Risk Management Plan - Australia-Specific Annex: Vitro Transcription From The Corresponding
Risk Management Plan - Australia-Specific Annex: Vitro Transcription From The Corresponding
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Australia-Specific Annex for BNT162b2 [mRNA]
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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................3
APPENDICES ...........................................................................................................................4
LIST OF ABBREVIATIONS....................................................................................................5
1. INTRODUCTION .................................................................................................................6
1.1. History of RMPs Submitted in Australia ..................................................................7
2. SAFETY SPECIFICATION..................................................................................................8
2.1. Epidemiology of the Indication(s) and Target Population(s)....................................8
2.2. Summary of the Safety Concerns..............................................................................8
2.2.1. Australia Specific Safety Concerns ..............................................................8
2.2.2. Proposed Changes to the Australia-specific Safety Concerns ......................8
3. PHARMACOVIGILANCE PLAN........................................................................................8
3.1. Routine Pharmacovigilance Activities in Australia ..................................................8
3.2. Additional Pharmacovigilance Activities................................................................10
3.2.1. Australia-Specific Additional Pharmacovigilance Activities.....................10
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LIST OF TABLES
Table 1. Sections of the EU RMP.............................................................................6
Table 2. History of RMPs Submitted in Australia....................................................7
Table 3. Summary of Safety Concerns in the EU RMP ...........................................8
Table 4. Routine Risk Minimisation Activities ......................................................11
Table 5. Summary of the RMP in Australia ...........................................................13
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APPENDICES
APPENDIX 1 FOLLOW-UP FORMS TO BE IMPLEMENTED IN AUSTRALIA
.........................................................................................................................NO DATA
APPENDIX 2 STUDY PROTOCOLS FOR PLANNED PHARMACOVIGILANCE
STUDIES IN AUSTRALIA .............................................................................NO DATA
APPENDIX 3 ADDITIONAL RISK MINIMISATION MATERIALS IN
AUSTRALIA....................................................................................................NO DATA
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LIST OF ABBREVIATIONS
AE adverse event
AESI adverse event of special interest
ASA Australian specific annex
CMI consumer medicine information (Australia)
COPD chronic obstructive pulmonary disease
COVID-19 coronavirus disease 2019
CSR clinical study report
DCA data capture aid
DNA deoxyribonucleic acid
eCTD electronic common technical document
EU European union
HLT high-level term
mRNA messenger ribonucleic acid
PhV pharmacovigilance
PI product information (Australia)
PSUR periodic safety update report
RMP risk management plan
SARS-CoV-2 severe acute respiratory syndrome coronavirus 2
SOC system organ class
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Australia-Specific Annex for BNT162b2 [mRNA]
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1. INTRODUCTION
This Australia-Specific Annex (ASA) relates to the approved EU Risk Management Plan
(RMP) version 1.0 for COVID-19 mRNA vaccine dated 21 December 2020, with a data lock
point of 17 December 2020.
Australian context is provided in this Addendum for the RMP sections identified in Table 1.
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Time
The history of EU RMPs submitted in Australia is provided in Table 2. This ASA is the first
version for COVID-19 mRNA vaccine to be submitted in Australia.
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2. SAFETY SPECIFICATION
2.1. Epidemiology of the Indication(s) and Target Population(s)
There are no significant differences between epidemiological information presented in the
EU RMP Module SI Epidemiology of the Indication(s) and Target Population (s) compared
to those applicable to the Australian population. Please refer to the EU RMP Part II- Module
SI.
There are no safety concerns for Australia that are additional to those proposed in the EU
RMP.
3. PHARMACOVIGILANCE PLAN
3.1. Routine Pharmacovigilance Activities in Australia
All routine pharmacovigilance (PhV) activities in the EU RMP will be implemented in
Australia. Refer to Part III, Section III.1 Routine Pharmacovigilance Activities of the EU
RMP.
Routine pharmacovigilance activities beyond adverse reaction reporting and signal detection
are planned to be implemented in Australia.
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Data Capture Aids have been created for this vaccine. They are intended to facilitate the
capture of clinical details about:
the nature and severity of COVID-19 illness in individuals who have received the
COVID-19 mRNA vaccine and is anticipated to provide insight into potential cases of
vaccine lack of effect or VAED. The DCA is provided in Annex 4 of the EU RMP;
potential anaphylactic reactions in individuals who have received the COVID-19 mRNA
vaccine. This DCA was internally approved on 22 December 2020.
Routine signal detection activities for the COVID-19 mRNA vaccine will include routine and
specific review of AEs consistent with the Adverse Events of Special Interest (AESI) list
provided in the EU RMP PART II.SVII.1.1 Risks not considered important for inclusion in
the list of safety concerns in the RMP.
Concise, critical analyses of adverse events (AEs) for COVID-19 mRNA vaccine will be
conducted and provided in the Periodic Safety Update Report (PSUR) in accordance with the
TGA requirements.
In addition to routine 6-monthly PSUR production, monthly summary safety reports will be
compiled to support timely and continuous benefit risk evaluations. Topics covered by
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Risk/benefit considerations.
Monthly reports and PSURs will include results of the observed versus expected analysis for
AESI as appropriate, including cases of Bell’s palsy and will present the results and details of
the statistical approach.
The pivotal trial Study C4591001 is an ongoing Phase 1/2/3, placebo-controlled, randomised,
observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and
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The primary efficacy analysis was efficacy against COVID-19 at least 14 days after the last
dose of vaccine in participants without evidence of prior SARS-CoV-2 infection at baseline.
The Phase 2/3 part of Study C4591001 commenced on 27 July 2020 and had met its primary
end points as at 14 November 2020. An interim clinical study report (CSR) comprising final
analysis for efficacy and safety data 1 month after Dose 2 for 37,586 participants with a
median of at least 2 months of follow-up, and available safety data for all 43,252 participants
was submitted 10 December 2020.
The final C4591001 CSR with supplemental follow-up is expected to be available for
submission by the end of 2023.
The study protocol for Study C4591001 is provided in Module 5.3.5.1 of the eCTD dossier.
The routine risk minimisation activities planned in Australia are described in Table 4.
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C4591018
ACCESS/VAC4EU
Interaction with other None Study: Local Product Information: None
vaccines Co-administration study with Section 4.5 Interactions with other
seasonal influenza vaccine medicines and other forms of
interactions
Long term safety data None Studies: None None
C4591001
C4591010
C4591011
C4591012
ACCESS/VAC4EU
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