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PEDIATRICS Vol. 101 No. 3 March 1998, pp. 453-458
, and
From the * Office of Vaccines Research and Review, Center for
Biologics Evaluation and Research, Food and Drug Administration,
Rockville, Maryland; the National Vaccine Injury Compensation
Program, Health Resources and Services Administration, Department of
Health and Human Services, Rockville, Maryland; and the § School of
Public Policy, Georgia Institute of Technology, Atlanta, Georgia.
| The first 300 words of the full text of this article appear below. |
 |
INTRODUCTION |
|---|
Concern over vaccine safety has been a major determinant of
immunization policy
from passage of the Biologics Control Act in 1902 to the recent American Academy of Pediatrics (AAP) and Advisory
Committee on Immunization Practices (ACIP) recommendations for expanded
use of inactivated polio (IPV) and acellular pertussis vaccines.1-4 With the availability of new vaccines
and vaccination options comes the challenge of how best to communicate
these options to patients and their parents. Lessons from the field of
risk communication on predictors of risk acceptability and vaccination decision heuristics provide insight into why some parents resist vaccination. This article provides a historical perspective on vaccine
adverse events and applies lessons from risk communication research to
help physicians improve their ability to discuss vaccine risks.
| |
HISTORICAL PERSPECTIVE |
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Immunizations have been described as the single most effective health intervention after clean water and sewage disposal,5 and have an extraordinary safety record. However, public policy has long reflected concern for the safety of vaccines and related biologics. In 1902, Congress passed the Biologics Control Act in response to the death of 13 children who had received injections of diphtheria antitoxin contaminated with tetanus toxin.6 This act required biologics to be manufactured in a manner that assured their safety, purity, and potency. Responsibility for these regulations was assigned originally to the Hygienic Laboratory of the Public Health Service, which evolved into the National Institutes of Health. The regulation of biologics including vaccines was transferred to the Food and Drug Administration (FDA) in 1972.
The first published accounts of serious adverse events after whole cell
pertussis vaccine occurred in 1933 with Madsen's7 report
of two deaths within 48 hours of immunization, and in 1948 with the
report in Pediatrics by Byers and Moll8 of
encephalopathy after diphtheria and tetanus toxoids combined with
whole-cell pertussis vaccine (DTwP). In 1955 the Cutter incident
occurred, in which
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