Abstract
Immunization is one of the most cost-effective and successful public health applications. The results of immunization are difficult to see as the incidence of disease occurrence is low while adverse effects following the immunization are noticeable, particularly if the vaccine was given to apparently healthy person. High safety expectations of population regarding the vaccines so they are more prone to hesitancy regarding presence of even small risk of adverse events which may lead to loss of public trust to the vaccination programs.
 Vaccine safety monitoring is needed as they now are administered to the general population and also available to special categories such as pregnant women and patients with different diseases whom not subjected to clinical trials as well as incorrect administration rout and presence of rare or delayed onset adverse events make the presence of surveillance system necessary. The aim of the current study was to measure the distribution, percentage, and frequency of adverse reactions related to vaccines administration in Iraq and to assess the causality, severity, seriousness of these adverse reactions. This study is a retrospective descriptive study for surveillance of vaccine safety conducted using Iraqi pharmacovigilance center database from 2014 till the end of 2018 . 2116 Adverse events were included and outcomes , severity , seriousness , and causality of adverse events were assessed. Majority of adverse events following immunization cases (90.97%) were mild, non serious (94.47%) and recovered (94.23%). Most reports were for general disorders and administration site conditions and the majority were for elevated body temperature and injection site reactions .
Highlights
Vaccine term is of broad meaning which refers to the biological product that enhances the immunity to prevent or sometimes treat diseases [1]
In order to identify and assess adverse reactions and events of drugs, the Pharmacovigilance depends on collection of information regarding the post-marketing events in post-marketing or approval phase of medications by a system that relays on spontaneous reporting system (SRS) in order to detect any problems with the vaccines, vaccination program or emergence of new adverse events that not reported in the trials [15]
The results of the current study revealed that the percent of Adverse events following immunization (AEFI) reports is increased during 2017 and 2018 compared with previous years which may be related to increased awareness of health care workers
Summary
Vaccine term is of broad meaning which refers to the biological product that enhances the immunity to prevent or sometimes treat diseases [1]. Based on the way of formulation and preparation, there are many types of vaccines given by different ways of administration. Monovalent vaccines are those with a single strain of antigen such as measles vaccine while polyvalent vaccines are those that contain more than one strain or serotype of the antigen such as of oral poliovirus vaccine (OPV). Inactivated vaccines are found using physical or chemical treatment so microorganisms get killed like inactivated polio vaccine (IPV) [4] Toxoid vaccines are another type of vaccines in which the toxin of microorganisms isolated, purified inactivated such as tetanus toxoid [5]. Adverse events following immunization (AEFI) is defined as “any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.”. Pharmacovigilance (PhV) according to WHO is defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems.” The purpose of PhV is to improve medication safety and health care, it acts as an indicator for clinical care standards[2,10]
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Schedule a callMore From: Iraqi Journal of Pharmaceutical Sciences ( P-ISSN: 1683 - 3597 , E-ISSN : 2521 - 3512)
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