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FDA approves first egg-free flu vaccine Flublok

Insect virus production method means more vaccine can be produced at a faster rate

Adult in the US will soon have access to Flublok, the first influenza vaccine approved by the Food and Drug Administration that requires neither eggs nor the influenza virus in its production.

Instead, the vaccine, which was developed by Protein Sciences in partnership with the US Department of Health and Human Services, is produced using  an insect virus (baculovirus).

This baculovirus is re-engineered by scientists so that it programmes the infected insect cells to generate large quantities of desired recombinant protein, such as hemagglutinin ­ the active ingredient in all inactivated influenza vaccines.

According to the FDA, this allows for production of “large quantities” of the protein, potentially meaning more vaccines will be able to be produced at a faster rate than they are now.

“This approval represents a technological advance in the manufacturing of an influenza vaccine,” said Dr Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research.

“The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus.”

The approval, which covers adults aged 18-49, comes after a study involving 2,300 people demonstrated the vaccine was 44.6 per cent effective against all circulating influenza strains, not just the strains that matched the strains included in the vaccine.

Protein Sciences is also developing Panblok in partnership with the US Department of Health and Human Services to protect against pandemic influenza.

It is made using the same insect virus process and is currently in phase II trials through a partnership with UMN Pharma.

18th January 2013

From: Sales

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