133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
9 February 2023
Chris McCashin
By email: [FYI request #21667 email]
Ref:
H2023019684
Tēnā koe Chris
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Hauora
(the Ministry of Health) on 29 January 2023 for information regarding the Medicines Adverse
Reactions Committee (MARC). You requested:
“Please provide the following since the start of 2021 including the Out of Session Meeting -
20 January 2021 relating to the Medicines Adverse Reactions Committee (MARC)
Meetings 185 - 192 and to include the following
Ultimately I am looking for all of the information MARC received from CARM and then the
work completed by MARC which I believe relate to Sections 2.0 and Sections 3.0 of the
minutes.
2.0 Matters Arising from the New Zealand Pharmacovigilance Centre CARM Quarterly Reports and fatal reports for which CARM assessed the causality to be at
least possible, Reports of Cases of Injuries etc etc, all of the information presented to
MARC by CARM
3.0 Pharmacovigilance Issues Matters referred to MARC under Section 36 of the Medicines Act 1981
I am specifically looking for all of the above relating to the Covid-19 vaccine. Such things
arising from the Medsafe Reports include but limited to being the 4 Causal Deaths relating
to the Covid-19 vaccine, all of the associated heart issues, pregnancy - suspect there
should be a number of things given the safety signals that have been reported by Medsafe.
Can you also please provide the standards for Section 36 of the Medicines Act 1981.
Ultimately want all of the Matters Referred to MARC by Medsafe
Following on from that can you please provide all of the Recommendations and Associated
Reporting completed by MARC.
As noted above - I am specifically asking for information relating to the Covid-19 vaccine
and not all the other reports referring to the other Medicines.
Can you also please provide the total number of matters referred to MARC by Medsafe
associated with the Covid-19 vaccine”
Section 36 of the Medicines Act 1981 publicly available here
:
www.legislation.govt.nz/act/public/1981/0118/latest/DLM55444.html.
MARC meetings that have taken place from the start of 2021, where a COVID-19 vaccine was
discussed are outlined in table 1 below. The table also provides links to the publicly available
meetings minutes which include details of MARC discussions:
Table 1:
Meeting date
Matter
Information
January 2021 –
Risk Management Plan for Comirnaty
Minutes publicly available
out of session
COVID-19 vaccine
here:
www.medsafe.govt.nz/profs/a
dverse/MinutesOoS-20-jan-
2021.htm
March 2021
Ad26.COV2.S (Janssen covid 19
Minutes publicly available
vaccines) Risk Management Plan
here:
www.medsafe.govt.nz/profs/a
dverse/Minutes185.htm
June 2021
Vaxzevria Risk Management Plan
Minutes publicly available
here:
www.medsafe.govt.nz/profs/a
dverse/Minutes186.htm#5.1
December 2021
Update of Risk Management Plan for
Minutes publicly available
Comirnaty to include vaccination of
here:
children 5 - < 12 years of age
www.medsafe.govt.nz/profs/a
dverse/Minutes188.htm
December 2021 – Discussion of recent myocarditis reports
Minutes publicly available
out of session
following COVID-10 vaccination with
here:
Comirnaty.
www.medsafe.govt.nz/profs/a
dverse/MinutesOOS-15-Dec-
2021.htm
December 2022
Comirnaty RMP version 8
Minutes publicly available
here:
www.medsafe.govt.nz/profs/a
dverse/Minutes192.htm
At some meetings, the MARC were provided oral updates, this includes oral updates of vaccines
signals that were taken to the COVID-19 Independent Safety Monitoring Board (CV-ISMB).
These meetings are outlined in table 2 overleaf. These issues were not discussed by the MARC,
therefore there is no further information to release.
Page 2 of 3
Table 2:
Meeting
Update
September 2022
Inform MARC of safety alert for Nuvaxovid
June 2022
Update on COVID-19 vaccine signals
March 2022
Update on general reporting trends for COVID-19 vaccines
Dec 2021
Update on COVID-19 vaccine signals
September 2021
Update of case reports of myocarditis and pericarditis with Comirnaty
in NZ
June 2021
Update on Medsafe work around myocarditis with the Comirnaty
vaccine and vaccine – induced thrombotic thrombocytopenia with
COVID – 19 vaccines
The Risk Management Plan for Comirnaty is available on the Medsafe website here:
www.medsafe.govt.nz/COVID-19/Comirnaty-RMP.pdf.
The Risk Management Plan for Vaxzevria is available on the Medsafe website here:
www.medsafe.govt.nz/COVID-19/AstraZeneca-RMP.pdf.
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
Manatū Hauora 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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