Abstract
Objectives:
Most vaccine safety data present only the postvaccination incidence of all adverse events rather than an estimate of attributable risk. This study sought to illustrate the difference between the 2 estimates with data from a hepatitis B immunization program.
Methods:
The incidence of health problems occurring before and after each dose of hepatitis B vaccine in a cohort of 1130 children were compared.
Results:
Although 47.5% of all children reported an adverse event during the 4 weeks following each of the 3 doses, adverse events attributable to immunization occurred in only 10.6% of children.
Conclusions:
Postimmunization incidence systematically overestimates the risk of adverse events. Estimating actual attributable risk is necessary to avoid false beliefs regarding immunization.
Publication types
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Comparative Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Adverse Drug Reaction Reporting Systems*
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Bias
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Child
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Data Interpretation, Statistical*
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Drug Hypersensitivity / epidemiology
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Drug Hypersensitivity / etiology
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Drug Monitoring / methods*
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Fever / chemically induced
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Fever / epidemiology
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Follow-Up Studies
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Gastrointestinal Diseases / chemically induced
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Gastrointestinal Diseases / epidemiology
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Headache / chemically induced
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Headache / epidemiology
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Hepatitis B Vaccines / adverse effects*
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Humans
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Incidence
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Quebec / epidemiology
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Respiratory Tract Diseases / chemically induced
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Respiratory Tract Diseases / epidemiology
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Risk Factors
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Urban Health / statistics & numerical data
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Vaccines, Synthetic / adverse effects*
Substances
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Engerix-B
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Hepatitis B Vaccines
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Vaccines, Synthetic