Vaccine safety

Robert M. Jacobson

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Rates of reported adverse events are remarkably low. VAERS identifies an adverse event rate approximating 11.4 reports per 100,000 vaccine doses. Approximately 15% of these reports represent SAEs, but less than 2% involve death; in most cases, reviews have shown no causal relation between the events and the vaccine. Across the spectrum of vaccines in use (including those directed against influenza and hepatitis B virus), many claims of adverse events regarding vaccines represent typical reactions to vaccinations. These reactions can be thought of as foreign-body reactions and predominate among the inactivated vaccines. In controlled studies, the adverse event rates that occur with vaccination resemble those that occur with placebo injections. Typical reactions associated with live viral and bacterial vaccines, such as MMR and varicella vaccines, may resemble attenuated forms of the disease for which the vaccine is directed. Other claims against vaccines represent chance-coincidence or misunderstood data; further studies of claims have vindicated the overall safety of the vaccines in most cases. Two documented safety concerns with vaccines, however, have demonstrated that vaccines (like other biologics and pharmacologic) can result in harm (eg, rotavirus and OPV vaccines). The denouement with these vaccines indicates the broad postmarketing data collection and evaluation that extends efforts made with prelicensure study to balance the benefits from vaccination with the risk for harm. Overall, measures including prelicensure study and postlicensure surveillance, such as VAERS, the Vaccine Safety Datalink Project, and the Clinical Immunization Safety Assessment Centers, have resulted in an exceptional safety profile for the vaccines in use.

Original languageEnglish (US)
Pages (from-to)589-603
Number of pages15
JournalImmunology and Allergy Clinics of North America
Volume23
Issue number4
DOIs
StatePublished - Nov 2003

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Vaccines
Safety
Vaccination
Measles-Mumps-Rubella Vaccine
Chickenpox Vaccine
Viral Vaccines
Bacterial Vaccines
Rotavirus Vaccines
Influenza B virus
Foreign-Body Reaction
Inactivated Vaccines
Biological Products
Hepatitis B virus
Immunization
Placebos
Injections

ASJC Scopus subject areas

  • Immunology and Allergy

Cite this

Vaccine safety. / Jacobson, Robert M.

In: Immunology and Allergy Clinics of North America, Vol. 23, No. 4, 11.2003, p. 589-603.

Research output: Contribution to journalArticle

Jacobson, Robert M. / Vaccine safety. In: Immunology and Allergy Clinics of North America. 2003 ; Vol. 23, No. 4. pp. 589-603.
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