ABSTRACT
INTRODUCTION: Rabies is a worldwide zoonotic viral disease with no specific treatment once symptoms occur; manifest disease is almost always fatal. WHO recommendations for exposed individuals include immediate attention to the wound and use of rabies immunoglobulin and/or vaccine for post-exposure prophylaxis (PEP). Here, we provide an overview of the clinical experience with a highly purified preparation of F(ab')2 fragments from equine rabies immunoglobulin (F(ab')2 pERIG; FavirabTM) in rabies PEP. Areas covered: Our review comprises a retrospective analysis of adverse event reports in the Sanofi Pasteur global pharmacovigilance database for F(ab')2 pERIG, including adverse event reports from eight Sanofi Pasteur-sponsored clinical trials and post-market surveillance data collected between 1995 and 2014. The general safety profile of F(ab')2 pERIG is discussed, as are the occurrence of rare anaphylactic reactions, and suspected intervention failure. Expert commentary: Over 20 years of clinical development and post-licensure experience has established the safety and effectiveness of F(ab')2 pERIG (FavirabTM) in rabies PEP.
Subject(s)
Immunoglobulin Fab Fragments/administration & dosage , Immunoglobulin Fab Fragments/adverse effects , Rabies Vaccines/administration & dosage , Rabies Vaccines/adverse effects , Rabies/prevention & control , Anaphylaxis/etiology , Animals , Humans , Immunoglobulin Fab Fragments/immunology , Pharmacovigilance , Post-Exposure Prophylaxis , Product Surveillance, Postmarketing , Rabies Vaccines/immunology , Retrospective StudiesABSTRACT
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.
