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While it sounds like something out of a science-fiction novel, researchers have spent years working on a new way to manufacture influenza vaccines by inserting genetically engineered pieces of the influenza virus into caterpillar cells.
The promise of this cell-based manufacturing technique is that it can produce vaccine in 1/3rd the time of the traditional egg-based technology; in as little as 2 months.
That would be a huge advantage during any novel virus outbreak, and would allow the decision on which flu strains to use in the seasonal vaccine to wait until a bit closer to the next flu season.
FluBlok, developed by Protein Sciences Corp, went before an FDA advisory panel today, and hit a bit of a brick wall when 6 of the 11 committee members cited a lack of safety data and voted against the cell-based vaccine.
The FDA isn’t bound by the advisory panel’s decision, but generally follows their advice. This doesn’t mean that FluBlok is out of the running as an alternative manufacturing technique, but it does mean that the company needs to provide more data ensuring the safety of the vaccine.
Maggie Fox of Reuters brings us more details.
FDA panel votes against new bug-based flu vaccine
Thu Nov 19, 2009 3:37pm EST
By Maggie Fox, Health and Science Editor
BETHESDA, Maryland (Reuters) - More safety data would be needed before a new type of influenza vaccine made in insect cells should get approval, federal advisers said on Thursday.
A divided committee advising the U.S. Food and Drug Administration said the new Protein Sciences Corp FluBlok vaccine appears effective among adults under age 50 but said the company has not shown that it is safe enough to be approved.
The vaccine is made using genetically engineered pieces of flu virus inserted into caterpillar cells, instead of the current method using whole virus grown in chicken eggs.
