A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003-2004.
The US Department of Defense requested that the Advisory Committee on Immunization Practices-Armed Forces Epidemiological Board joint Smallpox Vaccine Safety Working Group define the likelihood that smallpox vaccination played a causal role in the fatal illness of an Army reservist. Reported serious adverse events for which there was no a priori reason to discount the existence of a causal association with smallpox vaccine were reviewed to assess whether they were signals of constellations of vaccine-associated adverse events. A causal relationship between the immunization experience and the index patient's death was favored, but the implication of an individual vaccine was precluded. No new smallpox vaccine-associated clinical syndromes were identified. The data supported neutrality regarding the hypothesis that dilated cardiomyopathy was causally associated with smallpox vaccine-induced myocarditis. This review of sentinel cases augmented the ongoing safety review process and was transparent, but it shares limitations with other case-based causality-assessment methods.
Chapman
Louisa E
LE
Epidemiology and Surveillance Division, National Immunization Program, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. lec3@cdc.gov
Iskander
John K
JK
Chen
Robert T
RT
Neff
John
J
Birkhead
Guthrie S
GS
Poland
Gregory
G
Gray
Gregory C
GC
Siegel
Jane
J
Sepkowitz
Kent
K
Robertson
Rose Marie
RM
Yancy
Clyde
C
Guerra
Fernando A
FA
Gardner
Pierce
P
Modlin
John F
JF
Maurer
Toby
T
Berger
Tim
T
Flanders
W Dana
WD
Shope
Robert
R
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration / Q000706:statistics & numerical data*; D016022:Case-Control Studies; D015984:Causality; D006801:Humans; D032541:Mass Vaccination / Q000009:adverse effects* / Q000706:statistics & numerical data; D018571:Sentinel Surveillance; D012899:Smallpox / Q000517:prevention & control; D012900:Smallpox Vaccine / Q000009:adverse effects*; D014481:United States
C078786:DryVax vaccine; D012900:Smallpox Vaccine