Published: 27 January 2022
Committees
MINUTES OF THE OUT OF SESSION MEDICINES ADVERSE REACTIONS COMMITTEE MEETING
MINUTES OF THE OUT OF SESSION MEDICINES ADVERSE REACTIONS COMMITTEE MEETING
15 December 2021
The out of session meeting of the Medicines Adverse Reactions Committee (MARC) was held on 15 December 2021 via videoconference. The meeting commenced at 12.00 pm and closed at 1.15 pm.
MARC MEMBERS PRESENT
Dr C Cameron (Chair)
L Te Karu
Z Malik
Hon Assoc Prof M Rademaker
Dr A Pomerleau
Assoc Prof M Doogue
Dr M Tatley
MARC SECRETARIAT PRESENT
L Collings
T Coventry
N Zhong
MEDSAFE STAFF IN ATTENDANCE
S Kenyon
M Storey
INVITED GUESTS AND EXPERTS IN ATTENDANCE
No invited guests
1.0 Matters of administration
1.1 Welcome and apologies
The attendees were welcomed to the out of session meeting to discuss new reports that were notified to CARM and highlighted to Medsafe and the COVID-19 Vaccine and Immunisation Programme. Apologies were received from Assoc Prof L Parkin, Dr S Hanna, Dr C Kenedi, L McDermott, Dr A Romain and L Carlyon.
The purpose of the meeting was to seek comment on any action that should be taken by the Committee or Medsafe to improve the benefit-risk profile of Comirnaty in light of these reports. Due to short notice in calling the meeting, a quorum was unable to be formed and formal recommendations were not sought.
1.2 Potential conflicts of interest
There were no potential conflicts of interest which were considered likely to influence the discussions or decisions of the Committee at this meeting.
2.0 Pharmacovigilance issues
2.1 Matters Referred to the MARC by Medsafe
2.1.1 Discussion of recent myocarditis reports following COVID-19 vaccination with Comirnaty
Background
The Committee held an out of session meeting to discuss three myocarditis reports following vaccination with Comirnaty that were notified to CARM since November 2021 and highlighted to Medsafe and the COVID-19 Vaccine and Immunisation Programme. The investigation of the reports is ongoing. No comments were sought on the likelihood of causality for these reports as this is within the remit of other expert advisory groups. The Committee was asked to discuss any action that should be taken by the Committee or Medsafe to improve the benefit-risk profile with regard to potential vaccine-associated myocarditis and pericarditis.
Discussion
The Committee agreed that safety-netting advice about myocarditis and pericarditis should be routinely given at the time of vaccination. This is to ensure that patients are aware that they should seek medical attention if they experience symptoms indicative of myocarditis or pericarditis and mitigate the risks of delayed treatment.
The Committee acknowledged the challenges involved with triaging large volumes of patients with common non-specific symptoms such as heart palpitations. The Committee emphasised the importance of ensuring healthcare practitioners are familiar with the support and guidance available to them, such as the joint Australian and New Zealand document ‘Guidance on Myocarditis and Pericarditis after mRNA COVID-19 Vaccines’.
The Committee supported a further alert communication from Medsafe for healthcare professionals, vaccinators and consumers on myocarditis and pericarditis following vaccination with Comirnaty, including the importance of early recognition and treatment and a reminder to remain vigilant after booster doses and with children.
The Committee will contact the COVID-19 Immunisation Programme to support routine safety-netting advice regarding myocarditis and pericarditis at the time of vaccination and promoting healthcare practitioner access to the vaccination guidance and resources available to them.
The Chair thanked members, the Secretariat and Medsafe staff for their attendance and closed the meeting at 1.15 pm.
Dr Chris Cameron
Chair, Medicines Adverse Reactions Committee
Date: 20 January 2022
