Hector S Izurieta

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi Adverse events reported following live, cold-adapted, intranasal influenza vaccine
    Hector S Izurieta
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    JAMA 294:2720-5. 2005
  2. ncbi Outpatient transfusions and occurrence of serious noninfectious transfusion-related complications among US elderly, 2007-2008: utility of large administrative databases in blood safety research
    Mikhail Menis
    Analytic Epidemiology Branch, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Transfusion 52:1968-76. 2012
  3. ncbi Surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2009-2010
    Dale R Burwen
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
    Am J Public Health 102:1921-7. 2012
  4. ncbi Evaluation of Guillain-Barré Syndrome among recipients of influenza vaccine in 2000 and 2001
    Dale R Burwen
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Am J Prev Med 39:296-304. 2010
  5. ncbi Kawasaki disease after vaccination: reports to the vaccine adverse event reporting system 1990-2007
    Wei Hua
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, Food and Drug Administration FDA, Rockville, MD 20852 1448, USA
    Pediatr Infect Dis J 28:943-7. 2009
  6. ncbi Babesiosis among elderly Medicare beneficiaries, United States, 2006-2008
    Mikhail Menis
    Food and Drug Administration, Rockville, MD 20852, USA
    Emerg Infect Dis 18:128-31. 2012
  7. ncbi Application of the immunological disease continuum to study autoimmune and other inflammatory events after vaccination
    Helen C Koenig
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
    Vaccine 29:913-9. 2011
  8. ncbi Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005
    Sandra S Chaves
    Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA
    J Infect Dis 197:S170-7. 2008
  9. ncbi Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007
    Penina Haber
    Centers for Disease Control and Prevention, National Center for Immunizations and Respiratory Diseases, 1600 Clifton Rd, MS A 47, Atlanta, GA 30333, USA
    Pediatrics 121:1206-12. 2008
  10. ncbi Effectiveness of influenza vaccination
    M Miles Braun
    N Engl J Med 357:2730; author reply 2730-1. 2007

Collaborators

Detail Information

Publications11

  1. ncbi Adverse events reported following live, cold-adapted, intranasal influenza vaccine
    Hector S Izurieta
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    JAMA 294:2720-5. 2005
    ..Although prelicensure testing involved 20 228 vaccinees, clinical trials were not of sufficient size to detect rare adverse events reliably...
  2. ncbi Outpatient transfusions and occurrence of serious noninfectious transfusion-related complications among US elderly, 2007-2008: utility of large administrative databases in blood safety research
    Mikhail Menis
    Analytic Epidemiology Branch, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Transfusion 52:1968-76. 2012
    ..Our study evaluated types and quantities of transfused components as well as occurrence of TRALI, ABO, and Rh incompatibilities among the US elderly in the institutional outpatient setting during 2007 to 2008...
  3. ncbi Surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2009-2010
    Dale R Burwen
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
    Am J Public Health 102:1921-7. 2012
    ..We implemented active surveillance for Guillain-Barré syndrome (GBS) following seasonal or H1N1 influenza vaccination among the Medicare population during the 2009-2010 influenza season...
  4. ncbi Evaluation of Guillain-Barré Syndrome among recipients of influenza vaccine in 2000 and 2001
    Dale R Burwen
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Am J Prev Med 39:296-304. 2010
    ..Studies published after the IOM report have been limited by passively reported data or lack of validation of coded diagnoses...
  5. ncbi Kawasaki disease after vaccination: reports to the vaccine adverse event reporting system 1990-2007
    Wei Hua
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, Food and Drug Administration FDA, Rockville, MD 20852 1448, USA
    Pediatr Infect Dis J 28:943-7. 2009
    ..A review of RotaTeq (rotavirus vaccine live) clinical trial data revealed higher, though not statistically significantly, KD rates among RotaTeq vaccines than placebo recipients. In June 2007, the RotaTeq label was revised accordingly...
  6. ncbi Babesiosis among elderly Medicare beneficiaries, United States, 2006-2008
    Mikhail Menis
    Food and Drug Administration, Rockville, MD 20852, USA
    Emerg Infect Dis 18:128-31. 2012
    ..The highest babesiosis rates were in Connecticut, Rhode Island, New York, and Massachusetts, and findings suggested babesiosis expansion to other states...
  7. ncbi Application of the immunological disease continuum to study autoimmune and other inflammatory events after vaccination
    Helen C Koenig
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
    Vaccine 29:913-9. 2011
    ..We show how this could have important implications to assess mechanisms of potential immune-mediated adverse events following vaccination...
  8. ncbi Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005
    Sandra S Chaves
    Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA
    J Infect Dis 197:S170-7. 2008
    ..Ongoing safety surveillance and further studies may shed light on some of the hypothesized associations...
  9. ncbi Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007
    Penina Haber
    Centers for Disease Control and Prevention, National Center for Immunizations and Respiratory Diseases, 1600 Clifton Rd, MS A 47, Atlanta, GA 30333, USA
    Pediatrics 121:1206-12. 2008
    ..Although the new rotavirus vaccine (RotaTeq; Merck, West Point, PA) introduced in 2006 was not associated with intussusception in prelicensure trials, additional monitoring is important to ensure a complete safety profile...
  10. ncbi Effectiveness of influenza vaccination
    M Miles Braun
    N Engl J Med 357:2730; author reply 2730-1. 2007
  11. ncbi Aseptic meningitis: case definition and guidelines for collection, analysis and presentation of immunization safety data
    Terhi Tapiainen
    University Children's Hospital, Basel, Switzerland
    Vaccine 25:5793-802. 2007