CIOMS Guide To Vaccine Safety Communication - Executive summary.
Vaccine
; 37(3): 401-408, 2019 01 14.
Article
em En
| MEDLINE
| ID: mdl-30554796
ABSTRACT
BACKGROUND:
In 2018, the Council for International Organizations of Medical Sciences (CIOMS) issued their Guide to Vaccine Safety Communication. This has been built upon existing guidance and a new review of research and compilation of latest experiences, in order to fill, for the first time at global level, a specific niche for regulatory authorities in the contexts of vaccine hesitancy and informed choice. The Guide was developed by the international multi-stakeholder CIOMS Working Group on Vaccine Safety, formed to assist the Global Vaccine Safety Initiative (GVSI) of the World Health Organization (WHO).SUMMARY:
Besides the public health authorities responsible for immunization programmes, regulators have their own role in communicating about vaccine safety. As they are responsible for licensing vaccine products, they need to be transparent about their assessments of data on quality, safety and efficacy. Furthermore, they are responsible for continuous safety surveillance and keeping safe use advice to the public up-to-date. The Guide stresses the fundamental importance of regulatory bodies to have a system in place with defined functions and skilled persons who can efficiently run vaccine safety communication in collaboration with stakeholders. This system should take a strategic approach to communication, be integral to safety surveillance and risk assessment, and support vaccine safety communication plans (VacSCPs) adapted to vaccine types in local situations. The Guide provides recommendations and examples for the system components as well as a practical VacSCP template.CONCLUSIONS:
While the Guide should help strengthening regulatory bodies worldwide with regard to vaccine safety communication, it is meant to help regulators in resource-limited countries in particular. It can also be of interest to other stakeholders and be leveraged to other medicinal products.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Organização Mundial da Saúde
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Vacinas
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Sistemas de Notificação de Reações Adversas a Medicamentos
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Comunicação
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Congressos como Assunto
Tipo de estudo:
Etiology_studies
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Guideline
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Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Vaccine
Ano de publicação:
2019
Tipo de documento:
Article