LE PONT DE CLAIX, France, February 26 /PRNewswire/ --
BD, a leading global medical technology company, today announced that sanofi pasteur, the vaccines division of sanofi-aventis Group, received marketing authorization from the European Commission for the first intradermal (ID) influenza vaccine Intanza(R) or IDflu(R), using the innovative BD Soluvia(TM) microinjection system developed by BD.
The BD Soluvia microinjection system offers a proven, easy-to-use and reliable method of intradermal delivery, which integrates a 1.5 mm length BD microneedle with a 0.1 ml injected volume.(1) While most vaccines are injected into the muscle, the BD microneedle allows accurate intradermal vaccine delivery -- within the dermal layer of the skin. Intradermal vaccination provides direct and efficient access to the immune system. As a prefillable delivery device, the BD Soluvia microinjection system also provides key safety benefits for patients and the healthcare system, such as a high level of sterility assurance and reduced risks associated with vaccine preparation and administration.
We are delighted to have reached this milestone with our partner, sanofi pasteur, said Alexandre Conroy, President, BD Medical - Pharmaceutical Systems. BD is committed to developing innovative solutions to advance drug delivery with our pharmaceutical partners and pursuing the development of the BD Soluvia microinjection system for other potential applications.
The approval of the first ID microinjection influenza vaccine follows the favorable evaluation from the European Medicines Agency (EMEA) in December 2008 based on the review of data from clinical trials conducted by sanofi pasteur. These trials evaluated the safety and effectiveness of the ID influenza vaccine to generate an immune response. The BD microneedle has been shown to be intuitive for caregivers to use and the needle penetration barely perceptible by patients. The BD Soluvia microinjection system ensures easy and reliable administration of the vaccine to the dermal layer regardless of the subject's gender, age, ethnicity and body mass.(2)
BD is pleased to have its innovative microinjection system be part of the first intradermal flu vaccine, said Philippe Laurent, Vice President, Medical Affairs, BD Medical - Pharmaceutical Systems. The minimally invasive BD Soluvia microinjection system has the potential to increase patient participation in immunization programs.
About BD
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.
(1)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
(2)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
Vikki Lomas, Corporate Communications, Europe, +44-(0)-1865-781607, cell: +44-(0)-7827-894871, vikki_lomas@europe.bd.com; or Jeff Ezell, Public Relations, U.S., +1-201-847-5533, jeff_ezell@bd.com





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