title: Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program.
abstract: The effort to vaccinate the US population against the 2009 H1N1 influenza virus hinged, in part, on public confidence in vaccine safety. Early in the vaccine program, >20% of parents reported that they would not vaccinate their children. Concerns about the safety of the vaccines were reported by many parents as a factor that contributed to their intention to forgo vaccination (see www.hsph.harvard.edu/news/press-releases/2009-releases/survey-40-adults-absolutely-certain-h1n1-vaccine.html and www.med.umich.edu/mott/npch/reports/h1n1.htm). The safety profiles of 2009 H1N1 monovalent influenza vaccines were anticipated to be (and have been) similar to those of seasonal influenza vaccines, for which an excellent safety profile has been demonstrated. Here we describe steps taken by the US government to (1) assess the key federal systems in place before 2009 for monitoring the safety of vaccines and (2) integrate and upgrade those systems for optimal vaccine-safety monitoring during the 2009 H1N1 monovalent influenza vaccination program. These efforts improved monitoring of 2009 H1N1 vaccine safety, hold promise for enhancing future national monitoring of vaccine safety, and may ultimately help improve public confidence in vaccines.
authors.affiliation: National Vaccine Program Office, Office of Public Health and Science, Department of Health and Human Services, 200 Independence Ave, Washington, DC 20201, USA. daniel.salmon@hhs.gov
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Salmon
authors.forename: Aysha
authors.initials: A
authors.lastname: Akhtar
authors.forename: Michelle J
authors.initials: MJ
authors.lastname: Mergler
authors.forename: Kirsten S
authors.initials: KS
authors.lastname: Vannice
authors.forename: Hector
authors.initials: H
authors.lastname: Izurieta
authors.forename: Robert
authors.initials: R
authors.lastname: Ball
authors.forename: Grace M
authors.initials: GM
authors.lastname: Lee
authors.forename: Claudia
authors.initials: C
authors.lastname: Vellozzi
authors.forename: Patrick
authors.initials: P
authors.lastname: Garman
authors.forename: Francesca
authors.initials: F
authors.lastname: Cunningham
authors.forename: Bruce
authors.initials: B
authors.lastname: Gellin
authors.forename: Howard
authors.initials: H
authors.lastname: Koh
authors.forename: Nicole
authors.initials: N
authors.lastname: Lurie
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D002648:Child; D004196:Disease Outbreaks / Q000517:prevention & control*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D017589:Immunization Programs / Q000458:organization & administration; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D015397:Program Evaluation; D017751:Safety Management; D014481:United States; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines