Biomaterial Database

The safety of acellular pertussis vaccine vs whole-cell pertussis vaccine. A postmarketing assessment. 1996

S Rosenthal, and R Chen, and S Hadler

National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA, USA.

OBJECTIVE To determine the impact of the introduction of acellular pertussis vaccine for the fourth and fifth doses of the diphtheria and tetanus toxoids and pertussis vaccine series in children on rates of reported vaccine-associated adverse events in the United States. METHODS Analysis of postmarketing vaccine adverse event data from the Vaccine Adverse Event Reporting System during the years 1991 to 1993. METHODS Approximately 27 million doses of diphtheria and tetanus toxoids and pertussis vaccine and 5 million doses of diphtheria and tetanus toxoids and acellular pertussis vaccine were distributed from 1991 to 1993 to children 15 months to 7 years of age. METHODS Rates of reported fever, seizures, and hospitalizations after pertussis vaccination. RESULTS Rates of reported adverse events per 100,000 vaccinations were significantly lower after administration of diphtheria and tetanus toxoids and acellular pertussis vaccine than diphtheria and tetanus toxoids and pertussis vaccine for the following outcomes: all reports, 2.9 vs 9.8; fever, 1.9 vs 7.5; seizures, 0.5 vs 1.7; and hospitalizations, 0.2 vs 0.9. CONCLUSIONS These results confirm that minor adverse events are less frequent after administration of the acellular pertussis vaccine. In addition, these data suggested that seizures and hospitalizations associated with pertussis vaccination are less frequent after administration of the acellular pertussis vaccine in age groups for which it is now recommended.

UI	MeSH Term	Description	Entries
D007223	Infant	A child between 1 and 23 months of age.	Infants
D008297	Male		Males
D010567	Pertussis Vaccine	A suspension of killed Bordetella pertussis organisms, used for immunization against pertussis (WHOOPING COUGH). It is generally used in a mixture with diphtheria and tetanus toxoids (DTP). There is an acellular pertussis vaccine prepared from the purified antigenic components of Bordetella pertussis, which causes fewer adverse reactions than whole-cell vaccine and, like the whole-cell vaccine, is generally used in a mixture with diphtheria and tetanus toxoids. (From Dorland, 28th ed)	Vaccine, Pertussis
D011358	Product Surveillance, Postmarketing	Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.	Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D002648	Child	A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL.	Children
D002675	Child, Preschool	A child between the ages of 2 and 5.	Children, Preschool,Preschool Child,Preschool Children
D005260	Female		Females
D005334	Fever	An abnormal elevation of body temperature, usually as a result of a pathologic process.	Pyrexia,Fevers,Pyrexias
D006760	Hospitalization	The confinement of a patient in a hospital.	Hospitalizations
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man