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Vaccine safety.

Robert M Jacobson¹

¹Mayo Clinic Vaccine Research Group, Department of Pediatric and Adolescent Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Jacobson.robert@mayo.edu

Immunology and Allergy Clinics of North America

|February 3, 2004

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Vaccine adverse event rates are very low, with most reported events being typical reactions, not causally linked to vaccines. Post-market surveillance confirms the exceptional safety profile of vaccines.

Area of Science:

Immunology
Pharmacology
Public Health

Background:

Adverse event reports following vaccination are a public concern.
Understanding vaccine safety is crucial for public health initiatives.
Distinguishing between actual adverse events and coincidental occurrences is vital.

Purpose of the Study:

To evaluate the overall safety profile of vaccines.
To assess the rates and types of reported adverse events.
To examine the methodologies used for vaccine safety surveillance.

Main Methods:

Analysis of data from the Vaccine Adverse Event Reporting System (VAERS).
Review of controlled studies comparing vaccine adverse event rates to placebo.
Examination of postmarketing surveillance data and safety studies.

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Main Results:

Adverse event reporting rates are low, approximately 11.4 per 100,000 doses.
Serious adverse events (SAEs) account for about 15% of reports, with deaths being less than 2% and rarely causally linked.
Most reported events are typical, expected reactions to vaccines, similar to placebo injections.
While rare harms have been identified (e.g., rotavirus, OPV vaccines), comprehensive surveillance balances benefits against risks.

Conclusions:

Vaccines demonstrate an exceptional safety profile due to rigorous pre- and post-licensure evaluation.
Post-market surveillance systems like VAERS are essential for ongoing vaccine safety monitoring.
The benefits of vaccination significantly outweigh the minimal risks of harm.