European Union approves Novartis flu vaccine Optaflu

Optaflu, the first influenza vaccine to use a Novartis proprietary cell line for the production of viral antigen components rather than chicken eggs, has received European Union approval in all 27 member states, as well as Iceland and Norway.

Optaflu has been approved for use in vaccination against seasonal influenza. The use of a Novartis proprietary cell culture technology enables a faster and more flexible start-up of vaccine manufacturing, enabling faster response to a potential pandemic influenza threat.

The new vaccine is expected to be available in Germany and Austria for the 2007/2008 influenza season and to be available in the remaining EU countries for 2008. A submission for US regulatory approval is anticipated for 2008.

The technology could remove the reliance of chicken eggs for vaccine production in the event of an avian influenza pandemic. On a pandemic threat scale of one to six, WHO currently ranks the H5N1 risk at phase three. This virus is highly contagious in chickens, adding the possibility that a pandemic strain could emerge at a time when egg supplies are lower than usual due to a previous epidemic in chickens. Novartis proprietary cell culture line offers an alternative to traditional egg-derived vaccines.

Virus cultivation usng Novartis" proprietary cell line as an exclusive host, offers the possibility of more robust virus proliferation, since most circulating viral strains are unable to replicate in chicken eggs. It also offers the possibility for vaccine seed strain development that more closely matches the original "wild" virus because cell culture technology eliminates the need for passage through eggs where the virus may be forced to adapt in order to replicate.

As a result, the antigen included in the vaccine may express more authentically the surface of the wild type virus, potentially translating into a better immunogenic and effective response