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COVID-19 Vaccines : Safety Surveillance Manual.

Bibliographic Details
Format: eBook
Language:English
Published: Geneva : World Health Organization, 2020.
Edition:1st ed.
Subjects:
Electronic books.
Online Access:Click to View
Table of Contents:
  • Intro
  • Acknowledgements
  • Abbreviations and acronyms
  • Glossary
  • 1. Background
  • 2. Lessons learnt from novel vaccine introduction during pandemic and epidemic emergencies
  • 3. Objectives of this manual
  • 4. Intended audience
  • 5. Organization of the manual
  • 6. Scope of the manual
  • COVID-19 vaccines: description and general safety considerations for implementation
  • Stakeholders in COVID-19 vaccine safety surveillance
  • Establishing surveillance systems in countries using COVID-19 vaccines
  • Monitoring and responding to adverse events following immunization (AEFIs)
  • Monitoring and responding to adverse events of special interest (AESIs)
  • Safety data management systems, methods of post-introduction evaluation and assessing performance in countries using COVID-19 vaccines
  • Engaging with the pharmaceutical industry for COVID-19 vaccine safety surveillance
  • Regulatory reliance and work-sharing
  • COVID-19 vaccine safety communication
  • Key points
  • 1. Introduction
  • 2. General safety considerations for viral vaccines
  • 2.1 Inactivated viral vaccines
  • 2.2 Live-attenuated viral vaccines
  • 2.3 Viral vector-based vaccines
  • 2.4 Protein-based vaccines
  • 2.5 Nucleic acid vaccines
  • 2.5.1 mRNA vaccines
  • 2.5.2 DNA vaccines
  • 2.6 Characteristics and safety profile of COVID-19 vaccine candidates
  • 3. Safety implications for implementing immunization programmes
  • 3.1 Prioritising populations for COVID-19 vaccination
  • 3.2 Potential safety implications related to prioritization
  • 3.2.1 Safety implications in priority target populations
  • 3.2.2 Safety implications for immunization programmes
  • 3.2.3 Safety implication for vaccine pharmacovigilance
  • 3.3 Immunization strategies during COVID-19 vaccine introduction
  • 3.3.1 Safety considerations for COVID-19 vaccine administration in mass immunization campaigns.
  • 3.3.2 Safety considerations for all immunization programmes
  • Key points
  • 1. Introduction
  • 2. Identification of stakeholders and their roles
  • 3. National stakeholders
  • 3.1 Ministries of Health
  • 3.2 National regulatory authorities
  • 3.3 Expanded programmes on immunization and national immunization programmes
  • 3.4 National pharmacovigilance centres
  • 3.5 AEFI review committees
  • 3.6 National immunization technical advisory groups
  • 3.7 Vaccine manufacturers
  • 3.8 Academia
  • 3.9 Health care workers
  • 3.10 Beneficiaries
  • 3.11 Media
  • 3.12 Non-governmental organizations and professional societies
  • 4. Regional stakeholders
  • 4.1 Regional regulatory networks
  • 4.2 Regional technical advisory committees on vaccine safety
  • 5. Global stakeholders
  • 5.1 International Coalition of Medicines Regulatory Authorities
  • 5.2 The Council for International Organizations of Medical Sciences
  • 5.3 International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • 5.4 WHO prequalification
  • 5.5 WHO Global Advisory Committee on Vaccine Safety
  • 5.6 WHO Strategic Advisory Group of Experts
  • 5.7 WHO Immunization, Vaccines and Biologicals Department
  • 5.8 UNICEF
  • 5.9 Uppsala Monitoring Centre
  • 5.10 Brighton Collaboration
  • 5.11 COVID-19 Vaccines Global Access Facility
  • 5.12 Vaccine Safety Net
  • 5.13 The Coalition for Epidemic Preparedness Innovations
  • 5.14 International Federation of Pharmaceutical Manufacturers and Associations
  • 5.15 Developing Countries Vaccine Manufactures Network
  • Key points
  • 1. Introduction
  • 2. Key considerations for adaptation of vaccine safety surveillance systems
  • 3. Surveillance strategies to be adapted to COVID-19 vaccination strategies
  • 3.1 Application of surveillance concepts to COVID-19 vaccine-related AEFI and AESI.
  • 3.2 Routine passive surveillance for AEFIs following COVID-19 vaccine introduction
  • 3.3 Active surveillance for AESIs following COVID-19 vaccine introduction
  • 3.4 Specific provisions for additional national safety monitoring activities by COVID-19 vaccine manufacturers
  • 4. Serious AEFIs and AESIs
  • 5. Deaths following COVID-19 immunization
  • 6. Appendix
  • Appendix 6.1: Preparedness checklist for vaccine safety during pandemics recommended tool for national programme managers
  • Key points
  • 1. Introduction
  • 2. Standard vaccine safety definitions and their implications in vaccine safety in the COVID-19 context
  • 2.1 Adverse events following immunization
  • 2.2 Cause-specific definitions of AEFIs and implications COVID-19 context
  • 2.3 Serious AEFI
  • 2.4 Cluster
  • 2.5 Signal
  • 3. AEFI surveillance in the context of COVID-19 vaccine introduction
  • 3.1 AEFI detection, notification and reporting
  • 3.1.1 Role of routine passive reporting systems for AEFI detection and notification
  • 3.1.2 AEFI reporting
  • 3.2 Investigating potential COVID-19 vaccine‑related AEFIs
  • 3.2.1 Causality assessment of potential COVID-19 vaccine‑related AEFIs
  • 3.2.2 Country preparedness and capacity required for causality assessment for COVID-19 vaccine-related AEFIs
  • 3.2.3 Case selection and prerequisites for individual causality assessment
  • 3.2.4 Key considerations during causality assessments for COVID-19 vaccine- related AEFIs
  • 4. Tools for AEFI
  • 5. Appendices
  • Appendix 5.1: Standard COVID-19 AEFI reporting form
  • Appendix 5.2: AEFI linelist
  • Appendix 5.3: AEFI investigation form adapted for COVID-19 immunization
  • Key points
  • 1. Introduction
  • 2. Adverse events of special interest and preparedness prior to COVID-19 vaccine introduction
  • 2.1 Adverse events of special interest (AESIs).
  • 2.2 Identifying and shortlisting adverse events of special interest (AESIs)
  • 3. Active vaccine safety surveillance
  • 4. Key considerations for implementing AVSS systems
  • 4.1 Resources, governance and ethical considerations
  • 4.2 Co-ordination of AVSS systems
  • 4.3 Data collection for AVSS systems
  • 4.4 Specific methods used for AVSS
  • 5. Implementing AVSS systems for COVID-19 vaccine-related AESIs
  • 5.1 Delayed AESIs
  • 5.2 Severe and serious AESIs
  • 5.3 Identified AESIs in priority target groups
  • 5.4 Surveillance of AESIs during mass COVID-19 immunization campaigns
  • 5.5 Key resources for evaluating and processing COVID-19 vaccine listed AESIs
  • 6. Identifying, reporting and responding to COVID-19 vaccine-related AESIs
  • 6.1 AESI reporting and response mechanisms in AVSS systems
  • 6.1.1 AESIs detected though active vaccine safety surveillance systems
  • 6.1.2 Investigating AESI in patients exposed to COVID-19 vaccination
  • 6.1.3 Data analyses for AESI cases from active surveillance systems
  • 6.2 Reconciling AESI data
  • 6.3 Tools for active surveillance of AESIs
  • 6.4 Prioritizing preparedness for AESI
  • 6.5 AESI for special populations: pregnant women, neonates and immunocompromised individuals
  • 6.6 Sudden unexpected death as an AESI
  • 7. Appendices
  • Appendix 7.1: Summary of methods that can be used for active vaccine safety surveillance systems for AESIs
  • Appendix 7.2: COVID-19 AESI reporting form
  • Appendix 7.3: COVID-19 AESI linelisting form
  • Appendix 7.4: COVID-19 AESI confirmation forms (under development)
  • Appendix 7.5: AEFI investigation form adapted for AESI following COVID-19 immunization
  • Key points
  • 1. Introduction
  • 2. Sharing COVID-19 vaccine safety data
  • 2.1 Rationale for data sharing
  • 2.2 Ethics in safety data sharing and collaboration
  • 2.3 Generic data sharing model.
  • 2.4 Stakeholder mapping for AEFI data sharing
  • 2.5 Data sources
  • 2.5.1 Individual case safety reports (individual AEFI case reports)
  • 2.5.2 Aggregated safety data from different sources
  • 2.5.3 Ad-hoc research
  • 2.6 Data standards
  • 2.7 Data transformation
  • 2.8 Repositories
  • 3. Methods for rapid post-introduction evaluation of COVID-19 vaccine safety
  • 3.1 Study population
  • 3.2 Signal detection
  • 3.3 Vaccine exposure
  • 3.4 Analytic approaches for signal detection on electronic health record data
  • 3.4.1 Rapid cycle analyses for suspected adverse events
  • 3.4.2 Time-to-onset analysis
  • 3.4.3 Ecological methods
  • 3.4.4 Data mining for unexpected adverse events
  • 3.4.5 Signal evaluation
  • 3.5 Ongoing surveillance while signals are being evaluated and refined.
  • 3.6 Impact of change in health care use and provision on AESI identification and temporal trends
  • 3.7 Vaccine-associated enhanced disease
  • 4. Performance indicators
  • 5. Appendices
  • Appendix 5.1: Indicators and targets for monitoring the performance of pharmacovigilance systems in COVID-19 context
  • Appendix 5.2: Indicators and targets for monitoring the quality of pharmacovigilance systems in COVID-19 context
  • Key points
  • 1. Introduction
  • 2. Legal provisions and guidelines regarding COVID-19 vaccine safety
  • 3. Risk management plans
  • 3.1 Format and components of RMPs for COVID-19 vaccines
  • 3.2 Routine pharmacovigilance plan as part of the RMP
  • 3.3 Additional pharmacovigilance activities
  • 3.4 Specific considerations under different scenarios
  • Scenario 1: COVID-19 vaccines submitted for WHO prequalification or emergency use listing
  • Scenario 2: COVID-19 vaccines not submitted for WHO prequalification or emergency use listing
  • 4. Oversight
  • 5. Data sharing
  • 6. Training
  • 7. Funding
  • Key points
  • 1. Introduction.
  • 1.1 Definition of regulatory reliance.

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