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Pfizer/BioNTech vaccine benefit risk assessment

Mr T. Baker made this Official Information request to Ministry of Health

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From: Mr T. Baker

Dear Ministry of Health,

In Ministry of Health media release (3rd Feb 2021) announcing Medsafe approval of Pfizer/BioNTech vaccine, it was stated Medsafe had completed a "benefit risk assessment, which allows [Medsafe] to balance the benefits of the vaccine against any known risks such as side effects.".

Please provide full details of benefit risk assessment undertaken as part of Pfizer/BioNTech vaccine approval.

Yours faithfully,

T. Baker

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From: OIA Requests


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Kia ora

Thank you for your request for official information received on 10 March
2021 for:

"In Ministry of Health media release (3rd Feb 2021) announcing Medsafe
approval of Pfizer/BioNTech vaccine, it was stated Medsafe had completed a
"benefit risk assessment, which allows [Medsafe] to balance the benefits
of the vaccine against any known risks such as side effects.".
Please provide full details of benefit risk assessment undertaken as part
of Pfizer/BioNTech vaccine approval."

The Ministry's reference number for your request is: H202102755.

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 9 April 2021, being 20
working days after the day your request was received.  

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: [email address]

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From: OIA Requests


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Attachment H202102755 T Baker response letter.pdf
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Kia ora,

 

Please find attached a letter regarding your request for information.

 

Ngâ mihi,

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

 

 

 

 

 

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References

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1. mailto:[email address]

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From: Mr T. Baker

Dear OIA Requests,

Thank you for your response. Please provide the following relating to the Pfizer/BioNTech vaccine benefit risk assessment. It is my expectation that the information requested below is not subject to Sections 9(2)(b)(ii) or 9(2)(ba)(i) of the Act.

1. Based on the benefit risk assessment, how many deaths are foreseen as a result of adverse reactions to the Pfizer/BioNTech vaccine?
2. Based on the benefit risk assessment, how many serious life threatening events are foreseen as a result of adverse reactions to the Pfizer/BioNTech vaccine?
3. What are the age-stratified Covid-19 infection fatality rates (or similar) used in the benefit risk assessment for unvaccinated individuals?
4. What are the age-stratified Covid-19 infection fatality rates (or similar) used in the benefit risk assessment for vaccinated individuals?
5. What are the age-stratified Covid-19 hospitalisation rates (or similar) used in the benefit risk assessment for unvaccinated individuals?
6. What are the age-stratified Covid-19 hospitalisation rates (or similar) used in the benefit risk assessment for vaccinated individuals?
7. Based on the benefit risk assessment, how many lives are foreseen to be saved as a result of the Pfizer/BioNTech vaccine programme? Please provide lives foreseen to be saved given different vaccinated percentage of population.
8. Does the benefit risk assessment consider reopening of the borders, and free movement of New Zealand citizens and residents, as a benefit of the Pfizer/BioNTech vaccine programme? If so, when does the benefit risk assessment assume the New Zealand border will be reopened to isolation-free travel of New Zealand citizens and residents?
9. Does the benefit risk assessment consider reduced usage of Covid-19 Alert Level 2, 3 and 4 as a benefit of the Pfizer/BioNTech vaccine programme? If so, what is the frequency reduction considered in the benefit risk assessment for Levels 2, 3 and 4?
10. Does the benefit risk assessment consider the elimination of all alert levels (including level 1) as a benefit of the Pfizer/BioNTech vaccine programme? If so, when does the benefit risk assessment assume this could be possible?
11. Who were the authors of the assessment? Was the assessment peer reviewed? If so, who were the peer reviewers?
12. How many pages long is the official benefit risk assessment document?

Yours sincerely,

Mr T. Baker

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From: OIA Requests


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Kia ora

 

Thank you for your request for official information received 31 March 2021
for:

 

            "Please provide the following relating to the Pfizer/BioNTech
vaccine benefit risk assessment. It is my expectation that the information
requested below is not subject to Sections 9(2)(b)(ii) or 9(2)(ba)(i) of
the Act.

 

1. Based on the benefit risk assessment, how many deaths are foreseen as a
result of adverse reactions to the Pfizer/BioNTech vaccine?

2. Based on the benefit risk assessment, how many serious life threatening
events are foreseen as a result of adverse reactions to the
Pfizer/BioNTech vaccine?

3. What are the age-stratified Covid-19 infection fatality rates (or
similar) used in the benefit risk assessment for unvaccinated individuals?

4. What are the age-stratified Covid-19 infection fatality rates (or
similar) used in the benefit risk assessment for vaccinated individuals?

5. What are the age-stratified Covid-19 hospitalisation rates (or similar)
used in the benefit risk assessment for unvaccinated individuals?

6. What are the age-stratified Covid-19 hospitalisation rates (or similar)
used in the benefit risk assessment for vaccinated individuals?

7. Based on the benefit risk assessment, how many lives are foreseen to be
saved as a result of the Pfizer/BioNTech vaccine programme? Please provide
lives foreseen to be saved given different vaccinated percentage of
population.

8. Does the benefit risk assessment consider reopening of the borders, and
free movement of New Zealand citizens and residents, as a benefit of the
Pfizer/BioNTech vaccine programme? If so, when does the benefit risk
assessment assume the New Zealand border will be reopened to
isolation-free travel of New Zealand citizens and residents?

9. Does the benefit risk assessment consider reduced usage of Covid-19
Alert Level 2, 3 and 4 as a benefit of the Pfizer/BioNTech vaccine
programme? If so, what is the frequency reduction considered in the
benefit risk assessment for Levels 2, 3 and 4?

10. Does the benefit risk assessment consider the elimination of all alert
levels (including level 1) as a benefit of the Pfizer/BioNTech vaccine
programme? If so, when does the benefit risk assessment assume this could
be possible?

11. Who were the authors of the assessment? Was the assessment peer
reviewed? If so, who were the peer reviewers?

12. How many pages long is the official benefit risk assessment document?

 

The Ministry's reference number for your request is: H202103824.

 

As required under the Official Information Act 1982 we will endeavour to
respond to your request no later than 3 May 2021, being 20 working days
after the day your request was received.  

 

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: [email address]

 

 

show quoted sections

Link to this

From: OIA Requests


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Attachment H202103824 T Baker response.pdf
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Kia ora

 

Please find attached a response to your official information act request

 

Ngā mihi 

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

 

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1. mailto:[email address]

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Mr T. Baker left an annotation ()

This request was refused, hence has been addressed to the Ombudsman.

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From: OIA Requests


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Kia ora Taran

 

 

The Ministry of Health (the Ministry) has reconsidered parts of the
response to your request for official information relating to the benefit
risk assessment of the Pfizer/BioNtech COVID-19 vaccine (H202103824
refers). A copy of the response letter, provided to you on 20 April 2021,
is attached for reference.

 

For clarity, the Ministry stands by its decision to refuse the majority of
your request (questions 1-10) under section 18(e) of the OIA as the
requested information does not exist. However, the Ministry recognises
that questions 11 and 12 of your request were responded to based on a
narrow interpretation. While there is not one specific document that is
classified as the ‘official risk benefit assessment document’, there were
three (3) separate documents which formed part of the risk benefit
assessment. Outlined below are the Ministry’s revised responses to
questions 11 and 12:

 

11. Who were the authors of the assessment? Was the assessment peer
reviewed? If so, who were the peer reviewers?

 

Yes, the assessment was peer reviewed; however, information regarding the
individual(s) involved in the peer review process is withheld under
section 9(2)(g)(ii) of the OIA, to maintain the effective conduct of
public affairs through the protection of such Ministers, members of
organisations, officers, and employees from improper pressure or
harassment.

 

12. How many pages long is the official benefit risk assessment document?

 

As noted above, three (3) documents formed part of the risk benefit
assessment. Document “A” has 130 pages in total, Document “B” has 9 pages
in total, and Document “C” has 80 pages in total.

 

We would like to apologise for any inconvenience this may have caused.

 

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 calling 0800 802
602.

 

Ngâ mihi

 

 

OIA Services Team

 

[1]Ministry of Health information releases

[2]Unite against COVID-19

 

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1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/

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Virginia Crawford left an annotation ()

Clearly there was NO benefit risk assessment made. Simply relying on what Pfizer has published is simply evading the real issues here. Many thousands of people world wide have already died (37 or more here in New Zealand) and many more will sadly die. All these vaccines do is reduce mild to moderate symptoms.

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victor left an annotation ()

There is no risk benefit produced is the only logical conclusion.

If there was a RB analysis it would show the statistical impossibility that the government product sales program could add benefit into the population.

Statistically a product with ARR 0.84% into a population with a 'zero policy' can't ever provide individual immunity forget about the proven falsehood of 'population immunity'.

Which is why the fallacy of 'at risk susceptible' equating to those not had the government product is to be maintained.

Modeling out of Te Punaha Matatini (Hendy Plank etc) openly state:

'Injected assumes protection at a fixed rate' (as the level of garbage produced in nz to support policy)

BNT162B2 - Decline to zero in 70d
https://www.thelancet.com/journals/lance...(21)01642-1/fulltext

Without the statistical possibility of a benefit profile there is only a risk profile.

Which is why the closed circuit of local data manipulators are hiding behind 'sensitivity' which is extremely dangerous and excludes informed consent at every level with this single 'missing' document.

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D J Blair left an annotation ()

This is an amazing display from an agency that doesn't seem to put much importance on the their core service, the health CARE of new zealanders, a very blaze response to the point of disinterested. A total disgrace and I refrain from my next statement ....

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