Caterpillar-based flu shot not proven safe

Protein Sciences Corp. failed to prove its experimental flu vaccine is safe enough to be approved and more study is needed, a U.S. advisory panel said.
The shot, called FluBlok, is produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells. Members of the advisory panel to the U.S. Food and Drug Administration voted 6-to-5 that the company hadn’t proven the vaccine safe, saying clinical trials weren’t large enough to support mass production. Nine of the 11 panelists said the shot was as effective as licensed vaccines in adults ages 18 to 49.
Closely held Protein Sciences, based in Meriden, Conn., and backed by $147 million in U.S. contracts, is seeking to become the country’s first supplier to break from the 50-year-old technique of growing the vaccine in chicken eggs. The egg-based process has been blamed for delays in this year’s pandemic swine flu vaccine, and U.S. health officials have pledged to increase production times.
“The reason we’re struggling so much is the safety database isn’t very large,” said Pamela McInnes, director of the Division of Extramural Research at the National Institutes of Health and one of the panelists. “The company has clearly done some nice work, and there’s been a lot of progress made. There’s not a signal in my mind that I’m very worried, but we are missing information.” •