ESTABLISHING IMMUNIZATION SAFETY SURVEILLANCE SYSTEM IN ALBANIA

Abstract

INTRODUCTION: While vaccine use increases, adverse events following immunization are becoming a public concern with the rate of adverse events following immunization (AEFI) increasing with the number of administered doses of vaccines. The safety of vaccines is ensured during clinical studies before the licensure of the vaccine. However, clinical trials have limitations, such as, rare events that cannot be detected and events occurring in specific groups of people. The consequences of AEFI influence public health policies and the incidence of vaccine-preventable diseases, although these might not be related directly to vaccines themselves.OBJECTIVES: The objective of this article is to examine the evolution of vaccine safety issues in Albania by mapping stakeholders involved in vaccine safety control and analyzing the different periods when changes in the vaccine safety system has taken placeMETHODS: A grey literature review, by searching the archive of IPH, provided a list of different stakeholders involved in vaccine safety in Albania. By reviewing all documents of the various organizations included in vaccine safety, we differentiated and characterized the roles of each in this area.RESULTS: The main stakeholders involved in AEFI and vaccine safety in Albania are; the Institute of Public Health (IPH), which manages the National Immunization Program (NIP), the Directorate of Public Health (DPH) at the Ministry of Health (MoH), the 36 District Public Health Directories each with a microbiological laboratory for the assessment of AEFI, the pharmacovigilance center and National Regulatory Authority in the National Agency for Medicines and Medical Devices (NAMMD),National Immunization Safety Expert Committee in MoH and the Secretariat that supports the national AEFI committeeCONCLUSIONS: Despite huge progress over the last decade in Albania regarding vaccine safety, much remains to be achieved. The changes in the vaccine safety system have enforced and increased public trust on vaccination, leading to a strengthened National Immunization Program.