Published: 13 April 2021
Revised:  7 May 2021



20 JANUARY 2021

3 May 2021

Secretary’s note regarding the minutes for the out of session meeting of the Medicines Adverse Reactions Committee held on 20 January 2021. The version of the Risk Management Plan discussed under item 2.2.1 has been superseded by an updated version. This was reviewed by the Medicines Assessment Advisory Committee and considered acceptable prior to the provisional consent of Comirnaty. The updated Risk Management Plan is published on the Medsafe website.

The out of session meeting of the Medicines Adverse Reactions Committee (MARC) was held on 20 January 2021 via Microsoft Teams. The meeting commenced at 3pm and closed at 4pm.


  • Dr S Hanna
  • Mrs C Ryan
  • Dr K Eggleton
  • Ms J Tatler
  • Mrs I Raiman
  • Ms L Te Karu
  • Prof L Stamp
  • Hon Assoc Prof M Rademaker
  • Dr M Tatley


  • T Coventry (Advisor, Pharmacovigilance)
  • N Zhong (Advisor, Pharmacovigilance)


  • S Kenyon (Manager, Clinical Risk Management)
  • G Hill (Senior Medical Advisor, Pharmacovigilance)
  • V Cheer (Senior Advisor, Pharmacovigilance)
  • M Storey (Senior Advisor, Pharmacovigilance)


  • No invited guests.


1.1 Welcome and Apologies

The attendees were welcomed to the urgent out of session meeting to discuss the Risk Management Plan for the Comirnaty COVID-19 mRNA vaccine.

As the Chair was unable to attend the meeting, S Kenyon (Manager Clinical Risk Management Branch, Medsafe) chaired the discussion. The purpose of the meeting was to have an informal discussion about the Risk Management Plan and gain input on the urgent request for information to be submitted to Pfizer by Medsafe. Due to the absence of the Chair, 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 MARC at this meeting.


2.1 Matters Referred to the MARC under Section 36 of the Medicines Act 1981

No items.

2.2 Matters Referred to the MARC by Medsafe

2.2.1 Comirnaty/Tozinameran/BNT162b6, concentrated suspension for injection, 30 μg/0.3 mL, 0.45 mL multi-dose vial – Risk Management Plan


This paper summarises the Risk Management Plan (version 0.1) for Comirnaty/Tozinameran/BNT162b2, a COVID-19 mRNA vaccine jointly developed by BioNTech and Pfizer.

Comirnaty (COVID-19 mRNA) Vaccine contains messenger RNA (mRNA) encoding the viral spike (S) protein of SARS-CoV-2. Formulation in lipid nanoparticles (LNPs) enables delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease.

The proposed indication is active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus, in individuals 16 years of age and older.

Medsafe considers that the safety specification for this product is currently inadequate and does not accurately reflect the important known risks, important potential risks or missing information. The RMP should be updated to include the additional risks and state how the missing information will be addressed. The additional studies appear to generally address the information gaps, but the company should state specifically how they will provide information on the NZ concerns raised above. In addition the provision of the results of these studies and provision of safety updates should be made a condition of approval.

The Committee was asked to advise whether any changes to the suggested questions on the RMP were required.


The Committee discussed the role of Medsafe in the approval and post-market monitoring of COVID-19 vaccines. It was noted that review of the company Risk Management Plan is part of a full and robust clinical evaluation. The MARC was invited to comment on and suggest improvements to the Risk Management Plan. Knowing the identified risks and missing information is advantageous for post-market monitoring.

It was noted that the benefit-risk profile for a COVID-19 vaccine may be perceived differently in New Zealand compared to other countries, due to the fact that the virus is currently largely contained. The Committee emphasised that the benefits of preventing a future outbreak should be recognised, given that community transmission has been previously seen even with closed borders. The likelihood of a future community outbreak may be greater than in the past due to the emergence of a more infectious strain of the SARS-CoV-2 virus.

It was noted that given New Zealand’s current containment of the virus, the public may perceive adverse events following immunisation more negatively. Conversely, the Committee considered that public awareness of the risks associated with COVID-19 disease may mitigate this.

The Committee discussed the clinical trial information available to date. The low numbers of participants who were very elderly, of ethnic minorities, and with various important comorbidities were noted. It was also noted that the study design does not provide robust safety data in a number of populations. Nor does it provide adequate information about duration of immunity/need for booster doses, prevention of transmission, prevention of asymptomatic disease or prevention of severe disease. Given the limitations of the data, robust post-market information gathering is of the utmost importance.

The most important known risk with Comirnaty was considered to be reactogenicity. The rate of anaphylaxis may be higher than that of other vaccines. The Committee considered that being prepared for this risk and factoring this into messaging is important.

The Committee agreed with the proposed questions and comments on the Risk Management Plan. In particular, the need for more information on use in patients with renal and hepatic impairment, children and people with multiple comorbidities was emphasised. The need for information on coadministration with other vaccines was stressed, with upcoming influenza vaccination, herpes zoster/shingles in the over 65 year olds, and an adult catch-up programme for measles/mumps/rubella (MMR) vaccination likely to coincide with the introduction of any COVID-19 vaccine.

It was noted that low prevalence of COVID-19 infection in New Zealand means that vaccine-associated enhanced disease (VAED) may be less of a risk compared with other countries.

The Committee acknowledged the incredible work done to date in developing safe and effective vaccines through accelerated but well-established pathways. The Committee considered that messaging around the evaluation process and benefit-risk profile should recognise this.

The Committee agreed with the proposed requests for amendments to the Risk Management Plan and for confirmation that new safety information will be provided to Medsafe as it becomes available.

The Chair thanked members, the Secretariat and Medsafe staff for their attendance and closed the meeting at 4pm.

S Kenyon
Manager, Clinical Risk Management Branch, Medsafe
Date:31 March 2021

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