Americans reeled into a state of panic after hearing one of the
United States' only flu vaccine suppliers, Chiron, could provide
a mere half of the 100 million promised flu doses for the 2004 season.
Now, according to a 2003 report given to Congress, that same British
plant sent improperly made vaccine, by mistake, to U.S. consumers
just three years ago.
Moreover, whether that vaccine stayed
potent and sterile through its expiration date is in question--why?
Because the plant:
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First strayed from approved manufacturing methods (including
everything from having proven procedures to strong quality control,
testing and record-keeping)
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Then failed to document whether that would adversely affect
the vaccine's quality over time
Not only do these findings cast a negative light on the British
plant, but it also raises dubious eyebrows regarding the Food and
Drug Administration's (FDA) clear oversight of the plant and vaccine
industry. It wasn't until more than a year after millions of people
were given a dose of the "mishap vaccine" (for the 2001-2002
season) when the FDA discovered the mistake during a plant inspection
in mid-2003. Further, after a close examination, it appears many
unreported details about the plant's vaccine--most of which was
for the U.S. market--were revealed.
Skeletons in the Closet
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Four out of five batches of tested vaccine made for the 2001-2002
flu season lost potency prematurely
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In light of potency concerns, the plant's managers considered,
though decided against, recalling the flu vaccine in 2002
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Required quality-control tests before 2003 were simply overlooked
and others weren't done on time
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Prior to 2004, the plant sent the FDA test vaccine samples
labeled as one kind, though they were actually another
Another strike against the FDA: Despite the plant's obvious imperfections,
the FDA largely accepted the company's word that it would rectify
its shortcomings. It is suspected this lax on the FDA's part stems
from the fact Chiron is a crucial vaccine supplier, as it is one
of only two plants fully licensed to provide the United States with
doses. The FDA is working to approve additional flu vaccine suppliers.
Chiron is striving to upgrade the plant and hopes to supply the
United States with flu shots this fall.
USA
Today February 10, 2005
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