The objective of this study was to evaluate the safety of infant immunization with acellular pertussis vaccines in the U.S. The study consisted of reports of infant immunization against pertussis between January 1, 1995 (when whole-cell vaccine was in exclusive use) and June 30, 1998 (when acellular vaccine was in predominant use). The annual number of reported events categorized as non-fatal serious reported to the Vaccine Adverse Event Reporting System (VAERS) for all pertussis-containing vaccines declined between 1995 and 1998. It was concluded that VAERS data (although subject to the limitations of passive surveillance) support the prelicensure data with regard to the safety of the US licensed acellular pertussis vaccines that were evaluated.
AGENCY SPONSOR: Center for Biologics Evaluation and Research
FEDERAL CONTACT: Miles M. Braun, 301-827-3974
PIC ID: 7251
PERFORMER: Food & Drug Administration, Ctr. for Biologics Evaluation, Rockville, MD