CSL Seqirus Commends the National Advisory Committee on Immunization for Preferential Recommendation of Enhanced Influenza Vaccines for Adults 65 and Older

CSL Seqirus commends the National Advisory Committee on Immunization’s recent recommendation for adults 65 years of age and older to preferentially receive an enhanced influenza vaccine, which includes adjuvanted, high-dose and recombinant vaccines.

FLUAD® is now preferentially recommended by the National Advisory Committee on Immunization for adults 65 years of age and older.

MONTREAL, Dec. 21, 2023 /CNW/ - CSL Seqirus commends the National Advisory Committee on Immunization’s (NACI’s) recent recommendation for adults 65 years of age and older to preferentially receive an enhanced influenza vaccine, which includes adjuvanted, high-dose and recombinant vaccines. This recommendation is based on data from studies that show that all approved enhanced influenza vaccines are effective in reducing the risk of influenza-related hospitalization and medical encounters.

NACI summarizes that each enhanced influenza vaccine has increased vaccine efficacy and effectiveness compared to standard-dose vaccines, and all enhanced influenza vaccines are considered equally effective and safe.

NACI’s recent statement adds to a growing number of international recommendations regarding the effectiveness of enhanced influenza vaccines for adults 65 years of age and older. In July 2022, the

U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) also recommended adults 65 years of age and older to preferentially receive an enhanced influenza vaccine, including adjuvanted and high dose vaccines.i

NACI’s recommendations to include FLUAD® was made for both individual- and public health program- level decision making. “Provinces should be using every enhanced vaccine in their arsenal to ensure that adults 65 years of age and older are protected against influenza,” said Gregg Sylvester, MD, Chief Health Officer, CSL Seqirus. “We are proud to offer provincial immunization programs a safe and effective enhanced influenza vaccine to help protect older Canadians.”ii,iii

FLUAD® produced a robust immune response against 3 strains of influenza in randomized clinical trials and has a demonstrated safety profile. To complement this data, real-world data for FLUAD® showed effectiveness at reducing influenza-related hospitalizations for people aged 65 and over, versus FLUZONE HD.

Influenza causes an average of 12,200 hospitalizations and approximately 3,500 deaths each year in Canada, with the majority occurring in adults over 65 years of age.iv Canadians over 65 years of age accounted for 76% of the reported influenza-associated deaths during the 2022/23 flu season.vii Older adults are at greater risk due to immunosenescence, the age-associated decline of the immune system, and may result in a reduced immune response to antigens in the vaccine.v,vi Influenza A has been associated with the most severe disease in seniors. During the 2021/2022 and 2022/2023 seasons, Influenza A caused 98 to 100% of disease in the 65 years and older adults.

“The 2022/23 influenza season was especially challenging for Canadians and added to the already significant strain being experienced by our healthcare systems,” said Bertrand Roy, Ph.D., Country Head Medical Affairs Canada at CSL Seqirus. “We are pleased that NACI’s thorough review and recommendation will help immunizers optimize the delivery of annual influenza immunizations to help mitigate other potentially difficult flu seasons.”

NACI is a national advisory committee of experts in the fields of pediatrics, infectious diseases, immunology, pharmacy, nursing, epidemiology, pharmacoeconomics, social science and public health. NACI makes recommendations for the use of vaccines currently or newly approved for use in humans in Canada, including the identification of groups at risk for vaccine-preventable diseases for whom vaccination should be targeted.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL 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, CSL 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; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia 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 three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 30,000 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 inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita .

For more information about CSL, visit www.CSL.com.

CSL SEQIRUS and FLUAD® are trademarks of CSL Seqirus.

Intended Audience

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

References

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i CDC. Advisory Committee on Immunization Practices (ACIP). General Committee Information. Retrieved June 28, 2022 from https://www.cdc.gov/vaccines/acip/committee/index.html

ii Myers ML, Gallagher JR, Woolfork DD, Stradtmann-Carvalho RK, Maldonado-Puga S, Bock KW, Boyoglu-Barnum S, Syeda H, Creanga A, Alves DA, Kanekiyo M, Harris AK. Impact of adjuvant: Trivalent vaccine with quadrivalent-like protection against heterologous Yamagata- lineage influenza B virus. Front Immunol. 2022 Sep 30;13:1002286. doi: 10.3389/fimmu.2022.1002286. PMID: 36248851; PMCID: PMC9561127.

iii Danuta M Skowronski, Catharine Chambers, Gaston De Serres, Suzana Sabaiduc, Anne-Luise Winter, James A Dickinson, Jonathan B Gubbay, Steven J Drews, Kevin Fonseca, Hugues Charest, Christine Martineau, Rebecca Hickman, Tracy Chan, Agatha Jassem, Martin Petric, Caren Rose, Nathalie Bastien, Yan Li, Mel Krajden, Vaccine Effectiveness Against Lineage-matched and -mismatched Influenza B Viruses Across 8 Seasons in Canada, 2010–2011 to 2017–2018, Clinical Infectious Diseases, Volume 68, Issue 10, 15 May 2019, Pages

1754–1757, https://doi.org/10.1093/cid/ciy876

iv Government of Canada. (2020). Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for 2020–2021. Retrieved from: https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/canadian-immunization- guide-statement-seasonal-influenza-vaccine-2020-2021.html. Accessed November 2020.

v FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: Seqirus Inc; 2019.

vi 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.

vii Government of Canada. Fluwatch report: July 23 to August 26, 2023 (weeks 30-34). Retrieved from: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/fluwatch/2022-2023/weeks-30-34-july-23-august-26-2023.html

SOURCE CSL Seqirus

Company Codes: Australia:CSL, OTC-PINK:CSLLY

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