title: Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization.
abstract: Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Unfounded vaccine safety concerns have the potential of seriously derailing effective immunization activities. To address these issues, vaccine pharmacovigilance systems have been developed in many industrialized countries. As new vaccine products become available to prevent new diseases in various parts of the world, the demand for effective pharmacovigilance systems in low- and middle-income countries (LMIC) is increasing. To help establish such systems in all countries, WHO developed the Global Vaccine Safety Blueprint in 2011. This strategic plan is based on an in-depth analysis of the vaccine safety landscape that involved many stakeholders. This analysis reviewed existing systems and international vaccine safety activities and assessed the financial resources required to operate them. The Blueprint sets three main strategic goals to optimize the safety of vaccines through effective use of pharmacovigilance principles and methods: to ensure minimal vaccine safety capacity in all countries; to provide enhanced capacity for specific circumstances; and to establish a global support network to assist national authorities with capacity building and crisis management. In early 2012, the Global Vaccine Safety Initiative (GVSI) was launched to bring together and explore synergies among on-going vaccine safety activities. The Global Vaccine Action Plan has identified the Blueprint as its vaccine safety strategy. There is an enormous opportunity to raise awareness for vaccine safety in LMIC and to garner support from a large number of stakeholders for the GVSI between now and 2020. Synergies and resource mobilization opportunities presented by the Decade of Vaccines can enhance monitoring and response to vaccine safety issues, thereby leading to more equitable delivery of vaccines worldwide.
authors.forename: Ananda
authors.initials: A
authors.lastname: Amarasinghe
authors.forename: Steve
authors.initials: S
authors.lastname: Black
authors.forename: Jan
authors.initials: J
authors.lastname: Bonhoeffer
authors.forename: Sandra M Deotti
authors.initials: SM
authors.lastname: Carvalho
authors.forename: Alexander
authors.initials: A
authors.lastname: Dodoo
authors.forename: Juhani
authors.initials: J
authors.lastname: Eskola
authors.forename: Heidi
authors.initials: H
authors.lastname: Larson
authors.forename: Sunheang
authors.initials: S
authors.lastname: Shin
authors.forename: Sten
authors.initials: S
authors.lastname: Olsson
authors.forename: Madhava Ram
authors.initials: MR
authors.lastname: Balakrishnan
authors.forename: Ahmed
authors.initials: A
authors.lastname: Bellah
authors.forename: Philipp
authors.initials: P
authors.lastname: Lambach
authors.forename: Christine
authors.initials: C
authors.lastname: Maure
authors.forename: David
authors.initials: D
authors.lastname: Wood
authors.forename: Patrick
authors.initials: P
authors.lastname: Zuber
authors.forename: Bartholomew
authors.initials: B
authors.lastname: Akanmori
authors.forename: Pamela
authors.initials: P
authors.lastname: Bravo
authors.forename: María
authors.initials: M
authors.lastname: Pombo
authors.forename: Houda
authors.initials: H
authors.lastname: Langar
authors.forename: Dina
authors.initials: D
authors.lastname: Pfeifer
authors.forename: Stéphane
authors.initials: S
authors.lastname: Guichard
authors.forename: Sergey
authors.initials: S
authors.lastname: Diorditsa
authors.forename: Md Shafiqul
authors.initials: MS
authors.lastname: Hossain
authors.forename: Yoshikuni
authors.initials: Y
authors.lastname: Sato
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D019049:Developed Countries; D003906:Developing Countries; D006801:Humans; D007114:Immunization / Q000009:adverse effects; D017589:Immunization Programs; D007391:International Cooperation; D060735:Pharmacovigilance; D012449:Safety; D014612:Vaccines / Q000009:adverse effects*; D014944:World Health Organization
chemical_list: D014612:Vaccines