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07 Apr 2015

Doctors and patients will for the first time have access to single-dose vaccines covering the four most common flu viruses amid concerns a mutated strain that wreaked havoc in the northern hemisphere could take hold in Australia.

The Therapeutic Goods Administration has approved nine vaccines, including, for the first time, three quadrivalent formulations, as preparations advance for the roll-out of National Seasonal Influenza Immunisation Program from 20 April.

The TGA said the vaccines approved for the program provided coverage for two new strains following expert advice about the prevalence of different types of infections in the last 12 months.

The World Health Organisation and the Australian Influenza Vaccine Committee have recommended that vaccines this year cover one existing and two new strains – the California H1N1-like virus that has been in circulation since 2010, the Switzerland H3N2-like virus and the Phuket 2013-like virus.

In addition, the quadrivalent vaccines, FluQuadri, FluQuadri Junior, and Fluarix Tetra, will cover the Brisbane 2008-like virus.

Drug company Sanofi Pasteur, which manufactures two of the quadrivalent vaccines, said they were well tolerated and provided additional protection because they covered both B strains of the influenza virus as well as the two A strains – compared with trivalent vaccines that covered both A strains but only one B strain.

The national immunisation program, which usually commences in March, had been held back a month as manufacturers have scrambled to produce sufficient stocks of the vaccines.

“The double-strain change has resulted in manufacturing delays due to the time it takes to develop, test and distribute the reagents needed to make the vaccine,” a Health Department spokesperson said. “The commencement of the program is being delayed to ensure sufficient supplies of influenza vaccine are available from at least two suppliers in order to mitigate the risk of administration of bioCSL’s Fluvax to children under five years of age.”

The AMA and other health groups expressed alarm last year over revelations that 43 infants and toddlers were injected with Fluvax in 2013 despite warnings it could trigger fever and convulsions.

The TGA has repeated its advice that Fluvax is not registered for use on children younger than five years, and that it should only be used on children between five and nine years following “careful consideration of potential benefits and risks in the individual child”.

Fluvax will be supplied with prominent warning signs and labels to remind practitioners that it should not be administered to young children.

In a stroke of good fortune, the delay in the vaccination program has coincided with a relatively quiet start to the flu season, with reports that influenza activity has so far been weaker than that experienced at the same time last year.

The Health Department and the TGA said that, despite the delay, they do not expect any flu vaccine shortages, and the Government has committed $4.5 million over the next five years to provide free flu vaccination for Indigenous children aged between six months and five years.

The Government has also renewed the contract of the Australian Sentinel Practices Research Network, based at the University of Adelaide, to undertake national surveillance of flu-like illnesses.

The network, which has been operating for more than a decade, collates information from more than 200 GPs and medical practices across the nation to provide health authorities with an early warning of developing outbreaks. Its information is used in conjunction with data from hospitals.

Adrian Rollins


Published: 07 Apr 2015