Nov. 5 (Bloomberg) -- Novartis AG won German regulatory approval for its Celtura swine flu vaccine.

The country’s health regulator approved Celtura shots for use in adults and children as young as six months old, Basel, Switzerland-based Novartis said today in an e-mailed statement.

Celtura is produced using dog kidney cells rather than the more traditional vaccine-manufacturing method, which involves growing the virus in fertilized chicken eggs. The approval marks an “important milestone” in the process of replacing 50-year-old production methods with modern biotechnology, Novartis said. The cell culture technology has already been approved in Europe for use in producing the seasonal flu vaccine Optaflu. Novartis has also asked Swiss and Japanese regulators to approve Celtura.

“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,” Andrin Oswald, Chief Executive Officer of Novartis Vaccines and Diagnostics said in the statement. “We quickly ramped up capacity at our licensed cell culture facility in Marburg, Germany to respond to the need for a pandemic vaccine.”

The company has already won European and Swiss approval for its Focetria vaccine, which is made in the traditional way.

Adjuvants

Neither Celtura nor Focetria was submitted for use in the U.S. because of the use of a so-called adjuvant, which hasn’t been approved in the country. Adjuvants boost the potency of a vaccine and enable the same amount of antigen, or the substance that induces immunity, to be used to treat more people.

The MF59 adjuvant used in Celtura has already been used in more than 45 million doses of the flu shot Fluad and is supported by more than 12 years of clinical safety data, Novartis said.

Clinical studies in more than 1,850 people showed that a single dose of Celtura can induce an immune response “associated with protection against influenza” in people aged between 3 and 50 years, Novartis said.

To contact the reporter on this story: Dermot Doherty in Geneva at ddoherty9@bloomberg.net

Last Updated: November 5, 2009 06:56 EST