Chiron Vaccines
Background
Chiron Coproration is the fifth largest vaccine maker in the world. Based in Northern California, it is currently only
one of two companies licensed to provide injectable flu vaccine (a/k/a the flu shot ) in the United States.
Fluvirin®
Chiron makes Fluvirin®, a flu vaccine that was formerly produced by U.K. vaccine manufacturer PowderJect Pharmaceuticals until its acquisition by Chiron
in July 2003. The other is French vaccine manufacturer Aventis Pasteur, Inc., maker of
the FluZone® vaccine
According to the CDC, Fluvirin® is marketed as a formulation
with thimerosal as a preservative in multidose vials, and as a
formulation without thimerosal as a preservative in 0.5-mL
unit dose syringes.
In 2003 another vaccine manufacturer, Maryland-based MedImmune, received FDA approval to produce Live, Attenuated Influenza Vaccine ("LAIV")
marketed under the name FluMistTM.
Chiron Congressional Testimony
Testifying in February 2004 before the U.S. Senate Committee on Aging, Chiron Chairman Howard Pien assured Congress that:
Chiron Corporation’s $878 million acquisition of PowderJect Pharmaceuticals and its
influenza vaccine Fluvirin in July 2003 represents a major commitment to ensuring
that an adequate supply of vaccine is available to meet the needs of the United States.
(emphasis added)
But on October 5, 2004, Chiron Corp. was informed by the U.K. Medicines and Healthcare Products Regulatory
Agency that its license to produce vaccine at its Liverpool facility was suspended for three months. Chiron’s vaccine production facility was reported as being contaminated, according to U.K. standards.
Only a week later, the FDA took the dramatic step of announcing that Chiron’s Fluvirin® vaccine would not be available for the 2004 - 2005 flu season, since “none of the influenza vaccine manufactured by the Chiron Corporation for the U.S. market is safe for use”.
What went wrong? How could the United States have relied upon Chiron, one of only two flu vaccine manufacturers licensed by the FDA, to deliver roughly 46 to 48 million flu vaccine doses of the 100 million doses that health officials anticipated were needed for the 2004 - 2005 flu season?
How could this have happened to a company whose 2003 revenues totaled $1.75 billion?
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