133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
27 November 2025
Erika Whittome
By email: [FYI request #31451 email]
Ref:
H2025074974
Tēnā koe Erika
Response to your request for official information Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health – Manatū Hauora (the Ministry) on 4 November 2025 for:
The Ombudsman's office has shared a link to the report https://pdata0916.s3.us-east-
2.amazonaws.com/pdocs/100123/19736_S0335-M1_smsr-01apr2021-29apr2021.pdf
Given the report is not "in confidence", would you please share the requested information in
this OIA request on the report?
As noted in the Ministry’s response to your two previous requests on this topic (reference
H2025067924 and H2025069254), the document you provided the link to the BioNTech-Pfizer
Summary Monthly Safety Report (SMSR) 5, which contained a review of myocarditis and
pericarditis appears to be a Freedom of Information (FOI) release from the United States of
America and hosted on an American webserver.
This document was provided to Medsafe, the business unit in the Ministry responsible for the
regulation of therapeutic products, in confidence by the company. It was not ‘promulgated’ or
shared in meetings or included in memos or correspondence.
Therefore, your previous request(s) for the “
minutes of the meetings, memos, correspondence,
briefing reports, aide memoirs etc... of the actual review of this report SMSR 5 by the MoH and its
staff” is refused under section 18(g)(i) of the Act, that the information requested is not held by the
Ministry and there are no reasons for believing it is held by another department in New Zealand
subject to the Act.
As mentioned above, the report was shared in confidence with Medsafe. Therefore, it is not
appropriate to share outside of the intended recipients. A copy of the unredacted version of the
document remains to be withheld under the following sections of the Act:
• Section 9(2)(a), to protect the privacy of natural persons; and
• Section 9(2)(b)(ii), where its release would likely unreasonably prejudice the commercial
position of the person who supplied the information.
I have considered the countervailing public interest in release in making this decision and
consider that it does not outweigh the need to withhold at this time.
If you wish to discuss any aspect of your request with us, including this decision, please feel free
to contact the OIA Services Team on:
[email address]. 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 website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests. Nāku noa, nā
Chris James
Group Manager
Medsafe
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