Company Statement: Incorrect use of Fluvax® in children
20 April 2012
CSL Biotherapies is aware of some reports of incorrect use of Fluvax® vaccine in young children. The Company is very concerned by these reports and is taking further steps to reinforce to immunisation providers that Fluvax® vaccine must not be used in children under 5 years.
In 2010 Fluvax® vaccine was associated with increased reports of febrile events in children compared to previous seasons. As a result, Fluvax® vaccine is currently not licensed for use in children aged less than 5 years and the prescribing information for Fluvax® vaccine contains a boxed warning to this effect. In addition, Fluvax® vaccine should only be used in children aged 5 to less than 10 years if a timely alternative is not available.
Since the age restrictions for Fluvax® vaccine were introduced, CSL Biotherapies has continuously worked with authorities to guard against the incorrect use of its influenza vaccine in young children. The Company has undertaken a number of measures including updating the Product Information to include a boxed warning, distributing letters and reminders to immunisation providers to emphasise the restricted use, and reinforcing safety precautions in corporate and media communications.
CSL Biotherapies is implementing extra measures to support the safe administration of Fluvax® vaccine. Additional printed materials, including a magnet for vaccine refrigerators, containing a warning of the restricted use for Fluvax® vaccine will soon be issued to clinics. CSL Biotherapies also intends to make further changes to the packaging of Fluvax® vaccine next influenza season.
CSL Biotherapies continues to work with regulators on the investigations into the cause of the adverse events in children following the administration of CSL’s 2010 seasonal influenza vaccine. Until this has been resolved CSL Biotherapies will continue to fully support the age restrictions in place for the use of Fluvax®.
The Commonwealth Department of Health of Ageing (DoHA) recently released a review of data on the safety of seasonal influenza vaccines which concluded that Fluvax® vaccine remains suitable for use in adolescents and adults.
Incorrect use of Fluvax® vaccine and any side-effects that occur following its administration are considered adverse events and should be reported for investigation to CSL Medical Information on 1800 642 865.
Download this Statement:
Company Statement: Incorrect use of Fluvax® in children
Media Contact:Sharon McHale
Senior Director Public Affairs
Phone: +61 409 978 314
Email:
sharon.mchale@csl.com.au