C.Schooner H202113975.pdf

133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
4 November 2021
Chuck Schooner
By email:  [FYI request #17129 email]
Ref:
H202113975
Dear Chuck
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 11 October 2021
for information related to COVID-19 vaccination. Please find a response to each part of your
request below:
Up to and including 18 September 2021 a total of 68 deaths were reported to CARM after
the administration of the Comirnaty vaccine. Also, up to 30 June within 21 days of the
administration of either one or two vaccines a total of 749 people died. From this
information can the relevant agencies please provide:
- How many of these recorded deaths received compensation for the deaths and what
amounts?
- With these compensation payouts can you provide copies of the non-disclosure
agreements?
- A total payout to date for these deaths?
On 14 October 2021, these parts of your request were transferred to the Accident
Compensation Corporation (ACC) in accordance with section 14(b)(i) of the Act. You can expect
a response from ACC in due course.
Any and all correspondence from internal meetings and how these are to be
communicated to with the media outlets.
Material arising from internal meetings is not generally proactively shared with media. Al  official
information, including correspondence and meeting minutes can be requested by any person,
including media outlets, and wil  be provided subject to the provisions of the Act. However, the
Ministry of Health (the Ministry) did release this media statement on 30 August 2021 on the one
vaccine-related death recorded to date: www.health.govt.nz/news-media/media-
releases/clinicians-reminded-be-aware-myocarditis-and-pericarditis-symptoms.
Can you please provide for the last ten years all other vaccine related deaths (can be
combined in one) and charted next to the deaths against the Pfizer vaccine.
Reports of fatal outcomes for other vaccines is publicly available at:
www.medsafe.govt.nz/publications/OIA/19Sept19ADRReportsWithDeath.pdf. Please note, there
has only been one death possibly related to vaccination with Comirnaty in New Zealand, and
this is explained on the weekly Adverse Effects Following Immunisation (AEFI) report. This case
has been referred to the coroner for determination. All the other deaths are either under
investigation or unrelated to vaccination with Comirnaty. In the observed versus expected
analysis, there has been no increase in deaths since the introduction of Comirnaty vaccination
supporting the conclusion that deaths are not related to vaccination.

Can Medsafe also confirm how there was justification to approve this vaccine when it did
in July 2021 when there were statistics on government websites of the 1,000's of deaths
recorded in overseas countries?

In response to this part of your request it is important to note that the Act allows people to ask
for of icial information. It does not require the Ministry confirm or prove an opinion. This part of
your request asks the Ministry to confirm a justification. As such, this part of your request is
refused under section 18(g) of the Act, as the information requested is not held by the Ministry
and there are no grounds for believing it is held by any other agency subject to the Act.

What is the drop-dead date for Pfizer to complete outstanding conditions?

On 28 October 2021 Medsafe renewed its provisional approval of the Pfizer Comirnaty vaccine
until 3 November 2023. Pfizer New Zealand has met all obligations required to date by the
conditions of the provisional approval granted in February 2021, including provision of additional
data about the clinical trials and vaccine monitoring. Medsafe wil  continue to receive and
assess data from Pfizer about the administration of the vaccine and may grant full approval
during this period once Pfizer has submit ed a relevant application and information. There is
more information at: www.health.govt.nz/news-media/news-items/medsafe-renews-covid-19-
vaccine-provisional-approval while the Gazette notice is available at:
www.medsafe.govt.nz/COVID-19/Comirnaty-Gazette-Oct-2021.pdf.

How many deaths are required before Medsafe wil  revoke vaccine?

It appears this part of your request is misinterpreting coincidental events with causal events.
Vaccine approval is based on benefits versus risks analysis. As the deaths referred to earlier in
your request are not related to vaccination (apart from one suspected case), they do not impact
the benefit risk of the vaccine. Further information on the Medsafe approval process can be
found at:
  •  www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Medicines-Safety-and-
Pharmacovigilance.asp
•  www. medsafe.govt.nz/Consumers/Safety-of-Medicines/Medsafe-Evaluation-
Process.asp
•  www. medsafe.govt.nz/Consumers/Safety-of-Medicines/Vaccine-safety.asp
•  www. medsafe.govt.nz/COVID-19/monitoring-process.asp

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.

Please note that this response, with your personal details removed, may be published on the
Ministry of Health website at: www.health.govt.nz/about-ministry/information-releases.

Yours sincerely

Chris James
Group Manager
Medsafe
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