First Intradermal Influenza Vaccine Approved in the European Union

Sanofi Pasteur (Lyon, France), the vaccines division of the Sanofi-Aventis Group, has received marketing authorization from the European Commission for the first intradermal (ID) influenza vaccine using BD Soluvia microinjection system developed by BD (Franklin Lakes, NJ).

While most vaccines are injected into the muscle, the microinjection system, called “BD Soluvia” allows accurate vaccine delivery to the dermal layer of the skin using a 1.5-mm microneedle with a 0.1-mL injected volume.

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.

As a prefillable delivery device, the microinjection system also provides a high level of sterility assurance and reduced risks associated with vaccine preparation and administration.