ABSTRACT

This analysis looks at recent amendments to laws and regulations and offers a thorough summary of the current vaccination laws in the US. The Food and Drug Administration (FDA) is principally overseeing the regulatory framework for vaccinations, which guarantees the efficacy, safety, and quality of vaccines before and after their release onto the market. Important components include clinical trials conducted prior to licensure, post-marketing surveillance programs like the VAERS, and particular regulations mandated by the 1986 National Childhood Vaccine Injury Act (NCVIA). The FDA evaluates vaccines for safety and efficacy via several stages of clinical trials as part of its stringent pre- licensure procedure. The post-marketing surveillance system, which includes the Vaccine Safety Datalink (VSD) and VAERS, is essential for tracking side effects and maintaining public safety after licensure. New public health needs and improved vaccination safety monitoring have been addressed by recent legislative and regulatory revisions. These include revised procedures for the expedited consideration of vaccines during public health emergencies, such as the COVID-19 pandemic, improvements to the VICP, and adjustments to reporting requirements. The FDA Reauthorization Act (FDARA) and the 21stCentury Cures Act feature provisions that simplify the vaccine research and clearance process by using cutting-edge clinical trial designs and real-world evidence. Keywords: Vaccine, Vaccine Adverse Event Reporting System (VAERS), CDC, CBER
Publication date: 01/10/2025

https://ijbpas.com/pdf/2025/October/MS_IJBPAS_2025_9543.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.10.9543