Safety profile of the yellow fever vaccine Stamaril®: a 17-year review.
Since the creation by the manufacturer in 1993, of an electronic pharmacovigilance database for all spontaneous, voluntary reports of adverse events (AEs) after vaccination, 276 million doses of Stamaril® have been distributed worldwide. We review this database for the safety of Stamaril with emphasis on yellow fever (YF) vaccine associated acute viscerotropic and neurotropic diseases, anaphylaxis and on specific at risk groups: elderly adults, pregnant and lactating women and the immunosuppressed. Findings confirm that the vaccine's safety profile in routine practice is favorable and consistent with the summary of product characteristics. Estimated reporting rates of serious adverse events associated after Stamaril vaccination are lower than the previously published and widely cited estimates of the worldwide reporting rate for YF vaccines in general. These data provide important additional information for the prescribers in assessing the risks and benefits associated with the use of Stamaril in individuals exposed to YF virus.
Global Pharmacovigilance Department Sanofi Pasteur, 2 avenue du Pont Pasteur, 69367 Lyon cedex 07, France.
Pascale
P
Cottin
Matthias
M
Niedrig
Cristina
C
Domingo
D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D006801:Humans; D018570:Risk Assessment; D022341:Yellow Fever Vaccine / Q000008:administration & dosage* / Q000009:adverse effects*
D022341:Yellow Fever Vaccine