Kia ora,

 

Thank you for your request for official information received on 12 January
2022.

 

The Ministry of Health has consolidated this request with your earlier
request for official information under reference number: H202200226.  

 

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 10 February 2022, being
20 working days after the day your request was received.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. 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: [1][email address]

 

-----Original Message-----
From: ASE <[FOI #18165 email]>
Sent: Wednesday, 12 January 2022 3:40 pm
To: OIA Requests <[email address]>
Subject: Official Information request - Ministry of Health roles and
obligations, relating to liability waiver for Pfizer

 

Attn Ministry of Health,

 

Regarding a prior OIA Request, reference # H2021111261, portions of
indemnity agreements have been released. Regarding these agreements,
particularly the agreement with Pfizer,

 

• This agreement assigns "liability for adverse effects associated with
use of the vaccine" to ACC.

 

How was ACC consulted as part of this negotiation process?

 

• This agreement says "The liability associated with claims not covered by
ACC is relatively low-risk".

 

What liability is this referring to? How was this risk assessed?

 

• This agreement says "The potential economic and social benefits of a
vaccine are uncertain. The Ministry of Health is beginning work on
economic modelling in this area. The potential benefits depend on many
factors including how long and in what population groups the vaccine gives
protection, and how and when herd immunity can be achieved."

 

What evidence is there that these treatments can, or ever could, provide
"herd immunity" as a benefit? What evidence is there that these treatments
are "safe and effective", and that long-term benefits exceeds long-term
risks?

 

This clause appears to hold The Ministry of Health to an obligation to
conduct cost/benefit analyses regarding these treatments. Is that correct?
As recently as October 2021, The Ministry of Health has responded to
requests for a cost/benefit analysis, stating, "Your request for a cost
benefit analysis is refused under section 18(e) of the Act, as the
information does not exist." Why have such cost/benefit analyses not been
done?

 

• This agreement states "Medsafe is developing a strategy for monitoring
the vaccine once it is being used. This may include adverse reaction
reporting, active monitoring (via SMS text and real time analysis),
requirements on companies to provide adverse reaction information
globally, and sharing monitoring data with other regulators to identify
safety issues. This monitoring will allow Medsafe to take timely action if
a safety issue emerges."

 

Aside from pre-existing monitoring systems, what is the current state of
such monitoring strategies which have been developed specifically for this
purpose, and how has that evolved? What signals, thresholds and other
quantifiable metrics have been put in place to raise concerns, and what
policies are in place to act if/when those events happen?

 

What monitoring systems have been proposed or considered, but not
implemented? Why have such monitoring systems not been implemented?

 

• This agreement states "they are developing it in accelerated clinical
trials that are less likely than non-accelerated trials to detect uncommon
adverse effects or possible contraindications", and "most trials will be
shorter in length and study fewer people than what is typical. The impact
is a reduction in the known safety profile of the vaccine".

 

Given these acknowledgements, what is the basis of claims that no
shortcuts have been taken to ensure safety?

 

eg, "The vaccines have been developed very quickly but without taking any
shortcuts in the necessary processes or compromising safety."  -
[2]https://www.health.govt.nz/our-work/dise...

 

eg, "Study designs and regulatory approaches will vary between COVID-19
vaccine applicants, but most trials will be shorter in length and study
fewer people than what is typical. The impact is a reduction in the known
safety profile of the vaccine" - ibid

 

eg, "No shortcuts" in granting approval -

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

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

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

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

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

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

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

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

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

 

eg, NZ Vaccine Facts: Are vaccines safe? -
[12]https://scanmail.trustwave.com/?c=15517&...

 

nb, what data does The Ministry of Health hold, to substantiate the claims
in that video that "evidence shows that if you get a double dose, you're
far less likely to […] pass the virus on to others"? Is the The Ministry
of Health aware of US CDC statements since early August 2021 that "what
[vaccines] can’t do anymore is prevent transmission"? How has this
information guided The Ministry of Health?

 

• This agreement states "For example, RNA vaccines like BNT162 have not
previously been approved for human use in New Zealand and will require a
careful risk-benefit assessment as part of the regulatory approval
process."

 

With The Ministry of Health very actively "encouraging" (ie coercing)
everyone older than 12 to be subject to this treatment, and "offering" it
to children aged 5 and older, and (as of this writing) boasting about 92%
of people being "fully vaccinated" and 95% of people "partially
vaccinated", what "careful risk-benefit assessment" has been completed?

 

As recently as December 2021, when asked about risk-benefit assessments,
The Ministry of Health cited a paper stating: “The benefit risk balance of
Comirnaty (COVID-19 mRNA Vaccine) for active immunisation to prevent
coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals
16 years of age and older, is not clear”, and specifically regarding young
children, "Safety and efficacy have not been established in children under
16 years of age."

 

• This agreement states "A key aspect of our communications and engagement
approach is to recognise and acknowledge that public expectations of
potential vaccines may be unrealistic, and to actively manage these
expectations as part our stakeholder and public communication. This will
help to mitigate the risk of any claims relating to an ineffective vaccine
or negligent misstatement."

 

To what extent has The Ministry of Health been obligated to "actively
manage [public] expectations" of these treatments, or otherwise "mitigate
the risk of any claims relating to an ineffective vaccine or negligent
misstatement"? Please cite all examples of this contractual obligation
having influence over Ministry of Health messaging, policies, or any other
activities.

 

How exactly does The Ministry of Health define "ineffective vaccine"? How
has that definition changed since this agreement was drafted? How can The
Ministry of Health consider a vaccine to be effective (or even called a
"vaccine") if it does not protect against infection, does not protect
against disease transmission, does not confer herd immunity, selects for
vaccine-evasive variants, provides efficacy only in terms of symptom
suppression, provides that efficacy only for a period of months (with the
possibility that duration of efficacy shortens with additional treatment,
while risks and consequences of adverse effects may accumulate), has
unknown long-term safety consequences, and appears to confer negative
efficacy within months, particularly to new vaccine-evasive or
vaccine-preferential variants?

 

What parties does The Ministry of Health consider to be "stakeholders" in
these matters? Does The Ministry of Health consider the general public to
be a stakeholder that The Ministry of Health has an obligation to
represent in these matters? How does The Ministry of Health balance the
public health of the general public against other stakeholders, as this
clause requires?

 

• This agreement states "This vaccine candidate is an RNA vaccine. Due to
the relative newness of this platform, and truncated clinical trials
(which means a reduced ability to identify rare or long-term side
effects), we are unlikely to want to immunise the entire population using
solely this vaccine candidate."

 

With The Ministry of Health very actively "encouraging" (ie coercing)
everyone older than 12 to be subject to this treatment, and "offering" it
to children aged 5 and older, and (as of this writing) boasting about 92%
of people being "fully vaccinated" and 95% of people "partially
vaccinated", please explain how current policies are aligned with the
intention and rationale of this contractual clause.

 

Thank you

ASE

 

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

 

This is an Official Information request made via the FYI website.

 

Please use this email address for all replies to this request:

[13][FOI #18165 email]

 

Is [14][Ministry of Health request email] the wrong address for Official Information
requests to Ministry of Health? If so, please contact us using this form:

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

 

Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:

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

 

If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.

 

 

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

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References

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2. https://www.health.govt.nz/our-work/dise...
3. https://scanmail.trustwave.com/?c=15517&...
4. https://scanmail.trustwave.com/?c=15517&...
5. https://scanmail.trustwave.com/?c=15517&...
6. https://scanmail.trustwave.com/?c=15517&...
7. https://scanmail.trustwave.com/?c=15517&...
8. https://scanmail.trustwave.com/?c=15517&...
9. https://scanmail.trustwave.com/?c=15517&...
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11. https://scanmail.trustwave.com/?c=15517&...
12. https://scanmail.trustwave.com/?c=15517&...
13. mailto:[FOI #18165 email]
14. mailto:[Ministry of Health request email]
15. https://scanmail.trustwave.com/?c=15517&...
16. https://scanmail.trustwave.com/?c=15517&...

hide quoted sections

Tēnā koe ASE,

 

Thank you for your requests under the Official Information Act 1982 (the
Act) to the Ministry of Health (the Ministry) on 12 January 2022 for
information regarding the COVID-19 response. Each point of your request is
answered in turn.

 

A list of all advisory boards, panels, and any other groups or individuals
providing information or advice to The Ministry of Health in regards to
COVID-19 and related matters.

 

For each of those boards, panels, and any other groups or individuals, in
what capacity are they engaged with The Ministry of Health; eg what is
their defined role, purpose, scope.

 

For each of those boards, panels, and any other groups or individuals,
what advice have they provided to The Ministry of Health, and how has that
advice been actioned or not actioned?

 

A full disclosure of all conflicts of interest (including, but not
necessarily limited to financial and economic conflicts of interest,
professional and employment conflicts of interest, political and
ideological conflicts of interest), by all persons who are in those
advisory boards, panels, and any other such groups.

 

No list exists detailing all who contribute to the Ministry’s COVID-19
health response. As such, these parts of your request are refused under
section 18(g)(i) as 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. Please note, the Ministry receives advice on matters
relating to COVID-19 from a wide range of teams and groups across the
Ministry. The Ministry also consult with many individuals, both internally
and externally. The details of expert groups who provide leadership in key
health areas, including some related to COVID-19, is available on the
Ministry’s website
at: [1]www.health.govt.nz/about-ministry/leadership-ministry/expert-groups.

 

As it relates to the earlier part of this request, I would like to know
what policies, rules, guidance and protocols are in place to prevent
conflicts of interest. I would like to know how conflicts of interest are
assessed, monitored, and managed. I would like to know what actions have
been taken to assure that conflicts of interest do not adversely affect
public health advice that The Ministry of Health is receiving. I would
like to know what protocols are in place to ensure that The Ministry of
Health is holding itself accountable to its own rules.

 

Information relating to conflicts of interest is publicly available on the
Office of the Auditor-General’s website
at: [2]oag.parliament.nz/2020/conflicts/docs/conflicts-of-interest.pdf.

 

Regarding a prior OIA Request, reference # H2021111261, portions of
indemnity agreements have been released. Regarding these agreements,
particularly the agreement with Pfizer,

 

This agreement assigns "liability for adverse effects associated with use
of the vaccine" to ACC.

 

How was ACC consulted as part of this negotiation process?

 

This agreement says "The liability associated with claims not covered by
ACC is relatively low-risk".

 

What liability is this referring to? How was this risk assessed?

 

What evidence is there that these treatments can, or ever could, provide
"herd immunity" as a benefit? What evidence is there that these treatments
are "safe and effective", and that long-term benefits exceeds long-term
risks?

 

This clause appears to hold The Ministry of Health to an obligation to
conduct cost/benefit analyses regarding these treatments. Is that correct?
As recently as October 2021, The Ministry of Health has responded to
requests for a cost/benefit analysis, stating, "Your request for a cost
benefit analysis is refused under section 18(e) of the Act, as the
information does not exist." Why have such cost/benefit analyses not been
done?

 

Aside from pre-existing monitoring systems, what is the current state of
such monitoring strategies which have been developed specifically for this
purpose, and how has that evolved? What signals, thresholds and other
quantifiable metrics have been put in place to raise concerns, and what
policies are in place to act if/when those events happen?

 

What monitoring systems have been proposed or considered, but not
implemented? Why have such monitoring systems not been implemented?

 

Given these acknowledgements, what is the basis of claims that no
shortcuts have been taken to ensure safety?

 

nb, what data does The Ministry of Health hold, to substantiate the claims
in that video that "evidence shows that if you get a double dose, you're
far less likely to […] pass the virus on to others"? Is the The Ministry
of Health aware of US CDC statements since early August 2021 that "what
[vaccines] can’t do anymore is prevent transmission"? How has this
information guided The Ministry of Health?

 

With The Ministry of Health very actively "encouraging" (ie coercing)
everyone older than 12 to be subject to this treatment, and "offering" it
to children aged 5 and older, and (as of this writing) boasting about 92%
of people being "fully vaccinated" and 95% of people "partially
vaccinated", what "careful risk-benefit assessment" has been completed?

 

How exactly does The Ministry of Health define "ineffective vaccine"? How
has that definition changed since this agreement was drafted? How can The
Ministry of Health consider a vaccine to be effective (or even called a
"vaccine") if it does not protect against infection, does not protect
against disease transmission, does not confer herd immunity, selects for
vaccine-evasive variants, provides efficacy only in terms of symptom
suppression, provides that efficacy only for a period of months (with the
possibility that duration of efficacy shortens with additional treatment,
while risks and consequences of adverse effects may accumulate), has
unknown long-term safety consequences, and appears to confer negative
efficacy within months, particularly to new vaccine-evasive or
vaccine-preferential variants?

 

What parties does The Ministry of Health consider to be "stakeholders" in
these matters? Does The Ministry of Health consider the general public to
be a stakeholder that The Ministry of Health has an obligation to
represent in these matters? How does The Ministry of Health balance the
public health of the general public against other stakeholders, as this
clause requires?

 

With The Ministry of Health very actively "encouraging" (ie coercing)
everyone older than 12 to be subject to this treatment, and "offering" it
to children aged 5 and older, and (as of this writing) boasting about 92%
of people being "fully vaccinated" and 95% of people "partially
vaccinated", please explain how current policies are aligned with the
intention and rationale of this contractual clause.

 

The agreement that you are referring to were business cases released in
response to OIA request H2021111261. These were sent to the requester by
the Ministry for Business, Innovation and Employment (MBIE) not the
Ministry of Health. You should direct your questions regarding the
contents of the business cases to MBIE.

As you have noted in your request, the New Zealand Government has granted
Pfizer indemnity from any claims that may arise from use of their COVID-19
vaccine (Comirnaty). It is important to note, it is not unexpected for
pharmaceutical companies to seek indemnities from governments in
circumstances where clinical trials are restricted, or where a purchase
agreement is concluded before full trials are completed. Further details
about indemnity granted to Pfizer are commercially sensitive and withheld
under section 9(2)(b)(ii) where its release would likely unreasonably
prejudice the commercial position of the person who supplied the
information.

 

Furthermore, while the Act allows New Zealanders to ask for information
from Ministers and government agencies, there is no requirement for
agencies to prove an opinion. Parts of your questions and the statements
that support them appear designed to engage in a debate about the
Government’s COVID-19 vaccination programme, rather than a request for
official information. As such, the remaining parts of your request are
refused under section 18(g) of the Act.

 

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

 

[4]Ministry of Health information releases

[5]Unite against COVID-19

 

 

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References

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2. https://oag.parliament.nz/2020/conflicts...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/

hide quoted sections

Thank you for your Official Information Act request. This is
an automatic reply to let you know we received it.

In accordance with the Act, we'll let you know our decision within no more
than 20 working days. If you'd like to calculate the timeframe, you can
use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. This
means we may take some time in responding to your request. The Ministry
regularly updates information about the COVID-19 situation and publishes
OIA responses considered to be of public interest:
[2]https://www.health.govt.nz/about-ministr...

Please also refer to the Unite Against Covid-19 website for copies of
papers, minutes, and key advice for the decisions the Government has made
relating to COVID-19.

Sometimes we may need to clarify aspects of a request. You can expect to
hear from us soon if that is the case here.

Ngā mihi,

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [3][email address]

 

 

 

 

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