After positive trial results in Europe, Chiron has initiated a US Phase I/II study of a new flu vaccine offering faster production in the event of an vaccine supply shortfall or an avian flu pandemic.
The cell culture-derived influenza vaccine represents the next generation of influenza vaccine, offering significant advantages over traditional manufacturing methods.
A pivotal European Phase III study of Chiron's vaccine in 2004 met the safety and immunogenicity endpoints of the study and the company has also now completed enrollment of a second European Phase III study.
"Chiron is supporting public health authorities globally by working to make this next-generation vaccine available, both for prevention of annual influenza and as an important platform for pandemic preparedness," said Dan Soland, president of Chiron vaccines.
According to the World Health Organisation (WHO), the next flu pandemic is likely to result in 1 to 2.3 million hospitalisations and 280,000 to 650,000 deaths in industrialised nations alone.
In an average year in the US, seasonal influenza causes more than 200,000 hospitalisations and kills approximately 36,000 people, primarily in the over-65 population.
Chiron's flu cell culture vaccine, produced using canine kidney cells, eliminates the dependence on chicken eggs and would enable a more cost-effective, flexible and faster start-up of vaccine production.
Other vaccine manufacturers are also developing flu vaccines using similar cell-line based production methods.
Recently, rival firm Sanofi Pasteur announced plans to enter clinical trials next year with their pandemic influenza vaccine made from human cell-culture using Crucell's novel PER.C6 technology.
This will be the first influenza vaccine developed using human cell production technology to enter clinical trials in Europe.
"Moving from egg-based to cell-based influenza vaccine production is an important step in enhancing our preparedness against pandemic influenza and provides flexibility in meeting surges in influenza vaccine demand," said Walter Orenstein, associate director of the Emory Vaccine Center in Atlanta, Georgia.
The positive trial results are good news in what has been a difficult year for Chiron.
The firm recently announced it will yet again fall short of targets for its US flu vaccine deliveries this year due to continuing production problems with its British manufacturing plant.
In July of this year, Chiron had already announced a significant shortfall in the volume of influenza vaccine it was be able to ship to markets outside the US.
Last year, Chiron's 48-million dose production of Fluvirin flu vaccine was deemed unacceptable for use by the US Food and Drug Administration (FDA).
As a result, the plant that manufactures Fluvirin in Liverpool, England, was abruptly shut down due to contamination problems and has only recently been restarted.
The sudden loss of Chiron's total vaccine production last year cut the US vaccine supply in half and created a frantic search for flu shots nationwide.
Influenza vaccination is the most effective way to prevent influenza and vaccines are currently produced using embryonated chicken eggs.
However, a more timely and economical production method for producing new vaccines in large quantities is required to combat both seasonal vaccine shortages, which are currently occurring, and a potential future flu pandemic.
Chiron, based in California, is one of four manufacturers distributing flu vaccine this year, alongside Sanofi Pasteur, MedImmune and GlaxoSmithKline.