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Sanofi Pasteur Files for European Approval of the First Seasonal Influenza Vaccine Delivered by Intradermal Microinjection

Feb 13, 2008

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that it has filed a centralized marketing authorization application, in Europe, for the first influenza vaccine delivered by an innovative intradermal (ID) microinjection system. This file has been accepted for review by the European Medicines Agency (EMEA).

 

Clinical trials, involving more than 7,000 adult or elderly 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 study participants1,2.

 

With aging, the immune system tends to weaken – the elderly become not only more susceptible to infections, but also less responsive to vaccination,” said Robert Booy, MD, Co-Director at the National Centre for Immunisation Research and Surveillance (NCIRS), Sydney, Australia. “When infected with flu virus, the elderly may not be able to mount an adequate immune response and, as a result, they remain vulnerable to the more serious complications of flu. For this reason, there is a strong need to increase the immune response to vaccination in persons over 60 years of age and the data show that the new ID vaccine can effectively provide improved responses in this age group,” added Prof. Booy.

 

Vaccination via the ID route involves the introduction of the vaccine into the dermal layer of the skin. Due to the high concentration of specialized immune cells in this skin layer, and their ability to effectively stimulate an immune response, ID vaccination provides direct and efficient access to the immune system.

 

Sanofi Pasteur’s novel ID influenza vaccine overcomes the technical difficulties that have historically limited the use of this route of administration3 and provides reliable3,4 intradermal influenza immunization. This has been made possible with the development of a new, easy-to-use, pre-filled microinjection system, developed in collaboration with sanofi pasteur’s commercial partner, BD (Becton, Dickinson and Company). The thin needle of the micro-injection system has a length of only 1.5 mm, which provides for minimally invasive vaccination and ensures that the antigen is consistently deposited in the dermal layer of the skin4.

 

Seasonal influenza vaccination rates still remain relatively low in certain age-groups; the use of a new, easy-to-use and less invasive vaccine may support higher vaccination rates,” said Doctor Isabel Leroux-Roels, MD, clinical researcher at the Ghent Center for Vaccinology, Belgium.

 

Seasonal Influenza Overview

Influenza is a disease caused by a highly infectious virus that spreads easily from person to person, primarily when an infected individual coughs or sneezes. According to the World Health Organization (WHO), 5-15% of the population is affected with upper respiratory tract infections in annual influenza epidemics. Hospitalization and deaths mainly occur in high-risk groups (elderly, people with chronic conditions/illness). Although difficult to assess, these annual epidemics are thought to result in between three and five million cases of severe illness and between 300,000 and 500,000 deaths every year around the world5. Most deaths currently associated with influenza in industrialized countries occur among those over 65 years of age.

 

Influenza continues to be a major global health concern due to the nature of the genetic variation of the virus, which is capable of evading the body’s immune system. The risk of developing serious complications or death following influenza is highest among the elderly and those with chronic illnesses, such as asthma, diabetes or cardiovascular diseases. The efficacy of vaccination in reducing the burden of the disease, as well as the economic burden of treating influenza, is well established.

 

As the world leader in research, development and manufacturing of influenza vaccines, sanofi pasteur is working to develop new and improved influenza vaccines to save lives. In 2006, the company produced more than 170 million doses of seasonal influenza vaccine. Sanofi Pasteur’s Vaxigrip® and Fluzone® influenza virus vaccines are licensed in over 100 countries.

 

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT PARIS: SAN) and in New York (NYSE: SNY).

 

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than a billion doses of vaccine in 2006, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, sanofi pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us

 

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward- looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

 

References:

1. Booy R; Weber F; Saville M. Immunogenicity of a novel influenza vaccine delivered by intradermal microinjection in over 60 year-olds. Options for the control of Influenza VI. Toronto, Canada, June 2007

2. Intradermal influenza vaccination offers superior immunogenicity compared with conventional vaccine in the elderly, and is safe after two annual vaccinations in adults, Poster: Vaccine Congress in Amsterdam, December 2007. I. Leroux-Roels*1, G. Leroux-Roels1, D. Holland2, R. Booy3, F Weber4, M Saville4 1Center for Vaccinology, Belgium; 2Centre for Clinical Research and Effective Practice, New Zealand; 3National Centre for Immunisation Research and Surveillance, Australia, 4sanofi pasteur, France

3. Laurent PE, et al Vaccine 2007; 25:8833-42. Evaluation of the clinical performance of a new intradermal vaccine administration technique and associated delivery system

4. Laurent A, et al Vaccine 2007;25:6423–6430. Echographic measurement of skin thickness in adults by high frequency ultrasound to assess the appropriate microneedle length for intradermal delivery of vaccines

5. http://www.who.int/vaccine_research/diseases/ari/en/print.html

For further information: Sanofi Pasteur Pascal Barollier Media Relations Tel: + 33-(0)4-37-37-51-41 pascal.barollier@sanofipasteur.com