Abstract

THE COMPREHENSIVE STUDY ON VACCINE SAFETY MONITORING SYSTEM

Garudkar Pratiksha Mukund*, Wayal Prasad Navnath, Unde Aniket Nanasaheb, Walunj Jayesh Jalindar and Wadekar Ganesh Namdev

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Abstract

The Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration (FDA), and nine health care organizations collaborated on the vaccine safety datalink project. The FDA uses the Vaccine Adverse Event Reporting System (VARS) to conduct postlicensure vaccine safety monitoring. The VARS data is analyzed using a variety of statistical techniques, and the results are used by the CDC and FDA to inform future safety evaluations, recommendations, and regulatory actions. VSD investigators also publish significant studies demonstrating that the childhood vaccine is not linked to other developmental disabilities. In order to help healthcare professionals who administer vaccinations and may wish to report or gain a better understanding of a vaccine adverse event, we outline basic vaccine safety concepts, give an overview of VAERS, and explain how the CDC and FDA analyze VAERS data. Additionally, we discuss our advantages and disadvantages as well as frequent misconceptions regarding VAERS. Counseling specialists in the medical field will find the information in this review useful. Information about vaccine safety and the benefit-risk balance for patients, parents, and other stakeholders.

Keywords: Vaccination; vaccine adverse event; adverse event following immunization; spontaneous reporting; passive surveillance; vaccine safety; Vaccine Adverse Event Reporting System (VAERS) Surveillance; Vaccine safety; Immunization.