KEYWORD1:
Safety, Hepatitis B, SV40, SIDS

BACKGROUND:
In October 2000 the CDC and NIH contracted with the Institute of Medicine to form a committee to review vaccine safety concerns on an ongoing basis. The Immunization Safety Review Committee issues a report after each of its meetings. The Committee has issued 6 reports in 2 years.

OBJECTIVE:
The objectives are to assess the evidence about specific safety concerns. The recommendations about an appropriate public health response should help CDC and NIH prioritize their efforts regarding specific vaccine safety concerns.

METHOD:
The committee uses a consistent approach to review medical and public health literature in order to draw conclusions about the relationship between vaccine and adverse event and about the strength of the biological data supporting the theory. The committee recommends the appropriate public health response in terms of policy review and analysis, research, and communications.

RESULT:
The committee released three reports since National Immunization Conference 2002.

CONCLUSION:
The committee concluded that the evidence favors rejection of a causal relationship between Hepatitis B vaccine given to adults and incident and relapse MS, and that the biological evidence supporting the theory is weak. They concluded that the evidence is inadequate to accept or reject a causal relationship between SV40-contaminated polio vaccine (given from 1955-1963), but the biological evidence supporting the theory is moderate to strong. The committee’s most recent report on vaccinations in the first year of life and sudden unexpected death in infancy will be discussed. The recommendations will be discussed, in the context of the scientific and societal significance of each safety concern.
LEARNINGOBJECTIVES:
To understand how a consistent and independent review of vaccine adverse events can be used to guide recommendations for public health action.