Novartis gets green light for cell culture-based A/H1N1 flu vaccine

Swiss pharmaceutical giant Novartis announced on Thursday that it had received approval from the German regulatory authorities for a new A/H1N1 influenza vaccine made using cell cultures instead of the traditional egg-based methods.

The approval "marks an important milestone in the process of replacing 50 year-old egg-based flu vaccine production with modern biotechnology," the Basel-based company said in a statement.

The new vaccine, named Celtura, uses validated cell culture line for production of viral antigen components rather than traditional chicken eggs, according to the statement. The technology has previously been licensed in Europe for the production of a seasonal flu vaccine.

"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," said Andrin Oswald, CEO of Novartis' Vaccines and Diagnostics division.

Novartis said Celtura was made at a licensed cell culture facility in Germany, and the company "is close to completion of a second cell culture-based influenza vaccine manufacturing site in the United States, which is being built in partnership with the U. S. Department of Health and Human Services."

The company added that it would continue to pursue registration of the new vaccine in other major countries, including Japan and Switzerland.

The World Health Organization has said that vaccination is one of the best means for countries to protect their population against the A/H1N1 pandemic, which has so far killed over 5,700 people worldwide. More than 20 countries have started A/H1N1 flu vaccination campaigns with vaccines made using egg-based methods.

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