Pathfinder
Editor, Senior Moderator
Novel Flu Shot Made From Caterpillars Not Proven Safe (Update1)
By Tom Randall
Nov. 19 (Bloomberg) --
Protein Sciences Corp. failed to prove its experimental flu vaccine, FluBlok, is safe enough to be approved, and further study is needed, a U.S. advisory panel said.
The shot 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 said the studies weren?t large enough to ensure safety for mass production. There were several examples of face swelling and one person was hospitalized for a rare condition, and the vaccine couldn?t be ruled out as the cause.
Closely held Protein Sciences, based in Meriden, Connecticut, 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.?
http://www.bloomberg.com/apps/news?pid=20601124&sid=ahgs1cipLGGY
By Tom Randall
Nov. 19 (Bloomberg) --
Protein Sciences Corp. failed to prove its experimental flu vaccine, FluBlok, is safe enough to be approved, and further study is needed, a U.S. advisory panel said.
The shot 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 said the studies weren?t large enough to ensure safety for mass production. There were several examples of face swelling and one person was hospitalized for a rare condition, and the vaccine couldn?t be ruled out as the cause.
Closely held Protein Sciences, based in Meriden, Connecticut, 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.?
http://www.bloomberg.com/apps/news?pid=20601124&sid=ahgs1cipLGGY