Pandemic Flu Vaccine Approved for Children

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3 December 2009

The Therapeutic Goods Administration (TGA) has today approved for registration the Australian-made Panvax H1N1 Vaccine Junior enabling children from 6 months to 9 years of age to be protected against the pandemic H1N1 influenza.

The registration by the TGA follows rigorous evaluation of clinical trial data by the regulator and review by the expert Australian Drug Evaluation Committee (ADEC). The TGA has stated that children under 10 years of age will require two doses of the vaccine administered at least 28 days apart, in line with the process for children’s seasonal flu vaccinations.

The vaccine has already been approved for use in older children and adults. Since it became available to the Australian public in September 2009 5.1 million doses have been distributed to immunisation providers, of which 4.2 million doses have gone to GPs.

The Department of Health and Ageing will now commence distribution of detailed information on dosage requirements for various age groups to vaccine providers, including general practitioners, to enable them to commence vaccination of children under 10.

Within the next fortnight GPs and other vaccine providers should have supplies of the Panvax Junior. Parents are encouraged to get in early to receive their free vaccine to protect themselves and their children.

Pandemic (H1N1) 2009 influenza remains a threat and all Australians are encouraged to get vaccinated to protect both themselves and those who are vulnerable in the community.

People, including children, who are travelling overseas where pandemic influenza is now prevalent and the vaccine in short supply, are particularly at risk and should ensure they are vaccinated. Even one dose for children will give a good protective boost against this disease.

The Chief Medical Officer, Professor Jim Bishop has advised that it is highly possible Australia’s next flu season will begin much earlier, as has occurred in the Northern Hemisphere.

He has also warned that pandemic flu is not like the usual seasonal flu with evidence in Australia of serious health problems and deaths in younger, healthier people as well as pregnant women and others with underlying medical conditions. One third of deaths occurred in people with no previous medical conditions. The best protection for all Australians is vaccination.

It is important to understand that, while the seasonal flu vaccine for next year will contain protection against pandemic H1N1 influenza, along with other flu strains, there will be finite supplies of this vaccine, especially at the beginning of the next flu season. Priority will be given to older people and those with underlying medical conditions who are most vulnerable to seasonal flu. Further, other than those people eligible for free seasonal flu vaccine, most people will have to pay for their seasonal flu vaccine through the private market.

I urge all Australians to take advantage of the current availability of free pandemic flu vaccine over the coming holiday season to ensure they and their children are protected in advance of the start of the new school year and a possible early start to the next influenza season.

People can find out where they can access the free vaccine by calling 180 2007 or visiting www.healthemergency.gov.au

For all media inquiries, please contact the Minister's Office on 02 6277 7220

Background:

The TGA recommendation for children is for two doses of 0.25 mL per dose (7.5 µg HA) at least 28 days apart for children 6 to 35 months of age and two doses of 0.5 mL per dose (15 µg HA) at least 28 days apart for children from 36 months to 9 years of age.