The Vaccine Pharmacovigilance System of Kenya: Structure, Function and Capacity
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PROPOSAL ABSTRACT

Background: Vaccines are biological products which are used to produce or enhance immunity against vaccine preventable diseases (VPDs).  Public confidence in vaccines is critical to the success of any immunization programme.  For a National Immunization Programme (NIP) to achieve high and sustained population coverage, the vaccines have to be perceived as being very safe by a majority of the population.  The main aim of having a functional system for pharmacovigilance of vaccines is to facilitate early detection and analysis of adverse events following immunization (AEFI) and quick and appropriate response in order to minimize negative impact to the NIP and to the health of individuals.

Study objectives: The main objective of the study is to assess the state, management and capacity of the Kenyan vaccine pharmacovigilance system.  

Methodology: A mixed method study design will be employed. One method will be quantitative and it will involve cross-sectional review of AEFI reports. The second method which is qualitative will involve semi-structured interviews of key-informants. The study will be carried out at the pharmacy and poisons board (PPB) and the unit of vaccines and immunization services (UVIS). An inductive approach to qualitative data analysis will be used focusing on emergent themes arising from the key informant interviews.  Preparation for data analysis will involve transcription of data, coding and indexing of responses.  All qualitative data analysis will be done using ATLAS/ti. Version 4.2. Triangulation of findings within and across target groups will then be done to arrive at well-grounded findings. Quantitative data analysis will be done using Stata Statistical Software.

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