Update on Seasonal Influenza Vaccination of Children

Update on Seasonal Influenza Vaccination of Children

Melbourne, Australia — 30/07/2010

CSL Limited (CSL) supports the statement made today by the Commonwealth Chief Medical Officer regarding seasonal flu vaccine for young children.

Since becoming aware of an association between CSL’s influenza vaccine and increased febrile reactions in children in Australia during the 2010 Southern Hemisphere influenza season, CSL has worked closely with the Therapeutic Goods Administration (TGA) to investigate the cause.

In parallel with the TGA’s investigations, and in accordance with regulatory guidance, CSL has undertaken comprehensive analyses of clinical and epidemiological data, in depth reviews of manufacturing and quality processes and conducted laboratory testing of the vaccine.

Investigations conducted by both the authorities and CSL have excluded numerous possible causes.

“The unexpectedly high rate of these events has not been seen in previous seasons nor following the use of our H1N1 pandemic vaccine, and our manufacturing processes have not changed. CSL’s expert team continues to work with the TGA to identify further avenues of investigation,” said Dr Darryl Maher, Medical and Research Director for CSL Biotherapies.

“CSL supports a precautionary approach to the use of its influenza vaccine in children while investigations continue into the cause of the unexpected increase in febrile reactions,” added Dr Maher.

CSL recently completed its voluntary retrieval program for remaining 2010 paediatric influenza vaccine from medical clinics and distributors ensuring sufficient quantities of the vaccine continue to be available for testing.

“Safety is an absolute priority at CSL and we understand the important role influenza vaccine plays in public health. We are committed to working with regulators to resolve the events seen this season as quickly as possible” said Dr Maher.

For more information about the Chief Medical Officer’s announcement, visit: www.health.gov.au

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Media Contact:
Sharon McHale
Senior Director Public Affairs
Phone: +61 3 9389 1506
Mobile: +61 409 978 314
Email: sharon.mchale@csl.com.au

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