First Adjuvanted Quadrivalent Influenza Vaccine by Seqirus Receives EU Approval

MAIDENHEAD, England, June 8, 2020 /PRNewswire/ -- The European Commission has today given regulatory approval for the first adjuvanted quadrivalent influenza vaccine to become available across Europe. This new vaccine builds on the well-established technology used in an existing adjuvanted trivalent influenza vaccine (aTIV) available in several European countries. aTIV has demonstrated higher effectiveness in people aged 65+ years compared to standard, non-adjuvanted trivalent influenza vaccines.^[1] The new quadrivalent vaccine is specifically designed to protect adults aged 65 and over against four strains of seasonal influenza: two A strains along with two B strains, as opposed to a two A strains and a single B strain in the current vaccine.^[2]

The new adjuvanted quadrivalent vaccine (aQIV) will be manufactured in Liverpool, UK, by Seqirus, one of Europe's largest influenza vaccine producers and a global leader in influenza prevention.  In the 2018/19 influenza season, when aTIV was the main vaccine recommended in the 65+ age group in the UK, an analysis by Public Health England^[3] showed that overall adjusted influenza vaccine effectiveness for the aTIV against medically-attended laboratory confirmed influenza was 62% (3.4%, 85.0%). In recent influenza seasons prior to 2018/19 when all age groups 18+ were given non-adjuvanted influenza vaccines in the UK, vaccine effectiveness in the above 65 age group tended to be lower compared to the 18-64 age group.^[4],[5],[6]

Adding the additional B strain to the new vaccine can provide additional coverage, particularly in influenza seasons where B strains are more dominant, such as 2017/18. In that season, nearly half of all deaths from influenza in intensive care units reporting data to the European Centre for Disease Prevention and Control were due to B strain viruses.^[7]

Older people see a natural decline of their immune system with age, which makes them more vulnerable to becoming seriously ill with influenza. Ageing can also reduce the body's immune response to influenza vaccination. The adjuvant added to aQIV is designed to boost the immune response in older adults, and to help compensate for this effect.^[2],[8]

"In these times, even more than in most, it's important to have age appropriate vaccines to help protect against influenza," said Dr Raja Rajaram, Head of Medical Affairs, Europe. "We know that people who get vaccinated are less likely to become ill with influenza. This will potentially help to keep pressure off health systems during continuing concern over COVID-19. As a company, we are very focused on developing vaccines that offer better protection for people who are particularly vulnerable to influenza. We are delighted to be able to bring this vaccine to Europe, which offers healthcare professionals an additional tool on the front line of influenza prevention."

The granting of marketing authorisation by the European Commission is the first step in the process to make aQIV available for use in the 2021/22 influenza season.

About seasonal influenza

Seasonal influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. The European Centre for Disease Prevention and Control estimates that 15,000-70,000 people in Europe die from influenza-related complications each year, and encourages annual vaccination as the most effective way to prevent influenza.^[9]

About Seqirus

Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 20,000 people with operations in more than 60 countries.

Seqirus was established on 31 July 2015 following CSL's acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.

Seqirus operates state-of-the-art production facilities in the UK, the U.S., and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and a commercial presence in more than 20 countries.

For more information visit www.seqirus.com and www.csl.com.

References

^1. Fluad (aTIV) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/9223/smpc (accessed: 10 May 2020)
^2. Fluad Tetra (aQIV) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fluad-tetra-epar-product-information_en.pdf (accessed 01 June 2020) 
^3. Public Health England, Surveillance of influenza and other respiratory viruses in the UK, Winter 2018 to 2019, p.45. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/807472/Surveillance_of_influenza_and_other_respiratory_viruses_in_the_UK_2018_to_2019-FINAL.pdf (accessed: 10 May 2020)
^4. Pebody R et al. Effectiveness of seasonal influenza vaccine for adults and children in preventing laboratory-confirmed influenza in primary care in the United Kingdom: 2015/16 end-of-season results. Euro Surveill. 2016 Sep 22; 21(38): 30348.
^5. Pebody R et al. End-of-season Influenza Vaccine Effectiveness in Adults and Children, United Kingdom, 2016/17. Euro Surveill. 2017 Nov;22(44):17-00306
^6. Pebody R et al. End of season influenza vaccine effectiveness in adults and children in the United Kingdom in 2017/18. Euro Surveill. 2019 Aug 1; 24(31): 18-00488
^7. Adlhoch C et al. Dominant influenza A(H3N2) and B/Yamagata virus circulation in EU/EEA, 2016/17 and 2017/18 seasons, respectively. Euro Surveill. 2018 Mar 29; 23(13): 18-00146. 
^8. Haq K et al. Immunosenescence: influenza vaccination and the elderly. Curr Opin Immunol. 29C:38-42 (2014)
^9. ECDC Factsheet about seasonal influenza. Available at https://www.ecdc.europa.eu/en/seasonal-influenza/facts/factsheet (accessed: 10 May 2020)

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