Soju Chang

Summary

Publications

  1. ncbi request reprint Preventable mix-ups of tuberculin and vaccines: reports to the US Vaccine and Drug Safety Reporting Systems
    Soju Chang
    Office of Biostatistics and Epidemiology, US Food and Drug Administration FDA, 1401 Rockville Pike, Rockville, MD 20852, USA
    Drug Saf 31:1027-33. 2008
  2. 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
  3. ncbi request reprint Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003
    Ann W McMahon
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, Maryland 20852, USA
    Pediatrics 115:453-60. 2005
  4. doi request reprint Elective termination of pregnancy after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS): 1990-2006
    Soju Chang
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration, 1401 Rockville Pike, HFM 222, Rockville, MD 20852 United States
    Vaccine 26:2428-32. 2008
  5. ncbi request reprint Perinatal hepatitis B transmission and vaccination timing in a managed care cohort: assessment of the temporary delay in newborn hepatitis B vaccination due to thimerosal content
    Soju Chang
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration, Rockville, MD 20852, USA
    Pediatr Infect Dis J 26:329-33. 2007
  6. doi request reprint U.S. Postlicensure safety surveillance for adolescent and adult tetanus, diphtheria and acellular pertussis vaccines: 2005-2007
    Soju Chang
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852, United States
    Vaccine 31:1447-52. 2013

Detail Information

Publications6

  1. ncbi request reprint Preventable mix-ups of tuberculin and vaccines: reports to the US Vaccine and Drug Safety Reporting Systems
    Soju Chang
    Office of Biostatistics and Epidemiology, US Food and Drug Administration FDA, 1401 Rockville Pike, Rockville, MD 20852, USA
    Drug Saf 31:1027-33. 2008
    ..Errors involving the mix-up of tuberculin purified protein derivative (PPD) and vaccines leading to adverse reactions and unnecessary medical management have been reported previously...
  2. 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...
  3. ncbi request reprint Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003
    Ann W McMahon
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, Maryland 20852, USA
    Pediatrics 115:453-60. 2005
    ..In April 2002, the Advisory Committee on Immunization Practices (ACIP) encouraged providers to vaccinate healthy 6- to 23-month-old infants and children with trivalent influenza vaccine (TIV)...
  4. doi request reprint Elective termination of pregnancy after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS): 1990-2006
    Soju Chang
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration, 1401 Rockville Pike, HFM 222, Rockville, MD 20852 United States
    Vaccine 26:2428-32. 2008
    ..Good quality information may be obtained from controlled observational studies...
  5. ncbi request reprint Perinatal hepatitis B transmission and vaccination timing in a managed care cohort: assessment of the temporary delay in newborn hepatitis B vaccination due to thimerosal content
    Soju Chang
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration, Rockville, MD 20852, USA
    Pediatr Infect Dis J 26:329-33. 2007
    ..S. childhood immunization schedule, of vaccinations during the first 2 years of life...
  6. doi request reprint U.S. Postlicensure safety surveillance for adolescent and adult tetanus, diphtheria and acellular pertussis vaccines: 2005-2007
    Soju Chang
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852, United States
    Vaccine 31:1447-52. 2013
    ..However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs)...