S S Ellenberg

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. pmc The complicated task of monitoring vaccine safety
    S S Ellenberg
    Division of Biostatistics and Epidemiology, FDA, USA
    Public Health Rep 112:10-20; discussion 21. 1997
  2. ncbi request reprint Neonatal deaths after hepatitis B vaccine: the vaccine adverse event reporting system, 1991-1998
    M T Niu
    Division of Biostatistics and Epidemiology, Center for Biologic Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852 1448, USA
    Arch Pediatr Adolesc Med 153:1279-82. 1999
  3. ncbi request reprint Infant immunization with acellular pertussis vaccines in the United States: assessment of the first two years' data from the Vaccine Adverse Event Reporting System (VAERS)
    M M Braun
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Pediatrics 106:E51. 2000
  4. ncbi request reprint Independent data monitoring committees: rationale, operations and controversies
    S S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852 1448, U S A
    Stat Med 20:2573-83. 2001
  5. ncbi request reprint Evaluating the safety of combination vaccines
    S S Ellenberg
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    Clin Infect Dis 33:S319-22. 2001
  6. ncbi request reprint The epidemiology of fatalities reported to the vaccine adverse event reporting system 1990-1997
    L E Silvers
    US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Bethesda, MD, USA
    Pharmacoepidemiol Drug Saf 10:279-85. 2001
  7. ncbi request reprint Safety considerations for new vaccine development
    S S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, MD, USA
    Pharmacoepidemiol Drug Saf 10:411-5. 2001

Detail Information

Publications7

  1. pmc The complicated task of monitoring vaccine safety
    S S Ellenberg
    Division of Biostatistics and Epidemiology, FDA, USA
    Public Health Rep 112:10-20; discussion 21. 1997
    ..A continual effort to monitor these data effectively and to develop more precise ways of assessing risks of vaccines is necessary to ensure public confidence in immunization programs...
  2. ncbi request reprint Neonatal deaths after hepatitis B vaccine: the vaccine adverse event reporting system, 1991-1998
    M T Niu
    Division of Biostatistics and Epidemiology, Center for Biologic Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852 1448, USA
    Arch Pediatr Adolesc Med 153:1279-82. 1999
    ..To evaluate reports of neonatal deaths (aged 0-28 days) after hepatitis B (HepB) immunization reported to the national Vaccine Adverse Event Reporting System (VAERS)...
  3. ncbi request reprint Infant immunization with acellular pertussis vaccines in the United States: assessment of the first two years' data from the Vaccine Adverse Event Reporting System (VAERS)
    M M Braun
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Pediatrics 106:E51. 2000
    ..To evaluate the safety of infant immunization with acellular pertussis vaccines in the United States...
  4. ncbi request reprint Independent data monitoring committees: rationale, operations and controversies
    S S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852 1448, U S A
    Stat Med 20:2573-83. 2001
    ..It is also timely to consider the present and possible future regulatory status of data monitoring committees. Published in 2001 by John Wiley & Sons, Ltd...
  5. ncbi request reprint Evaluating the safety of combination vaccines
    S S Ellenberg
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    Clin Infect Dis 33:S319-22. 2001
    ....
  6. ncbi request reprint The epidemiology of fatalities reported to the vaccine adverse event reporting system 1990-1997
    L E Silvers
    US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Bethesda, MD, USA
    Pharmacoepidemiol Drug Saf 10:279-85. 2001
    ..To examine the fatalities reported to the federally administered Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, in its first 7 years...
  7. ncbi request reprint Safety considerations for new vaccine development
    S S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, MD, USA
    Pharmacoepidemiol Drug Saf 10:411-5. 2001
    ....