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Seqirus Presents New Late-Breaking Data at ESWI 2020 Highlighting Value of MF59®-Adjuvanted Seasonal Influenza Vaccine

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Seqirus, a global leader in influenza prevention and influenza pandemic response, today presented new late-breaking data from a systematic review and meta-analysis at the European Scientific Working Group on Influenza (ESWI) virtual conference demonstrating the benefit of an MF59®-adjuvanted trivalent seasonal influenza vaccine (aTIV) for adults 65 years and older.[1] Results indicate that relative vaccine effectiveness (rVE) favored aTIV over non-adjuvanted standard dose quadrivalent and trivalent influenza vaccines in averting influenza-related medical encounters.1 aTIV was comparable to a high-dose TIV (TIV HD) for the same outcome.1

Influenza causes significant morbidity and mortality in adults 65 years and older, as demonstrated by higher hospitalization and death rates in most recent years, compared with young, healthy adults.[2] Seasonal influenza vaccine effectiveness may be impacted by age-related immune function decline in this population, which can result in reduced immune response to standard influenza vaccines.[3],[4] The MF59® adjuvant included in aTIV is designed to enhance the immune response to the influenza strains contained in the vaccine in adults 65 years and older.[5],[6],[7]

The data presented at ESWI 2020 comes from a systematic review and meta-analysis of 16 real-world studies out of the extensive clinical legacy over a period of 20 years during which more than 155 million doses of the vaccine have been distributed.[8] It evaluated the effectiveness of vaccination with aTIV relative to non-adjuvanted egg-based influenza vaccines or no vaccine in adults 65 years or older.1

“To have results from a systematic review and meta-analysis provides an additional level of evidence for the benefit of adjuvanted influenza vaccines in older adults who face age-related immune decline” said Brenda L. Coleman, RN, PhD, Infectious Disease Epidemiologist, Sinai Health System, Toronto; Assistant Professor, Dalla Lana School of Public Health, University of Toronto.

“Adults age 65 years and older are at significantly higher risk for complications from seasonal influenza. At Seqirus, we’re focused on utilizing advanced technology like the MF59® adjuvant to potentially offer better protection against influenza for those most vulnerable, like older adults, compared to younger people” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus.

The adjuvanted quadrivalent vaccine containing the second B strain recommended by the WHO will replace aTIV and was approved in Europe in March 2020 and is available for the 2020/21 influenza season.[9]

About the Study

This abstract is a systematic review and meta-analysis of real-world observational studies that evaluated the effectiveness of vaccination with MF59® adjuvanted trivalent seasonal influenza vaccine (aTIV) relative to vaccination with non-adjuvanted egg-based influenza vaccines or no vaccine in adults 65 years of age and above.1

The systematic review using Cochrane methods included 21 studies after screening 4,374 peer-reviewed journal articles and grey literature published between January 1, 1997 and July 15, 2020.1 Of these 21 studies, 16 of these were considered sufficiently comparable to include in one of the meta-analyses.1 Pooled relative vaccine effectiveness (rVE) estimates are presented with their 95% confidence intervals.1

Meta-analysis of studies found that aTIV was effective in reducing general practice visits and hospital admissions (absolute VE).1 Pooled estimates of rVE favored aTIV over non-adjuvanted standard dose quadrivalent and trivalent influenza vaccines in averting influenza-related medical encounters.1 aTIV was comparable to high-dose TIV in averting influenza-related medical encounters.1 Although substantial heterogeneity was observed, estimates for relative vaccine effectiveness were consistently in favor of aTIV over the standard-dose non-adjuvanted vaccines, with the exception of one study.1

About Seasonal Influenza 

Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.[10] Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.10 The Joint Committee on Vaccination and Immunisation (JCVI) recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.[11]Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.10 Preliminary estimates from the CDC report that from October 1, 2019, through April 4, 2020, there were an estimated 410,000 to 740,000 influenza-related hospitalizations in the U.S.[12] Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.10 The CDC recommends that people get vaccinated by the end of October.[13] However, getting vaccinated too early (for example, in July or August), can be associated with reduced protection against influenza infection later in the flu season.13

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). 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. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

About CSL

CSL (ASX:CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus - provides life-saving products to more than 100 countries and employs more than 27,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about CSL Limited, visit www.csl.com.

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

Intended Audience

This press release is issued from Seqirus UK Inc. in maidenhead, UK, and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of Seqirus products.

Forward-Looking Statements

This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

MF59® is a registered trademark of Seqirus UK Limited or its affiliates.

UK/aTIV/1220/0019

MEDIA CONTACT 
Emmanuella Dekoner
+44 (0) 7920 500 496
Emmanuella.Dekonor@seqirus.com



[1] Effectiveness of the MF59-Adjuvanted Trivalent Seasonal Influenza Vaccine Among Adults Aged 65 or Older, a Systematic Review and Meta-analysis. Presented at ESWI.

[2] Public Health England (PHE). (2020). Surveillance of influenza and other respiratory viruses in the UK. available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/895233/Surveillance_Influenza_and_other_respiratory_viruses_in_the_UK_2019_to_2020_FINAL.pdf. Accessed December 2020.

[3] Monto AS, Ansaldi F, Aspinall R, et al. (2009). Influenza control in the 21st century: Optimizing protection of older adults. Vaccine. 2009;27(37):5043-5053.

[4] McElhaney JE, Verschoor CP, Andrew MK, et al. (2020). The immune response to influenza in older humans: beyond immune senescence. BMC.

[5] Frey SE, Aplasca-De Los Reyes MR, Reynales H, et al. (2014). Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32:5027-5034.

[6] O'Hagan DT, Ott GS, Nest GV, et al. (2013). The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines. 2013;12(1):13-30.

[7] Banzhoff A, Pellegrini M, Del Giudice G, et al. (2008). MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respir Viruses. 2008;2(6):243-24.

[8] Data on file. Seqirus Inc; 2019.

[9] European Medicines Agency (EMA). FLUAD® TETRA SmPC. (2020) available at: https://www.ema.europa.eu/en/documents/product-information/fluad-tetra-epar-product-information_en.pdf. Accessed December 2020.

[10] CDC. (2019). Key Facts about Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed November 2020.

[11] Joint Committee on Vaccination and Immunisation (JCVI). (2020). Advice on influenza vaccines for 2021/22. Retrieved from: https://app.box.com/s/t5ockz9bb6xw6t2mrrzb144njplimfo0/file/737845224649. Accessed December 2020.

[12] CDC. (2020). 2019-2020 U.S. Flu season: Preliminary burden estimates. Retrieved from: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm. Accessed November 2020. [13] CDC. (2020). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed November 2020.