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.[1]
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.[2],[3]
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.[4],[5],[6],[7]
“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.[8],[9]
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.
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