First cell-based flu vaccine available on the National Immunisation Program

CSL Seqirus has  confirmed that its cell-based influenza vaccine, Flucelvax® QUAD [quadrivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures)], will be available on the National Immunisation Program (NIP) for the 2024 Australian influenza season.

Flucelvax QUAD is the first and only cell-based influenza vaccine available in Australia and will be reimbursed for people at higher risk of complications from flu, including:

  • Aboriginal and Torres Strait Islander peoples aged 5 to 64 years
  • pregnant women
  • people aged 5 to 64 years with co-existing medical conditions, including:
  • cardiac disease
  • chronic respiratory conditions
  • chronic neurological conditions
  • immunocompromising conditions
  • diabetes and other metabolic disorders
  • chronic renal failure
  • functional or anatomical asplenia
  • long-term aspirin therapy in children aged 5 to 10 years.1

Cell-based vaccines like Flucelvax QUAD are designed to be a close match to the strains selected by the World Health Organisation (WHO) as likely to be prevalent for the upcoming flu season.

As a cell-based vaccine, Flucelvax QUAD is not affected by egg adapted vaccine virus mismatch seen in some flu seasons, which may bring potential clinical advantages.5

According to a recent study, cell-based flu vaccines demonstrated between 10 and 15% greater relative effectiveness in preventing test-confirmed influenza among people aged four to 64 years of age, across three recent seasons in the United States (2017/18 – 2019/20) compared to traditional egg-based vaccines.4

Cell-based vaccines allow Australia to be less reliant on traditional egg-based influenza vaccines and the intensive manufacturing processes they utilise.1

Influenza is a serious disease and continues to return to pre-COVID levels of circulation. In 2023 there were more than 252,000 influenza cases and 3,696 hospitalisations reported across Australia.6 Modelling suggests the true burden of flu may be higher than reported.7

According to infectious diseases expert, Professor Robert Booy, access to Flucelvax QUAD via the National Immunisation Program for the upcoming flu season is welcome news for healthcare professionals and their eligible patients.

“Seasonal circulation of influenza is expected to continue, which means vulnerable groups remain at high risk of infection and potentially life-threatening complications.

“Being able to offer a cell-based influenza vaccine to vulnerable patients on the NIP gives us an important option for protection against the virus, which ultimately enables more Australians to be prepared for flu season,” commented Professor Booy.

“Those considered most vulnerable include people aged 65+, children under five, pregnant women, Indigenous Australians and people aged five to 64 with co-existing medical conditions. In 2023, approximately 25% of the population aged five to 64 years were vaccinated against influenza.6 With coverage like that, there’s certainly a strong chance that many vulnerable Australian’s are not getting vaccinated against influenza.”

Results from the 2023 Australian Attitudes to Influenza Index, commissioned by CSL Seqirus, indicated that healthcare professionals are highly respected providers of influenza information, with seven in 10 (70%) Australians trusting healthcare professionals to provide them with information about influenza.8

Importantly, among Australians who didn’t intend to get vaccinated against influenza in 2023, 15% said they would be encouraged to get an influenza vaccination if their GP or pharmacist recommended it.8

“With the data indicating an ongoing trend for Australians to get vaccinated for influenza,8 healthcare professionals are best placed to educate individuals about the vaccine choices available and what is best for them and their family,” stated Professor Booy.

Dr Julianne Bayliss, Vaccines Medical Director at CSL Seqirus says influenza vaccination is incredibly important to help take pressure off the healthcare system.

“As an Australian company, we’re proud to make this cell-based flu vaccine available to help protect the most vulnerable people in our community and reduce pressure on our health system,” said Dr Bayliss.

“Flucelvax QUAD is also available for Australians who do not qualify for influenza vaccination via the NIP.  With 58% of Australians not aware of what flu vaccine options were available to them in 2023,8 GPs, nurses and pharmacists are best placed to discuss prevention options to help Australians make informed decisions about what suits their individual needs.”

Flucelvax QUAD will be produced in Australia from 2027 when CSL Seqirus’ world-class, cell-based vaccine manufacturing facility comes online in Tullamarine, Melbourne.

CSL Seqirus’ adjuvanted influenza vaccine, Fluad Quad®, will also be available on the NIP for Australians aged 65 and over in 2024. Afluria Quad® will no longer be available on the NIP.

MINIMUM PRODUCT INFORMATION

Flucelvax® Quad (Inactivated Quadrivalent Influenza Vaccine (prepared in cell cultures)) – Suspension for injection.  Indication: For the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine, for use in adults and children 6 months of age and older. Contraindications: Individuals with known severe allergic reactions (e.g. anaphylaxis) to any component of the vaccine or to a previous dose of any influenza vaccine. Precautions: Treatment and supervision for anaphylactic reactions should be available. Antibody response in immunocompromised patients may be lower. Careful consideration for use in history of Guillain-Barré syndrome within 6 weeks of previous influenza vaccination. Postpone immunisation in patients with febrile illness or acute infection. A protective immune response may not be elicited in all vaccine recipients. Use in Pregnancy (Category A): Recommended for pregnant women. The safety of Flucelvax® Quad in pregnancy has not been assessed in randomised clinical trials. There was no evidence of adverse foetal, newborn or pregnancy outcomes attributable to the vaccine during any stage of pregnancy from data collected in a prospective Pregnancy Exposure Registry. There are no reproductive and developmental toxicity studies with Flucelvax® Quad. Reproductive and developmental toxicity data from cell-based trivalent influenza vaccine (TIVc) do not predict an increased risk of developmental abnormalities. Use in Lactation: Not been evaluated in nursing mothers. Interactions: No data available on co-administration with other vaccines. Based on clinical experience with TIVc, Flucelvax® Quad can be given at the same time as other vaccines (in separate limbs) (adverse reactions may be intensified). Adverse Effects: Local – pain, erythema. Systemic – headache, fatigue, irritability and/or sleepiness (children 6 months – 6 years), upper respiratory tract infection, nasopharyngitis (See full PI). Dosage and Administration: Intramuscular injection only: single 0.5mL dose (children <9 years may require 2 doses – see full PI). Presentation: 0.5mL single-use syringe. Storage: Store at 2°C to 8°C; must not be frozen; protect from light. Based on Approved Product Information.

 

REFERENCES

  1. Pharmaceutical Benefits Advisory Committee (PBAC) meeting outcomes September 2022 PBAC Intracycle meeting. Available from: https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2022-09/September-2022-PBAC-Web-Outcomes-v2.pdf
  2. Flucelvax Product Information. Available from: https://labeling.seqirus.com/PI/AU/Flucelvax/EN/Flucelvax-Product-Information.pdf
  3. CDC. 2023. Cell-based Flu Vaccines. Available from: https://www.cdc.gov/flu/prevent/cell-based.htm
  4. Stein et al. Abstract accepted for ESWI 2023, September 2023, Valencia, Spain
  5. Wu NC et al. PLoS Pathog . 2017;13(10)
  6. Australian Government. Department of Health and Aged Care. Australian Influenza Surveillance Report – 2023 End of Season Summary. Available from: https://www.health.gov.au/resources/publications/aisr-2023-national-influenza-season-summary?language=en
  7. Muscatello, D et al. Vaccine vol. 39,52 (2021): 7578-7583. Accessed March 2023
  8. Australian Attitudes to Influenza Index. Conducted by YouGov on behalf of CSL Seqirus. Fieldwork was undertaken between 8th – 13th February 2023.

 

About the survey

This survey was conducted by YouGov on behalf of CSL Seqirus. All figures, unless otherwise stated, are from YouGov Plc. Total sample size was 1017 adults. Fieldwork was undertaken between 8th – 13th February 2023. The survey was carried out online. The figures have been weighted and are representative of Australian adults (aged 18+).

 

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