Responsibility of Ian Town to provide unbiased science advice

J Bruning made this Official Information request to Ministry of Health

The request was successful.

From: J Bruning

Dear Ministry of Health,
This is a request for information from Ian Town.

BACKGROUND TO THE REQUEST.
Ian Town has responsible positions as:
Chief Science Advisor to the Ministry of Health;
Chair of the Ministry of Business, Innovation and Employment - COVID-19 Vaccine Strategy Science and Technical Advisory Group to March 2021.
Chair of the Ministry of Health COVID-19 Vaccine Technical Advisory Group (CV TAG) from March onwards
COVID-19 Technical Advisory Group

These positions place you in a senior position with significant oversight and power relating to the provision of science advice throughout the duration of the COVID-19 pandemic.
In this position you are responsible for not just supplying information that supports policy, but you have responsibility for supplying controversial information (as per the Cabinet Manual) to relevant Ministers.

In addition, the provision of science advice should be based on robust science. Principles of administrative law require that all relevant considerations must be taken into account in the formulation of policy.

This mRNA vaccine is a novel gene therapy; it reduces symptoms and so does not conform to the standard parameters expected of a vaccine. The original clinical trials demonstrated that cardiac events were higher in the placebo group.

As the senior science advisor, it would be expected that your role would include overseeing rolling reviews of the scientific literature to understand and identify risk relating to vaccine efficacy and safety, and the evidence relating to existing treatments that had a long history of safe use (therefore did not require rigorous clinical trials to establish safety) which could be recommended for treatment based on the Bradford Hill criteria. These treatments would also be important for vulnerable multimorbid patients where polypharmacy resulted in increased risk of side effects from treatment mixtures. Newer treatments would not provide such assurance.

As science advisor such reviews were important because:
1. The government was planning for the entire population to submit to the novel gene therapy. The New Zealand government signalled its policy position of population-level vaccine take-up by purchasing sufficient vaccines for the entire country, and the Auditor-General’s office released a report on the design and planning of the wider roll-out. https://oag.parliament.nz/2021/vaccines/...
2. People were mandated as a condition of employment to accept the novel gene therapy.
3. The novel gene therapy was authorised based on provisional consent, which meant that it evaded long term clinical trial testing; and the existing trials were underpowered in relation to risk concerning immunosuppressed and multimorbid populations.
4. There was no compulsory reporting system for adverse events, which was previously accepted convention for medicines released under emergency use authorisation. It is well known that under-reporting of iatrogenic harm is a legacy of voluntary reporting systems (Lazarus Report).
5. From an early stage it was understood that it was only the elderly and infirm, and the severely multimorbid, who were at risk. This created a risk profile for those who were not at risk of COVID-19 being placed at risk from the mRNA gene therapy.
6. Vaccinations were introduced in other countries (such as Israel) much earlier than in New Zealand, and this gave New Zealand scientists, as well as officials and civil society, the opportunity to understand the risk profile of the mRNA gene therapy as recorded in the white, grey and peer reviewed scientific literature.
7. Risk is a matter of judgement and information. Safety signals need not accrue before investigation, as the FDA has acknowledged, ‘it only takes a single well-documented adverse event to justify a safety signal investigation’
8. The provisional consent granted to Pfizer was narrowly dependent on Pfizer supplying data. This created an ethical black box as not only was the data hidden via commercial in confidence agreements, much of the data remained unpublished and not exposed to public peer review. Therefore norms of transparency and accountability would entail that independent public sector scientists would be reviewing the published literature using methodological review protocols to communicate information on risk to officials and to Ministers.

This is important as from February 2021, the white literature, such as Pfizer’s post marketing study, demonstrated that 1223 deaths had were reported by February 28th 2021.
See: BNT162b2. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event
Reports. FDA-CBER-2021-5683-0000054. https://drtrozzi.org/wp-content/uploads/...
authorization-Adverse-Event-Reports.pdf

Kiwis are vulnerable to cardiac arrest. The Pfizer-paid Thomas et al. 6 month safety and efficacy paper demonstrated that in the placebo group, one person had a cardiac arrest, while in the BNT162b2 four participants died from cardiac arrest.

In addition, the peer reviewed literature demonstrated that mRNA vaccines were susceptible to waning and breakthrough infection was more common than was communicated in New Zealand media. Israel, who like New Zealand almost exclusively used the BNT162b2 mRNA gene therapy, demonstrated that breakthrough in Delta was a significant problem. Once Omicron arrived the problem of waning and breakthrough increased, due to substantial mutations (Araf, Y. et al 2022).

The following studies were referred to Liz Craig and the Health Select Committee on October 11, 2021, prior to mandates:
Chau et al. An observational study of breakthrough SARS-CoV-2 Delta variant infections among vaccinated healthcare workers in Vietnam. EClinicalMedicine (2021) 41:101143
Shitrit et al. Nosocomial outbreak caused by the SARS-CoV-2 Delta variant in a highly vaccinated population, Israel, July 2021. July 2021.
Euro Surveill. 2021;26(39):pii=2100822. https://doi.org/10.2807/1560 7917.ES.2021.26.39.2100822
Gazit et al. Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity: reinfections versus breakthrough infections. medRxiv preprint. 10.1101/2021.08.24.21262415
Levine-Tiefenbrun et al. Viral loads of Delta-variant SARS-CoV2 breakthrough infections following vaccination and booster with the BNT162b2 vaccine. medRxiv preprint (2021) 10.1101/2021.08.29.21262798;
Brown et al. Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021. MMWR 20:31;1059-1062
Farinholt et al. Transmission event of SARS-CoV-2 Delta variant reveals multiple vaccine breakthrough infections. medRxiv (2021)
Servillita et al. Predominance of antibody-resistant SARS-CoV-2 variants in vaccine breakthrough cases from the San Francisco Bay Area, California. (2021) 10.1101/2021.08.19.21262139

Ethically, vaccine mandates would not occur for a vaccine that did not prevent transmission and infection, for a novel vaccine for which there was little safety data.

The question is, were the officials and Ministers supplied with such information or did the machinery of government look the other way, which would undermine administrative and public law - rule of law - principles.

OFFICIAL INFORMATION ACT REQUEST

Please supply the following, from February 2020 onwards:

(1) Directives and memos from yourself to New Zealand public health officials and scientists to review the published and peer-reviewed literature to analyse, understand and report on:

(a) Risk of adverse events temporally relate to injection of BNT162b2.
(b) Waning and breakthrough following injection for Delta and Omicron variants.
(c) Evidence for treatments using existing and repurposed medications with a long history of safe use Delta and Omicron variants.
(d) Data on natural immunity Delta and Omicron variants.

(2) Allocated funding to undertake this work.

(3) Where such work is not undertaken please forward all relevant information such as terms of reference, reports, work scopes etc. that demonstrate that the above reviews of the scientific literature were not necessary/required or otherwise.

(4) Please advise who was in charge of undertaking and producing such reviews to supply this information to the relevant Ministers if this was not yourself in your capacity as Chief Science Advisor and as Chair of multiple COVID-19 committees.

Thank you

Yours faithfully,

J Bruning

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Kia ora,  

  

Thank you for your request for official information. The Ministry's
reference number for your request is: H2022009819.  

  

As required under the Official Information Act 1982, the Ministry 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 related to this request, please do not hesitate to
get in touch. 

 

Ngā mihi 

  

OIA Services Team 

M[2]inistry of Health information releases 
U[3]nite against COVID-19 

 
------------------- Original Message -------------------
From: J Bruning <[FOI #20192 email]>;
Received: Tue Aug 09 2022 17:10:20 GMT+1200 (New Zealand Standard Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Responsibility of Ian Town to
provide unbiased science advice

Dear Ministry of Health,
This is a request for information from Ian Town.

BACKGROUND TO THE REQUEST.
Ian Town has responsible positions as:
Chief Science Advisor to the Ministry of Health;
Chair of the Ministry of Business, Innovation and Employment - COVID-19
Vaccine Strategy Science and Technical Advisory Group to March 2021.
Chair of the Ministry of Health COVID-19 Vaccine Technical Advisory Group
(CV TAG) from March onwards
COVID-19 Technical Advisory Group

These positions place you in a senior position with significant oversight
and power relating to the provision of science advice throughout the
duration of the COVID-19 pandemic.
In this position you are responsible for not just supplying information
that supports policy, but you have responsibility for supplying
controversial information (as per the Cabinet Manual) to relevant
Ministers.

In addition, the provision of science advice should be based on robust
science. Principles of administrative law require that all relevant
considerations must be taken into account in the formulation of policy.

This mRNA vaccine is a novel gene therapy; it reduces symptoms and so does
not conform to the standard parameters expected of a vaccine. The original
clinical trials demonstrated that cardiac events were higher in the
placebo group.

As the senior science advisor, it would be expected that your role would
include overseeing rolling reviews of the scientific literature to
understand and identify risk relating to vaccine efficacy and safety, and
the evidence relating to existing treatments that had a long history of
safe use (therefore did not require rigorous clinical trials to establish
safety) which could be recommended for treatment based on the Bradford
Hill criteria. These treatments would also be important for vulnerable
multimorbid patients where polypharmacy resulted in increased risk of side
effects from treatment mixtures. Newer treatments would not provide such
assurance.

As science advisor such reviews were important because:
1.      The government was planning for the entire population to submit to
the novel gene therapy. The New Zealand government signalled its policy
position of population-level vaccine take-up by purchasing sufficient
vaccines for the entire country, and the Auditor-General’s office released
a report on the design and planning of the wider roll-out.
[4]https://scanmail.trustwave.com/?c=15517&...
2.      People were mandated as a condition of employment to accept the
novel gene therapy.
3.      The novel gene therapy was authorised based on provisional
consent, which meant that it evaded long term clinical trial testing; and
the existing trials were underpowered in relation to risk concerning
immunosuppressed and multimorbid populations.
4.      There was no compulsory reporting system for adverse events, which
was previously accepted convention for medicines released under emergency
use authorisation. It is well known that under-reporting of iatrogenic
harm is a legacy of voluntary reporting systems (Lazarus Report).
5.      From an early stage it was understood that it was only the elderly
and infirm, and the severely multimorbid, who were at risk. This created a
risk profile for those who were not at risk of COVID-19 being placed at
risk from the mRNA gene therapy.
6.      Vaccinations were introduced in other countries (such as Israel)
much earlier than in New Zealand, and this gave New Zealand scientists, as
well as officials and civil society, the opportunity to understand the
risk profile of the mRNA gene therapy as recorded in the white, grey and
peer reviewed scientific literature.
7.      Risk is a matter of judgement and information. Safety signals need
not accrue before investigation, as the FDA has acknowledged, ‘it only
takes a single well-documented adverse event to justify a safety signal
investigation’
8.      The provisional consent granted to Pfizer was narrowly dependent
on Pfizer supplying data. This created an ethical black box as not only
was the data hidden via commercial in confidence agreements, much of the
data remained unpublished and not exposed to public peer review. Therefore
norms of transparency and accountability  would entail that independent
public sector scientists would be reviewing the published literature using
methodological review protocols to communicate information on risk to
officials and to Ministers.

This is important as from February 2021, the white literature, such as
Pfizer’s post marketing study, demonstrated that 1223 deaths had were
reported by February 28th 2021.
See: BNT162b2. 5.3.6 Cumulative Analysis of Post-authorization Adverse
Event
Reports. FDA-CBER-2021-5683-0000054.
[5]https://scanmail.trustwave.com/?c=15517&...
authorization-Adverse-Event-Reports.pdf

Kiwis are vulnerable to cardiac arrest. The Pfizer-paid Thomas et al. 6
month safety and efficacy paper demonstrated that in the placebo group,
one person had a cardiac arrest, while in the BNT162b2 four participants
died from cardiac arrest.

In addition, the peer reviewed literature demonstrated that mRNA vaccines
were susceptible to waning and breakthrough infection was more common than
was communicated in New Zealand media. Israel, who like New Zealand almost
exclusively used the BNT162b2 mRNA gene therapy, demonstrated that
breakthrough in Delta was a significant problem. Once Omicron arrived the
problem of waning and breakthrough increased, due to substantial mutations
(Araf, Y. et al 2022).

The following studies were referred to Liz Craig and the Health Select
Committee on October 11, 2021, prior to mandates:
Chau et al. An observational study of breakthrough SARS-CoV-2 Delta
variant infections among vaccinated healthcare workers in Vietnam.
EClinicalMedicine (2021) 41:101143
Shitrit et al. Nosocomial outbreak caused by the SARS-CoV-2 Delta variant
in a highly vaccinated population, Israel, July 2021. July 2021.
Euro Surveill. 2021;26(39):pii=2100822.
[6]https://scanmail.trustwave.com/?c=15517&...
7917.ES.2021.26.39.2100822
Gazit et al. Comparing SARS-CoV-2 natural immunity to vaccine-induced
immunity: reinfections versus breakthrough infections. medRxiv preprint.
10.1101/2021.08.24.21262415
Levine-Tiefenbrun et al. Viral loads of Delta-variant SARS-CoV2
breakthrough infections following vaccination and booster with the
BNT162b2 vaccine. medRxiv preprint (2021) 10.1101/2021.08.29.21262798;
Brown et al. Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine
Breakthrough Infections, Associated with Large Public Gatherings —
Barnstable County, Massachusetts, July 2021. MMWR 20:31;1059-1062
Farinholt et al. Transmission event of SARS-CoV-2 Delta variant reveals
multiple vaccine breakthrough infections. medRxiv (2021)
Servillita et al. Predominance of antibody-resistant SARS-CoV-2 variants
in vaccine breakthrough cases from the San Francisco Bay Area, California.
(2021) 10.1101/2021.08.19.21262139

Ethically, vaccine mandates would not occur for a vaccine that did not
prevent transmission and infection, for a novel vaccine for which there
was little safety data.

The question is, were the officials and Ministers supplied with such
information or did the machinery of government look the other way, which
would undermine administrative and public law - rule of law - principles.

OFFICIAL INFORMATION ACT REQUEST

Please supply the following, from February 2020 onwards:

(1) Directives and memos from yourself to New Zealand public health
officials and scientists to review the published and peer-reviewed
literature to analyse, understand and report on:

(a)     Risk of adverse events temporally relate to injection of BNT162b2.
(b)     Waning and breakthrough following injection for Delta and Omicron
variants.
(c)     Evidence for treatments using existing and repurposed medications
with a long history of safe use Delta and Omicron variants.
(d)     Data on natural immunity Delta and Omicron variants.

(2) Allocated funding to undertake this work.

(3) Where such work is not undertaken please forward all relevant
information such as terms of reference, reports, work scopes etc. that
demonstrate that the above reviews of the scientific literature were not
necessary/required or otherwise.

(4) Please advise who was in charge of undertaking and producing such
reviews to supply this information to the relevant Ministers if this was
not yourself in your capacity as Chief Science Advisor and as Chair of
multiple COVID-19 committees.

Thank you

Yours faithfully,

J Bruning

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Kia ora J Bruning,

Thank you for your request for official information, received on 9 August
2022 requesting: 

"(1) Directives and memos from yourself to New Zealand public health
officials and scientists to review the published and peer-reviewed
literature to analyse, understand and report on:

(a)     Risk of adverse events temporally relate to injection of BNT162b2.

(b)     Waning and breakthrough following injection for Delta and Omicron
variants.

(c)     Evidence for treatments using existing and repurposed medications
with a long history of safe use Delta and Omicron variants.

(d)     Data on natural immunity Delta and Omicron variants.

(2) Allocated funding to undertake this work.

(3) Where such work is not undertaken please forward all relevant
information such as terms of reference, reports, work scopes etc. that
demonstrate that the above reviews of the scientific literature were not
necessary/required or otherwise.

(4) Please advise who was in charge of undertaking and producing such
reviews to supply this information to the relevant Ministers if this was
not yourself in your capacity as Chief Science Advisor and as Chair of
multiple COVID-19 committees.”

 

The Ministry of Health has decided to extend the period of time available
to respond to your request under section 15A of the Official Information
Act 1982 (the Act) as further research and collation is required.

 

You can now expect a response to your request on, or before, 26 September
2022.

You have the right, under section 28 of the Act, to ask the Ombudsman to
review my decision to extend the time available to respond to your
request.

Ngâ mihi,

 

OIA Services

Government and Executive Services

Manatû Hauora Ministry of Health

 

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Kia ora J Bruning,

 

Thank you for your request under the Official Information Act 1982 (the
Act) to Manatû Hauora (Ministry of Health) on 9 August 2022. Please find a
response to each of your requests below.

 

1) Directives and memos from yourself to New Zealand public health
officials and scientists to review the published and peer-reviewed
literature to analyse, understand and report on:

(a)     Risk of adverse events temporally relate to injection of BNT162b2.

 

All COVID-19 Vaccine Technical Advisory Group (CV TAG) memos are available
here:
[1]www.health.govt.nz/about-ministry/leadership-ministry/expert-groups/covid-19-vaccine-technical-advisory-group-cv-tag.

For information related to this part of your request please refer to the
following documents:

o Myocarditis following vaccination: COVID-19 Vaccine Technical Advisory
Group (CV TAG) recommendations on the use of the Pfizer vaccine – 21
July 2021:
[2]www.health.govt.nz/system/files/documents/pages/20210721_-_cv_tag_myocarditis_following_vaccination.pdf
o Recommendations to provide a booster vaccination: COVID-19 Vaccine
Technical Advisory Group (CV TAG) – 10 November 2021:
[3]www.health.govt.nz/system/files/documents/pages/20211110_-_cv-tag_-_booster_vaccinations.pdf
o Decision to use the Pfizer mRNA COVID-19 vaccine for children aged
5-11 years: COVID-19 Vaccine Technical Advisory Group (CV TAG)
recommendations – 15 December 2021:
[4]www.health.govt.nz/system/files/documents/pages/20211215_-_cv_tag_-_decision_to_use_vaccine_in_5-11-year-olds.pdf
and;
o Booster doses after myocarditis/pericarditis: COVID-19 Vaccine
Technical Advisory Group (CV TAG) recommendations – 30 March 2022:
[5]www.health.govt.nz/system/files/documents/pages/cv_tag_boosters_after_myocarditis_and_pericarditis.pdf.

 

(b)     Waning and breakthrough following injection for Delta and Omicron
variants.

 

For information related to this part of your request please refer to the
following documents:

o Second booster update: COVID-19 Vaccine Technical Advisory Group (CV
TAG) recommendations – 22 June 2022:
[6]www.health.govt.nz/system/files/documents/pages/cv_tag_second_boosters_update.pdf.
o Recommendations on the COVID-19 booster vaccination interval for those
aged 18 years and over in the context of Omicron – 1 February 2022:
[7]www.health.govt.nz/system/files/documents/pages/20220201_-_cv_tag_recommendations_on_booster_interval.pdf.

 

(c)     Evidence for treatments using existing and repurposed medications
with a long history of safe use Delta and Omicron variants.

 

The Manatû Hauora COVID-19: Science news webpage is is public facing and
updated every two to three weeks. Please refer specifically to the 19 July
2021 update regarding Pharmaceutical treatments:
[8]www.health.govt.nz/system/files/documents/pages/csu_42_19_july_2021_covid-19_pharmaceutical_treatments_summary_conflicting_meta-analyses_of_ivermectin_updated_1.pdf.

 

(d)     Data on natural immunity Delta and Omicron variants.

 

For information related to this part of your request please refer to
COVID-19 Vaccine Technical Advisory Group (CV TAG) recommendations:
Vaccination after infection with SARS-CoV-2 - 22 March 2022:
[9]www.health.govt.nz/system/files/documents/pages/cv_tag_vaccination_after_infection.pdf

 

(2) Allocated funding to undertake this work.

 

Manatû Hauora does not hold or collect information down to the level
requested. Funding is allocated as a broader approach to research and
insights, and from this, decisions are made on the specific research
activities that are undertaken. While the Act allows New Zealanders to ask
for information from Ministers and government agencies, there is no
requirement for agencies to create new information or compile information
they do not hold. As such this part of your request is refused under
section 18(g)(i) of the Act, as the information requested is not held by
Manatû Hauora and there are no grounds for believing it is held by
another agency subject to the Act.

 

(3) Where such work is not undertaken please forward all relevant
information such as terms of reference, reports, work scopes etc. that
demonstrate that the above reviews of the scientific literature were not
necessary/required or otherwise.

 

Manatû Hauora does not hold information relating to this part of your
request. As such, this part of your request is refused under section
18(g)(i) as the information requested is not held by Manatû Hauora and
there are no grounds for believing it is held by another agency subject to
the Act.

 

(4) Please advise who was in charge of undertaking and producing such
reviews to supply this information to the relevant Ministers if this was
not yourself in your capacity as Chief Science Advisor and as Chair of
multiple COVID-19 committees.

 

The Manatû Hauora Science and Technical Advisory team work alongside the
COVID-19 Technical Advisory Group (CV-TAG) to provide this information to
the relevant Ministers.

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: [10][email address] or by calling 0800
802 602.

 

Ngâ mihi,

 

OIA Services

Government and Executive Services

Manatû Hauora Ministry of Health

 

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