Pandemic (H1N1) influenza vaccine: TGA approves vaccine against Pandemic (H1N1) 2009 influenza

18 September 2009

Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has today approved the registration of Panvax® H1N1 influenza vaccine, for use in adults and children 10 years of age and over.

Panvax® H1N1 is manufactured by the Australian company, CSL Limited, using the same processes as those used to manufacture seasonal influenza vaccines.

The TGA has not approved the vaccine for use in children less than 10 years of age, and is awaiting further data from CSL on the results of a paediatric clinical trial currently in progress. It is expected these data will be provided to the TGA for evaluation in the near future.

Clinical trial data have demonstrated that Panvax® H1N1 is effective and well tolerated, with a side effect profile similar to that of seasonal flu vaccines. A single dose has been shown to provide an adequate immune response in most healthy adults 8-10 days after receiving the vaccine.

Common shortlived side effects that occur with seasonal flu vaccines and may occur with Panvax® H1N1 include soreness at the site of injection, headache, mild fever, body aches and fatigue for a short time after vaccination. As with all medicines there is always the potential for unexpected or rare serious side effects to occur. In line with its usual practice, the TGA will be closely monitoring any side effects from the use of Panvax® H1N1.

Healthcare practitioners and consumers are encouraged to report any side effects by telephoning 18 02 007 or by using the online reporting form available from the TGA website.

Information on the roll-out of vaccine can be found at www.healthemergency.gov.au.

About the Therapeutic Goods Administration (TGA)

  • The TGA is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
  • TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance).
  • The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
  • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.
  • To report a problem with a medicine or medical device, please see information on the TGA website.