Pfizer/BioNTech vaccine benefit risk assessment - exists or not?
Mr T. Baker made this Official Information request to Ministry of Health
The request was successful.
From: Mr T. Baker
Dear Ministry of Health,
Regarding Ministry of Health OIA Ref: H202205215, an error appears to have been made in stating that the Ministry of Health (nor any other agency) has not undertaken risk benefit work regarding Pfizer Covid vaccine.
In response to the request:
"Risk / Benefit analysis of the vaccine when it was approved
- If one was not completed then why not?
- Risk / Benefit analysis of the vaccine after the death of one person was confirmed
- If one was not completed then why not?
- Risk / Benefit analysis of the vaccine after the death of a second person was confirmed
- If one was not completed then why not?
- Risk / Benefit analysis of the vaccine at today's date taking into account all of the data
collected by Ministry of Health and Medsafe
- Can the Ministry of Health confirm if there are any control groups that were put in place
as a way to analyse their own data - if not why not?"
The Ministry responded that: "The Ministry has not undertaken any risk benefit analysis work regarding vaccines. As such your request is refused under section 18(g)(i) of the Act, as the information requested is not held by the Ministry and there are no grounds for believing it is connected more closely with the functions of another agency subject to the Act."
However, in the Ministry of Health press release (3 Feb 2021) announcing provisional approval of the Pfizer vaccine, it was stated: "“All the data is considered and we then complete a benefit risk assessment, which allows us to balance the benefits of the vaccine against any known risks such as side effects. We have determined there may be some minor side effects such as a painful arm and headaches – these are not uncommon in other vaccines."
Please clarify the following:
- Did the Ministry of Health undertake a "Risk / Benefit analysis of the vaccine when it was approved"?
- If not, why did the Ministry of Health state it did in press release of 3rd February 2021?
- If so, why did the Director of National Immunisation Programme state no risk benefit work had been undertaken as part of their response to OIA Ref: H202205215?
Yours faithfully,
Mr T. Baker
From: OIA Requests
Kia ora Mr. Baker,
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------------------- Original Message -------------------
From: Mr T. Baker <[FYI request #20167 email]>;
Received: Sun Aug 07 2022 16:48:16 GMT+1200 (New Zealand Standard Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Pfizer/BioNTech vaccine benefit
risk assessment - exists or not?
Dear Ministry of Health,
Regarding Ministry of Health OIA Ref: H202205215, an error appears to have
been made in stating that the Ministry of Health (nor any other agency)
has not undertaken risk benefit work regarding Pfizer Covid vaccine.
In response to the request:
"Risk / Benefit analysis of the vaccine when it was approved
- If one was not completed then why not?
- Risk / Benefit analysis of the vaccine after the death of one person was
confirmed
- If one was not completed then why not?
- Risk / Benefit analysis of the vaccine after the death of a second
person was confirmed
- If one was not completed then why not?
- Risk / Benefit analysis of the vaccine at today's date taking into
account all of the data
collected by Ministry of Health and Medsafe
- Can the Ministry of Health confirm if there are any control groups that
were put in place
as a way to analyse their own data - if not why not?"
The Ministry responded that: "The Ministry has not undertaken any risk
benefit analysis work regarding vaccines. As such your request is refused
under section 18(g)(i) of the Act, as the information requested is not
held by the Ministry and there are no grounds for believing it is
connected more closely with the functions of another agency subject to the
Act."
However, in the Ministry of Health press release (3 Feb 2021) announcing
provisional approval of the Pfizer vaccine, it was stated: "“All the data
is considered and we then complete a benefit risk assessment, which allows
us to balance the benefits of the vaccine against any known risks such as
side effects. We have determined there may be some minor side effects such
as a painful arm and headaches – these are not uncommon in other
vaccines."
Please clarify the following:
- Did the Ministry of Health undertake a "Risk / Benefit analysis of the
vaccine when it was approved"?
- If not, why did the Ministry of Health state it did in press release of
3rd February 2021?
- If so, why did the Director of National Immunisation Programme state no
risk benefit work had been undertaken as part of their response to OIA
Ref: H202205215?
Yours faithfully,
Mr T. Baker
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From: OIA Requests
Kia ora Mr Baker,
Please find attached the response to your request for information.
Ngā mihi
OIA Services Team
M[1]inistry of Health information releases
U[2]nite against COVID-19
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Chris McCashin left an annotation ()
Okay given this is the most recent response to Benefit / Risk analysis this confirms that there has only been one benefit / risk analysis done which states the Benefit / Risk "is not clear". Per Ministry of Health documentation under other Official Information Act Requests and I quote "The process for removal of an approved medicine from the market is different. It involves a review of the risk-benefit of the product following reported adverse events where a signal is identified that the product has potential for harm". So I suspect that there have been no risk-benefit analysis because the CV-ISMB despite death and injury continue to say that there aren't any identified signals. That has to be the only way they are avoiding doing a risk benefit analysis. There was a weight loss product Reductil taken off the shelf as an increased risk of serious cardivascular events such as heart attacks and stroke. This therapy has increased illness ten-fold including the above conditions. The damn is about to burst on the MOH, Medsafe, Medical profession as to the massive cover up there is.
Chris McCashin left an annotation ()
This is despite the CV-ISMB throughout all of their memos stating that the risk / benefit is still in favor of vaccine but can't provide one. https://fyi.org.nz/request/20204-cv-ismb...
Athina Andonatou left an annotation ()
The link supplied www.health.govt.nz/system/files/document.... comes up with this message "Sorry - you don’t have permission to access this page on our server"
Chris McCashin left an annotation ()
I know the Risk / Benefit document they link too (though it’s not coming up here) is the one that concludes “the risk benefit profile is not clear”. It’s now time for some serious pressure to be applied to MOH, Medsafe, Politicians and we start getting to the bottom of things. How does an untested, emergency use “treatment” get mandated, can kill people, has thousands of injuries and stays in circulation. The new bivalent vaccine was tested on mice only and got approved!! The pharmaceutical industry is corrupt and the regulators and medical industries have been captured and / or threatened into silence and submission. Mr James has some serious questions to answer now that the new normal involves children dropping dead and having cardiac arrests
Catherine Jamieson left an annotation ()
Hi
Did anyone save a copy of the documents in H202106950 which is the link that no longer works for public access? I am looking specifically for a copy of the MAAC minutes 2/2/21 which was included in that document set. but all of it would be great.
Alternatively if anyone has requested by OIA or otherwise that access be reinstated could I have a reference to follow or link.
MAAC minutes are where the risk benefit analysis reference sits and like most of you I would like a copy.
Thank you and regards
Catherine Jamieson left an annotation ()
HI All
I have sourced a copy of MAAC Minutes but am still looking for Document 10 that has the Risk Benefit Summary. I have the wording but looking for a copy of the page (according to above pg 94). The entire document ideally but if not then the header page and the page with the Risk Benefit summary.
thanks again.
Regards
R Bailey left an annotation ()
I have the document.
Saved to Google drive. 👇
https://drive.google.com/file/d/1wuxQMUg...
Erika Whittome left an annotation ()
In Australia, the following was released in foi-2389-06.pdf
Nonclinical Evaluation Report
BNT162b2 [mRNA] COVID-19 vaccine
(COMIRNATYTM)
Submission No: PM-2020-05461-1-2
Sponsor: Pfizer Australia Pty Ltd
January 2021
Summary (page 4)
BNT162b2 (V9) was found to be immunogenic in non-clinical studies in mice, rats and rhesus macaques. BNT162b2 (V9) induced humoral and cellular immune responses in mice and monkeys. However, antibodies and T cells in monkeys declined quickly after 5 weeks after the second dose of BNT162b2 (V9) raising long term immunity concerns.
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Chris McCashin left an annotation ()
They failed to answer properly the same questions here. https://fyi.org.nz/request/19080-risk-be...
Whoever signed off the vaccine must be now starting to worry given healthy children are dropping dead which was entirely predictable given what was going on overseas before this poison was signed off in NZ
Link to this