Diekema.ppt [Compatibility Mode] - Institute of Medicine

Proposed Framework for Determining When
Vaccine-Associated Febrile Seizures Should Lead
to a Change in ACIP Recommendations
• Confirmation of febrile seizures through review of clinical
data and standardized classification
• Level of certainty vaccine is causing observed increase
in seizures
– Timing of seizures related to vaccine administration
– Association with administration of a single vaccine, multiple
vaccines, or specific vaccine doses in a series
– Additional factors that might influence or confound the
association (E.g., increased circulation of naturally-occurring
infection; medications; underlying conditions)
• Age stratified rate and relative risk of vaccine-associated
febrile seizures and excess cases expected in the
population
• Evidence for potential explanations (I.e., new product,
new vaccine ingredient or manufacturing process,
adulterant, etc.)