Regulatory Affairs

Novartis Obtains Approval From Germany Regulatory Authorities For Celtura

PBR Staff Writer Published 05 November 2009

Celtura is a cell culture-based Influenza A pandemic vaccine

Novartis has received approval from the German regulatory authorities for its adjuvanted cell culture-based Influenza A(H1N1) 2009 monovalent vaccine, Celtura. Novartis said that it will continue to pursue registration in other major countries, including Japan and Switzerland.

Reportedly, Celtura is manufactured in Marburg, Germany and is an MF59 adjuvanted inactivated influenza virus vaccine indicated for active immunisation of persons six months of age and older against influenza disease caused by the novel pandemic A(H1N1) influenza virus. The vaccine contains 3.75ug of antigen and 0.125ml of MF59. It will be offered in multi-dose vials and in single-dose pre-filled syringes.

The company said that the clinical studies conducted with more than 1,850 subjects evaluated Celtura's tolerability and immunogenicity. The studies showed that even with the lowest antigen content (3.75ug) a single Celtura dose can induce immune responses associated with protection against influenza in individuals from 3 to 50 years of age.

In the study, the safety and tolerability profiles were as expected. The vacine uses a validated cell culture line for production of viral antigen components rather than traditional chicken eggs. The technology has previously been licensed in Europe for the production of the seasonal flu vaccine, Optaflu.

The company has already begun delivery of the company's egg-based pandemic vaccines, Fluvirin A(H1N1) monovalent vaccine to the US and Focetria A(H1N1) monovalent vaccine to countries around the world. The FDA has approved the Fluvirin A(H1N1) vaccine on September 15, 2009, and the EMEA approved the Focetria A(H1N1) vaccine on September 29, 2009.

Andrin Oswald, CEO of vaccines and diagnostics at Novartis, said: "Our modern cell culture technology can enable a faster start-up of vaccine manufacturing, offering the ability to respond more quickly to future pandemic threats

"We quickly ramped up capacity at our licensed cell culture facility in Marburg, Germany to respond to the need for a pandemic vaccine. Also we are close to completion of a second cell culture-based influenza vaccine manufacturing site in the US, which is being built in partnership with the US Department of Health and Human Services (HHS)."