Improperly Made Flu Vaccine Given to Millions of Americans
February 26, 2005
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:
First strayed from approved manufacturing methods (including everything from having proven procedures to strong quality control, testing and record-keeping)
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
Four out of five batches of tested vaccine made for the 2001-2002 flu season lost potency prematurely
In light of potency concerns, the plant's managers considered, though decided against, recalling the flu vaccine in 2002
Required quality-control tests before 2003 were simply overlooked and others weren't done on time
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