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Safety and efficacy of Pfizer Comirnaty

Heather Darby made this Official Information request to Ministry of Health

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From: Heather Darby

Dear Ministry of Health,

Kindly provide the studies and evidence relied on in relation to determining the safety and efficacy of Pfizer Comirnaty being administered to adults in NZ.

Yours faithfully,

Heather

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From: OIA Requests

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...

 

In accordance with the Act, we'll let you know our decision within no more
than 20 working days. If you'd like to calculate the timeframe, you can
use the Ombudsman's online calculator
here: [2]http://www.ombudsman.parliament.nz/

If you have any questions while we're processing your request, please let
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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References

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1. https://www.health.govt.nz/our-work/dise...
2. http://scanmail.trustwave.com/?c=15517&a...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/

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From: OIA Requests


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Kia ora Heather,

 

Thank you for your emails. Your requests have been consolidated under
section 18(A) of the Official Information Act 1982 (the Act):

 

Please provide the updated information for clauses 5-7, 9-21, 26-29,
32-38, 40-42, 45-49 and clause 51 of the 58 clauses for Provisional
Consent for Comirnaty.

Kindly provide the studies and evidence relied on in relation to
determining the safety and efficacy of Pfizer Comirnaty being administered
to adults in NZ.

Please provide me material evidence which proves beyond reasonable doubt
that the Pfizer Comirnaty Injections stop transmission of either
SARS-COV-2 or COVID-19.

 

Regarding part one of your request, this information is commercially
sensitive and therefore withheld under the following sections of the Act:

 

o Section 9(2)(b)(ii) as its release would likely unreasonably prejudice
the commercial position of the person who supplied the information.  
o Section 9(2)(ba)(ii) to protect information that is subject to an
obligation of confidence and making it available would likely damage
the public interest.

 

Publicly available information regarding the provisional consent can be
found here:

[1]www.medsafe.govt.nz/COVID-19/status-of-applications.asp

[2]www.medsafe.govt.nz/COVID-19/q-and-a-vaccine-approval.asp

                                            

Preliminary results from studies carried out by researchers have shown
that two doses of the Pfizer vaccine can substantially
reduce transmission of the
virus: [3]www.health.govt.nz/system/files/documents/pages/science_updates_7_may_2021.pdf.  For
example, this study here: 
[4]https://www.nejm.org/doi/full/10.1056/ne...

 

However, more data is required to understand the extent of the effect that
vaccination has on transmission of the Delta variant. A summary of
currently available data can be found on the US CDC science brief
page here: [5]www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.  

 
The Immunisation Handbook (chapter 5) provides references to scientific
studies conducted regarding COVID-19 and the vaccine and its
safety: [6]www.health.govt.nz/our-work/immunisation-handbook-2020/5-coronavirus-disease-covid-19  
 

Medsafe also publishes up to date information regarding the
Comirnaty vaccine, including its clinical efficacy and
safety: [7]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: [8]www.medsafe.govt.nz/COVID-19/vaccine-approval-process.asp   

·        The Ministry also regularly updates the Science News page
for up-to-date information regarding COVID-19 and the
Vaccine: [9]www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-resources-and-tools/covid-19-science-news. 

 

More studies and research regarding the vaccine can be found on PubMed
here: [10]https://pubmed.ncbi.nlm.nih.gov/ and the New England Journal of
Medicine here: [11]https://www.nejm.org/coronavirus. 

The following link provides information on vaccine effectiveness and other
health
measures: [12]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 is
that vaccination reduces transmission and the severity of COVID if
infected. 

 

Please refer to the vaccination stats that reinforce this: 

[13]www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-data-and-statistics/covid-19-case-demographics#age-gender. 

These statistics show that most of the people who are infected with
COVID-19 and/or in hospital are unvaccinated.   

 

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 phone on 0800
802 602.

 

Ngā mihi 

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [14][email address]

 

 

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References

Visible links
1. https://www.medsafe.govt.nz/COVID-19/sta...
2. https://www.medsafe.govt.nz/COVID-19/q-a...
3. https://www.health.govt.nz/system/files/...
4. https://www.nejm.org/doi/full/10.1056/ne...
5. https://www.cdc.gov/coronavirus/2019-nco....
6. https://www.health.govt.nz/our-work/immu....
7. https://www.medsafe.govt.nz/profs/PUArti...
8. https://www.medsafe.govt.nz/COVID-19/vac...
9. https://www.health.govt.nz/our-work/dise...
10. https://pubmed.ncbi.nlm.nih.gov/
11. https://www.nejm.org/coronavirus
12. https://www.health.govt.nz/our-work/dise...
13. https://www.health.govt.nz/our-work/dise...
14. mailto:[email address]

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