title: Monitoring vaccine safety during an influenza pandemic.
abstract: In the event that a vaccine is available during an influenza pandemic, vaccine safety monitoring will occur as part of comprehensive public health surveillance of the vaccination campaign. Though inactivated influenza vaccines have been widely used in the United States and much is known about their safety profile, attention will need to be paid to both common self-limited adverse reactions and rarer, more serious events that may or may not be causally related to vaccination. The primary surveillance systems used to generate and test hypotheses about vaccine safety concerns are the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), respectively. Examples of recent use of these systems to investigate influenza vaccine safety and enhancements planned for use during a pandemic are presented. Ethical issues that will need to be addressed as part of an overall vaccine safety response include risk communication and injury compensation. Advance planning and the use of available technologic solutions are needed to respond to the scientific and logistic challenges involved in safely implementing mass vaccination during a pandemic.
authors.affiliation: Immunization Safety Office, Office of the Chief Science Officer, Office of the Director, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. jxi0@cdc.gov
authors.forename: John
authors.initials: J
authors.lastname: Iskander
authors.forename: Penina
authors.initials: P
authors.lastname: Haber
authors.forename: Guillermo
authors.initials: G
authors.lastname: Herrera
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D004189:Disaster Planning; D018563:Disease Notification / Q000379:methods*; D004196:Disease Outbreaks / Q000517:prevention & control*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000175:diagnosis* / Q000517:prevention & control*; D019221:Mandatory Reporting; D011159:Population Surveillance / Q000379:methods*; D014481:United States
chemical_list: D007252:Influenza Vaccines