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The Global Vaccine Safety Initiative (GVSI)

12th December 2018

Vaccine safety initiative has been a vital chapter in vaccine programs of W.H.O. In 2011, WHO and its partners developed a strategic document on vaccine safety called the Global Vaccine Safety Blueprint and in March 2012 it was launched. The GVSI aims to establish effective vaccine pharmacovigilance systems in all countries by 2020.This document sets out various indicators the objective of which is to make sure that all the countries have at least a minimal capacity to ensure vaccine safety. It aims to establish national capacity for an organized approach to vaccine pharmacovigilancein the world’s poorest countries through the coordinated efforts of major stakeholders. The blueprint objectives(1 – 4) of the initiative mention the components of vaccine pharmacovigilance and the objectives (5 – 8)cover supporting elements for the vaccine safety system to function effectively.

Eight Strategic Objectives:

1. AEFI Detection: Spontaneous reporting of adverse events following immunization (AEFI) is the first step to ensure that vaccine products are safe to use and are being administered in a safe manner. Almost half the world’s population lives in countries without an effective system for monitoring the safety of vaccines. The objective of Global Vaccine Safety Initiative (GVSI) has the objective to ensure that monitoring of vaccine safety takes place even in the poorest settings.
2. Investigation of safety signals: A vaccine safety signal is new safety information that indicates a potential association between a vaccine and an event previously unknown or incompletely documented, that can cause an impact to health. Epidemiological analyses are usually needed to establish the causality between the vaccine and the signal. The GVSI has the goal that the safety signals will be assessed properly and then appropriate action will be taken accordingly.
3. Vaccine safety communication: To chalk out plans through which vaccine safety can be communicated at country level to promote awareness regarding vaccine risks and benefits, perceptions of risk, and to prepare for the management of any adverse events and concerns about vaccine safety.
4. Tools and methods: Most of the times vaccines are safe but occasionally they cause serious adverse events. This initiative also takes care so that internationally harmonized tools and methods are developed to support the country vaccine safety activities.
5. Regulatory framework: The Global Vaccine Safety Initiative will promote a routine system so that the safety and efficacy of specific vaccines are reviewed.
6. Technical support and trainings: Trainings on vaccine pharmacovigilance is an essential component of this initiative and hencewith collaboration with its various partners comprising of technical experts, WHO develops, administers, evaluates and revises vaccine safety training packages.
7. Global analysis and response: The Global Vaccine Safety Initiative also aims to provide an expert advice on vaccine safety issues at national, regional and international levels.
8. Public-private information exchange: The Global Vaccine Safety Initiative (GVSI) aims to establish an efficient system to facilitate the collection and exchange of information about vaccine safety issues between national regulatory authorities, manufacturers and multilateral agencies.

In fine it can concluded that it is a great initiative towards vaccine safety. There is a huge opportunity to increase consciousness for vaccine safety in low and middle income countries and still lot can be done to gather support from a large number of capable stakeholders for the GVSI between now and 2020. Successful implementation of this initiative would lead to more equitable delivery of safe vaccines worldwide and pave the path for a better vaccine safety system all across the globe.

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