Lyon, February 13, 2008 – Sanofi Pasteur MSD has applied for the European licensure for the first seasonal influenza vaccine delivered by intradermal (ID) microinjection. The European Medicines Agency (EMEA) has accepted the filing and started its review.
Clinical trials, involving more than 7,000 participants, evaluated the safety and ability to generate an immune response of this novel (ID) seasonal influenza vaccine.
The ID vaccine generated a superior level of seroprotective immune response against all tested influenza strains, compared with standard intramuscular (IM) influenza vaccination, in participants over 60 years of age.
With ageing, the immune system tends to weaken – the elderly become not only more susceptible to infections but also less responsive to classical intramuscular vaccination, a phenomenon known as immunosenescence.
“As a natural consequence of ageing, the immune system of the elderly becomes less able to fight off influenza infection as well as the more serious influenza-related complications. This underscores the strong rationale for a better-performing vaccine in the elderly,” explains Dr. Jean-Pierre Michel, professor and chair of rehabilitation and geriatrics at the University of Geneva Medical School in Switzerland.
“The concept of this vaccine is based on the fact that there is a high concentration of specialised immune cells in the intradermal skin layer and their ability to effectively provide an improved immune response,” says Patrick Poirot, vice-president for Medical and Scientific Affairs at Sanofi Pasteur MSD.
A proprietary new, pre-filled and ready-to use microinjection system with a very fine and short needle provides accurate and reliable intradermal delivery of the vaccine.
If approved, Sanofi Pasteur MSD will market the vaccine within its territory . Outside this territory, the vaccine will be marketed by sanofi pasteur, one of Sanofi Pasteur MSD’s parent companies.
About seasonal influenza Worldwide, up to half a million deaths occurring annually, mainly in the elderly, are attributed to influenza and its complications. For the European Union, the European Centre for Disease Prevention and Control (ECDC) estimated in December 2007 that up to 220,000 people die each year from seasonal influenza. The illness is usually more severe in elderly adults because of a weakening of the immune system and the increased frequency of other diseases, such as chronic cardiopulmonary, renal or metabolic diseases. In the elderly and in people with underlying chronic diseases, influenza infection not only causes primary illness but also can lead to severe secondary medical complications, including secondary bacterial pneumonia, and aggravation of underlying medical conditions, such as congestive heart failure, asthma, or diabetes.
As the leading provider of influenza vaccines in Europe, Sanofi Pasteur MSD is committed to developing new and improved influenza vaccines to save lives. For the 2006-2007 season, Sanofi Pasteur MSD distributed more than 37 million doses of influenza vaccines in Europe. In 2007, sanofi pasteur reached a new production record for its seasonal influenza vaccines with more than 180 million doses.
About Sanofi Pasteur MSD Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.
Contact: Dr. Arne Näveke Executive Director, Communication Europe Sanofi Pasteur MSD Tel +33 4 37 28 40 40 anaveke@smpsd.com
