Immunization - Safety Monitoring Systems for the 2009

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-h1n1vaccine.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. Pediatrics 2011;127:S78–S86 AUTHORS: Daniel A. Salmon, PhD, MPH,a Aysha Akhtar, MD, MPH,b Michelle J. Mergler, MHS,a Kirsten S. Vannice, MHS,a Hector Izurieta, MD, MPH,c Robert Ball, MD, MPH, ScM,b Grace M. Lee, MD, MPH,d Claudia Vellozzi, MD, MPH,e Patrick Garman, PhD,f Francesca Cunningham, PharmD,g Bruce Gellin, MD, MPH,a Howard Koh, MD, MPH,h and Nicole Lurie, MD, MSPH,i the H1N1 Working Group of the Federal Immunization Safety Task Force aNational Vaccine Program Office, hAssistant Secretary for Health, and iAssistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, Washington, DC; cAnalytic Epidemiology Branch, Division of Epidemiology, bOffice of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD; dDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School and Children’s Hospital Boston, Division of Infectious Diseases and Dept of Laboratory Medicine, Boston, MA; eImmunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA; fMilitary Vaccine Agency, United States Army, Falls Church, VA; gNational Center for Patient Safety, Pharmacy Benefits Management Services, Department of Veterans Affairs, Washington, DC