tetano
Editor, Senior Moderator
As the influenza season gears up, the FDA?s Pediatric Advisory Committee unanimously supported an FDA decision to continue monitoring and surveillance for any events surrounding the licensed vaccines during this season.
The panel heard ongoing surveillance data on two licensed influenza vaccines: Afluria (CSL Limited) and Fluarix (GlaxoSmithKline Biologicals). Despite an initial indication for use in children aged 6 months, the CDC?s Advisory Committee on Immunization Practices last year limited Afluria use to children and adults aged older than 9 years, after data from Australia and New Zealand suggested that children younger than 5 years were experiencing increased rates of fevers and febrile seizures.
According to Michael Nguyen, MD, of the FDA?s Division of Epidemiology, Office of Biostatistics and Epidemiology, as a result of these safety markers, CSL Limited is now conducting in vitro and in vivo studies to evaluate cytokine responses to various forms of this vaccine. Nguyen said the quick action last year by the ACIP to limit the vaccine to those aged older than 9 years led to no reported febrile convulsions in the US population.
The pediatric advisory committee also heard data on safety markers with Fluarix, and the researchers said there were no significant adverse events related to this vaccine last year.
The FDA?s advisory panel urged continued surveillance of any adverse events during this season.
This year?s influenza vaccine contains the same three stains of influenza as last year: A/California/7/09 (H1N1)-like virus (pandemic H1N1 2009 influenza virus), A/Perth /16/2009 (H3N2)-like virus, and B/Brisbane/60/2008-like virus.
http://www.pediatricsupersite.com/view.aspx?rid=87863
The panel heard ongoing surveillance data on two licensed influenza vaccines: Afluria (CSL Limited) and Fluarix (GlaxoSmithKline Biologicals). Despite an initial indication for use in children aged 6 months, the CDC?s Advisory Committee on Immunization Practices last year limited Afluria use to children and adults aged older than 9 years, after data from Australia and New Zealand suggested that children younger than 5 years were experiencing increased rates of fevers and febrile seizures.
According to Michael Nguyen, MD, of the FDA?s Division of Epidemiology, Office of Biostatistics and Epidemiology, as a result of these safety markers, CSL Limited is now conducting in vitro and in vivo studies to evaluate cytokine responses to various forms of this vaccine. Nguyen said the quick action last year by the ACIP to limit the vaccine to those aged older than 9 years led to no reported febrile convulsions in the US population.
The pediatric advisory committee also heard data on safety markers with Fluarix, and the researchers said there were no significant adverse events related to this vaccine last year.
The FDA?s advisory panel urged continued surveillance of any adverse events during this season.
This year?s influenza vaccine contains the same three stains of influenza as last year: A/California/7/09 (H1N1)-like virus (pandemic H1N1 2009 influenza virus), A/Perth /16/2009 (H3N2)-like virus, and B/Brisbane/60/2008-like virus.
http://www.pediatricsupersite.com/view.aspx?rid=87863