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).
OBJECTIVE
To evaluate the safety of infant immunization with acellular pertussis vaccines in the United States.


BACKGROUND
The US Food and Drug Administration approved the first acellular pertussis vaccine for use in infants in the United States on July 31, 1996.


METHODS
Adverse events in the United States after infant immunization with pertussis-containing vaccines, representing temporal (but not necessarily causal) associations between vaccinations and adverse events.


METHODS
Reports to the Vaccine Adverse Event Reporting System (VAERS), a passive national surveillance system.


METHODS
Reports concerning 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) were analyzed, if the reports were entered into the VAERS database by November 30, 1998.


RESULTS
During the study, there were 285 reports involving death, 971 nonfatal serious reports, and 4514 less serious reports after immunization with any pertussis-containing vaccine. For 1995 there were 2071 reports; in 1996 there were 1894 reports; in 1997 there were 1314 reports, and in the first half of 1998 there were 491 reports. Diphtheria-tetanus-pertussis vaccine (DTP) was cited in 1939 reports, diphtheria-tetanus-whole-cell pertussis-Haemophilus influenzae type b vaccine (DTPH) in 2918 reports, and diphtheria-tetanus-acellular pertussis vaccine (DTaP) in 913 reports. The annual number of deaths during the study was 85 in 1995, 82 in 1996, 77 in 1997, and 41 in the first half of 1998. The annual number of reported events categorized as nonfatal serious (defined as events involving initial hospitalization, prolongation of hospitalization, life-threatening illness, or permanent disability) to VAERS for all pertussis-containing vaccines declined: 334 in 1995, 311 in 1996, 233 in 1997, and 93 in the first half of 1998. Similarly, the annual number of less serious reports to VAERS for pertussis-containing vaccines declined: 1652 in 1995, 1501 in 1996, 1004 in 1997, and 357 in the first half of 1998. A comparison of the adverse event profiles (proportional distributions) for DTaP, DTP, and DTPH, as well as an analysis of specific adverse events considered in a 1991 Institute of Medicine report on the safety of diphtheria-tetanus-pertussis vaccine, did not identify any new, clear safety concerns.


CONCLUSIONS
These findings reflect the administration of millions of doses of acellular pertussis vaccine and are reassuring with regard to the safety of marketed acellular pertussis vaccines. 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 we evaluated.
Braun
M M
MM
Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA. braunm@cber.fda.gov
Mootrey
G T
GT
Salive
M E
ME
Chen
R T
RT
Ellenberg
S S
SS
D016907:Adverse Drug Reaction Reporting Systems; D001723:Birth Rate; D002423:Cause of Death; D002493:Central Nervous System Diseases / Q000139:chemically induced; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects; D018073:Haemophilus Vaccines / Q000009:adverse effects; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D010567:Pertussis Vaccine / Q000009:adverse effects*; D011159:Population Surveillance; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration; D022282:Vaccines, Acellular / Q000009:adverse effects
D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D010567:Pertussis Vaccine; D022282:Vaccines, Acellular; C080881:diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine