Febrile adverse events associated with CSL's 2010 seasonal influenza vaccine
In Australia last year, CSL’s 2010 seasonal influenza vaccine, Fluvax®, was associated with increased reports of febrile reactions in children compared to previous seasons. The febrile events occurred predominantly in children under the age of 5, shortly after vaccination.
Despite extensive scientific investigations involving Australia’s Therapeutic Goods Administration (TGA), the US Food and Drug Adminstration (FDA) and other international experts, CSL is yet to establish the root cause of the association between Fluvax® vaccine 2010 and the unexpected increase in febrile reactions. Investigations are continuing.
To mitigate the risk of further febrile events in children, CSL has not sought approval for the use of Fluvax® vaccine in children under five years for the 2011 Southern Hemisphere season. The prescribing information for 2011 Fluvax® vaccine will carry a boxed warning to this effect and CSL has written to doctors and immunisation providers to reinforce the warning.
There were also reports of fever and associated symptoms in children aged between five and less than nine years in Australia in 2010. As such, the prescribing information for 2011 Fluvax® vaccine will contain a precaution about its use in this age group.
The New Zealand Ministry of Health is recommending that healthcare professionals restrict the use of Fluvax® vaccine to persons aged 9 years and above.
Ongoing safety monitoring of CSL’s seasonal influenza vaccine in both Southern and Northern Hemisphere countries continues to support its use in adults and older children, especially those most at risk from the complications of influenza.
Until a root cause can be establised for the unexpected increase in febrile reactions, CSL will continue to work with regulators and vaccine policy makers in all relevant countries to ensure age-appropriate restrictions remain in place for the use of its seasonal influenza vaccine.
Parents wishing to have their children vaccinated against influenza or who have any concerns about influenza vaccination should seek advice from their doctor.
Updated 18 February 2011
Additional Resources:
Medicine Data Sheet
everybody.co.nz – Influenza
Fluvax product page
Therapeutic Goods Administration (TGA) website
US Food and Drug Administration (FDA) Website
Previous CSL Statements and Press Releases
CSL Media Contact:
Sharon McHale
Snr Director, Public Affairs
Phone: +61 3 9389 1506
Mobile: +61 409 978 314
Email:
sharon.mchale@csl.com.au