New Study Confirms Seasonal Flu Vaccine Designed for Seniors Improved Protection Against Influenzaˡ

DORVAL, QC, Nov. 5, 2013 /CNW/ - Newly published data in the medical journal Vaccine shows that FLUAD*, an influenza vaccine indicated specifically for people 65 years and older, provided significantly improved protection against influenza in the elderly in comparison to non-adjuvanted trivalent influenza vaccine in this age group.¹ The investigator-led Canadian study focused on British Columbia with seniors who are at an increased risk of influenza or pneumonia and who suffer the greatest morbidity and mortality of any age group from seasonal influenza infections.²

Available in Canada, FLUAD* is indicated for active immunization against influenza in adults 65 years and older. This age group generally has a lower immune response to regular seasonal flu vaccines. FLUAD* is the first and only seasonal flu vaccine coupled with MF59* adjuvant available in Canada. Another recently published Canadian study comparing FLUAD* to non-adjuvanted trivalent influenza vaccine formulations found FLUAD* to generate a significantly higher protective immune response against the influenza A vaccine strains in an elderly population.³

"Canadian seniors are a high-risk group for suffering serious consequences from contracting seasonal influenza," says Dr. Anthony D'Urzo, Associate Professor and General Practitioner, University of Toronto, Department of Family and Community Medicine, Primary Care Lung Clinic, Toronto. "The study results indicate that there is a benefit in seniors receiving an adjuvanted vaccine that could reduce the risk of hospitalization and an increased risk of complications, especially if they have conditions like diabetes, cardiovascular or respiratory disease."

Influenza in Canada
Influenza is a common respiratory illness that affects up to an estimated 1 in 5 Canadians each year.⁴ Up to 90 per cent of influenza-attributable deaths occur in adults 65 years of age or older and each year, an average of 20,000 hospitalizations and between 2,000 and 8,000 deaths are attributed to influenza and pneumonia in Canada.¹ Influenza vaccines are recommended for most people, especially for people in high-risk groups such as seniors and people with weak immune systems.⁵

In addition to the serious consequences of influenza, older people can also lose up to five per cent of muscle power and one per cent of aerobic capacity per day of bed rest.⁶ Given that flu symptoms can last up to three weeks, seniors may not have the functional reserve to recover from illness as quickly as they once could.⁶

About the study
The comparative effectiveness of adjuvanted and unadjuvanted trivalent inactivated influenza vaccine (TIV) in the elderly study by Van Buynder PG, et al. evaluated the comparative effectiveness of adjuvanted trivalent influenza vaccine (ATIV), and unadjuvanted trivalent influenza vaccine (TIV) in reducing laboratory confirmed influenza in the elderly. Elderly in three British Columbia health authorities during winter 2011-12 were included in a community based case control study design.

The methodology used in this study is consistent with the recommendations of the European Centre for Disease Prevention and Control for vaccine effectiveness studies.¹ It has previously been used in Canadian settings to assess the pandemic vaccine effectiveness.¹

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2012, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. For further information, please consult www.novartis.ca.

About FLUAD*
FLUAD* is the first and only seasonal flu vaccine coupled with MF59* adjuvant and is indicated for active immunization against influenza in adults 65 years and older.⁷ This age group generally has a lower immune response to regular seasonal flu vaccines, and also has underlying health problems.⁸ FLUAD* is proven to induce a higher immune response and higher protection against mismatched strains than conventional non-adjuvanted vaccines in adults 65 years and older.¹

It has more than 12 years of clinical experience and more than 60 million doses have been distributed worldwide.⁹

FLUAD* has been shown to reduce the risk of hospitalization due to influenza or pneumonia in individuals 65 years and older.¹ The overall safety profile of FLUAD* in adults 65 years and older is based on data from 39 studies. Overall, 12,889 subjects were exposed to at least one dose with FLUAD*.⁷

Safety data after first vaccination for subjects 65 years of age and older were pooled from 31 trials, safety data after second consecutive vaccination were pooled from five studies and after third consecutive vaccination from two studies. The most frequently reported solicited systemic adverse events were headache, fatigue, malaise and myalgia (muscle soreness). Most reports of systemic reactions were mild to moderate in severity and generally transient, with 1 per cent or less of subjects reporting a severe systemic reaction across all studies.⁷ The most common FLUAD* local adverse drug reactions are pain at the injection site, temperature at the injection site, and erythema. The incidence of subjects reporting any solicited systemic reactions was generally slightly higher in the FLUAD* than in the comparator group (17% vs. 12%). Reactions are generally mild or moderate and of limited duration.⁷

*Fluad and MF59 are registered trademarks.

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^{1 Van Buynder PG, et al. The comparative effectiveness of adjuvanted and unadjuvanted trivalent inactivated influenza vaccine (TIV) in the elderly. Vaccine (2013), http://dx.doi.org/10/1015/j.vaccine.2013.07.059
2 Public Health Agency of Canada, 2012. People > 65 Years of Age.
3 Scheifele DW, McNeil SA, Ward BJ, Dionne M, Cooper C, Coleman B, Loeb M, Rubinstein E, McElhaney J, Hatchette T, Li Y, Montomoli E, Schneeberg A, Bettinger JA, Halperin SA, Research Network PI. Safety, immunogenicity, and tolerability of three influenza vaccines in older adults: Results of a randomized, controlled comparison. Human Vaccines & Immunotherapeutics 2013; 9:0 - -1; PMID: 23839537;
4 Public Health Agency of Canada, 2012. Influenza Immunization "The Flu Shot".
5 Canadian Lung Association, 2012.
6 McElhaney, JE. The unmet needs in the elderly: Designing new influenza vaccines for older adults. Vaccine 23S1 (2005) S1/10-21/25
7 FLUAD* Product Monograph. Novartis Pharmaceuticals Canada Inc., June 3, 2013
8 Centers for Disease Control and Prevention. What you should know and do this flu season if you are 65 years and over. August 22, 2013. Available at: http://www.cdc.gov/flu/about/disease/65over.htm. Accessed on September 19, 2013
9 Data on File
10 Mannino S. et al. Effectiveness of Adjuvanted Influenza Vaccination in Elderly Subjects in Northern Italy. Am J Epidemiol. 2012 September 15; 176(6): 527-533}.

SOURCE: Novartis Pharmaceuticals Canada Inc.