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Request for further information regarding SARS CoV 2 vaccination program

Andrew Lewis made this Official Information request to Ministry of Health

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From: Andrew Lewis

Dear Ministry of Health,

Freedom of information act request regarding SARS CoV2 (Covid19) immunisation program

The government is rolling out SARS CoV2 vaccine and has provided information on the government web site and through media advertising campaign.

The government clearly makes the claim that the product being offered is safe and effective.

As a concerned individual I would like more information in order to understand what is meant by safe and effective in order to make a truly informed choice regarding the product/procedure being offered by the government. With that goal in mind I respectfully request the following information to be supplied and any questions to be answered.

Any use of the word product in the following request refers to Pfizer Covid 19 vaccine and any other vaccine intended for public use against Covid 19 disease.

1.The medical procedure the government is offering in this program, is deemed to be a vaccine against the virus that causes Covid-19 disease ( SARS CoV 2). Please supply references to peer reviewed scientific papers the government is relying on to support the implied claim that this product actually performs the actions of a vaccine.

A vaccine is :-

‘a substance containing a virus or bacterium in a form that is not harmful, given to a person or animal to prevent them from getting the disease that the virus or bacterium causes.' - Cambridge dictionary.

Please supply references to the peer reviewed science and any information in emails or meeting notes the government is relying on to prove that this product stops transmission of SARS CoV2 between individuals and prevents infection by SARS CoV2?

2. The government claims the product has been used ‘successfully all around the world’. Please supply the data the government is relying on to make this claim and please supply any data and/or correspondence which defines what successful means in this context.

3. Effectiveness

(a) The government is claiming 95% effectiveness for this product. Please supply references to peer reviewed science and/or correspondence with Pfizer to substantiate this claim and that shows this claim includes 95% effectiveness in stopping transmission and 95% effectiveness in preventing the recipient of the product from subsequently contracting the disease and that details how long any protection will last? Ashley Bloomfield in the video on Ministry of Health web site states that ‘our research’ indicated protection for 8 months. Please supply the ‘our research’ he is referring to. He also says the expectation is for a longer period of protection. Please supply the information on which that statement is based.

(b) Ashley Bloomfield clearly states in the video on Ministry of Health website that the vaccine may not fully protect all who receive it. Please supply any data on record (scientific reviews, emails, meeting notes etc.) that clarifies what is meant by full protection and how ‘all’ is quantitatively defined.

(c) The Number Needed to Treat (NNT) is a well accepted determinant of medical efficacy and cost effectiveness of a medical intervention and is defined thus:-

The Number Needed to Treat (NNT) is the number of patients you need to treat to prevent one additional bad outcome (death, stroke, etc.). For example, if a drug has an NNT of 5, it means you have to treat 5 people with the drug to prevent one additional bad outcome. More detailed discussion of the nature of the NNT measure can be found in the EBM Note on summarising the effects of therapy in the journal Evidence-Based Medicine 1997;2:103-4.
https://www.cebm.ox.ac.uk/resources/ebm-...

Please supply references to peer reviewed science detailing the NNT for this product.

(d) Please provide any information (peer reviewed scientific data, emails, meeting notes etc.) on record which affirms that the product will protect not only against the current SARS CoV 2 virus but against future variants of said virus.

4. Safety

(a) The government’s regulating authority, Medsafe, has approved this product. Please provide the results of Medsafe’s own safety testing and any other information that proves the product has been subjected to all the normal safety trials which would ordinarily be needed to give approval for use in the New Zealand population? Please supply information the government is relying on to confirm or deny that approval in this context means emergency use authorisation.

(b) Ashley Bloomfield in his video presentation clearly states that this product has been subjected to the same high safety standards as other vaccines. Please supply any information (scientific data, emails, meeting notes etc.) on which this statement is based.

(c)The government claims this product is safe. According to the Cambridge dictionary safe means ‘not dangerous or likely to cause harm'. The reality is, as we know that all medicines have side effects. Please supply information the government is relying to guarantee this product will not cause permanent harm (including death) to any recipient.

(d) The potential long term effects of this product are not known since it has not been tested long enough. Please supply any information (scientific data, emails, meeting notes etc.) which may indicate long term negative health impact of this product.

(e) Ashley Bloomfield states that before any individual is given this product a Health Care Provider will assess whether it is safe to administer to any particular individual. Please provide information which states what is meant by Health Care Provider. Please provide information which details the qualifications of a vaccinator who is not a recognised, registered health care professional.

(f) Please provide the assessment criteria the Health Care Provider/vaccinator will use to determine suitability/safety of this product for a particular individual.

(g) Please supply a list of all the ingredients in this product both active and inactive and please supply details of human cell lines used in the manufacture of this product.

(h) Please supply information (scientific data, emails, meeting notes) that clarifies whether the lipid nano-particles in this product will/will not cross the blood brain barrier.

(i) Please supply the data you have on record (peer reviewed science, emails, meeting notes other correspondence with Pfizer) that indicates the expected allergic response to poly-ethylene glycol (PEG) contained within this product.

(j) Please supply information (peer reviewed scientific data, emails, meeting notes etc) which confirm mRNA fragments in this product will not have long term genetic consequences to human biology.The government fact sheet ((https://covid19.govt.nz/assets/resources... ) clearly states that there is no possibility this product will affect DNA. Please supply the definitive evidence being relied on by government for that statement and that clearly shows that reverse transcriptase activity within the cell is incapable of incorporating product mRNA into human DNA.

(k) Please supply information (peer reviewed scientific data, emails, meeting notes etc) you have on record which confirms that antibody dependent enhancement which may lead to exacerbation of Covid 19 symptoms will not occur.  

Data from the study of SARS-CoV and other respiratory viruses suggest that anti-SARS-CoV-2 antibodies could exacerbate COVID-19 through antibody-dependent enhancement (ADE) - https://pubmed.ncbi.nlm.nih.gov/32908214/

(l) Please supply information (peer reviewed scientific data, emails, meeting notes etc) which you have on record regarding the matter of viral immune escape in relation to this product.

5. Please supply information (peer reviewed scientific data, emails, meeting notes etc) that is on record which details the isolation of the virus named SARS CoV 2 .

6. If someone is already immune to SARS CoV 2, assessed by antibody titre, then provide information you have as to why they would need to take this product to protect them.

7.Please supply information the government is relying on to deny the New Zealand population the access to proven therapeutic interventions including Ivermectin, Hydroxy-chloroquine / zinc.

8.Please supply information on record the government is using to deny the New Zealand population the information necessary to maintain a strong immune function particularly the role of vitamin D in maintaining a healthy immune system.

9. The Medicines Act 1981 section 23 states that a NEW medicine (which this product is) may be given provisional use authorisation for a LIMITED number of people. Please provide the legislation which authorises the minister to override this statute and give this product to the whole population.

I thank you for your kind attention.

Yours faithfully,

Andrew Lewis

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From: Andrew Lewis

Dear Ministry of Health,

Please tell me why there is a delay supplying the information I my requested?

Thank you for your kind attention
Yours faithfully,

Andrew Lewis

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From: OIA Requests

Good morning Andrew, 
Can you please provide a reference that was received in response to your
request. 
Alternatively, can you please resend your OIA request to us for us to
search for you. 
Kind regards,
OIA

--------------------------------------------------------------------------

From: Andrew Lewis <[FOI #15147 email]>
Sent: Sunday, 16 May 2021 22:00
To: OIA Requests <[email address]>
Subject: Re: Official Information request - Request for further
information regarding SARS CoV 2 vaccination program
 
Dear Ministry of Health,

Please  tell me why there is a delay supplying the information I my
requested?

Thank you for your kind attention
Yours faithfully,

Andrew Lewis

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References

Visible links
1. https://scanmail.trustwave.com/?c=15517&...

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From: Andrew Lewis

Dear OIA Requests,
Andrew Lewis,

Below is s a copy of the receipt email .

In the reply you sent just now is the transcript of the request and here is the link to the request which I note appears to have had its status removed. Previously it was showing status delayed. Why has that been changed?

https://fyi.org.nz/request/15147-request...

Receipt email
Please click on the link below to confirm your email address. Then your Official Information request to Ministry of Health will be sent.

https://fyi.org.nz/c/knunewijkuo851yhz87

We will not reveal your email address to anybody unless you or the law tell us to.

-- the FYI team

Yours sincerely,

Andrew Lewis

Link to this

From: OIA Requests

Hi Andrew,
Thank you for your prompt response. 
Due to administrative error your OIA has now been logged and we will
endeavour to provide you with a response as soon as possible.
Please note the information below appears to be information sent between
you and the FYI website.
In the reply you sent  just now is the transcript of the request and here
is the link to the request which I note appears to have had its status
removed. Previously it was showing status delayed. Why has that been
changed?
Kind regards,
OIA

--------------------------------------------------------------------------

From: Andrew Lewis <[FYI request #15147 email]>
Sent: Monday, 17 May 2021 10:54
To: OIA Requests <[email address]>
Subject: Re: Official Information request - Request for further
information regarding SARS CoV 2 vaccination program
 
Dear OIA Requests,
Andrew Lewis,

Below is s a copy of the receipt email .

In the reply you sent  just now is the transcript of the request and here
is the link to the request which I note appears to have had its status
removed. Previously it was showing status delayed. Why has that been
changed?

[1]https://scanmail.trustwave.com/?c=15517&...

Receipt email
Please click on the link below to confirm your email address. Then your
Official Information request to Ministry of Health will be sent.

[2]https://scanmail.trustwave.com/?c=15517&...

We will not reveal your email address to anybody unless you or the law
tell us to.

-- the FYI team

Yours sincerely,

Andrew Lewis

show quoted sections

Link to this

From: OIA Requests


Attachment image001.jpg
3K Download


Kia ora

 

Thank you for your request for official information received 13 April 2021
for:

 

            " Please supply references to peer reviewed scientific papers
the government is relying on to support the implied claim that this
product actually performs the actions of a vaccine. Please supply
references to the peer reviewed science and any information in emails or
meeting notes the government is relying on to prove that this product
stops transmission of SARS CoV2 between individuals and prevents infection
by SARS CoV2?

 

2. The government claims the product has been used ‘successfully all
around the world’. Please supply the data the government is relying on to
make this claim and please supply any data and/or correspondence which
defines what successful means in this context.

 

Effectiiveness:

 

(a) The government is claiming 95% effectiveness for this product. Please
supply references to peer reviewed science and/or correspondence with
Pfizer to substantiate this claim and that shows this claim includes 95%
effectiveness in stopping transmission and 95% effectiveness in preventing
the recipient of the product from subsequently contracting the disease and
that details how long any protection will last? Ashley Bloomfield in the
video on Ministry of Health web site states that ‘our research’ indicated
protection for 8 months. Please supply the ‘our research’ he is referring
to. He also says the expectation is for a longer period of protection.
Please supply the information on which that statement is based.

 

(b) Ashley Bloomfield clearly states in the video on Ministry of Health
website that the vaccine may not fully protect all who receive it. Please
supply any data on record (scientific reviews, emails, meeting notes etc.)
that clarifies what is meant by full protection and how ‘all’ is
quantitatively defined.

 

(c) Please supply references to peer reviewed science detailing the NNT
for this product.

 

(d) Please provide any information (peer reviewed scientific data, emails,
meeting notes etc.) on record which affirms that the product will protect
not only against the current SARS CoV 2 virus but against future variants
of said virus.

 

4. Safety:

 

(a)Please provide the results of Medsafe’s own safety testing and any
other information that proves the product has been subjected to all the
normal safety trials which would ordinarily be needed to give approval for
use in the New Zealand population? Please supply information the
government is relying on to confirm or deny that approval in this context
means emergency use authorisation.

 

(b) Ashley Bloomfield in his video presentation clearly states that this
product has been subjected to the same high safety standards as other
vaccines. Please supply any information (scientific data, emails, meeting
notes etc.) on which this statement is based.

 

(c) Please supply information the government is relying to guarantee this
product will not cause permanent harm (including death) to any recipient.

 

(d) Please supply any information (scientific data, emails, meeting notes
etc.) which may indicate long term negative health impact of this product.

 

(e) Please provide information which states what is meant by Health Care
Provider. Please provide information which details the qualifications of a
vaccinator who is not a recognised, registered health care professional.

 

(f) Please provide the assessment criteria the Health Care
Provider/vaccinator will use to determine suitability/safety of this
product for a particular individual.

 

(g) Please supply a list of all the ingredients in this product both
active and inactive and please supply details of human cell lines used in
the manufacture of this product.

 

(h) Please supply information (scientific data, emails, meeting notes)
that clarifies whether the lipid nano-particles in this product will/will
not cross the blood brain barrier.

 

(i) Please supply the data you have on record (peer reviewed science,
emails, meeting notes other correspondence with Pfizer) that indicates the
expected allergic response to poly-ethylene glycol (PEG) contained within
this product.

 

(j) Please supply information (peer reviewed scientific data, emails,
meeting notes etc) which confirm mRNA fragments in this product will not
have long term genetic consequences to human biology.The government fact
sheet clearly states that there is no possibility this product will affect
DNA. Please supply the definitive evidence being relied on by government
for that statement and that clearly shows that reverse transcriptase
activity within the cell is incapable of incorporating product mRNA into
human DNA.

 

(k) Please supply information (peer reviewed scientific data, emails,
meeting notes etc) you have on record which confirms that antibody
dependent enhancement which may lead to exacerbation of Covid 19 symptoms
will not occur.

 

(l) Please supply information (peer reviewed scientific data, emails,
meeting notes etc) which you have on record regarding the matter of viral
immune escape in relation to this product.

 

5. Please supply information (peer reviewed scientific data, emails,
meeting notes etc) that is on record which details the isolation of the
virus named SARS CoV 2 .

 

6. If someone is already immune to SARS CoV 2, assessed by antibody titre,
then provide information you have as to why they would need to take this
product to protect them.

 

7.Please supply information the government is relying on to deny the New
Zealand population the access to proven therapeutic interventions
including Ivermectin, Hydroxy-chloroquine / zinc.

 

8.Please supply information on record the government is using to deny the
New Zealand population the information necessary to maintain a strong
immune function particularly the role of vitamin D in maintaining a
healthy immune system.

 

9. The Medicines Act 1981 section 23 states that a NEW medicine (which
this product is) may be given provisional use authorisation for a LIMITED
number of people. Please provide the legislation which authorises the
minister to override this statute and give this product to the whole
population."

 

The Ministry's reference number for your request is: H20210XXX.

 

Due to an administrative error your request was not logged in our system.
We apologise for any inconvenience. We will endeavour to respond to your
request as soon as possible.   

 

If you have any queries related to this request, please do not hesitate to
get in touch.

 

Ngâ mihi

 

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [email address]

 

 

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From: Andrew Lewis

Dear OIA Requests,
You have not given any answers???

Yours sincerely,

Andrew Lewis

Link to this

From: OIA Requests


Attachment image001.png
7K Download

Attachment H202106023.pdf
237K Download View as HTML


Kia ora

 

Please find attached a letter regarding your request for official
information. We apologise for the delay in getting this to you.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [email address]

 

 

show quoted sections

Link to this

From: Andrew Lewis

Dear OIA Requests,

Dear Chris

Thank you for your response to my request and I accept your apologies for the delay.

In your second paragraph you say parts 1,2,3,4 (b) to (d) and (h) to (l) 5,6,7,and 8 are asking for comment, I apologise for that confusion I thought I was asking for information and the definitions were given for clarification. If I’d have known that you were going to answer my request in person then I would not have included that information as I am sure you are knowledgable about what a vaccine is (historically) and what absolute risk reduction is.

I note that you say “the information requested is not held by the ministry and there are no grounds for believing it is held by another agency subject to the act”. To clarify, am I to understand the ministry of health has no information concerning the points requested in the above paragraph and related to the original request?

Regarding 4(a) I am aware of the approval status of Cormirnaty under section 23 of the medicines act. This does not confirm that Medsafe has done its own safety testing does it? I assume there is none unless rebutted.

One final request, please supply the Comirnaty vaccine package insert information.

Thank you for your kind attention

Yours sincerely,

Andrew Lewis

Link to this

From: OIA Requests

Kia ora Andrew Lewis

Confirming that the Ministry of Health stands by its decision to refuse parts 1,2,3,4 (b) to (d) and (h) to (l) 5,6,7,and 8.

The Comirnaty COVID-19 vaccine data sheet is publicly available at: https://www.medsafe.govt.nz/profs/Datash...

Ngā mihi

OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]

Confirming that the

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Link to this

From: Andrew Lewis

Dear OIA Requests, [a name would be nice, give it a more personal approach and show there is an individual taking responsibility for the response]

Thank you for confirming that the Ministry of Health has no information on file to be able to respond to my request.
Please do not insult my intelligence by offering a vaccine data sheet reference when I requested the package insert which as you know all vaccines have as detailed here
https://www.vaccinesafety.edu/package_in...
You will note Covid 19 vaccine is missing from this list.

Yours sincerely,

Andrew Lewis

Link to this

From: OIA Requests


Attachment image001.png
7K Download

Attachment H202107070.pdf
1.1M Download View as HTML


Kia ora Andrew

 

Please find attached a letter regarding your request for official
information.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [email address]

 

 

show quoted sections

Link to this

From: Andrew Lewis

Dear OIA Requests,
Thank you for your response. In answer to your statement - 'I trust this information fulfils your request." No it does not. The information supplied is NOT a vaccine package insert is it? As you are aware, or should be aware, a vaccine package insert contains information such as contraindications, warnings and precautions, adverse reactions, drug interactions, incidence of adverse reactions. I won't go on, I think the message is clear. This is the reason for the request , to have access to the said information.

For the third time of asking, please supply the package insert for Comirnaty, i.e the information which usually accompanies every vaccine made.

Yours sincerely,

Andrew Lewis

Link to this

From: OIA Requests

Kia ora Andrew,

Thank you for your further correspondence relating to your Official Information Act Request. I acknowledge that you are not satisfied with the information we have provided you to date.

The documentation provided to you in the letter dated 21 June, including the 'Dear Healthcare Professional' letter as well as the 'Instructions for multi-dose vial Pfizer/BioNTech vaccine: preparation and administration' is supplied to all vaccination providers within every delivery of Pfizer COVID-19 vaccine. At this time, no further product specific documentation is accompanied with Pfizer deliveries and therefore, the Pfizer COVID-19 vaccine (Comirnaty).

The product labels also include a QR code, which when scanned accesses New Zealand-specific product information for Comirnaty.

For healthcare professionals, this information is consistent with the New Zealand data sheet and includes details of the contraindications, warnings and precautions, adverse reactions, drug reactions and incidence of adverse reactions. This data sheet is publicly available at: www.medsafe.govt.nz/profs/Datasheet/c/co....

For others who are not healthcare professionals this information is the New Zealand Consumer Medicine Information (CMI) document. This document is also publicly available at: www.medsafe.govt.nz/Consumers/CMI/c/comi....

Please note that package inserts are not required to be provided with any medicines in New Zealand, however all relevant product information can be found in the data sheet or CMI on the Medsafe website.

Educational resources and information pamphlets and posters on COVID-19 immunisation can be found on the following link: www.health.govt.nz/our-work/diseases-and....

We have provided you all information that the Ministry of Health holds in relation to your request and as such, we can be of no further assistance to you at this time.

Ngā mihi

OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]

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Virginia Crawford left an annotation ()

Although there has been a vast improvement on the information available to "consumers", a CRITICAL piece of information is still missing, namely that the rollout of Cominarty is still EXPERIMENTAL and that the trial is still ongoing.

It has been suggested that with millions of doses having been administered world wide, the vaccine has now been proved to be safe and effective.

What this means however is that the TRIAL is simply a VERY LARGE one.

Furthermore, considerably more than 20,000 people have already reportedly died, with this number increasing daily.

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