High-Dose Influenza Vaccine Recognized as a New Option with Demonstrated Superior Efficacy* for Adults 65 Years and Older

- Canada's National Advisory Committee on Immunization recognizes superior efficacy of
high-dose vaccine for adults 65 years of age and older compared to standard dose trivalent 
influenza vaccine -

TORONTO, Feb. 24, 2016 /CNW/ - Sanofi Pasteur announces Health Canada's approval of FLUZONE^® High-Dose vaccine, the first and only influenza vaccine developed for adults 65 years of age and older with evidence demonstrating that it is significantly more effective in preventing lab-confirmed influenza illness versus a standard dose trivalent influenza vaccine (TIV).^1-3

In its immunization advisory statement for the upcoming 2016/2017 influenza season, Canada's National Advisory Committee on Immunization (NACI) has stated: 'Considering the burden of disease associated with influenza A(H3N2) and the evidence of superior efficacy of high dose TIV compared to standard dose TIV, it appears that high dose TIV would provide the greatest benefit to the ≥65 years age group.'⁴

As the immune system declines with age, older adults do not respond to standard dose influenza vaccines as well as younger adults.^1,4,5 FLUZONE^® High-Dose vaccine was developed to address the need for an enhanced immune response in those 65 years of age and older.¹ Importantly, FLUZONE^® High-Dose was recognized by Health Canada and NACI to have demonstrated higher efficacy against lab-confirmed influenza illness compared to a standard dose vaccine in adults 65 years of age and older.^1-3

"Reducing the rates of influenza and its complications in the senior adult population is a key public health priority," said Dr. Janet McElhaney, Geriatrician, Medical Lead for Seniors Care, Health Sciences North Volunteer Association Chair in Healthy Aging and Scientific Director for the Advanced Medical Research Institute of Canada. "There is now strong data which demonstrates that this high dose vaccine provides those 65 years of age and older with enhanced protection against influenza. This is the first randomized trial that has shown not only an increase in efficacy, but has also translated into clinically important outcomes."

A large, randomized, controlled study, published in the New England Journal of Medicine, in a study population of approximately 32,000 adults 65 years of age and older, demonstrated that about one quarter (24.2%, 95% CI: 9.7 to 36.5) of all breakthrough influenza illnesses caused by any influenza viral types or subtypes could be prevented if high dose vaccine were used instead of a standard dose TIV.^1,2,*

"Public health authorities have long recognized a large unmet need among seniors as it relates to influenza and have been asking for the development of more effective influenza vaccines for this age group who are more vulnerable to the consequences of the flu," said Dr. Dion Neame, Head, Scientific and Medical Affairs, Sanofi Pasteur Limited. "As a company, we invested in a large efficacy trial which has provided robust evidence that addresses a public health priority to help reduce influenza illness among adults 65 years and older. FLUZONE^® High-Dose vaccine has been available in the U.S. since 2009, and we look forward to bringing this innovation to Canada this fall."

Impact of Influenza on Adults 65 Years and Older in Canada: Key Facts

• Adults 65 years and older experience heightened susceptibility to influenza-related complications due in large part to a natural and progressive weakening of the immune system with age.^1,4,5
• Adults 65 years of age and older represent 15 per cent of Canadian population but account for 70 per cent of total influenza-related hospitalizations and 90 per cent of total influenza-related deaths.^6,7
• While most people can recover from influenza in as few as seven days, it may take longer for adults 65 years of age as they are at risk of developing more severe complications, including pneumonia or worsening underlying medical conditions.⁴

All adults 65 years of age and older are advised to receive an influenza vaccine annually according to NACI as this age group is considered to be at particularly high risk of influenza-related complications or hospitalization.^4,5

About FLUZONE^® High-Dose Vaccine

FLUZONE^® High-Dose is a trivalent vaccine that contains four times the amount of hemagglutinin (HA) per strain as compared to a standard dose vaccine.^1,2 FLUZONE^® High-Dose is indicated for active immunization against influenza caused by the specific strains of influenza virus contained in the vaccine in adults 65 years of age and older. It is administered as a single 0.5 mL injection by the intramuscular route.¹ Higher rates of some injection-site and systemic reactions were observed among recipients of the high-dose vaccine compared to standard-dose vaccine, but most reactions were mild and resolved within three days.^1,4

For more information about FLUZONE^® High-Dose Influenza Vaccine, please visit: www.sanofipasteur.ca/PM/fluzoneHD_e.

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.ca

References                                                                          

1	Product Monograph: FLUZONE® High-Dose Influenza Virus Vaccine Trivalent Types A and B (Split Virion). Sanofi Pasteur.  Approved September 2015
2	DiazGrana1os, C. A. et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. The New England journal of medicine 371, 635-645 (2014).
3	DiazGranados, C. A. et al. Prevention of serious events in adults 65 years of age or older: A comparison between high-dose and standard-dose inactivated influenza vaccines. Vaccine 33, 4988-4993 (2015).
4	Public Health Agency of Canada (2016). An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI): Canadian Immunization Guide Chapter on Influenza and Interim Statement on Seasonal Influenza Vaccine for 2016-2017.
5	Public Health Agency of Canada (2016). An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI): A Review of the Literature of High Dose Seasonal Influenza Vaccine for Adults 65 Years and Older.
6	Centers for Disease Control and Prevention. What You Should Know and Do this Flu Season If You Are 65 Years and Older. http://www.cdc.gov/flu/about/disease/65over.htm.
7	Statistics Canada. 2011 Census of Canada: Topic-based tabulations. https://www12.statcan.gc.ca/census-recensement/2011/dp-pd/hlt-fst/as-sa/Pages/highlight.cfm?TabID=1&Lang=E&Sex=1&tableID=24&PRCode=01. Accessed June 2015.

*The pre-specified statistical superiority criterion for the primary endpoint (lower limit of the 2-sided 95% CI of the vaccine efficacy of FLUZONE^® High-Dose relative to FLUZONE^® >9.1%; p-value against H0:VE ≤ 9.1% = 0.022 one-sided) was met in a large, randomized, double-blinded, active-controlled clinical trial with approximately 32,000 subjects 65 years of age and older. The primary endpoint was the occurrence of laboratory-confirmed influenza caused by any influenza viral types or subtypes, in association with a protocol-defined influenza-like illness.^1,2

SOURCE Sanofi Pasteur

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