Kia ora,

 

Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...

 

Please be advised that due dates for requests received from 29 November
2021 onwards take into account the following periods:

 

Christmas (25 December 2021)

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Day after News Year's Day (2 January 2022)

 

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us know via [3][email address]

 

Ngā mihi  

OIA Services Team  

   

[4]Ministry of Health information releases  

[5]Unite against COVID-19 

 

 

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Kia ora Erika,  

 

Thank you for your request for official information. The Ministry's
reference number for your request is: H202117411.  

 

Please be advised that due dates for requests received from 29 November
2021 onwards take into account the following periods:  

 

Christmas (25 December 2021) 

Summer Holidays (25 December to 15 January) 

New Year's Day (1 January 2022) 

Day after News Year's Day (2 January 2022) 

 

Your request has been logged and you can expect a reply no later than
28 January 2022 as required under the Official Information Act 1982.  

 

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. 

 

Ngā mihi 

 

OIA Services 

Government Services 

Office of the Director-General 

Ministry of Health 

E: [1][email address] 

 

 

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From: Erika Whittome <[FOI #17904 email]>
Sent: Friday, 10 December 2021 11:31
To: OIA Requests <[email address]>
Subject: Official Information request - Safety of the Comirnaty/ Pfizer
injection
 
Dear Ministry of Health,
Globally the infection fatality rate for Covid-19 is less than 1 percent
from WHO on page 4 for those under 70 years
[2]https://scanmail.trustwave.com/?c=15517&...

NZ has 44 deaths with Covid-19 as of 9 Dec 2021:
[3]https://www.health.govt.nz/our-work/dise....

There are 117 deaths post Comirnaty on Medsafe’s latest safety report
dated 20 Nov 2021
[4]https://www.medsafe.govt.nz/COVID-19/saf... .

The Comirnaty medicine has killed more than the virus itself in NZ.

Where exactly is the criteria for safety or pharmacovigilance for
Comirnaty stated? 

Mr Tim Hanlon  lists himself on LinkedIn as the "Covid-19 Vaccination
Programme Lead/Group Manager for Post Event (Pharmocoviligance, Vaccine
Effectiveness and Population Protection) at the MoH. Would he please
respond to this OIA request?

Is the MoH taking guidance from Pfizer on Comirnaty's safety? Or do they
have their own safety criteria? I see Pfizer agreement has been kept
secret by the government in this official information request.
[5]https://scanmail.trustwave.com/?c=15517&...

What is the MoH's  definition of "safe" please?

Yours faithfully,

Erika Whittome

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References

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1. mailto:[email address]
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3. https://www.health.govt.nz/our-work/dise...
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6. https://scanmail.trustwave.com/?c=15517&...
7. https://scanmail.trustwave.com/?c=15517&...

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Kia ora Erika 

 

Thank you for your email. Please find responses to your request below. 

Where exactly is the criteria for safety or pharmacovigilance for
Comirnaty stated? 

 

Medsafe does not have a set 'threshold' where if reached, a particular
vaccination approval will be revoked. Further information on
the Medsafe approval process can be found at:    

* [1]www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Medicines-Safety-and-Pharmacovigilance.asp  
* www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Medsafe-Evaluation-Process.asp   
* www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Vaccine-safety.asp   
* www.medsafe.govt.nz/COVID-19/monitoring-process.asp  

 

Is the MoH taking guidance from Pfizer on Comirnaty's safety? Or do they
have their own safety criteria? 

 

Medsafe publishes up to date information regarding the Comirnaty vaccine,
including its clinical efficacy and safety:
[2]www.medsafe.govt.nz/profs/PUArticles/June2021/Spotlight-on-Comirnaty-vaccine.html. The
following links may also be useful to you:   

 

* Information regarding the approval process of the vaccine can be found
here: [3]www.medsafe.govt.nz/COVID-19/vaccine-approval-process.asp    
* Information regarding the efficacy and safety of the vaccine can be
found
here: [4]www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-health-advice-public/about-covid-19/covid-19-about-delta-variant    
* The Ministry also regularly updates the Science News page for up to
date information regarding COVID-19 and the Vaccine:
[5]www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-resources-and-tools/covid-19-science-news.
 

 

 

What is the MoH's definition of "safe" please? 

 

Medsafe assesses medicine and vaccine applications against internationally
established criteria. The stringent requirements vaccines must meet in
order to be approved remain in place under emergency circumstances, such
as the COVID-19 pandemic. Medsafe has found that the benefits of
vaccination with the Pfizer vaccine continue to greatly outweigh the risk
of both COVID-19 infection and vaccine side effects. More information
about the vaccine evaluation and approval process can be found at the link
in the above paragraph.  

 

Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [6][email address] or by calling 0800
802 602.  

  

Ngā mihi  

 

OIA Services Team  

 

[7]Ministry of Health information releases  

[8]Unite against COVID-19  

 

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References

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1. http://www.medsafe.govt.nz/Consumers/Saf...
2. http://www.medsafe.govt.nz/profs/PUArtic...
3. http://www.medsafe.govt.nz/COVID-19/vacc...
4. http://www.health.govt.nz/our-work/disea...
5. http://www.health.govt.nz/our-work/disea...
6. mailto:[email address]
7. https://www.health.govt.nz/about-ministr...
8. https://covid19.govt.nz/

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