Pfizer Covid Vaccine Risk Benefit Analysis / Risk-Benefit Asessment
M Bell made this Official Information request to Ministry of Health
The request was partially successful.
From: M Bell
Dear Ministry of Health,
This OIA request is directed specifically toward Maree Roberts: Deputy Director-General, Strategy Policy and Legislation
Greetings Maree,
In a previous OIA request response (ref H202205215) the Ministry of Health stated that there was no “risk benefit analysis” work done on the Pfizer Covid 19 vaccine.
However on the MBIE business case for the indemnity in favour of Pfizer and Biontech it says that the vaccine “will require a careful risk benefit assessment as part of the regulatory approval process.”(page 2) and also that “Medsafe will be undertaking a risk-benefit assessment as part of the regulatory approval process to ensure the vaccine meets internationally accepted criteria for safety, quality and effectiveness.” (page 10) This business case was of course signed off by yourself on behalf of the ministry of health.
My specific requests and questions:
1 was there such a “risk-benefit assessment” done or not?
2 if yes please provide the document(s).
3 if it was decided not to perform this please provide the correspondence on exactly how this decision was arrived at in opposition to what was signed off in the indemnity business case.
Thanks and regards,
M Bell
From: OIA Requests
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From: OIA Requests
Kia ora
Thank you for your request for official information. The reference number
for your request is: H2024034684
As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
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OIA Services Team
Manatū Hauora | Ministry of Health
[4]Ministry of Health information releases
------------------- Original Message -------------------
From: M Bell <[FOI #25342 email]>;
Received: Sat Jan 06 2024 16:54:15 GMT+1300 (New Zealand Daylight Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Pfizer Covid Vaccine Risk Benefit
Analysis / Risk-Benefit Asessment
Dear Ministry of Health,
This OIA request is directed specifically toward Maree Roberts: Deputy
Director-General, Strategy Policy and Legislation
Greetings Maree,
In a previous OIA request response (ref H202205215) the Ministry of Health
stated that there was no “risk benefit analysis” work done on the Pfizer
Covid 19 vaccine.
However on the MBIE business case for the indemnity in favour of Pfizer
and Biontech it says that the vaccine “will require a careful risk benefit
assessment as part of the regulatory approval process.”(page 2) and also
that “Medsafe will be undertaking a risk-benefit assessment as part of the
regulatory approval process to ensure the vaccine meets internationally
accepted criteria for safety, quality and effectiveness.” (page 10) This
business case was of course signed off by yourself on behalf of the
ministry of health.
My specific requests and questions:
1 was there such a “risk-benefit assessment” done or not?
2 if yes please provide the document(s).
3 if it was decided not to perform this please provide the correspondence
on exactly how this decision was arrived at in opposition to what was
signed off in the indemnity business case.
Thanks and regards,
M Bell
****************************************************************************
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legal privilege.
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If you have received this message in error, please notify the sender
immediately and delete this message.
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2. mailto:[email address]
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4. https://www.health.govt.nz/about-ministr...
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From: OIA Requests
Tçnâ koe M Bell,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health - Manatû Hauora (the Ministry) on 6 January
2024 for information regarding the Comirnaty (Pfizer) COVID-19 vaccine.
You requested:
“Was there such a “risk-benefit assessment” done or not? if yes please
provide the document(s). if it was decided not to perform this please
provide the correspondence on exactly how this decision was arrived at in
opposition to what was signed off in the indemnity business case.”
Pfizer, the pharmaceutical company responsible for developing and
producing the COVID-19 vaccine, provides Medsafe with safety information
from clinical studies performed using that medicine.
Medsafe evaluates the results from these clinical studies to determine if
the safety profile is acceptable. Medsafe reviews the risks and benefits
for each specific medicine to ensure that the safety profile is acceptable
(i.e., the benefits of the medicine outweigh the risks). There is no
specific document outlining benefit/risk assessment. The principles are
embedded throughout the approval process.
You may be interested in Medsafe’s evaluation reports of the Comirnaty
(Pfizer) COVID-19 vaccine, which is available in a previous OIA response
at:
[1]www.health.govt.nz/system/files/documents/information-release/h202106950_-_response.pdf.
If you wish to discuss any aspect of your request with us, including this
decision, please feel free to contact the OIA Services Team on:
[2][email address].
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
Manatû Hauora | Ministry of Health
M[4]inistry of Health information releases
U[5]nite against COVID-19
****************************************************************************
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immediately and delete this message.
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1. http://www.health.govt.nz/system/files/d...
2. mailto:[email address]
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4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/
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From: OIA Requests
Tçnâ koe M Bell,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health - Manatû Hauora (the Ministry) on 6 January
2024 for information regarding the Comirnaty (Pfizer) COVID-19 vaccine.
You requested:
“Was there such a “risk-benefit assessment” done or not? if yes please
provide the document(s). if it was decided not to perform this please
provide the correspondence on exactly how this decision was arrived at in
opposition to what was signed off in the indemnity business case.”
Pfizer, the pharmaceutical company responsible for developing and
producing the COVID-19 vaccine, provides Medsafe with safety information
from clinical studies performed using that medicine. Medsafe evaluates the
results from these clinical studies to determine if the safety profile is
acceptable. Medsafe reviews the risks and benefits for each specific
medicine to ensure that the safety profile is acceptable (i.e., the
benefits of the medicine outweigh the risks). There is no specific
document outlining benefit/risk assessment. The principles are embedded
throughout the approval process.
You may be interested in Medsafe’s evaluation reports of the Comirnaty
(Pfizer) COVID-19 vaccine, which is available in a previous OIA response
at:
[1]www.health.govt.nz/system/files/documents/information-release/h202106950_-_response.pdf.
If you wish to discuss any aspect of your request with us, including this
decision, please feel free to contact the OIA Services Team on:
[2][email address].
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
Manatû Hauora | Ministry of Health
M[4]inistry of Health information releases
U[5]nite against COVID-19
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
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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References
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1. http://www.health.govt.nz/system/files/d...
2. mailto:[email address]
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/
hide quoted sections
From: M Bell
Dear OIA Requests,
It is very hard to know what is actually being said in your response...
You say that there is no specific document that demonstrates that a “risk-benefit assessment” was done, and that “the principles (of a risk-benefit assessment) are embedded throughout the approval process”.
Does this mean that there were more than one document (if so please provide these), OR does this mean that there was another method method of achieving a “risk-benefit assessment” as required in the Pfizer indemnity, such as in some way the “embedded principles” you mention?
If the latter please explain exactly what “the principles (of a risk-benefit assessment) are embedded throughout the approval process” means and how these principles adequately demonstrate that a “risk-benefit assessment” was completed as required in the Pfizer indemnity
According to the clinical evaluation link that you provided, the Pfizer data said that adverse events and serious adverse events go up very significantly compared to the placebo group. Hence because the data is showing a clear increased risk of adverse events, then surely a “risk-benefit assessment” would also need to compare this with the risk of serious disease from COVID and demonstrate that you are better off to be injected? Please state very clearly whether this has been done or not.
Yours sincerely,
M Bell
From: M Bell
Dear OIA Requests,
Can you please respond to my request for clarification on Jan 31.
Yours sincerely,
M Bell
From: OIA Requests
Kia ora M Bell,
Thank you for your follow up request on 31 January 2024 for:
“You say that there is no specific document that demonstrates that a
“risk-benefit assessment” was done, and that “the principles (of a
risk-benefit assessment) are embedded throughout the approval process”.
Does this mean that there were more than one document (if so please
provide these), OR does this mean that there was another method method of
achieving a “risk-benefit assessment” as required in the Pfizer indemnity,
such as in some way the “embedded principles” you mention?
If the latter please explain exactly what “the principles (of a
risk-benefit assessment) are embedded throughout the approval process”
means and how these principles adequately demonstrate that a “risk-benefit
assessment” was completed as required in the Pfizer indemnity
According to the clinical evaluation link that you provided, the Pfizer
data said that adverse events and serious adverse events go up very
significantly compared to the placebo group. Hence because the data is
showing a clear increased risk of adverse events, then surely a
“risk-benefit assessment” would also need to compare this with the risk of
serious disease from COVID and demonstrate that you are better off to be
injected? Please state very clearly whether this has been done or not.”
The documents in H202106950 refer to a section within the report on
benefit risk, but this is conditional on the rest of the report and the
expert advice obtained. Determining the benefit risk is a process. The
benefit/risk analysis was undertaken by Medsafe prior to the Pfizer
COVID-19 vaccine (Comirnaty) being granted provisional consent for use in
New Zealand. Please refer to document 10 on page 94:
[1]www.health.govt.nz/system/files/documents/information-release/h202106950_response.pdf.
COVID-19 vaccines in use in New Zealand were developed through a
combination of major international collaboration and have been thoroughly
assessed for safety. In addition, all medicines and vaccines used in New
Zealand are assessed through a detailed approval process. This includes
the assessment of results from clinical trials to help demonstrate the
efficacy and safety of the vaccines, as well as data to support their
manufacture and quality. More information about their vaccine evaluation
and approval process can be found here:
[2]www.medsafe.govt.nz/COVID-19/vaccine-approval.asp
Additionally, there are ongoing measures to monitor the safety of COVID-19
vaccines. More information is available at:
[3]www.medsafe.govt.nz/COVID-19/safety-monitoring.asp.
If you wish to discuss any aspect of your request with us, including this
decision, please feel free to contact the OIA Services Team on:
[4][email address].
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:
[5][email address] or by calling 0800 802 602.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[6]inistry of Health information releases
U[7]nite against COVID-19
--------------------------------------------------------------------------
From: M Bell <[FOI #25342 email]>
Sent: Wednesday, 14 February 2024 16:47
To: OIA Requests <[email address]>
Subject: Re: Response to your request for official information, ref:
H2024034684 CRM:0001153
Dear OIA Requests,
Can you please respond to my request for clarification on Jan 31.
Yours sincerely,
M Bell
-----Original Message-----
Tçnâ koe M Bell,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health - Manatû Hauora (the Ministry) on 6
January
2024 for information regarding the Comirnaty (Pfizer) COVID-19 vaccine.
You requested:
“Was there such a “risk-benefit assessment” done or not? if yes please
provide the document(s). if it was decided not to perform this please
provide the correspondence on exactly how this decision was arrived at in
opposition to what was signed off in the indemnity business case.”
Pfizer, the pharmaceutical company responsible for developing and
producing the COVID-19 vaccine, provides Medsafe with safety information
from clinical studies performed using that medicine. Medsafe evaluates
the
results from these clinical studies to determine if the safety profile is
acceptable. Medsafe reviews the risks and benefits for each specific
medicine to ensure that the safety profile is acceptable (i.e., the
benefits of the medicine outweigh the risks). There is no specific
document outlining benefit/risk assessment. The principles are embedded
throughout the approval process.
You may be interested in Medsafe’s evaluation reports of the Comirnaty
(Pfizer) COVID-19 vaccine, which is available in a previous OIA response
at:
[1]www.health.govt.nz/system/files/documents/information-release/h202106950_-_response.pdf.
If you wish to discuss any aspect of your request with us, including this
decision, please feel free to contact the OIA Services Team on:
[2][email address].
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
Manatû Hauora | Ministry of Health
M[4]inistry of Health information releases
U[5]nite against COVID-19
References
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4. [11]https://www.health.govt.nz/about-ministr...
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[12]https://aus01.safelinks.protection.outlo...
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2. http://www.medsafe.govt.nz/COVID-19/vacc...
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4. mailto:[email address]
5. mailto:[email address]
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7. https://covid19.govt.nz/
8. http://www.health.govt.nz/system/files/d...
9. mailto:[email
10. mailto:[email
11. https://www.health.govt.nz/about-ministr...
12. https://covid19.govt.nz/
13. https://fyi.org.nz/help/officers
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Catherine Jamieson left an annotation ()
'This includes
the assessment of results from clinical trials to help demonstrate the
efficacy and safety of the vaccines,'
What of process 1/process 2?
https://twitter.com/joshg99/status/16627...
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M Bell left an annotation ()
It appears from the only specific document provided, that the RISK of COVID mortality was stated to be low, plenty of data was available confirming this. It appears that only unsubstantiated conjecture was applied to make the risks for other outcomes seem larger. Conversely the BENEFIT of injections was not demonstrated, but what was demonstrated by Pfizer data that while in the short term statistically there were less “cases of symptomatic laboratory-confirmed COVID-19”, by the same statistical metric there was a significant increased RISK compared to the placebo group as follows.
(a) you are is 6.75 times more likely to get severe covid if injected.
(b) you are 4.2 times more likely to have an adverse event.
(c) you are 6 times more likely to have a serious adverse event.
Yet despite that it was still determined to be good enough as it was then stated that a provisional consent was appropriate.
I think it’s going to be popcorn time if the coming public inquiry gets to looking properly at this because according to this there was no serious attempt to compare apples with apples, the true risk of getting harmed by covid without being injected, compared to the net benefit of being injected. Yet even the sanitized marketing spin from Pfizer clearly demonstrates there was harm applied from the injections and the benefits remained largely unsubstantiated and unqualified.
This surely fails to comply with the requirement business case for the Pfizer indemnity that a “careful risk benefit assessment” would be done, and fails any sense of due diligence in respect to the safety of the NZ people.
Thankyou anyway to the MoH OIA staff for the time and effort in the response.
Link to this