Flu Bug – New Vaccine Comes from Insect Cells
November 20, 2009
Reuters
By Maggie Fox
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 of growing virus in chicken eggs. The company says it could produce a vaccine much more quickly — in two months, versus five to six months for vaccines made using eggs.
“This is a promising technology, and I think we need it,” said Dr. Bruce Gellin, head of the Health and Human Services Department’s National Vaccine Program Office and a member of the panel. He said companies making such new vaccines would be paying close attention to the panelists’ comments.
The U.S. government is struggling to vaccinate the population against H1N1, which the U.S. Centers for Disease Control and Prevention estimates has infected 22 million Americans and killed 3,900 since April.
Fewer than 50 million doses of H1N1 vaccine are now available.
Some panel members were concerned about some side-effects seen in a few of the 3,200 people who volunteered to test it, such as a woman who had Bell’s palsy, a temporary paralysis of the face, that flared up an hour after she was vaccinated.
They also worried that several people who volunteered to test the vaccine had been “lost to follow-up”, meaning the researchers had been unable to find out how they fared after being vaccinated.
“I don’t feel the safety database is large enough,” said Pamela McInnes of the National Institutes of Health. She said the vaccine is a new formulation and so the burden of proof is higher than simply changing the influenza strain from one season to another.
“I feel the safety data do not raise significant red flags,” disagreed Dr. Jack Stapleton of the University of Iowa.
“What we are dealing with, rock bottom, is a pretty mediocre vaccine,’ said Dr. Theodore Eickhoff, a professor emeritus at the University of Colorado School of Medicine and a panel member.
The vaccine is made using cells from a caterpillar and would be the first influenza vaccine made using cell cultures approved in the United States.
The FDA usually follows the recommendations of its advisory committees.
The Vaccines and Related Biological Products Advisory Committee said the data show the vaccine works well enough in adults aged up to 50, but six of 11 members said studies do not show the vaccine works safely.
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Bug Spray Cause of Death in Infant
November 3, 2009
Associated Press
WILLIAMSTON, S.C. — Authorities say bug spray that produces a fog to kill insects may be to blame for the death of a 10-month-old South Carolina boy and his critically injured 2-year-old brother.
Anderson County Deputy Coroner Don McCown said the boys’ mother had been using foggers because of an insect problem. Elizabeth Whitfield called 911 on Sunday to report her youngest boy was having trouble breathing. Paramedics took all three to a hospital, where Jacob Whitfield died.
Kenneth Whitfield remained in critical condition, and Elizabeth Whitfield returned to the ER with breathing problems.
McCown says investigators found seven fogger containers in the single-wide mobile home. He says a single fogger is typically used to treat 6,000 cubic feet.
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