Novartis completes first batch of influenza A(H1N1) vaccine

BASEL, Switzerland Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, the vaccine against the novel H1N1 influenza virus responsible for the current pandemic, weeks ahead of expectations, the vaccine manufacturer announced Friday.

The quick turnaround was made possible through cell-based manufacturing technology, which allows vaccine production to be initiated once a pandemic virus strain is identified without the need to adapt the virus strain to grow in eggs, as with traditional vaccine technologies. This advance has cut weeks off the time required to begin vaccine production, Novartis stated.

“The speed advantages of our cell-based production approach and our unwavering commitment to address this public health emergency have resulted in our ability to provide the fastest possible response to this outbreak,” stated Andrin Oswald, CEO of Novartis Vaccines and Diagnostics.

This first batch of 10 liters of wild type influenza A(H1N1) vaccine monobulk will be used for pre-clinical evaluation and testing and is also being considered for use in clinical trials. It demonstrates the value of the cell-based production approach, that is also being used by Novartis with reassortant influenza A(H1N1) seed.

Based on this success with the wild type, Novartis expects to be able to achieve rapid scale up of influenza A(H1N1) vaccine manufacture with reassortant seed, which was provided by the Centers for Disease Control and Prevention on May 27. The company plans to start clinical trials with that vaccine in July and expects licensure in the fall 2009.

More than 30 governments have made requests to Novartis to supply them with influenza A(H1N1) vaccine ingredients, including a $289 million order made by the U.S. Department of Health and Human Services.