Pandemic (H1N1) influenza vaccine: TGA approves Pandemic (H1N1) 2009 influenza vaccine for use in children aged from 6 months of age

3 December 2009

Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has today approved the use of Panvax® H1N1 influenza vaccine to include children aged from 6 months of age.

In addition, the TGA has also approved Panvax H1N1 Junior® influenza vaccine specifically for use in children aged from 6 months up to 3 years of age.

The TGA approved the use of Panvax® H1N1 influenza vaccine in children, and Panvax H1N1 Junior®, following analysis of paediatric clinical trial data.

The TGA approved Panvax® H1N1 influenza vaccine on 18 September 2009 for use in adults and children over 10 years of age.

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

Information on the vaccination dosage and planned roll-out of the vaccine programme can be found at www.healthemergency.gov.au.

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.

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.