Hector S Izurieta

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint 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
  2. doi request reprint Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines
    Hector S Izurieta
    Food and Drug Administration FDA, MD, United States
    Vaccine 31:3623-7. 2013
  3. ncbi request reprint 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
  4. doi request reprint 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
  5. doi request reprint Incidence of endophthalmitis after corneal transplant or cataract surgery in a medicare population
    Dongyi Tony Du
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland Electronic address
    Ophthalmology 121:290-8. 2014
  6. pmc 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
  7. doi request reprint 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
  8. doi request reprint A simulation study to compare three self-controlled case series approaches: correction for violation of assumption and evaluation of bias
    Wei Hua
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Pharmacoepidemiol Drug Saf 22:819-25. 2013
  9. pmc 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
  10. doi request reprint 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

Collaborators

Detail Information

Publications15

  1. doi request reprint 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...
  2. doi request reprint Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines
    Hector S Izurieta
    Food and Drug Administration FDA, MD, United States
    Vaccine 31:3623-7. 2013
    ..While this paper discusses only the vaccine component, the same system could also be eventually used for monitoring drug effectiveness (including the use of substandard drugs) and drug safety. ..
  3. ncbi request reprint 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...
  4. doi request reprint 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...
  5. doi request reprint Incidence of endophthalmitis after corneal transplant or cataract surgery in a medicare population
    Dongyi Tony Du
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland Electronic address
    Ophthalmology 121:290-8. 2014
    ....
  6. pmc 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...
  7. doi request reprint 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...
  8. doi request reprint A simulation study to compare three self-controlled case series approaches: correction for violation of assumption and evaluation of bias
    Wei Hua
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Pharmacoepidemiol Drug Saf 22:819-25. 2013
    ..In this simulation study, we compared the performance of the standard SCCS approach and two alternative approaches when the event-independent exposure assumption was violated...
  9. pmc 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...
  10. doi request reprint 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...
  11. doi request reprint Hyperimmune globulins and same-day thrombotic adverse events as recorded in a large healthcare database during 2008-2011
    Mikhail Menis
    Center for Biologics Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland
    Am J Hematol 88:1035-40. 2013
    ..Our study, for the first time, identified increase in the same-day TE DC risk with GamaSTAN S/D IG >10 cc and suggests potentially elevated TE risk with other HIGs...
  12. ncbi request reprint 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
  13. ncbi request reprint Effectiveness of influenza vaccination
    M Miles Braun
    N Engl J Med 357:2730; author reply 2730-1. 2007
  14. doi request reprint 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...
  15. doi request reprint 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...