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Novartis gets US approval for Flucelvax flu jab made in cells

First vaccine approved that does not rely on use of fertilised chicken eggs for production

Novartis Flucelvax

Novartis has become the first vaccine manufacturer to win approval in the US for a seasonal flu vaccine that does not rely on the use of fertilised chicken eggs for its production.

Flucelvax is made using mammalian cell culture technology and has been approved by the FDA to prevent seasonal influenza in people aged 18 or over.

Approval of the new vaccine is the first major pay-off for Novartis' considerable investment in cellular manufacture, which is designed to make it quicker and easier to manufacture flu vaccines and accelerate the start-up of production in the event of a pandemic.

Production takes place in a closed, sterile environment, which significantly reduces the risk of impurities ending up in the vaccine, said Novartis. It added that, unlike conventional flu vaccines, Flucelvax does not contain preservative such as thimerosal.

The new vaccine is currently made at Novartis' cell-based manufacturing plant in Marburg, Germany, but will eventually transfer to a new facility in Holly Springs, North Carolina, that started initial production runs last year.

The Holly Springs site – a $1bn project set up with nearly $500m in US federal support – is the first facility of its kind in the US and will supply vaccines against both seasonal and pandemic strains of the flu virus.

"Flucelvax will be produced in Holly Springs once the facility is ready for full-scale commercial production," said Novartis in a statement.

The FDA noted that cell culture has already been in use for several decades to produce other licensed vaccines, and Flucelvax's approval is a key development in efforts to switch over the US flu vaccine supply to the new technology.

The agency issued guidance in 2010 designed to encourage the adoption of cell-based vaccine production in the wake of fears of an H1N1 pandemic influenza outbreak.

Experience gained from that scare made it clear that traditional production methods in chicken eggs were unlikely to meet expected demand for vaccination in the event of a serious pandemic.

Flucelvax comes at a time when Novartis has been accused of falling behind in the seasonal flu vaccines market, with competitors such as GlaxoSmithKline and AstraZeneca/Medimmune coming to market with new quadrivalent (four-strain) vaccines rather than the traditional trivalent (three-strain) varieties.

Novartis is reported to still be a couple of years away from launching a four-strain flu vaccine.

21st November 2012

From: Sales

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