These data support the efficacy of the MF59™-adjuvanted seasonal influenza vaccine in stimulating the immune system, especially in elderly people who have a waning immune system. The results also provide evidence of the relationship between influenza infection and the activation of undesirable atherosclerotic events. In addition, the relationship between influenza infection and increased susceptibility to Streptococcus pneumoniae (pneumonia) is well established.

“We see that the sustained protection provided by an adjuvanted vaccine against seasonal influenza in an elderly population shows promise for reduced hospitalization,” said Joan Puig-Barberá, Ph.D., M.P.H., M.D., lead study investigator, Center of Public Health of Castellón, Castellón, Spain. “As so many of these elderly people have a diminishing immune system and are often affected by serious medical conditions, providing improved influenza prevention during a time of increased vulnerability can be a major factor in boosting their overall health outcomes.”

Three studies were performed in the people greater than 64 years of age during the 2004-2005 influenza season in three health districts in Valencia, Spain. The districts included 105,454 subjects who received vaccination with MF59™-adjuvanted sub-unit influenza vaccine. Each case was paired with one or two controls; controls were matched for hospital, hospitalization date and gender. The risk of hospitalization after the start of the influenza season was significantly lower in vaccinated subjects compared with non-vaccinated subjects. Adjusted odds ratios were: 0.13 or 87 percent reduction, [p=0.013] for ACS; 0.07 or 93 percent reduction, [p=0.007] for CVA; 0.31 or 69 percent reduction, [p=0.005] for pneumonia.

“Novartis has been leading the adjuvanted influenza vaccine category since the introduction of Fluad® in 1997. This new study demonstrates the advantages seen, in terms of reductions in hospitalization, in a vulnerable population vaccinated with Fluad®. These findings further validate previous data, from more than 25 million doses of Fluad® administered, and support the improvement in efficacy seen with Fluad® in the elderly,” said Joerg Reinhardt, Chief Executive Officer, Novartis Vaccines and Diagnostics. “Our proprietary adjuvant, MF59™, is also utilized in the development of our pandemic and pre-pandemic influenza vaccines.”

Puig-Barberá and colleagues published their study in Vaccine 16 October 2007, Volume 25: Issue 42, pages 7313-7321 (doi 10.1016/j.vaccine.2007.08.039). Elsevier Ltd. publishes Vaccine. Full article text can be found online at: www.elsevier.com/locate/vaccine.

About Fluad®
Fluad®, the only MF59™-adjuvanted seasonal influenza vaccine, is licensed for active immunization against influenza in elderly subjects (65 years of age and over) in 12 European Union countries (Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, Portugal, Republic of Ireland, Spain and Sweden) with a Mutual Recognition Procedure and an additional 13 countries worldwide (Argentina, Australia, Czech Republic, Colombia, Croatia, Hong Kong, Mexico, Philippines, Republic of South Africa, Singapore, China, New Zealand and Thailand).

Fluad® is registered under different brand names by Novartis Vaccines including Gripguard® in France and Chiromas® in Spain.

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