Kia ora

 

Thank you for taking the time to write to Hon Dr Ayesha Verrall, Minister
for COVID – 19 Response, Minister for Research, Science and Innovation,
Minister for Seniors, and Associate Minister of Health. Your email will be
carefully considered and noted and should a response be required it will
be sent in due course.

 

Ngâ  Mihi 

 

Office of Hon Dr Ayesha
Verrall

Minister for COVID-19
Response

Minister of Research,
Science and Innovation
Minister for Seniors

Associate Minister of
Health

 

Email:
[email address]

Private Bag 18041,
Parliament Buildings,
Wellington 6160, New
Zealand

 

 

[1]https://covid19.govt.nz/assets/resources...

[2]www.covid19.govt.nz

[3]www.mbie.govt.nz

[4]https://officeforseniors.govt.nz

[5]www.health.govt.nz

 

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References

Visible links
2. http://www.covid19.govt.nz/
3. http://www.mbie.govt.nz/
4. https://officeforseniors.govt.nz/
5. https://www.health.govt.nz/

Kia ora Chris,

Thank you for your email of 19 July in which you submitted an Official Information Act request as follows

"It is really important to be aware that there are rare side effects that become more frequent at the younger age group and that's why we have a lower age limit at the moment and we continue to track whether or not it's safe to widen access there"

I am just trying to understand this statement and what you mean by this - please confirm if I have interpreted what you said correctly.

- Rare side effects of the vaccine are more frequent in younger age brackets - I am assuming this is yes based on the above statement?
- We continue to track whether or not it's safe to widen access there - I am assuming you mean that you are looking to jab even younger children? Yes or No - this is despite you saying just before that the side effects are more frequent in our younger generation

If you can answer the above questions and please provide the following information

- Please provide all reports, analysis, email correspondence, memos formal and informal, data, warnings that show side effects are more frequent in younger age brackets as your statement clearly states this.
- I note the Medsafe Reports per table 11 state AEFI's in children - continue to monitor. Please provide the process documents, reports completed specifically associated with this category. Ultimately I want to know all of the work, reports completed by the authorities that show the process completed by Medsafe whereby they continue to monitor AEFI's in children, the memos associated, the reports provided to minister, how warnings are notified to minister, risk benefit analysis, do they monitor monthly, weekly, fortnightly, minutes associated with monitoring meetings.

As an example, I have taken some of these "Rare" side effects per Medsafe reports which are in the thousands, but here are some Bell's Palsy, Guillain-Barre syndrome, Cerebral Haemorrhage, Multi-system inflammatory syndrome, Cardiac arrest, stroke, suicide, autoimmune issues. More than enough data is available that shows Covid impacted the elderly (until mass vaccination and changing death counts) - how is Cardiac arrest, stroke, GBS a better outcome than a child suffering a mild flu? There lives are now ruined when they could have walked it off.

Please provide a risk / benefit analysis for under 20 age group using the available Medsafe data If one has not been completed then why not?

Please note the date of this request, as it sounds like you are aiming to jab even younger children - please provide a risk / benefit analysis and also note are you really wanting to be responsible for inflicting our most vulnerable to any of the above?

Minister Verrall is considering your request in accordance with the Act, and you can expect a response by 16 August

Ngā mihi

Office of Hon Dr Ayesha Verrall
Minister for COVID-19 Response
Minister of Research, Science and Innovation

Minister for Seniors
Associate Minister of Health

Email: [email address]
Private Bag 18041, Parliament Buildings, Wellington 6160, New Zealand

show quoted sections

Kia ora Chris,

Please find attached the Ministers response to your request for official information.

Ngā mihi,

Daniel Martin
Health Private Secretary | Office of Hon Dr Ayesha Verrall
Minister for COVID-19 Response
Minister of Research, Science and Innovation
Minister for Seniors
Associate Minister of Health
Private Bag 18041, Parliament Buildings, Wellington 6160, New Zealand

show quoted sections

Kia ora Chris,

Thank you for your follow up email. You requested:

Can you please provide the hyperlinks in the letter in a response to this
follow up
Also just confirming - this letter quotes the "Original benefit / risk
assessment for the Pfizer Covid-19 vaccine in a previous response under
the Act"
I refer you to that document and quote directly from the "Benefit Risk
Assessment"
Summary - The benefit risk balance of Comirnaty (COVID-19 mRNA Vaccine)
for active immunisation to prevent coronavirus disease 2019 (COVID-19)
caused by SARS-CoV-2, in individuals 16 years of age and older, is not
clear. At this stage, there is evidence only for short-term protection,
and longer-term safety data are lacking. However, experience with the
vaccine is accumulating rapidly.
So based on the above can the Minister confirm - is the only Benefit Risk
assessment that has been relied on from day 1 concluded  that the benefit
risk ratio "is not clear".
Despite thousands of injuries, confirmed deaths, suspect deaths there has
only been one benefit / risk assessment completed that had the conclusion
"is not clear".
I refer you to numerous CV-ISMB Memos notably
17 September 2021 - "benefits outweigh risks" - so can I conclude when the
CV-ISMB mentioned this in their memo
1. They are using this original benefit / risk assessment - Yes or No 2. 
Have not completed a new benefit / risk assessment - Yes or No 3.  Have
stated the benefits outweigh risks yet don't have any supporting
documentation - Yes or No
Memos in September, October, December and more all quote despite
suspicious deaths that benefits outweigh the risks.
So based on the above can I confirm that despite the CV-ISMB regularly
stating the above they don't have one benefit / risk assessment as
supporting evidence?

Please find the hyperlinks from your previous response (AVOIA68 refers)
here:

[1]www.health.govt.nz/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-boosters#additiona
[2]www.health.govt.nz/system/files/documents/pages/cv_tag_boosters_after_myocarditis_and_pericarditis.pdf
[3]www.health.govt.nz/about-ministry/leadership-ministry/expert-groups/covid-19-vaccine-technical-advisory-group-cv-tag
The Coronavirus Immunisation handbook:
[4]www.health.govt.nz/our-work/immunisation-handbook-2020/5-coronavirus-disease-covid-19.
The vaccine datasheet:
[5]www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf
[6]www.health.govt.nz/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-information-health-professionals/covid-19-vaccine-strategy-planning-insights/covid-19-who-were-working#ismb
The COVID-19 vaccine safety monitoring process is described on the Medsafe
website at: [7]www.medsafe.govt.nz/COVID-19/monitoring-process.asp
Manatū Hauora has released the original benefit/risk assessment for the
Pfizer COVID-19 vaccine in a previous response under the Act, this is
available at:
[8]www.health.govt.nz/system/files/documents/information-release/h202106950_response.pdf

The COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB)
provides expert advice to the Director-General of Health (now the National
Director of the National Public Health Service) about the COVID-19
vaccine.
 
The CV-ISMB continues to review the available safety information on
Comirnaty, and they have continued to advise that the benefits of
vaccination outweigh the risk of side effects. Please refer to the CV-ISMB
media releases and interim report, which are available
at: [9]www.health.govt.nz/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-information-health-professionals/covid-19-vaccine-strategy-planning-insights/covid-19-who-were-working#ismb.

Furthermore, the text referred to in your request can be found on page 96
of the release. The initial summary is in the same section and notes that
a provisional approval may be appropriate. The document was worded this
way to allow the application to be referred to the Medicines Assessment
Advisory Committee (MAAC) as Medsafe must follow the process in the
legislation. This in turn led to the decision memo (document 15) where
approval was recommended. This this would only occur if benefit risk was
favourable.

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: [10][email address] or by calling 0800
802 602.   

 

Nāku noa, nā

 

Joanne Francey

Health Private Secretary | Office of Hon Dr Ayesha Verrall

Minister for COVID-19 Response

Minister of Research, Science and Innovation
Minister for Seniors

Associate Minister of Health

Private Bag 18041, Parliament Buildings, Wellington 6160, New Zealand

 

 

show quoted sections

 

Kia Ora Chris

 

Please see attached the Ministers response to your Official Information
Act Request

 

Ngā mihi

 

 

Office of Hon Dr Ayesha
Verrall

Minister for COVID-19
Response

Minister of Research,
Science and Innovation
Minister for Seniors

Associate Minister of
Health

 

Email:
[email address]

Private Bag 18041,
Parliament Buildings,
Wellington 6160, New
Zealand

 

 

 

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Kia ora Chris,

 

Thank you for your request for official information which was transferred
from the Office of Hon Ayesha Verrall and received by Manatū Hauora on 14
October 2022. The reference number for your request is H2022013223.    

 

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 related to this request, please do not hesitate to
get in touch. 

 

Ngā mihi 

  

OIA Services Team 

M[2]inistry of Health information releases 
U[3]nite against COVID-19 

 

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References

Visible links
1. http://www.ombudsman.parliament.nz/
2. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/

Tçnâ koe Chris,  

 

Thank you for your request under the Official Information Act 1982 (the
Act) which was transferred from the Office of Hon Ayesha Verrall to Manatû
Hauora (the Ministry of Health) on 14 October 2022 for:  

 

“I am really struggling with the responses.  The one and only benefit /
risk assessment says that the “benefit / risk” is not clear.  You then go
on to say that provisional approval would not be granted unless the
benefits outweigh the risks. 

 

Your comments have been noted and Manatû Hauora has nothing further to
add.  This information has been provided to you in a previous response
under the Act (AVOIA68 refers).  

 

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 

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References

Visible links
1. mailto:[email address]
2. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/

Kia ora Chris, 
Thank you for your email of 11 November 2022. 
Your comments have been noted and Manatū Hauora 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: [email address] or by calling
0800 802 602.

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: Chris McCashin <[FOI #19959 email]>
Sent: Friday, 11 November 2022 15:34
To: OIA Requests <[email address]>
Subject: Re: Response to your official information act request, ref:
H2022013223
 
Dear OIA Requests,

Thanks for acknowledging that there is not one benefit risk assessment
that Medsafe can provide.

Can you please remove / amend all publications / websites /
correspondence, advertising, memos any and all information on websites
that says “Benefits of vaccination against Covid-19 far outweigh the
potential risks of vaccination” until you can provide some reporting that
substantiates this claim

Yours sincerely,

Chris McCashin

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