– Canada’s National Advisory Committee on Immunization recognizes superior efficacy of
high-dose vaccine for adults 6five years of age and older compared to standard dose trivalent
influenza vaccine –
TORONTO, Feb. 24, 2016 /CNW/ – Sanofi Pasteur announces Good health Canada’s approval of FLUZONE® High-Dose vaccine, the very first and only influenza vaccine made for adults 6five years of age and older along with evidence demonstrating that it is significantly much more efficient in preventing lab-confirmed influenza ailment 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 actually stated: ‘Curious about the burden of health problem associated along with influenza A(H3N2) and the evidence of superior efficacy of higher dose TIV compared to standard dose TIV, it appears that higher dose TIV would certainly give the greatest reward to the ≥6five years age group.’4
As the immune system declines along with age, older adults do not respond to standard dose influenza vaccines also as younger adults.1,4,5 FLUZONE® High-Dose vaccine was made to manage the necessity for an enhanced immune response in those 6five years of age and older.1 Importantly, FLUZONE® High-Dose was recognized by Good health Canada and NACI to have actually demonstrated greater efficacy versus lab-confirmed influenza ailment compared to a standard dose vaccine in adults 6five years of age and older.1-3
“Lowering the rates of influenza and its complications in the senior adult population is a crucial public Good health priority,” said Dr. Janet McElhaney, Geriatrician, Medical Lead for Seniors Care, Good health Sciences North Volunteer Association Chair in Healthy and balanced Aging and Scientific Director for the Advanced Medical Research Institute of Canada. “There is now durable data which demonstrates that this higher dose vaccine provides those 6five years of age and older along with enhanced protection versus influenza. This is the very first randomized trial that has actually revealed not only an enhance in efficacy, yet has actually likewise translated in to clinically Necessary outcomes.”
A large, randomized, controlled study, published in the New England Diary of Medicine, in a study population of about 32,000 adults 6five years of age and older, demonstrated that concerning one quarter (24.2%, 95% CI: 9.7 to 36.5) of every one of breakthrough influenza illnesses caused by any type of influenza viral types or subtypes could be prevented if higher dose vaccine were used as opposed to a standard dose TIV.1,2,*
“Public Good health authorities have actually long recognized a large unmet necessity among seniors as it relates to influenza and have actually been asking for the development of much more efficient influenza vaccines for this age group that are much 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 actually offered robust evidence that addresses a public Good health priority to recommendations reduce influenza ailment among adults 6five years and older. FLUZONE® High-Dose vaccine has actually been available in the U.S. because 2009, and we anticipate bringing this innovation to Canada this fall.”
Impact of Influenza on Adults 6five Years and Older in Canada: crucial Facts
- Adults 6five years and older experience heightened susceptibility to influenza-related complications due in large section to a natural and progressive weakening of the immune system along with age.1,4,5
- Adults 6five years of age and older represent 1five per cent of Canadian population yet account for 70 per cent of total influenza-related hospitalizations and 90 per cent of total influenza-related deaths.6,7
- While most individuals Can easily recover from influenza in as few as seven days, it might take longer for adults 6five years of age as they are at risk of producing much more major complications, including pneumonia or worsening underlying medical conditions.4
All adults 6five 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 higher 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 quantity of hemagglutinin (HA) per strain as compared to a standard dose vaccine.1,2 FLUZONE® High-Dose is indicated for energetic immunization versus influenza caused by the individual strains of influenza virus contained in the vaccine in adults 6five years of age and older. It is administered as a single 0.five mL injection by the intramuscular route.1 greater rates of some injection-site and systemic reactions were observed among recipients of the high-dose vaccine compared to standard-dose vaccine, yet most reactions were mild and resolved within three days.1,4
For much more guide concerning FLUZONE® High-Dose Influenza Vaccine, please visit: http://ift.tt/1R1aPJs.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has actually core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal Good health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides much more compared to 1 billion doses of vaccine each year, making it feasible to immunize much more compared to 500 million individuals across the globe. A globe leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting versus twenty infectious diseases. The company’s heritage, to produce vaccines that protect life, dates spine much more compared to a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests much more compared to EUR 1 million in research and development. For much more information, please visit: www.sanofipasteur.ca
References
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1 |
Product Monograph: FLUZONE® High-Dose Influenza Virus Vaccine Trivalent Types A and B (Split Virion). Sanofi Pasteur. Approved September 2015 |
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2 |
DiazGrana1os, C. A. et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. The Brand-new England Diary of medicine 371, 635-64five (2014). |
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3 |
DiazGranados, C. A. et al. Prevention of significant events in adults 6five years of age or older: A comparison between high-dose and standard-dose inactivated influenza vaccines. Vaccine 33, 4988-4993 (2015). |
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4 |
Public Good 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. |
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5 |
Public Good health Agency of Canada (2016). An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI): A Review of the Literature of higher Dose Seasonal Influenza Vaccine for Adults 6five Years and Older. |
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6 |
Centers for health problem manage and Prevention. Just what You Ought to Understand and Do this Flu Season If You Are 6five Years and Older. http://ift.tt/YaxBm9. |
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7 |
Statistics Canada. 2011 Census of Canada: Topic-based tabulations. http://ift.tt/1R1aMNT. Accessed June 2015. |
*The pre-stated statistical superiority criterion for the primary endpoint (lesser limit of the 2-sided 95% CI of the vaccine efficacy of FLUZONE® High-Dose relative to FLUZONE® >9.1%; p-value versus H0:VE ≤ 9.1% = 0.022 one-sided) was met in a large, randomized, double-blinded, active-controlled clinical trial along with about 32,000 subjects 6five years of age and older. The primary endpoint was the occurrence of laboratory-confirmed influenza caused by any type of influenza viral types or subtypes, in association along with a protocol-defined influenza-love illness.1,2
SOURCE Sanofi Pasteur
For further information: or to arrange an interview, please contact: Sanofi Pasteur Limited: Danielle Richardson, T. 416-667-2700 ext. 6950, Danielle.Richardson@sanofipasteur.com
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