The Therapeutic Goods Administration (TGA) is investigating reports of an increase in adverse events to the seasonal flu vaccine in Western Australia (WA), where all children 6 months to 5 years have been offered a free seasonal flu vaccination.
The pattern and rate of adverse reactions reported by WA have not been seen in other states, and the TGA will test batches of the vaccine used in WA for any abnormalities.
Other states and territories seasonal flu vaccination programs have focused on individuals in high risk categories.
The TGA is investigating the WA data to determine whether the adverse reactions reported in WA relate to the vaccine, or the WA program delivery.
However, until it can be established what is causing the rise in adverse events in some children in WA, Australia's Chief Medical Officer, Professor Jim Bishop, is writing to all immunisation providers to advise them not to administer seasonal flu vaccinations to all children 5 years of age and under until further notice.
What the TGA is doing
The TGA has contacted the manufacturer, CSL Ltd, to confirm which batches of vaccine were used in WA and is obtaining samples of the vaccine to test in its laboratories to determine if there are any abnormalities in the batches of vaccine used in WA.
States and territories have been asked to report any adverse events related to seasonal influenza urgently to the Therapeutic Goods Administration. States and territories have also been asked to provide details on batch numbers and type of vaccine.
The TGA is urgently convening an expert scientific advisory panel to review the information from WA, and is seeking additional information from the manufacturer, CSL Ltd, and from regulatory colleagues internationally.
What parents and caregivers should do
If you have concerns because your child has received the seasonal flu vaccination please contact your doctor. Reported adverse reactions include fever, vomiting and febrile convulsions.
Whether there are any implications for swine flu vaccine
At this stage there do not appear to be implications for the swine flu vaccine Panvax®. Professor Bishop's advice relates only to the seasonal flu vaccination program for children 5 years of age and under.
It is safe to have the Panvax® H1N1 vaccine, even if you are already immune to the virus, just as it is safe to get a seasonal influenza vaccination if you've already had seasonal flu.
The TGA's assessment and the advice of its expert committees is that Panvax® and Panvax H1N1 Junior® are safe, effective vaccine for prevention of the H1N1 influenza.
Swine flu vaccination as alternative to seasonal flu vaccine
Panvax® H1N1 vaccine only protects you against the pandemic (H1N1) 2009 influenza virus. People can still be infected by seasonal influenza viruses circulating in the community. To reduce the risk of influenza during Australia's winter months people should still get the seasonal flu vaccine, particularly if they are in a high risk seasonal flu group. High risk categories include:
- People aged 65 years and over;
- Aboriginal and Torres Strait Islander people aged 15 years and over; and
- Pregnant women.