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CIOMS guide to vaccine safety communication [Pehme köide]

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  • Formaat: Paperback / softback, 60 pages, kõrgus: 300 mm
  • Ilmumisaeg: 12-Jan-2018
  • Kirjastus: World Health Organization
  • ISBN-10: 9290360917
  • ISBN-13: 9789290360919
Teised raamatud teemal:
CIOMS guide to vaccine safety communicationSuurem pilt
  • Formaat: Paperback / softback, 60 pages, kõrgus: 300 mm
  • Ilmumisaeg: 12-Jan-2018
  • Kirjastus: World Health Organization
  • ISBN-10: 9290360917
  • ISBN-13: 9789290360919
Teised raamatud teemal:
Püsilink: https://www.kriso.ee/db/9789290360919.html
The CIOMS Guide to Vaccine Safety Communication provides an overview of strategic communication issues faced by medicines regulators, those responsible for vaccination policies and programs and other stakeholders including:

(1) the launch of newly-developed vaccines for the first time to market,
(2) the introduction of current or underutilized vaccines into new countries, regions, or populations, and
(3) the handling of any new safety issue arising during the life-cycle of a vaccine.

The Guide sources from existing guidance documents and compiles recommendations relevant from a regulatory perspective, providing a common ground in a way that has not been achieved otherwise at a global level. It stresses the fundamental importance of regulatory bodies having a system in place with skilled persons who can efficiently run vaccine safety communication in collaboration with stakeholders. It presents information and examples with color-coding for quick access to three levels of guidance and offers a CIOMS template to use to create a Vaccine Safety Communication Plan.
Acknowledgements iii
Foreword viii
Acronyms and Abbreviations ix
Reader's Guide x
Chapter 1 Introduction
1(6)
Chapter 2 Considerations for Vaccine Safety Communication
7(15)
2.1 Audiences and aims of vaccine safety communication
7(2)
Figure 2.1 The social-ecological model (SEM)
8(1)
2.2 Communicating evidence and uncertainties for informed decision-making
9(2)
Guidance Summary 2.2 Addressing uncertainty in vaccine safety
10(1)
2.3 Transparency for honest communication and public trust-building
11(4)
Guidance Summary 2.3 Building trust in vaccine safety
11(1)
Example 2.3 Re-building trust in the MMR vaccine in the United Kingdom
12(3)
2.4 Perceptions of risk as a trigger of vaccine hesitancy
15(7)
Figure 2.4 The WHO Strategic Advisory Group of Experts (SAGE) on Immunization Model of determinants of vaccine hesitancy
16(2)
Guidance Summary 2.4 Addressing vaccine hesitancy
18(1)
Example 2.4.1 Overcoming hesitancy against the MMR vaccine in sub-populations in Sweden
18(2)
Example 2.4.2 The need for understanding public concerns over HPV vaccines prior to licensure and launch
20(2)
Chapter 3 Product Life-Cycle Management Approach To Vaccine Safety and Communication
22(11)
3.1 Communication as part of vaccine pharmacovigilance
22(1)
3.2 Pre-licensure and launch phase
23(5)
Example 3.2.1 The need for understanding concerns in different communities over the Ebola virus and vaccines prior to launching clinical trials
23(2)
Guidance Summary 3.2.1 Concept of risk management systems for medicinal products
25(1)
Figure 3.2 Risk management cycle
25(1)
Guidance Summary 3.2.2 Types of risk minimization measures for medicinal products
26(1)
Example 3.2.2 Risk management planning for DTPw-HBV quadrivalent vaccine
26(1)
Example 3.2.3 The introduction of pentavalent vaccines in Kerala, India, supported by close interactions with the healthcare community and the media
27(1)
3.3 Post-licensure phase
28(5)
Example 3.3.1 Addressing the risk of febrile seizures with a serogroup B meningococcal vaccines in the United Kingdom
29(2)
Example 3.3.2 Addressing the safety concern of narcolepsy for the H1N1 pandemic influenza vaccine used in Sweden
31(2)
Chapter 4 Vaccine Safety Communication Plans (Vacscps)
33(9)
4.1 Application of a strategic communication approach to vaccine safety
33(2)
Figure 4.1 The P-Process of strategic health communication
33(1)
Checklist 4.1 Management considerations for VacSCPs
34(1)
4.2 Developing VacSCPs on the basis of a model template
35(3)
Template 4.2 Template for strategic vaccine type- and situation-specific vaccine safety communication plans (VacSCPs)
36(1)
Guidance Summary 4.2 Developing communication strategies on vaccine benefits and risks
37(1)
4.3 Monitoring, evaluating and maintaining VacSCPs
38(4)
4.3.1 Monitoring of debates and sentiments in communities and the public
39(1)
Example 4.3.1 Social media monitoring during polio supplementary immunization activities (SIA) in Israel
40(1)
Example 4.3.2 Utility of online news media monitoring for prepared communicating of the outcome of a safety assessment for HPV vaccines at the European Medicines Agency (EMA)
40(2)
Chapter 5 Vaccine Safety Communication Systems
42(10)
5.1 Functions of vaccine safety communication systems
42(1)
Checklist 5.1 Key functions of vaccine safety communication systems
42(1)
5.2 Multistakeholder network
42(8)
Table 5.2.1 Main stakeholders involved in the vaccine safety communication process
43(1)
Checklist 5.2 Establishing and maintaining national stakeholder networks
43(1)
Table 5.2.2 Purposes of multistakeholder interactions
44(1)
Example 5.2 Managing an adverse event following immunization with HPV vaccine in the United Kingdom
45(5)
5.3 Regional and international awareness and collaboration
50(2)
Figure 5.3 Relationships of parties in global vaccine safety
50(2)
Chapter 6 Capacity Building for Vaccine Safety Communication Systems
52(4)
6.1 Skills and capacity requirements
52(1)
Checklist 6.1 Skills and capacity requirements for vaccine safety communication
52(1)
6.2 Contents and objectives of training
53(2)
Table 6.2 Curriculum for vaccine safety communication
53(1)
Example 6.2.1 Training programme on vaccine safety communication by the WHO Regional Office for Europe (WHO-EURO)
54(1)
Example 6.2.2 Training resources of the Network for Education and Support in Immunisation (NESI)
54(1)
6.3 Comprehensive approach to capacity building
55(1)
Annex 1 Reading List 56(5)
Annex 2 Contribution to the Cioms Guide to Active Vaccine Safety Surveillance 61(2)
Annex 3 Membership, External Reviewers, and Meetings 63