Surveillance systems and methods for monitoring the post-marketing safety of influenza vaccines at the Centers for Disease Control and Prevention

Expert Opin Drug Saf. 2016 Sep;15(9):1175-83. doi: 10.1080/14740338.2016.1194823. Epub 2016 Jun 16.

Abstract

Introduction: Annual influenza vaccine safety monitoring is an important component of the influenza vaccination program in the United States to ensure that vaccines are safe, which is important for maintaining public trust in the national vaccination program. This is specially the case for influenza vaccines since the antigen composition of the viruses of which the vaccine is made often changes from one season to the next, based on the circulating strain of influenza virus.

Areas covered: This review describes the two surveillance systems used by the Centers for Disease Control and Prevention (CDC) to monitor the safety of influenza vaccines: 1) the Vaccine Adverse Event Reporting System (VAERS); and 2) the Vaccine Safety datalink (VSD).

Expert opinion: VAERS and VSD are used routinely to monitor the safety of influenza vaccines in the United States, and over the years they have demonstrated their value in monitoring vaccine safety since their implementation in 1990. Both systems, although different, complemented each other well to study febrile seizures in young children following influenza vaccination during the 2010-2011 influenza season. Other examples of potential safety concerns after influenza vaccines are also presented and discussed.

Keywords: Epidemiology; VAERS; VSD; influenza vaccine; surveillance; vaccine safety.

Publication types

  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Centers for Disease Control and Prevention, U.S.
  • Humans
  • Immunization Programs
  • Influenza Vaccines / administration & dosage*
  • Influenza Vaccines / adverse effects
  • Influenza, Human / prevention & control
  • Product Surveillance, Postmarketing*
  • United States

Substances

  • Influenza Vaccines