT162b2
Dear Ministry of Health,
On 28 Sept 2023 my original request was transferred to Health New Zealand
Te Whatu Ora. To date I am still pursuing answers to my original
questions although I have narrowed in more specifically where omissions in
the responses to my initial request have been identified.
Today Health New Zealand have informed via HNZ00043798 that they are not
able to respond to this request as they do not hold this information.
Therefore I am returning to the Ministry of Health for answers.
Firstly I am requiring receiving location data that was not supplied in
HNZ00030152, namely:-
1. Please include distribution data as per the original request for
batches - EP2163, EP9605, ER7449, ET3045, ET9096
2. Please include any distribution data additional to that already
provided for the following batches (and distribution data in respect of
any other batches additional to those mentioned in this request that may
not have been supplied in HNZ00030152 table) to provide a complete
response to the initial request. EX2405, FA5833, FC3558, FC5029, FD0927,
FD9234, FE2090, FE3064, FE8163, FF2382, FF4206, FG0050, FG3716
Secondly the Medsafe product detail for the purple cap (Tozinameran 0.5
mg/mL equivalent to 30 μg/0.3mL dose) product is below.
[5]https://www.medsafe.govt.nz/regulatory/P...
There was an amendment to the product detail for the Tozinameran 30mcg
product with PBS buffer where a new excipient was available from December
2021.
[6]https://www.medsafe.govt.nz/regulatory/P...
Please notify which batch numbers contained the initial excipient
formation and which batch numbers contained the excipient available from
December 2021.
Yours faithfully,
Catherine Jamieson
****************************************************************************
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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.
****************************************************************************
References
Visible links
1. http://www.ombudsman.parliament.nz/
2. mailto:[email address]
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://www.medsafe.govt.nz/regulatory/P...
6. https://www.medsafe.govt.nz/regulatory/P...
hide quoted sections
From: OIA Requests
Kia ora Catherine,
Thank you for your request of 15 May 2024 for further information
regarding location data and batch numbers:
Today Health New Zealand have informed via HNZ00043798 that they are not
able to respond to this request as they do not hold this information.
Therefore I am returning to the Ministry of Health for answers.
Firstly I am requiring receiving location data that was not supplied in
HNZ00030152, namely:-
1. Please include distribution data as per the original request for
batches - EP2163, EP9605, ER7449, ET3045, ET9096
2. Please include any distribution data additional to that already
provided for the following batches (and distribution data in respect of
any other batches additional to those mentioned in this request that may
not have been supplied in HNZ00030152 table) to provide a complete
response to the initial request. EX2405, FA5833, FC3558, FC5029, FD0927,
FD9234, FE2090, FE3064, FE8163, FF2382, FF4206, FG0050, FG3716
Secondly the Medsafe product detail for the purple cap (Tozinameran 0.5
mg/mL equivalent to 30 μg/0.3mL dose) product is below.
[1]https://www.medsafe.govt.nz/regulatory/P...
There was an amendment to the product detail for the Tozinameran 30mcg
product with PBS buffer where a new excipient was available from December
2021.
[2]https://www.medsafe.govt.nz/regulatory/P...
Please notify which batch numbers contained the initial excipient
formation and which batch numbers contained the excipient available from
December 2021.
The Ministry of Health holds no information regarding your request, hence
the transfer to Health New Zealand - Te Whatu Ora. The Ministry has
nothing further to add.
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
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases
U[5]nite against COVID-19
------------------------------------------------------------------------
From: OIA Requests <[email address]>
Sent: Friday, 17 May 2024 10:19
To: Catherine Jamieson <[FOI #23680 email]>
Subject: Acknowledgement of your request for official information ref:
H2024041515 CRM:0114063
Kia ora Catherine,
Thank you for your request for official information. The reference number
for your request is: H2024041515
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: [6]http://www.ombudsman.parliament.nz/
If you have any queries, please feel free to contact the OIA Services Team
on [7][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account.
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: [8][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
[9]Ministry of Health information releases
-------
From: Catherine Jamieson
<[FOI #23680 email]>;
Received: Wed May 15 2024 14:24:30 GMT+1200 (New Zealand Standard Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Re: Official Information request - Altered composition of
Comirnaty BNT162b2
Dear Ministry of Health,
On 28 Sept 2023 my original request was transferred to Health New Zealand
Te Whatu Ora. To date I am still pursuing answers to my original
questions although I have narrowed in more specifically where omissions in
the responses to my initial request have been identified.
Today Health New Zealand have informed via HNZ00043798 that they are not
able to respond to this request as they do not hold this information.
Therefore I am returning to the Ministry of Health for answers.
Firstly I am requiring receiving location data that was not supplied in
HNZ00030152, namely:-
1. Please include distribution data as per the original request for
batches - EP2163, EP9605, ER7449, ET3045, ET9096
2. Please include any distribution data additional to that already
provided for the following batches (and distribution data in respect of
any other batches additional to those mentioned in this request that may
not have been supplied in HNZ00030152 table) to provide a complete
response to the initial request. EX2405, FA5833, FC3558, FC5029, FD0927,
FD9234, FE2090, FE3064, FE8163, FF2382, FF4206, FG0050, FG3716
Secondly the Medsafe product detail for the purple cap (Tozinameran 0.5
mg/mL equivalent to 30 μg/0.3mL dose) product is below.
[10]https://www.medsafe.govt.nz/regulatory/P...
There was an amendment to the product detail for the Tozinameran 30mcg
product with PBS buffer where a new excipient was available from December
2021.
[11]https://www.medsafe.govt.nz/regulatory/P...
Please notify which batch numbers contained the initial excipient
formation and which batch numbers contained the excipient available from
December 2021.
Yours faithfully,
Catherine Jamieson
****************************************************************************
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.
****************************************************************************
References
Visible links
1. https://www.medsafe.govt.nz/regulatory/P...
2. https://www.medsafe.govt.nz/regulatory/P...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/
6. http://www.ombudsman.parliament.nz/
7. mailto:[email address]
8. mailto:[email address]
9. https://www.health.govt.nz/about-ministr...
10. https://www.medsafe.govt.nz/regulatory/P...
11. https://www.medsafe.govt.nz/regulatory/P...
hide quoted sections
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M Bell left an annotation ()
Quote from medsafe: The qualitative formulation for Comirnaty 0.5mg/ml has not changed since its initial approval.
Interesting choice of words, uses the adjective “qualitative”, this is unwarranted since the actual question focuses on whether there has been an “altered composition”. Is there some language inversion going on here? Since there is clear evidence extant that there has been variation in the batches coming out of Pfizer, suggest get them to clarify again according to the language that was used in the original question, and to supply unequivocal answers, ie...
“....has the product composition of Comirnaty BNT162b2 entering New Zealand (other than that for use in the under 12s) altered at any time from the original product imported into New Zealand in the first delivery in early 2021?” Please answer with one of the following YES / NO / DON'T KNOW.
Link to this