First European application filed for product using intradermal microinjection system BD Soluvia

Novel influenza vaccine delivered using BD's innovative technology

18-Feb-2008 - France

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, has submitted the first application in Europe to deliver a vaccine using BD Soluvia, a microinjection system developed by BD (Becton, Dickinson and Company). The submission for the first influenza vaccine using BD Soluvia has been accepted for review by the European Medicines Agency (EMEA).

Sanofi Pasteur conducted clinical trials on more than 7000 subjects to evaluate safety and the ability to generate an immune response of the novel intradermal (ID) influenza vaccine. Compared with intramuscular (IM) injection, ID delivery was shown to be especially effective in enhancing the immune response in the elderly. Independently, BD conducted clinical trials involving more than 700 subjects and 3500 injections with BD Soluvia, and demonstrated that the system was safe and easy to use. Clinical testing showed that the BD microneedle is barely perceptible when it enters the skin and ensures the administration of the injected solution to the dermal layer irrespective of the subject's gender, age, ethnicity and body mass.

BD Soluvia is a prefillable microinjection system that is integrated with a tiny BD microneedle. While most vaccines are injected into the muscle, the BD microneedle allows the vaccine to be accurately delivered intradermally -- within the dermal layer of the skin. The dermal layer contains a dense network of lymphatic vessels feeding local lymph nodes, resulting in rapid and efficient access of the vaccine into the immune system. It also contains a high concentration of potent immune cells that play a key role to initiate the immune response following vaccination.

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