Australia's Therapeutic Goods Administration (TGA), has approved the registration of a pandemic influenza (swine flu) vaccine, for use in adults and children aged 10 years and over. The vaccine is manufactured using the same process as that used to manufacture seasonal influenza vaccines.

A clinical trial in Australian adults has indicated that the pandemic vaccine has a similar safety profile to that of seasonal influenza vaccine, with a low risk of adverse events¹. A single dose has also been shown to generate a sufficient immune response in most healthy adults 8-10 days after receiving the vaccine.

The vaccine has not yet been approved for use in children less than 10 years of age - the TGA is awaiting further data from a paediatric clinical trial currently in progress. 

As with all medicines there is always the potential for unexpected or rare serious side effects to occur².  In line with its usual practice, the TGA will be closely monitoring any side effects from the use of the new vaccine.

The initial rollout of the vaccine will concentrate on vaccinating front-line healthcare workers and vulnerable people who are at greater risk of experiencing severe effects from pandemic influenza.

The priority groups¹ for vaccination are:

• Front line health care and community care workers who have direct contact with patients
• People with underlying chronic medical conditions such as asthma, cancers, HIV, heart disease, diabetes, and chronic kidney failure
• People who are obese with a BMI over 35
• Indigenous people and remote and isolated communities with indigenous people
• Children in special schools, initally only 10 years and over until child safety data is available
• Pregnant women
• Parents and guardians of children aged 0-6 months

Other Australians will also be able to access the vaccine¹.  State and Territory governments have been developing plans for the delivery of a vaccination program to their population and the Australian Health Protection Committee (AHPC) has recommended that this begin from 30 September 2009.

The Australian Government has purchased 21 million doses of the vaccine from CSL Limited. More than 4 million doses of the vaccine are already in warehouses in major cities and next week state health authorities will begin delivering the vaccine to immunisation providers including hospitals and GPs.

The vaccine is being delivered in multi-dose vials. This is consistent with countries around the world also seeking to deliver mass vaccination programs. Guidelines³ for the safe use of the vials have been developed by Australia's specialist immunisation reference group, the Australian Technical Advisory Group ion Immunisation (ATAGI) in consultation with the Royal Australasian College of General Practitioners (RACGP) and the Australian Nursing Federation (ANF). 

Australians seeking further information on the pandemic vaccine or the program roll-out should contact the Pandemic Flu hotline on 1802007 or visit www.healthemergency.gov.au 

References

1. Department of Health & Ageing TGA green light announcement  TGA_Greenlights_Pandemic_Flu_Vaccine
2. Theratpeutic Goods Administration:  TGA website alert
3. Guidelines for the administration of pandemic (H1N1) influenza vaccine from multi-dose vials (MDV)  Guidelines_Pandemic_Vaccination

Content Updated (Tuesday, 22nd September 2009)