Jun 13, 2007 (CIDRAP News) – The European Union (EU) has approved Novartis's seasonal influenza vaccine, Optaflu, putting the Swiss company in a position to become the first to market a flu vaccine grown in cell culture rather than eggs.
The vaccine has been approved for use in all 27 EU member states plus Iceland and Norway, Novartis announced today. It is expected to be available in Germany and Austria for the upcoming flu season and in the rest of the EU in 2008-09.
EU approval was expected after the European Medicines Agency's Committee for Medicinal Products for Human Use endorsed the vaccine on Apr 26.
"Optaflu marks the first major innovation in influenza vaccine manufacturing in over 50 years," Dr. Jorg Reinhardt, CEO of Novartis Vaccines and Diagnostics, said in a news release.
"The use of a Novartis proprietary cell culture technology enables a faster and more flexible start-up of vaccine manufacturing, offering the potential to more quickly respond to a potential pandemic influenza threat," the company announcement said.
Flu vaccines have been produced in chicken eggs since the 1950s. Growing the viruses in cell cultures is seen as much more flexible and somewhat faster than egg-based production, which takes several months. Several companies are developing cell-based production methods.
In 2001 European regulators approved a cell-based vaccine made by Solvay Pharmaceuticals for sale in the Netherlands, but the company has not marketed it. Solvay's Web site says that market introduction of the vaccine is expected in the near future.
Novartis said it expects to apply next year for US approval of Optaflu. In May 2006 the US government awarded Novartis a $220 million contract to develop cell-based flu vaccines, and in July 2006 the company announced plans for a $600 million plant in North Carolina to produce them.
Jun 13 Novartis news release
Apr 27 CIDRAP News story "Panel supports EU approval of cell-based flu vaccine"
Jun 27, 2005, CIDRAP News story "Momentum builds for cell-culture flu vaccines"