Susan S Ellenberg
Affiliation: University of Pennsylvania
- Evaluating the safety of new vaccines: summary of a workshopSusan S Ellenberg
Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA
Am J Public Health 95:800-7. 2005..The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions...
- Pediatric deaths reported after vaccination: the utility of information obtained from parentsLinda E Silvers
U S Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Rockville, Maryland 20855, USA
Am J Prev Med 22:170-6. 2002..This investigation explored whether routinely interviewing parents for follow-up of VAERS pediatric deaths would provide additional information important to vaccine safety...
- Monitoring the safety of vaccines: assessing the risksSusan S Ellenberg
Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA
Drug Saf 25:145-52. 2002....
- Analytical, practical and regulatory issues in prevention studiesSusan S Ellenberg
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, 1401 Rockville Pike, HFM 210, Rockville, MD 20852, USA
Stat Med 23:297-303. 2004....
- Is the use of placebo controls ethically permissible in clinical trials of agents intended to reduce fractures in osteoporosis?Baruch A Brody
Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA
J Bone Miner Res 18:1105-9. 2003..Active control trials are permissible and desirable if they can be designed and conducted in ways that overcome the interpretive difficulties often associated with such trials...
- Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001Weigong Zhou
Epidemic Intelligence Service Program, Epidemiology Program Office, CDC, USA
MMWR Surveill Summ 52:1-24. 2003..Therefore, postmarketing monitoring of adverse events after vaccinations is essential. The cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events...
- A global perspective on vaccine safety and public health: the Global Advisory Committee on Vaccine SafetyPeter I Folb
Medical Research Council, PO Box 19070, Tygerberg 7505, Cape Town, South Africa
Am J Public Health 94:1926-31. 2004....