UID:
almahu_9949830112902882
Format:
1 online resource (232 pages)
Edition:
1st ed.
ISBN:
9789240018280
Note:
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.
Additional Edition:
Print version: COVID-19 Vaccines Geneva : World Health Organization,c2020
Language:
English
Keywords:
Electronic books.
Bookmarklink