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Introduction:

Adverse events following immunization (AEFI) are potential complications that occur after receiving a vaccination. These events can range from mild reactions such as fever and soreness at the injection site to severe reactions such as anaphylaxis. Post marketing surveillance is a crucial component of monitoring the safety of vaccines after they have been approved for use. It helps to detect and investigate any potential safety concerns that may arise once the vaccine is being administered to the general population.

Background of study:

Vaccines have greatly contributed to the control and eradication of many infectious diseases. However, like any medicinal product, vaccines are not without risk. AEFI can occur due to factors such as individual susceptibility, vaccine-related factors, or errors in the administration of the vaccine. It is important to have robust surveillance systems in place to monitor and evaluate the safety of vaccines post marketing.

Problem Statement:

Despite the extensive pre-licensure testing of vaccines, rare adverse events may only manifest once the vaccine is being used in large populations. It is essential to continuously monitor the safety of vaccines to maintain public confidence in immunization programs. There is a need for effective post marketing surveillance systems to detect and investigate AEFI in a timely manner.

Objective of study:

The main objective of this thesis is to examine the current practices and challenges in post marketing surveillance of AEFI. Specifically, the study aims to:

1. Review the existing literature on AEFI surveillance
2. Identify the limitations and gaps in current surveillance systems
3. Propose recommendations for improving the monitoring of AEFI
4. Evaluate the significance of AEFI surveillance for public health

Limitation of study:

This study is limited to examining the surveillance of AEFI in the context of post marketing monitoring of vaccines. Other aspects of vaccine safety, such as pre-marketing clinical trials or manufacturing practices, are not within the scope of this research.

Scope of study:

The study will focus on AEFI surveillance in the context of routine immunization programs. Special emphasis will be placed on the detection, reporting, and investigation of adverse events following the administration of vaccines.

Significance of study:

This research is significant as it addresses the critical issue of vaccine safety and public health. By examining the surveillance of AEFI, the study aims to contribute to the improvement of post marketing monitoring systems and enhance the safety of immunization programs.

Structure of the Thesis:

Chapter 1: Introduction
1.1 Introduction
1.2 Background of study
1.3 Problem Statement
1.4 Objective of study
1.5 Limitation of study
1.6 Scope of study
1.7 Significance of study
1.8 Structure of the Thesis
1.9 Definition of terms

Chapter 2: Literature Review
2.1 Overview of AEFI
2.2 Historical perspective on AEFI surveillance
2.3 Current practices in post marketing surveillance
2.4 Challenges in AEFI surveillance
2.5 Global initiatives for monitoring vaccine safety
2.6 Methods for detecting and investigating AEFI
2.7 Risk communication and public perception of AEFI
2.8 Vaccine safety monitoring in special populations
2.9 Ethical considerations in AEFI surveillance
2.10 Future directions in AEFI research

Chapter 3: Research Methodology
3.1 Research design
3.2 Data collection methods
3.3 Sampling techniques
3.4 Data analysis procedures
3.5 Ethical considerations
3.6 Research limitations
3.7 Validity and reliability of the study
3.8 Research implications

Chapter 4: Discussion of Findings
4.1 Overview of AEFI surveillance data
4.2 Analysis of AEFI reporting systems
4.3 Evaluation of AEFI investigation protocols
4.4 Comparison of AEFI surveillance practices
4.5 Recommendations for enhancing AEFI monitoring
4.6 Implications for public health policy
4.7 Future research directions

Chapter 5: Conclusion and Summary
5.1 Summary of findings
5.2 Conclusions
5.3 Contributions to the field
5.4 Recommendations for future research
5.5 Final thoughts

Thesis Overview:

Adverse events following immunization (AEFI) pose a potential risk to public health and require robust surveillance systems to monitor their occurrence. This thesis examines the post marketing surveillance of AEFI with a focus on improving the monitoring and reporting of vaccine safety. The study will review the existing literature on AEFI surveillance, identify challenges in current systems, and propose recommendations for enhancing AEFI monitoring. The research aims to contribute to the field of vaccine safety and public health by addressing the critical issue of AEFI surveillance. Through an in-depth analysis of AEFI practices, this study seeks to improve the detection and investigation of adverse events following immunization and ultimately enhance the safety and efficacy of immunization programs.

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