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CSL Receives TGA Approval to Register Panvax®, Avian Flu Vaccine

CSL Receives TGA Approval to Register Panvax®, Avian Flu Vaccine

Melbourne, Australia — 17-06-2008

CSL Limited announced today that it has received approval from the Australian Therapeutic Goods Administration (TGA) to register Panvax®, CSL’s avian influenza vaccine. Developed by CSL in collaboration with the Australian government, Panvax is intended for use in the prevention of influenza caused by a pandemic strain of avian influenza virus.

“We are extremely pleased to have received approval to register Panvax in Australia,” said Mary Sontrop, General Manager of CSL Biotherapies, a group member company of CSL and the business unit responsible for developing and manufacturing Panvax. “In the event of a pandemic, CSL will rapidly gear up to manufacturing levels that will ensure all Australians have access to safe, effective coverage against avian flu. We continue to work collaboratively with the World Health Organisation and with the Australian scientific community to maintain a high level of avian flu preparedness.”

“I congratulate CSL and the investigators who worked with them on their development and registration of the Panvax avian influenza vaccine, said Australian Minister for Health and Ageing, the Hon Nicola Roxon MP. “This places Australia in an excellent position in terms of its preparedness to manage an avian flu pandemic should one arise and should reassure all Australians”.

CSL is the only vaccine supplier that manufactures influenza vaccines in Australia. Through its recent and continuing investment of more than $80m in Fluvax® (a vaccine against seasonal influenza) CSL remains committed to the ongoing provision of influenza vaccines to the Australian community.

CSL acknowledges the significant contributions made by those Australians who participated in the clinical studies to enable the development of this important vaccine.

About Panvax
Panvax is a vaccine that can be used only when an influenza pandemic has been officially declared by the Australian Government in consultation with the World Health Organisation. An influenza pandemic occurs when a new strain of the type A influenza virus emerges that is so different to the seasonal influenza virus strains that it spreads rapidly from person to person. In that case, it can cause serious illness because very few people have any immunity to the new virus strain.

CSL has a long history of manufacture of a seasonal influenza virus vaccine, Fluvax®, and applied this knowledge and experience to the development of Panvax. Three randomised, double blind clinical studies were conducted in Australia to assess the immunogenicity and/or safety of the vaccine in adults aged 18 to 64 years, and older adults aged 65 years and over. The vaccine, administered as a two-dose regimen, was found to be safe and well tolerated.

About CSL
With major facilities in Australia, Germany, Switzerland and the US, CSL has over 9,000 employees working in 27 countries. The CSL Group has a combined heritage of outstanding contribution to medicine and human health with more than 90 years experience in the development and manufacture of vaccines and plasma protein biotherapies.

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