Novartis Gains EU Approval for Pandemic Flu Vaccine

May 23, 2007
BioPharm International Editors

Focetria, a new human vaccine from Novartis (Basel, Switzerland, www.novartis.com) designed for use following the declaration of an influenza pandemic, has received European Union (EU) approval in all 27 member states as well as Iceland and Norway.

Focetria, a new human vaccine from Novartis (Basel, Switzerland, www.novartis.com) designed for use following the declaration of an influenza pandemic, has received European Union (EU) approval in all 27 member states as well as Iceland and Norway. Focetria will be manufactured to contain the influenza strain declared at the time of a pandemic by the World Health Organization (WHO). It will also include the proprietary adjuvant MF59, developed by Novartis, which could extend the vaccine supply by allowing for smaller amounts of viral antigens to be used in each dose compared to vaccines without this adjuvant.

Novartis has also received a positive opinion supporting EU approval of its cell culture–derived seasonal influenza vaccine Optaflu, which is aiming to become the first influenza vaccine to utilize a mammalian cell line, rather than chicken eggs, for antigen production. The Committee for Medicinal Products for Human Use (CHMP), which reviews applications for all 27 countries in the EU as well as Iceland and Norway, has recommended approval of this new vaccine. The EU generally follows the recommendations of the CHMP and delivers its final decision within two to three months.