Solvay Pharmaceuticals announced today that it has obtained European marketing approval for its new virosomal influenza vaccine: INVIVAC®.
This European registration follows the completion of a Mutual Recognition Procedure (MRP), with The Netherlands acting as Reference Member State. Norway and the following 13 EU member states will now grant a marketing authorization to INVIVAC®: Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain, Sweden and the United Kingdom. Registration was already obtained in The Netherlands and Switzerland earlier this year.
INVIVAC® is a virosomal influenza vaccine with a unique mechanism of action. Clinical studies have shown that the virosomal influenza vaccine is safe and efficacious, particularly in elderly patients and people with low antibody titers before vaccination. Virosomes stimulate B lymphocytes of the immune system to produce antibodies but also have the potential to stimulate T-cells. This broader immune response is important for the protection against influenza-related diseases. T-cells recognize and eliminate infected cells and are therefore important for the recovery process after an influenza infection. Elderly people may have a weakened immune system, therefore T-cell stimulation by the virosomal vaccine INVIVAC® may be beneficial for the elderly.
INVIVAC® will be available for the coming 2004 flu season in Switzerland, The Netherlands, and the UK. Norway and the EU member states that now grant a marketing authorization will follow in 2005. For the other EU member states Solvay Pharmaceuticals will start a repeat-use MRP in 2005.
Solvay Pharmaceuticals has licensed in the virosomal technology from Berna Biotech in Switzerland, and is producing INVIVAC® itself.
Sjirk Kok, Head of the Influenza Business Group, says: “We are very pleased to obtain this European registration as we believe that INVIVAC® is a good addition to our existing Influvac® portfolio, which again shows our expertise in the prevention and control of influenza.”