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FDA Confirms Chiron Flu Vaccine Not Usable, Says
Search for More Vaccine Continues
Oct. 16, 2004 - Just to make it official - the U.S.
Food and Drug Administration issued a statement late yesterday
confirming the earlier decision by British inspectors that the Chiron
influenza vaccine is not save for use. But, the FDA did say the search
for more vaccine is continuing.
"Literally every known manufacturer of flu vaccine
in the world is being contacted and some progress is being made.
Additionally the quarantined lots of Chiron vaccine already in the
United States are being ever further evaluated. We do not want to create
false hope but we want to explore every option." they said in a prepared
statement.
British authorities suspended the license of Chiron
Corp., supplier of half the U.S. flu vaccine, for three months on
October 5, because
of problems at its manufacturing plant in Liverpool, England. The
shutdown prohibited the company from supplying any flu vaccine for
three months. By then the peak of the flu season will have passed.
FDA inspectors this week went to Liverpool to
review the Chiron data that was used to shut the plant.
Following is the statement issued yesterday by the
FDA.
FDA Statement
"Today, we are announcing that none of the
influenza vaccine manufactured by the Chiron Corporation for the US
market is safe for use. This determination is based on FDA's evaluation
and inspection of Chiron's influenza vaccine manufacturing plant in
Liverpool, England, which concluded this afternoon.
"The purpose of the FDA inspection was both to
evaluate Chiron's investigation, testing and assessment of the defects
detected in nine of the one hundred lots of their finished flu vaccine (Fluvirin)
manufactured for this year's flu season and also to evaluate their
determination that the risk of defects was confined to those specific
lots.
"The safety of the vaccine supply is of the highest
priority to FDA and the Department of Health and Human Services. FDA has
today provided Chiron with our inspectional observations and has met
with the company to evaluate their response and assure that the
necessary corrective actions are taken. We will work with Chiron and the
UK government in correcting the deficiencies in the plant.
"The Department of Health and Human Services will
continue to exhaust every avenue to secure more flu vaccine for this
season. Literally every known manufacturer of flu vaccine in the world
is being contacted and some progress is being made. Additionally the
quarantined lots of Chiron vaccine already in the United States are
being ever further evaluated. We do not want to create false hope but we
want to explore every option."
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