Health Canada Approves FLUAD®, New Influenza Vaccine for Seniors

Provides enhanced vaccine immunogenicity and protection against flu strains not included in current vaccine

MONTREAL, Feb. 22 /CNW/ - Health Canada has approved FLUAD®, a Novartis seasonal flu vaccine for adults 65 years and older.  Canadian seniors are the hardest hit of all age groups by seasonal influenza and account for 90 per cent of influenza deaths and 70 per cent of hospitalizations.1

As individuals age, their immune systems decline making them more susceptible to influenza and the risks associated with getting ill.  FLUAD® is the first seasonal flu vaccine in Canada to contain an adjuvant (MF 59) to help boost the immune response and help provide better protection against the flu.2   FLUAD® has been licensed and used extensively in Europe since 1997 with in excess of 50 million doses being administered.  Studies have shown that FLUAD® enhances the vaccine's immune response in older adults (≥ 65 years of age), including those with chronic diseases, compared with conventional non-adjuvanted vaccines.3  Importantly, research also shows that FLUAD can help protect against influenza strains not included in the vaccine.4

"We know that the seasonal flu and subsequent diseases such as pneumonia are a leading cause of death among Canadian seniors and we are seeing that Canadians are increasingly complacent about vaccination this flu season," says Dr. Jay Keystone, Director of the Medisys Travel Health and Immunization Clinic in Toronto and Professor of Medicine at the University of Toronto.  "FLUAD should provide added protection for seniors to help them get through the tough winter months and will be critical for influenza prevention."

The ability to mount an effective immune response against infection gradually wanes with age.  As such, the degree of protection conferred by traditional influenza vaccines is lower in the elderly than in healthy adults.  Vaccination with FLUAD has been shown to improve the effectiveness of influenza vaccines in the elderly.5

Seasonal Flu in Canada:

  • Influenza usually affects 10-15 per cent of the population yearly.6
  • Roughly 70,000-75,000 hospitalizations per year are related to influenza.7
  • It causes 4000 deaths annually; with 80-90 per cent of the deaths in seniors 65 and older.8

FLUAD® Influenza Vaccine:

  • Hospitalization rates for pneumonia, cardiovascular disease and cerebrovascular disease were reduced in FLUAD recipients aged ≥65 years, compared with unvaccinated individuals.9 
  • Enhanced immunogenicity was maintained with repeat annual vaccinations.1
  • FLUAD demonstrated significant clinical effectiveness in older adults compared with no vaccination. 11
  • FLUAD elicited greater immunogenicity against heterovariant (drifted) strains than non-adjuvanted vaccines in older adults12
  • FLUAD was more immunogenic than a non-adjuvanted vaccine in subjects ≥ 65 years of age, with the differences most pronounced in those ≥ 75 years of age13

The National Advisory Committee on Immunization (NACI) states that influenza vaccination reduces the number of doctor visits, hospitalizations and deaths in those 65 years of age and older.14

FLUAD has an established heritage of more than 12 years clinical experience and is well tolerated in adults ≥ 65 years of age. More than 50 million doses of FLUAD have been distributed worldwide.

FLUAD will be available in Canada for seniors in the fall 2011. 

The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology, such as "to file", "may", "should", "potential", "promise", "plans", "will", or similar expressions, or by express or implied discussions regarding potential new indications or labeling for FLUAD® or regarding potential future revenues from FLUAD®. You should not place undue reliance on these statements.  Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with FLUAD* to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that FLUAD® will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that FLUAD® will achieve any particular levels of revenue in the future. In particular, management's expectations regarding FLUAD® could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc. provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas.  In 2009, the Company invested close to $110 million in research and development and conducted hundreds of clinical trials across the country seeking new treatments in Ophthalmology, Respiratory, Neurosciences (including MS), Immunology and Infectious diseases, Cardiovascular, Oncology (including Hematology) and organ transplantation. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc. and Sandoz Canada Inc. For further information about Novartis Canada, please consult

® is a registered trademark.


1 Public Health Agency of Canada - Information on Seniors and the Flu Virus (Seasonal Flu and H1N1 Flu) 10, 2011.  
3 Banzhoff A et al. Gerontology 2003;49:177-184; Podda A. Vaccine 2001;19:2673-2680; Minutello M et al. Vaccine 1999;17:99-104; Squarcione S et al. Vaccine. 2003;21:1268-1274; Li R et al. Immun Ageing. 2008;5:2.
4 ]Minutello M et al. Vaccine 1999;17:99-104; De Donato S et al. Vaccine1999;17:3094-101; Del Giudice G et al. Vaccine 2006;24:3063-5 ; Ansaldi F et al. Vaccine 2008;26:1525-1529; O'Hagan DT and Pellegrini M. IVW 2009, Poster 112
5 Nicholson KG, Wood JM, Zambon M. Influenza. Lancet 2003;362:1733-45.; Banzhoff A, Nacci P, Podda A. A new MF59-adjuvanted influenza vaccine enhances the immune response in the elderly with chronic diseases: results from an immunogenicity meta-analysis. Gerontology 2003;49:177-84; Baldo V, Baldovin T, Floreani A, Carraro AM, Trivello R, Family Medicine Group of Pianiga. MF59-adjuvanted influenza vaccine con- fers superior immunogenicity in adult subjects (18-60 years of age) with chronic diseases who are at risk of post-influenza complications. Vaccine 2007;25:3955-61.
6 Schanzer et al 2006.
7 Menec, 2003.
8 Menec, 2003
9 Puig-Barbera J, Diez-Domingo J, Perez Hoyos S, Belenquer Varea A, Gonzalez Vidal D. - Effectiveness of the MF59-adjuvanted influenza vaccine in preventing emergency admissions for pneumonia in the elderly over 64 years of ageVaccine.  2004; 23:283-289; Puig-Barbera J, Diez-Domingo J, Varea AB, et al. Vaccine. 2007; 25:7313-7321. Effectiveness of MF59-adjuvanted subunit influenza vaccine in preventing hospitalizations for cardiovascular disease, cerebrovascular disease and pneumonia in the elderly.
10 Podda A. Vaccine 2001;19:2673-2680; Minutello M et al. Vaccine 1999;17:99-104. 
11 Puig-Barberà J et al. Vaccine 2007;25:7313-7321.
12 Minutello M et al. Vaccine 1999;17:99-104; De Donato S et al. Vaccine 1999;17:3094-101; Del Giudice G et al. Vaccine 2006;24:3063-5 ; Ansaldi F et al. Vaccine 2008;26:1525-1529; O'Hagan DT and Pellegrini M. IVW 2009, Poster 112
13 Squarcione S et al. Vaccine. 2003;21:1268-1274.
14 National Advisory Committee on Immunization (NACI). Statement on Seasonal Trivalent Inactivated Influenza Vaccine (TIV) for 2010-2011, Volume 36, August 2010, pg. 13. 

SOURCE Novartis Pharmaceuticals Canada Inc.

For further information:

For additional information or to arrange an interview with a physician, please contact:

Lauren Bondar
Fleishman-Hillard Canada

Lise Huneault
Novartis Pharmaceuticals
514-631-6775 ext.  1203


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