Australians 65 and older become first in the world to access FLUAD® Quad

2 April 2020

Australians 65 and older have become the first in the world to access FLUAD® Quad (adjuvanted quadrivalent influenza vaccine) following addition to the National Immunisation Program in 2020(1)

  • FLUAD® Quad is a new vaccine that is preferentially recommended over the standard quadrivalent influenza vaccines provided on the National Immunisation Program (NIP) in 2020 for Australians aged 65 years and older (2)
  • People aged 65 years and over have significantly higher rates of hospitalisation and death from influenza compared to younger adults (3)
  • Protecting older Australians against influenza is particularly important in the context of the concurrent COVID-19 pandemic.
  • The Government has fast-tracked the approval of FLUAD® Quad to ensure nationwide availability prior to the 2020 influenza season (4)

Seqirus Australia (a CSL company) welcomes the inclusion of FLUAD® Quad (adjuvanted quadrivalent influenza vaccine) on the 2020 National Immunisation Program for adults aged 65 years and older – with Australia the first country in the world to offer this vaccine (1).

FLUAD® Quad is an adjuvanted quadrivalent influenza vaccine.5 As with other quadrivalent influenza vaccines, the four antigens have been updated to include the strains recommended by WHO to be representative of those expected to circulate in the Southern Hemisphere winter 2020. These are:

    • –  two influenza type A strains (A/Brisbane/02/2018 (H1N1) pdm09 – like virus and A/South Australia/34/2019 (H3N2) – like virus), and
    • –  two influenza type B strains (B/Washington/02/2019 – like virus and B/Phuket/3073/2013 – like virus) (5)

Influenza can have a substantial negative impact on adults 65 years and older with higher hospitalisation and death rates compared to younger, healthier adults (3). Between 1997 and 2016, 80 per cent of influenza deaths in Australia were in people aged 65 and over (6).

FLUAD® Quad has been formulated with MF59 adjuvant, which stimulates recruitment of immune cells at the site of injection and helps to trigger production of antibodies in adults aged 65 years and above, who may not always respond as well as younger people to vaccines (5,7). The antibody response to FLUAD® Quad is similar to FLUAD ® (adjuvanted trivalent influenza vaccine) which is increased when compared to the response to a standard dose vaccine without adjuvant.5 Specific antibody levels have not been correlated with protection from influenza (5).

The NIP listing comes on the back of the Australian Government’s move to fast-track the approval of the vaccine to ensure availability in advance of the 2020 influenza season (4). Annual vaccination remains the most effective way to prevent influenza infection, and FLUAD Quad is preferentially recommended over standard QIVs for Australians aged 65 years and older (8).

The immunogenicity of FLUAD Quad was evaluated in a multi-centre, randomised, double-blind, non- inferiority, comparator-controlled study conducted in subjects 65 years of age and older in the 2017-18 Northern Hemisphere influenza season (5).

Non-inferiority of the immune response of FLUAD Quad to that of FLUAD (aTIV-1) and aTIV-2 among adults 65 years of age or older was assessed as a co-primary endpoint. Results showed FLUAD Quad was non-inferior for all four influenza strains for both HI antibody titres and seroconversion rates and superior for the alternate B strains (5,9).

Adverse events associated with FLUAD Quad include injection site pain, fatigue and headache.5 The majority of the adverse events reported were mild or moderate in intensity and resolved within 3 days. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available and persons with a history of anaphylaxis to egg should be vaccinated only in medical facilities with staff experienced in recognising and treating anaphylaxis (5).

Associate Professor Woodward AM, Director, Aged Care Research and the Head of Memory Clinic at Austin Health said that “this is not the year you want to get flu, nor be complacent about the significant impact influenza has each year on our public health system, particularly the more severe cases that end up in intensive care units (ICU).”

“Vaccinating for flu is always important – but this year it will be particularly critical, and especially for older Australians and those with chronic diseases.”

“While the flu vaccine does not protect against the COVID-19 virus, immunising against the flu – particularly in high-risk groups like those aged 65 and over – may help to reduce the risk of diagnostic uncertainty between flu and COVID-19 and reduce pressure on our health system and ICUs.”

Seqirus Asia Pacific Head of Medical Affairs, Dr Jonathan Anderson congratulated the Federal Government and Minister Hunt for continuing Australia’s world-leading public immunisation program and fast tracking the approval of FLUAD Quad for Australians aged 65 and over.

“Seqirus is proud to continue our partnership with the Australian Government which has enabled us to deliver a world-first launch of our adjuvanted quadrivalent vaccine and further build on our commitment to deliver public health innovation for Australians.”

Read the full media release and view the product information.

FLUAD Quad_Medical media release_1 April 2020

Fluad Quad AU PI AUST R 313724 and AUST R 316323_1 Nov2019


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