133 Molesworth Street
PO Box 5013
Wellington 6140
11 April 2022
New Zealand
T+64 4 496 2000
Erika Whittome
By email: [FYI request #19065 email]
Ref:
H202205202
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 (the Ministry) on 6 April 2022 about the approval of the Pfizer Comirnaty COVID-19
vaccine. Specifically, you asked:
“1. Please provide the minutes for when Pfizer "post marketing" data was reviewed with
"intense scrutiny" by Medsafe or the appropriate government authority (EPA or otherwise).
2. Please provide the minutes for when Medsafe wrote their own safety data sheet for the
Pfizer "Comirnaty" medicine.
3. The Pfizer post marketing report is 38 pages long and lists 1,290 adverse events below
copied from Appendix 1. Please provide the meeting minutes for when Medsafe redacted
the "Comirnaty" adverse events reported by Pfizer and reduced the list to the following 4
rows in one table on Medsafe's safety data sheet in
https://medsafe.govt.nz/Profs/datasheet/c/comirnatyinj.pdf.
MEDSAFE Table 2:Adverse reactions from COMIRNATY post marketing experience
System Organ Class Adverse Drug Reaction
1. Immune system disorders :
Anaphylaxis
Hypersensitivity reactions (e.g. rash, pruritis, urticaria, angioedema)
2. Cardiac disorders :
Myocarditis
Pericarditis
Gastrointestinal disorders
Diarrhoea
Vomiting
3. Musculoskeletal and connective tissue disorders:
Pain in extremity (arm)
4. General disorders and administration site conditions:
Extensive swelling of vaccinated limbs
PFIZER APPENDIX 1. LIST OF ADVERSE EVENTS OF SPECIAL INTEREST
FDA-CBER-2021-5683-0000083
BNT162b2
5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
(https://scanmail.trustwave.com/?c=15517&d=zOrM4ugvJChaX3p5jNhYDX_EFcqUHiWh
wWlN5NBIWA&u=https%3a%2f%2fphmpt%2eorg%2fwp-
content%2fuploads%2f2021%2f11%2f5%2e3%2e6-postmarketing-experience%2epdf)
Your questions appear linked to the publication in the United States of the
Cumulative Analysis
of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through
28-Feb-2021 document (hereafter the Cumulative Analysis Report). The Ministry received
several requests about the genesis of the Cumulative Analysis Report and has published three
responses about it. These responses emphasise that the Cumulative Analysis Report was
prepared in the United States to meet a specific legal purpose in that country. The responses
also emphasise that while adverse events following immunisation (AEFI) occur after vaccination
that does not mean they were caused by vaccination. They then go on to outline how Medsafe
and the Centre for Adverse Reactions Monitoring (CARM) at the University of Otago investigate
and assess events to establish whether there is any link between AEFI and vaccination.
Three published responses are available under the 12 January 2022 publication date for
Information on Pfizer Cumulative Analysis Report at:
www.health.govt.nz/about-
ministry/information-releases/responses-official-information-act-requests. Several other
responses have been published on FYI website. Your request is therefore refused under section
18(d) of the Act on the grounds that the information sought is publicly available.
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
Jan Torres
Acting Manager, OIA Services
Office of the Director-General
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