Bulletin of the World Health Organization
Volume 92, Number 9, September 2014, 621-696
http://www.who.int/bulletin/volumes/92/9/en/

Perspectives
The Global Vaccine Safety Initiative: enhancing vaccine pharmacovigilance capacity at country level
Christine G Maure a, Alexander N Dodoo b, Jan Bonhoeffer c & Patrick LF Zuber a
a. Department of Essential Medicines and Health Products, World Health Organization, Avenue Appia 20, 1211 Geneva 27, Switzerland.
b. Centre for Tropical Clinical Pharmacology and Therapeutics, University of Ghana, Accra, Ghana.
c. Brighton Collaboration Foundation, Basel, Switzerland.
(Submitted: 19 March 2014 – Accepted: 21 March 2014 – Published online: 31 July 2014.)
Bulletin of the World Health Organization 2014;92:695-696. doi: http://dx.doi.org/10.2471/BLT.14.138875
Excerpt
“…The Decade of Vaccines, which was launched in 2010, aims to increase coordination within the vaccine community worldwide. The Global Vaccine Action Plan1 – the framework endorsed by the World Health Assembly for the Decade of Vaccines – includes a vaccine safety strategy, the Global Vaccine Safety Blueprint.2
The aim of the blueprint is to enhance the safety of vaccines through effective use of pharmacovigilance principles and methods. Its three strategic goals are: to assist LMICs to have at least minimal capacity for vaccine safety activities; to enhance capacity for vaccine safety assessment in countries that introduce newly developed vaccines, that introduce vaccines in settings with novel characteristics, or that manufacture and use prequalified vaccines; and to establish a global support structure for vaccine safety. The blueprint proposes eight complementary strategic objectives. Four of these objectives aim to improve the technical aspects of spontaneous reporting, active surveillance and risk communication; and to ensure the availability of harmonized methods and tools. The remaining four objectives promote the establishment of effective managerial principles to facilitate international collaboration and information exchange relating to vaccine safety monitoring. Implementing the blueprint is a task that requires coordinated participation of vaccine safety stakeholders worldwide. To that end, the World Health Organization (WHO) launched the Global Vaccine Safety Initiative in March 2012.
In its initial phase, the Global Vaccine Safety Initiative is attempting to build a global support structure by linking existing vaccine safety initiatives. Numerous projects are already addressing one or more of the blueprint’s strategic objectives. Some of the top priorities for the initiative are to identify such projects and engage their sponsors in collaboration, and to help disseminate their products and experiences. Therefore, a Global Vaccine Safety Initiative portfolio of activities has been assembled, where activities are prioritized based on their expected impact, geographical relevance, feasibility, usefulness and sustainability.3 For each activity, the portfolio recognizes the roles of initiators, managers and donors. All stakeholders in global pharmacovigilance can use this portfolio to help identify ongoing efforts, allow for better synergies, minimize duplications and enable resource mobilization…