ALC-0315 correspondence
Maxwell made this Official Information request to Ministry of Health
The request was successful.
From: Maxwell
Dear Ministry of Health,
I am writing as a New Zealand citizen.
The Gazette notice for Comirnaty / COVID-19 mRNA vaccine (https://www.medsafe.govt.nz/COVID-19/Com...) states a number of conditions which are still "under review" according to the Medsafe overview page as of today Thu 7 Oct 2021 (https://www.medsafe.govt.nz/COVID-19/sta...).
Can you please supply all related correspondence with regards to conditions 26-29, 32-38 in the above Gazette notice, specifically with respect to ALC-0315, the synthetic lipid nanoparticle.
This correspondence should include original and updated versions of manufacturing processes, starting materials reports, discussion papers, evaluations, specifications, method validation reports, stability data, emails, etc. held or received by Medsafe and/or related agencies.
I look forward to your response.
Yours faithfully,
Maxwell
From: OIA Requests
Kia ora Maxwell,
Thank you for your request for official information received on 7 October
2021 for:
"The Gazette notice for Comirnaty / COVID-19 mRNA vaccine
([1]https://www.medsafe.govt.nz/COVID-19/Com...)
states a number of conditions which are still "under review" according to
the Medsafe overview page as of today Thu 7 Oct 2021
([2]https://www.medsafe.govt.nz/COVID-19/sta...).
Can you please supply all related correspondence with regards to
conditions 26-29, 32-38 in the above Gazette notice, specifically with
respect to ALC-0315, the synthetic lipid nanoparticle.
This correspondence should include original and updated versions of
manufacturing processes, starting materials reports, discussion papers,
evaluations, specifications, method validation reports, stability data,
emails, etc. held or received by Medsafe and/or related agencies.”
The Ministry's reference number for your request is: H202113809.
As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 5 November 2021, being
20 working days after the day your request was received.
Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame.
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngâ mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [3][email address]
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References
Visible links
1. https://www.medsafe.govt.nz/COVID-19/Com...
2. https://www.medsafe.govt.nz/COVID-19/sta...
3. mailto:[email address]
hide quoted sections
From: OIA Requests
Tçnâ koe Maxwell
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health (the Ministry) on 7 October 2021 for
information related to:
“The Gazette notice for Comirnaty / COVID-19 mRNA vaccine
(https://www.medsafe.govt.nz/COVID-19/Com...)
states a number of conditions which are still "under review" according to
the Medsafe overview page as of today Thu 7 Oct 2021
([1]https://www.medsafe.govt.nz/COVID-19/sta...).”
Specifically, you requested:
“Can you please supply all related correspondence with regards to
conditions 26-29, 32-38 in the above Gazette notice, specifically with
respect to ALC-0315, the synthetic lipid nanoparticle.
This correspondence should include original and updated versions of
manufacturing processes, starting materials reports, discussion papers,
evaluations, specifications, method validation reports, stability data,
emails, etc. held or received by Medsafe and/or related agencies.”
The information you have requested is commercially sensitive. Therefore,
your request is refused in full under section 9(2)(b)(ii) of the Act where
its release would likely unreasonably prejudice the commercial position of
the person who supplied the information.
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.
Nâku noa, nâ
Nick Allan
Manager
OIA Services Team
[3]Ministry of Health information releases
[4]Unite against COVID-19
****************************************************************************
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References
Visible links
1. https://www.medsafe.govt.nz/COVID-19/sta...)
2. mailto:[email address]
3. https://www.health.govt.nz/about-ministr...
4. https://covid19.govt.nz/
hide quoted sections
From: Maxwell
Dear Nick Allan,
You may use Section 9(2) to refuse the above request, but as per the Ombudsmen's office:
============================
"A mere assertion of prejudice will not be sufficient; nor will vague and unsubstantiated
references to ‘commercial sensitivity’ or ‘confidentiality’."
Agencies must be able to:
1. demonstrate that the third party has a commercial position; and
2. explain how release of the information at issue would be likely unreasonably to prejudice
that position."
============================
While it is clear that the third party has a commercial position, can you kindly elaborate by listing each correspondence item of those requested, explaining how it's release unreasonably prejudices the third party's position.
Yours sincerely,
Maxwell
From: OIA Requests
Kia ora Maxwell,
Thank you for your email.
Releasing the information you requested, i.e. each correspondence item,
would unreasonably prejudice the commercial position of the Pfizer, who
are the subject of the information. The vaccine was required to protect
the health and safety of New Zealanders from the Covid-19 epidemic. The
release of this information would impede the Crown’s negotiation position
in purchasing Covid-19 vaccines from various organisations to purchase
sufficient vaccines. The Crown had entered into confidentiality disclosure
agreements with the Pfizer at all stages of the negotiations, which
includes all correspondences between the Crown and Pfizer. All details
relating to their Covid-19 vaccine, including the delivery schedules, are
supplied by Pfizer under obligations of confidence and not to be disclosed
publicly.
It would not be in the public’s interest to make this information
available at this time as it would affect the ability of the government to
continue to purchase COVID-19 vaccines, other vaccines e.g. influenza
vaccines, or medicines now and in the future to protect the people of New
Zealand.
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: [email address] or by calling 0800 802
602.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
------------------------------------------------------------------------
From: Maxwell <[FYI request #17081 email]>
Sent: Tuesday, 19 October 2021 08:48
To: OIA Requests <[email address]>
Subject: Re: Response to your official information act request
(ref_H202113809)
Dear Nick Allan,
You may use Section 9(2) to refuse the above request, but as per the
Ombudsmen's office:
============================
"A mere assertion of prejudice will not be sufficient; nor will vague and
unsubstantiated
references to ‘commercial sensitivity’ or ‘confidentiality’."
Agencies must be able to:
1. demonstrate that the third party has a commercial position; and
2. explain how release of the information at issue would be likely
unreasonably to prejudice
that position."
============================
While it is clear that the third party has a commercial position, can you
kindly elaborate by listing each correspondence item of those requested,
explaining how it's release unreasonably prejudices the third party's
position.
Yours sincerely,
Maxwell
-----Original Message-----
Tçnâ koe Maxwell
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health (the Ministry) on 7 October 2021 for
information related to:
“The Gazette notice for Comirnaty / COVID-19 mRNA vaccine
([2]https://www.medsafe.govt.nz/COVID-19/Com...)
states a number of conditions which are still "under review" according to
the Medsafe overview page as of today Thu 7 Oct 2021
([1]https://www.medsafe.govt.nz/COVID-19/sta...).”
Specifically, you requested:
“Can you please supply all related correspondence with regards to
conditions 26-29, 32-38 in the above Gazette notice, specifically with
respect to ALC-0315, the synthetic lipid nanoparticle.
This correspondence should include original and updated versions of
manufacturing processes, starting materials reports, discussion papers,
evaluations, specifications, method validation reports, stability data,
emails, etc. held or received by Medsafe and/or related agencies.”
The information you have requested is commercially sensitive. Therefore,
your request is refused in full under section 9(2)(b)(ii) of the Act
where
its release would likely unreasonably prejudice the commercial position
of
the person who supplied the information.
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.
Nâku noa, nâ
Nick Allan
Manager
OIA Services Team
[3]Ministry of Health information releases
[4]Unite against COVID-19
References
Visible links
1. [3]https://www.medsafe.govt.nz/COVID-19/sta...)
2. [4]mailto:[email address]
3. [5]https://www.health.govt.nz/about-ministr...
4.
[6]https://scanmail.trustwave.com/?c=15517&...
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References
Visible links
1. mailto:[email address]
2. https://www.medsafe.govt.nz/COVID-19/Com...
3. https://www.medsafe.govt.nz/COVID-19/sta...)
4. mailto:[email
5. https://www.health.govt.nz/about-ministr...
6. https://scanmail.trustwave.com/?c=15517&...
7. https://scanmail.trustwave.com/?c=15517&...
hide quoted sections
From: Maxwell
Dear OIA Requests,
Thank you for clarifying the reasons for refusing disclosure of the conditions 26-29, 32-38 in the Gazette notice New Zealand Gazette, 3 February 2021, Notice No. 2021-go338 (https://gazette.govt.nz/notice/id/2021-g...). I am happy to accept this decision based on the reasons given under Section 9(2)(b)(ii) of the Act.
As a related request, can you please confirm whether the New Zealand Sponsor met the obligations within the timelines specified, 9 August 2021?
If the related dates were altered by mutual agreement with Medsafe, can you confirm any new due date(s) set for each condition referenced above and whether the New Zealand Sponsor has met the new timelines specified?
Yours sincerely,
Maxwell
From: OIA Requests
Kia ora Maxwell,
Thank you for your follow up request for official information received on
19 October 2021 for:
"As a related request, can you please confirm whether the New Zealand
Sponsor met the obligations within the timelines specified, 9 August 2021?
If the related dates were altered by mutual agreement with Medsafe, can
you confirm any new due date(s) set for each condition referenced above
and whether the New Zealand Sponsor has met the new timelines specified?”
The Ministry's reference number for your request is: H202114681.
As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 17 November 2021, being
20 working days after the day your request was received.
Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame.
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngâ mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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References
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1. mailto:[email address]
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From: OIA Requests
Tçnâ koe Maxwell
Thank you for your follow up request under the Official Information Act
1982 (the Act) to the Ministry of Health (the Ministry) on 19 October
2021. You stated:
“Thank you for clarifying the reasons for refusing disclosure of the
conditions 26-29, 32-38 in the Gazette notice New Zealand Gazette, 3
February 2021, Notice No. 2021-go338
([1]https://gazette.govt.nz/notice/id/2021-g...) I am happy to accept
this decision based on the reasons given under Section 9(2)(b)(ii) of the
Act.”
You requested:
“As a related request, can you please confirm whether the New Zealand
Sponsor met the obligations within the timelines specified, 9 August 2021?
If the related dates were altered by mutual agreement with Medsafe, can
you confirm any new due date(s) set for each condition referenced above
and whether the New Zealand Sponsor has met the new timelines specified?”
The sponsor, Pfizer New Zealand Ltd, met all relevant obligations in the
conditions of provisional consent by 9 August 2021.
Please note that on 28 October 2021 Medsafe renewed the provisional
consent for Comirnaty. All conditions that have been met to date have been
removed from the renewed consent. For more information see
[2]http://www.medsafe.govt.nz/COVID-19/stat...
Medsafe also issued a media release on this:
[3]www.health.govt.nz/news-media/news-items/medsafe-renews-covid-19-vaccine-provisional-approval.
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: [4][email address] or by calling 0800
802 602.
Nâku noa, nâ
Nick Allan
Manager
OIA Services Team
[5]Ministry of Health information releases
[6]Unite 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.
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References
Visible links
1. https://gazette.govt.nz/notice/id/2021-g...)%20I
2. http://www.medsafe.govt.nz/COVID-19/stat...
3. http://www.health.govt.nz/news-media/new...
4. mailto:[email address]
5. https://www.health.govt.nz/about-ministr...
6. https://covid19.govt.nz/
hide quoted sections
victor left an annotation ()
'The information you have requested is commercially sensitive. Therefore,
your request is refused in full under section 9(2)(b)(ii) of the Act'
How can ingredient elements compounds and molecules be withheld ?
Government policy is shutting business and ruining countless lives, segregating society and promoting open discrimination while the direct collateral damage mounts while repeatedly citing commercial sensitivity to deny informed consent.
MOH and IMAC then narrow contraindications to exclude allergic reactions or not absolutely include them as exemption criteria , while refusing to disclose ingredients elements compounds and molecules known to be contained within the product.
Unconscionable.
Things to do with this request
- Add an annotation (to help the requester or others)
- Download a zip file of all correspondence
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victor left an annotation ()
'The sponsor, Pfizer New Zealand Ltd, met all relevant obligations in the
conditions of provisional consent by 9 August 2021.'
If this were factually true and correct then why was the tracking table removed from the portal in close proximity to the provisional extension being announced?
At the time the 58 conditions tracking table was removed there were numerous items outstanding as 'under review' and monthly ongoing.
http://web.archive.org/web/2021102612224...
Where is the evidence that all 58 provisions were met and documents illustrating the actions and compliance under each clause with transparency for public trust and confidence
Link to this