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
Kia ora,
The OIA team at Manatū Hauora is currently on holiday break. We will
return on 8 January 2024.
Please note, over the holiday period there are three weeks that don’t
count as ‘working days’. For Official Information Act (OIA) requests, that
period is 25 December 2023 to 14 January 2024 (inclusive). OIA requests
received after 27 November 2023 may take a bit longer than you expected.
If you'd like to calculate the timeframe, you can use the Ombudsman's
online calculator here: [1]http://www.ombudsman.parliament.nz/
Have a safe and happy holiday period.
Ngā mihi
OIA Services
Government and Executive Services | Te Pou Whakatere Kāwanatanga
Manatū Hauora | Ministry of Heath
show quoted sections
References
Visible links
1. http://www.ombudsman.parliament.nz/
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
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, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account.
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.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
[4]Ministry of Health information releases
------------------- Original Message
show quoted sections
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
show quoted sections
References
Visible links
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/
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
show quoted sections
References
Visible links
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/
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
show quoted sections
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...
Things to do with this request
- Add an annotation (to help the requester or others)
- Download a zip file of all correspondence
Offensive? Unsuitable?
Requests for personal information and vexatious requests are not considered valid requests for Official Information (read more).
If you believe this request is not suitable, you can report it for attention by the site administrators
Report this requestAct on what you've learnt
Similar requests
Ministry of Health roles and obligations, relating to liability waiver for Pfizer
To Ministry of Health by ASE
Where is the Medsafe report stating the Comirnaty BNT162b2 product is safe and effective?
To Ministry of Health by J Bruning
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