| JWissmille 2004-10-24, 2:08 am |
| ".......... U.S. health regulators say they found quality-control problems at
a flu vaccine factory in Liverpool, England, in June 2003 but did not begin a
full inspection of the plant again until Sunday, five days after British
authorities yanked the company's license because of tainted vaccine........"
October 11, 2004
FDA red-flagged flu vaccine factory
By Anita Manning, USA TODAY
U.S. health regulators say they found quality-control problems at a flu
vaccine factory in Liverpool, England, in June 2003 but did not begin a full
inspection of the plant again until Sunday, five days after British authorities
yanked the company's license because of tainted vaccine.
The British regulatory decision cut the U.S. vaccine supply in half.
Food and Drug Administration officials Sunday defended their oversight of the
plant, saying that inspections of vaccine plants are normally done every two
years, and U.S. officials were not notified until Aug. 25 by vaccine maker
Chiron Corp. of more serious problems of bacterial contamination in 6 million
to
8 million doses of flu vaccine.
FDA official Karen Midthun said that in June 2003, inspectors found some
batches of flu vaccine that had contained bacteria and had been reprocessed.
The
license did not allow reprocessing, she said. The company told the FDA that it
was fixing the problem, Midthun said.
But in August, Chiron notified FDA it had found bacteria in another batch of
vaccine, she said.
Congressional representatives, in a hearing Friday, wanted to know how the
FDA was so blindsided.
"The British government immediately announced that it had already purchased a
backup supply of vaccine," after notification in August of problems, said
U.S. Rep. Henry Waxman, D-Calif.. But in the USA, "public health officials
appear
to have been taken completely by surprise."
Midthun said Chiron had assured the FDA that only a few lots of vaccine were
involved and that further testing of the doses for contamination were negative.
As recently as Sept. 28, Chiron officials said they would distribute 46
million to 48 million doses in early October.
But on Oct. 6, the British government suspended Chiron's license, citing
"breaches of good manufacturing practice leading to possible product
contamination."
Contributing: Noelle Knox in Liverpool, England.
Find this article at:
http://www.usatoday.com/news/health...u-vaccine_x.htm
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