Sanofi Pasteur Files for European Approval

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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 participants.

 

"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 reliable, 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 skin.

 

"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.  

 

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