Studies showing that the Comirnaty/Pfizer-BioNTech 'vaccine' is 'safe and effective'
Debbie made this Official Information request to Ministry of Health
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From: Debbie
Dear Ministry of Health,
Would you please provide the studies that Jacinda Ardern, the Minister of Health and the Director General of Health refer to when they state the Comirnaty/Pfizer-BioNTech 'vaccine' is "safe and effective" for everyone 5 years and up, as well as pregnant women?
It appears this is still under provisional/emergency approval on your Medsafe site and
AEFI reports up to and including 28 February 2022 number 58,118 as well as 156 deaths. As most of the Covid death numbers in New Zealand are listed as death 'with' Covid rather than 'from' Covid;- and concurrently with our high vaccination rates, we now have one of the highest Covid case numbers per population in the world, please advise what scientific studies our Government is relying on to continue to make this 'safe and effective' statement to the New Zealand public.
Yours faithfully,
Debbie
From: OIA Requests
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From: OIA Requests
Kia ora Debbie,
Thank you for your request for official information. The Ministry's
reference number for your request is: H202204772.
As required under the Official Information Act 1982, the Ministry 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/
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: [2][email address]
-----Original Message-----
From: Debbie <[FOI #19000 email]>
Sent: Tuesday, 29 March 2022 3:23 pm
To: OIA Requests <[email address]>
Subject: Official Information request - Studies showing that the
Comirnaty/Pfizer-BioNTech 'vaccine' is 'safe and effective'
Dear Ministry of Health,
Would you please provide the studies that Jacinda Ardern, the Minister of
Health and the Director General of Health refer to when they state the
Comirnaty/Pfizer-BioNTech 'vaccine' is "safe and effective" for everyone 5
years and up, as well as pregnant women?
It appears this is still under provisional/emergency approval on your
Medsafe site and AEFI reports up to and including 28 February 2022 number
58,118 as well as 156 deaths. As most of the Covid death numbers in New
Zealand are listed as death 'with' Covid rather than 'from' Covid;- and
concurrently with our high vaccination rates, we now have one of the
highest Covid case numbers per population in the world, please advise what
scientific studies our Government is relying on to continue to make this
'safe and effective' statement to the New Zealand public.
Yours faithfully,
Debbie
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From: OIA Requests
Kia ora Debbie
Thank you for your request to the Ministry of Health (the Ministry) for
information under the Official Information Act 1982 (the Act) on 29 March
2022 for:
“the studies that Jacinda Ardern, the Minister of Health and the Director
General of Health refer to when they state the Comirnaty/Pfizer-BioNTech
'vaccine' is "safe and effective" for everyone 5 years and up, as well as
pregnant women?
It appears this is still under provisional/emergency approval on your
Medsafe site and AEFI reports up to and including 28 February 2022 number
58,118 as well as 156 deaths. As most of the Covid death numbers in New
Zealand are listed as death 'with' Covid rather than 'from' Covid;- and
concurrently with our high vaccination rates, we now have one of the
highest Covid case numbers per population in the world, please advise what
scientific studies our Government is relying on to continue to make this
'safe and effective' statement to the New Zealand public.”
The Comirnaty data sheet provides a summary of all the studies. This is
available from:
[1]www.medsafe.govt.nz/profs/datasheet/c/comirnaty0.3mlGreyCapinj.pdf.
All the clinical trials have been published in the New England Journal of
Medicine. These are available
from [2]www.nejm.org/coronavirus?query=main_nav_lg.
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.
Ngâ mihi
OIA Services Team
[4]Ministry of Health information releases
[5]Unite against COVID-19
****************************************************************************
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attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
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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. http://www.medsafe.govt.nz/profs/datashe...
2. http://www.nejm.org/coronavirus?query=ma...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/
hide quoted sections
From: Debbie
Dear OIA Requests,
Thank you for your reply, but would you please answer this request specifically and provide a copy of the exact study/studies that the Prime Minister, Health Minister and the Director General of Health relied on in February 2021 to state unequivocally this "vaccine" is "safe and effective." For all of the New Zealand population, including children over 5 years of age, as well as pregnant woman. Not just the small group of at risk New Zealanders that Medsafe initially provisionally approved it for. There were no studies confirming this at both of the links you provided, only confirmation there is still much unknown and there is no long term study data to make this claim.
The Comirnaty data sheet at the link you provided does not confirm this Comirnaty/Pfizer-BioNTech 'vaccine' is completely "safe and effective" as the Prime Minister states. These include, but are not limited to; (direct cut and paste from link you sent me)
4.4 Special warnings and precautions for use
"Hypersensitivity and anaphylaxis
Events of anaphylaxis have been reported."
"Very rare cases of myocarditis and pericarditis have been observed following vaccination with COMIRNATY... Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition."
"Immunocompromised individuals
The efficacy, safety and immunogenicity of COMIRNATY has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy."
"Duration of protection
The duration of protection afforded by COMIRNATY is unknown as it is still being determined by ongoing clinical trials."
"Paediatric use
The safety and efficacy of COMIRNATY in children aged less than 5 years of age have not yet been established."
4.5 Interactions with other medicines and other forms of interactions
"No interaction studies have been performed.
Concomitant administration of COMIRNATY with other vaccines has not been studied."
4.6 Fertility, pregnancy and lactation
"Pregnancy
There is limited experience with use of COMIRNATY in pregnant women."
"Lactation
It is unknown whether tozinameran is excreted in human milk."
Adolescents 12 to 15 years of age – after 2 doses
"The safety evaluation in Study C4591001 is ongoing."
Children 5 to 11 years of age – after 2 doses
"The safety evaluation in Study C4591007 is ongoing."
Tabulated list of adverse reactions from clinical studies and post-authorisation experience.
Adverse reactions observed during clinical studies are listed below; (followed by a whole chart of adverse reactions that do not sound "safe")
Post-marketing experience
"Although the events listed in Table 3 were not observed in the clinical trials, they are considered adverse drug reactions for COMIRNATY as they were reported in the post-marketing experience. As these reactions were derived from spontaneous reports, the frequencies could not be determined and are thus considered as not known."
Table 3:Adverse reactions from COMIRNATY post marketing experience
These are very serious adverse drug reactions that are listed in the table.
The Vaccine efficacy data does not state the absolute risk reduction, which has been calculated as 0.84%. "Relative" risk is misleading to the general public.
Reading this document at the link you sent me it is clear that many conclusions are based on animal only trials, not human. It is also very clear that the study is ongoing and there is no way long term side effects can be evaluated .Which is why Medsafe only granted Provisional consent?
I note that in another OIA request the NZ Government confirmed earlier receipt of the recently ordered release of Pfizer study documents, but these also list a myriad of adverse reactions to be mindful of.
Thanks in advance for providing the exact study.
Yours sincerely,
Debbie
From: OIA Requests
Kia ora Debbie,
Thank you for your follow up request for official information. The
Ministry's reference number for your request is: H202205449.
As required under the Official Information Act 1982, the Ministry 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/
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: [2][email address]
-----Original Message-----
From: Debbie <[FYI request #19000 email]>
Sent: Thursday, 14 April 2022 4:20 pm
To: OIA Requests <[email address]>
Subject: Re: Response to your request for official information -
H202204772
Dear OIA Requests,
Thank you for your reply, but would you please answer this request
specifically and provide a copy of the exact study/studies that the Prime
Minister, Health Minister and the Director General of Health relied on in
February 2021 to state unequivocally this "vaccine" is "safe and
effective." For all of the New Zealand population, including children over
5 years of age, as well as pregnant woman. Not just the small group of at
risk New Zealanders that Medsafe initially provisionally approved it for.
There were no studies confirming this at both of the links you provided,
only confirmation there is still much unknown and there is no long term
study data to make this claim.
The Comirnaty data sheet at the link you provided does not confirm this
Comirnaty/Pfizer-BioNTech 'vaccine' is completely "safe and effective" as
the Prime Minister states. These include, but are not limited to; (direct
cut and paste from link you sent me)
4.4 Special warnings and precautions for use "Hypersensitivity and
anaphylaxis Events of anaphylaxis have been reported."
"Very rare cases of myocarditis and pericarditis have been observed
following vaccination with COMIRNATY... Healthcare professionals should be
alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees
should be instructed to seek immediate medical attention if they develop
symptoms indicative of myocarditis or pericarditis such as (acute and
persisting) chest pain, shortness of breath, or palpitations following
vaccination. Healthcare professionals should consult guidance and/or
specialists to diagnose and treat this condition."
"Immunocompromised individuals
The efficacy, safety and immunogenicity of COMIRNATY has not been assessed
in immunocompromised individuals, including those receiving
immunosuppressant therapy."
"Duration of protection
The duration of protection afforded by COMIRNATY is unknown as it is still
being determined by ongoing clinical trials."
"Paediatric use
The safety and efficacy of COMIRNATY in children aged less than 5 years of
age have not yet been established."
4.5 Interactions with other medicines and other forms of interactions "No
interaction studies have been performed.
Concomitant administration of COMIRNATY with other vaccines has not been
studied."
4.6 Fertility, pregnancy and lactation
"Pregnancy
There is limited experience with use of COMIRNATY in pregnant women."
"Lactation
It is unknown whether tozinameran is excreted in human milk."
Adolescents 12 to 15 years of age – after 2 doses "The safety evaluation
in Study C4591001 is ongoing."
Children 5 to 11 years of age – after 2 doses "The safety evaluation in
Study C4591007 is ongoing."
Tabulated list of adverse reactions from clinical studies and
post-authorisation experience.
Adverse reactions observed during clinical studies are listed below;
(followed by a whole chart of adverse reactions that do not sound "safe")
Post-marketing experience
"Although the events listed in Table 3 were not observed in the clinical
trials, they are considered adverse drug reactions for COMIRNATY as they
were reported in the post-marketing experience. As these reactions were
derived from spontaneous reports, the frequencies could not be determined
and are thus considered as not known."
Table 3:Adverse reactions from COMIRNATY post marketing experience These
are very serious adverse drug reactions that are listed in the table.
The Vaccine efficacy data does not state the absolute risk reduction,
which has been calculated as 0.84%. "Relative" risk is misleading to the
general public.
Reading this document at the link you sent me it is clear that many
conclusions are based on animal only trials, not human. It is also very
clear that the study is ongoing and there is no way long term side effects
can be evaluated .Which is why Medsafe only granted Provisional consent?
I note that in another OIA request the NZ Government confirmed earlier
receipt of the recently ordered release of Pfizer study documents, but
these also list a myriad of adverse reactions to be mindful of.
Thanks in advance for providing the exact study.
Yours sincerely,
Debbie
-----Original Message-----
Kia ora Debbie
Thank you for your request to the Ministry of Health (the Ministry) for
information under the Official Information Act 1982 (the Act) on 29 March
2022 for:
“the studies that Jacinda Ardern, the Minister of Health and the Director
General of Health refer to when they state the Comirnaty/Pfizer-BioNTech
'vaccine' is "safe and effective" for everyone 5 years and up, as well as
pregnant women?
It appears this is still under provisional/emergency approval on your
Medsafe site and AEFI reports up to and including 28 February 2022 number
58,118 as well as 156 deaths. As most of the Covid death numbers in New
Zealand are listed as death 'with' Covid rather than 'from' Covid;- and
concurrently with our high vaccination rates, we now have one of the
highest Covid case numbers per population in the world, please advise
what scientific studies our Government is relying on to continue to make
this 'safe and effective' statement to the New Zealand public.”
The Comirnaty data sheet provides a summary of all the studies. This is
available from:
[1][3]www.medsafe.govt.nz/profs/datasheet/c/comirnaty0.3mlGreyCapinj.pdf.
All the clinical trials have been published in the New England Journal of
Medicine. These are available
from [2][4]www.nejm.org/coronavirus?query=main_nav_lg.
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.
Ngâ mihi
OIA Services Team
[4]Ministry of Health information releases
[5]Unite against COVID-19
References
Visible links
1.
[5]http://www.medsafe.govt.nz/profs/datashe...
2.
[6]http://scanmail.trustwave.com/?c=15517&a...
3. [7]mailto:[email address]
4. [8]https://www.health.govt.nz/about-ministr...
5.
[9]https://scanmail.trustwave.com/?c=15517&...
-------------------------------------------------------------------
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[10][FYI request #19000 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[11]https://scanmail.trustwave.com/?c=15517&...
If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.
-------------------------------------------------------------------
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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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6. http://scanmail.trustwave.com/?c=15517&a...
7. mailto:[email
8. https://www.health.govt.nz/about-ministr...
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From: OIA Requests
Kia ora Debbie,
Please see attached the response to your OIA request.
Ngā mihi
OIA Services Team
[1]Ministry of Health information releases
[2]Unite against COVID-19
****************************************************************************
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attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
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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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