Where are the satisfied conditions for the provisional approval of Comirnaty?
Erika Whittome made this Official Information request to Ministry of Health
Response to this request is long overdue. By law Ministry of Health should have responded by now (details and exceptions). The requester can complain to the Ombudsman.
From: Erika Whittome
Dear Ministry of Health,
The provisional approval in the Gazette for the Comirnaty medicine had 8 conditions here https://www.medsafe.govt.nz/COVID-19/Com...
I see the Gazette now full approval for this medicine dated Nov 2023 here:
https://gazette.govt.nz/assets/pdf-cache...
Would you kindly share the evidence of these 8 conditions being approved?
I will copy and paste the 8 conditions:
The New Zealand Sponsor must fulfil the following obligations within the timelines specified, which may be altered by mutual agreement with Medsafe:
1. The New Zealand site of batch release will only release batches for distribution in New Zealand once the sponsor has verified that the shipping temperature profile meets specifications.
2. Provide independent batch certification, such as UK National Institute for Biological Standards and Control (NIBSC) certification, EU Official Control Authority Batch Release (OCABR) certification, Australian TGA batch release assessment, or any other certification agreed with Medsafe, on request for all batches distributed in New Zealand.
3. Provide any reports on the duration of efficacy and the requirement for booster doses within five working days of these being produced.
4. Provide any reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure,immunogenicity, efficacy in population subgroups and results from post-marketing studies, within five working days of these being produced.
5. Provide the final Clinical Study Reports for Study C4591001 and Study BNT162-01 within five working days of these being produced.
6. Provide Periodic Safety Update Reports according to the same schedule as required by the EMA.
7. Provide monthly safety reports, as well as all safety reviews they conduct or become aware of.
8. Perform the required pharmacovigilance activities and interventions detailed in the agreed RMP and any agreed updates to the RMP. An RMP should be submitted at the request of Medsafe or whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important milestone being reached.
Yours faithfully,
Erika Whittome
From: OIA Requests
Kia ora Erika
Thank you for your request for official information. The reference number
for your request is: H2023033891
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. However, over the holiday period there
are 3 weeks that don’t count as ‘working days’. For Official Information
Act (OIA) requests, the holiday period is 25 December 2022 to 15 January
2023 (inclusive). This affects OIA requests received on or after 27
November 2022. 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
------------------- Original Message
show quoted sections
From: OIA Requests
Tçnâ koe Erika
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health | Manatû Hauora (the Ministry) on 11
December 2023. You requested:
“1. The New Zealand site of batch release will only release batches for
distribution in New Zealand once the sponsor has verified that the
shipping temperature profile meets specifications.
2. Provide independent batch certification, such as UK National Institute
for Biological Standards and Control (NIBSC) certification, EU Official
Control Authority Batch Release (OCABR) certification, Australian TGA
batch release assessment, or any other certification agreed with Medsafe,
on request for all batches distributed in New Zealand.
3. Provide any reports on the duration of efficacy and the requirement for
booster doses within five working days of these being produced.
4. Provide any reports on efficacy including asymptomatic infection in the
vaccinated group, vaccine failure, immunogenicity, efficacy in population
subgroups and results from post-marketing studies, within five working
days of these being produced.
5. Provide the final Clinical Study Reports for Study C4591001 and Study
BNT162-01 within five working days of these being produced.
6. Provide Periodic Safety Update Reports according to the same schedule
as required by the EMA.
7. Provide monthly safety reports, as well as all safety reviews they
conduct or become aware of.
8. Perform the required pharmacovigilance activities and interventions
detailed in the agreed RMP and any agreed updates to the RMP. An RMP
should be submitted at the request of Medsafe or whenever the risk
management system is modified, especially as the result of new information
being received that may lead to a significant change to the benefit/risk
profile or as the result of an important milestone being reached.”
Manatû Hauora does not hold any information relating to parts 1, 6 and 7
of your request; however, I have been advised that this information is
held by Te Whatu Ora – Health New Zealand. For this reason, I have decided
to transfer these parts of your request to their agency under section
14(b)(i) of the Act. You can expect a response from Te Whatu Ora in due
course.
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.
Ngâ mihi
OIA Services Team
Manatû Hauora | Ministry of Health
M[2]inistry of Health information releases
U[3]nite against COVID-19
show quoted sections
References
Visible links
1. mailto:[email address]
2. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/
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.
show quoted sections
From: OIA Requests
Kia ora Erika,
Please find attached our response to your official information request.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: Erika Whittome
Dear OIA Requests,
You letter says “ Certificates for last three deliveries are attached to this letter as Document 1. ”
There ain’t no attachments?
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Thank you for your email. Apologies for the oversight. Please find
attached your final response, including the attachmen.t
Ngâ mihi
OIA Services Team
Manatû Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
------------------------------------------------------------------------
From: Erika Whittome <[FOI #25124 email]>
Sent: Wednesday, 31 January 2024 05:40
To: OIA Requests <[email address]>
Subject: Re: Response to your official information request ref:H2023033891
CRM:0001017
Dear OIA Requests,
You letter says “ Certificates for last three deliveries are attached to
this letter as Document 1. ”
There ain’t no attachments?
Yours sincerely,
Erika Whittome
show quoted sections
From: Erika Whittome
Dear OIA Requests,
Your reply only covers a couple of batch lots. I understand there are over 50 batch lots.
Where are the satisfying conditions for all the batches please?
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Thank you for your request for official information. The reference number for your request is: H2024035636
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: http://www.ombudsman.parliament.nz/
If you have any queries, please feel free to contact the OIA Services Team on [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: [email address] or by calling 0800 802 602.
Ngā mihi
OIA Services Team
Ministry of Health information releases
show quoted sections
From: hnzOIA
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Kia ora Erica,
Thank you for your request for information regarding Comirnaty vaccine on
28 January. Please find attached our response to your request.
We apologies for the delay in responding 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
Health New Zealand | Te Whatu Ora
show quoted sections
References
Visible links
1. mailto:[email address]
2. file:///tmp/foiextract20240301-34-x4qqzd#
From: Erika Whittome
Dear hnzOIA,
You have shared pages and pages of temperature reports of storage facilities. This was not one of the conditions for approval.
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Please find attached our response to your official information request.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: Erika Whittome
Dear OIA Requests,
I am still waiting on the complete information requested for these conditions, especially a items 3,4,5 and very importantly the reports. Eg where are any sub clinical reports on myocarditis and pericarditis?
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Please refer to the information provided to you on 30 January 2024 under
reference H2023033891. The Ministry of Health- Manatū Hauora stands by its
decision sent on and 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: [1][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[2]inistry of Health information releases
U[3]nite against COVID-19
--------------------------------------------------------------------------
From: Erika Whittome <[FOI #25124 email]>
Sent: Tuesday, 5 March 2024 06:11
To: OIA Requests <[email address]>
Subject: Re: Response to your official information request ref:
H2024035636 CRM:0294086
Dear OIA Requests,
I am still waiting on the complete information requested for these
conditions, especially a items 3,4,5 and very importantly the reports. Eg
where are any sub clinical reports on myocarditis and pericarditis?
Yours sincerely,
Erika Whittome
show quoted sections
From: Erika Whittome
Dear OIA Requests,
I have lodged a complaint to the ombudsman
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Please find attached our response to your follow up official information
request attached.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: Erika Whittome
Dear OIA Requests,
There were conditions for full approval, and the details of these satisfied conditions have not been supplied in this request for information. Instead the response is " changes were processed through a changed Medicine notification."
Under which section of the Medicines Act is such a change made please?
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Thank you for your request for official information. The reference number
for your request is: H2024037922
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
------------------- Original Message
show quoted sections
From: OIA Requests
Kia ora Erika,
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
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: Erika Whittome
Dear OIA Requests,
Just for clarity, you have provided documents but none of them are Periodic Safety Update Reports which were a condition for the conditional approval:
6. Provide Periodic Safety Update Reports according to the same schedule as required by the EMA.
Kindly supply these under the Official Information Act 1982.
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Thank you for your request for official information. The reference number
for your request is: H2024048146
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: Erika Whittome <[5][FOI #25124 email]>
Sent: Friday, 2 August 2024 10:14
To: OIA Requests <[6][email address]>
Dear OIA Requests,
Just for clarity, you have provided documents but none of them are
Periodic Safety Update Reports which were a condition for the conditional
approval:
6. Provide Periodic Safety Update Reports according to the same schedule
as required by the EMA.
Kindly supply these under the Official Information Act 1982.
Yours sincerely,
Erika Whittome
show quoted sections
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. mailto:[FOI #25124 email]
6. mailto:[email address]
From: Erika Whittome
Dear OIA Requests,
I am following up on the periodic safety report. The report for the EU has been published here https://tkp.at/wp-content/uploads/2023/0...
Where are the NZ periodic safety reports please?
Yours sincerely,
Erika Whittome
From: Erika Whittome
Dear OIA Requests,
I have lodged a complaint with the Ombudsman today regarding this OIA request not being answered
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika
Thank you for your email. Please note the due date of your follow up
request is 30 August 2024. You can expect a response in due course.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
--------------------------------------------------------------------------
From: Erika Whittome <[FOI #25124 email]>
Sent: Friday, 23 August 2024 09:04
To: OIA Requests <[email address]>
Subject: Re: Acknowledgement of your request for official information ref:
H2024048146 CRM:0114636
Dear OIA Requests,
I have lodged a complaint with the Ombudsman today regarding this OIA
request not being answered
Yours sincerely,
Erika Whittome
show quoted sections
From: OIA Requests
Kia ora Erika,
Please find attached our response to your official information request.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: Erika Whittome
Dear OIA Requests,
Where is the information on how 8 conditions were originally specified in the Gazette for provisional approval and then those 8 conditions can be discarded?
Would you kindly share the minutes, memos correspondence etc on how the original 8 conditions can be discarded?
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora
Kia ora Erika,
Thank you for your request for official information. The reference number
for your request is: H2024050978
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
show quoted sections
From: OIA Requests
Kia ora Erika,
Thank you for your request for official information received on 7
September 2024 for:
“Where is the information on how 8 conditions were originally specified in
the Gazette for provisional approval and then those 8 conditions can be
discarded?
Would you kindly share the minutes, memos correspondence etc on how the
original 8 conditions can be discarded?”
The Ministry of Health - Manatû Hauora is contacting you to clarify your
request.
Can you please clarify what you mean by the 8 conditions specified in the
Gazette?
Please clarify your request by the 27 September, so that the Ministry can
proceed further with your request.
Ngâ mihi
OIA Services Team
Manatû Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: Erika Whittome
Dear OIA Requests,
The provisional approval in the Gazette for the Comirnaty medicine had 8 conditions.
You have told me that original conditions are no longer applicable. Changes were processed through a changed Medicine notification.
The changes were processed through a changed medicine notification under section 24 of the
Medicines Act 1981.
Kindly share the information for how those 8 conditions have been abandones and now processed with a "changed medicine notification" .
Please include all meeting minutes, memos, correspondence etc to come to the decision to abandon those 8 original conditions.
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Please find attached a response to your request for official information.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
U[2]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
From: Erika Whittome
Dear OIA Requests,
Useful Information has not been supplied, especially the periodic safety reports which were a condition.
Nor has any info been supplied on how these conditions were abandoned . It’s been 8 months and my complaint remains with the Ombudsman
Yours sincerely,
Erika Whittome
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Nic left an annotation ()
Perhaps inquiring as to the NZ regulators reliance on the manufacturers word that the *contents* of the product meet safety standards, such as contaminants and safety of ingredients. Which include the known toxicity of the LNP's and the lack of an 'off switch' for mRNA replication within the body. Instead of the stability of the product governed by temperature regulation.
Link to this