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FLU SHOT AND INFLUENZA VACCINE SHORTAGE

flu shot influenza vaccine, FDA Drug Approval, Chiron On October 5, 2004, U.S. based vaccine manufacturer Chiron Corp. (the world's fifth largest vaccine maker) was informed by the U.K.’s Medicines and Healthcare Products Regulatory Agency ('MHRA') that its license to produce vaccine at its Liverpool facility was suspended for three months.

An estimated 46-50 million Chiron flu vaccines -- roughly one-half of the 100 million flu shots that federal health officials anticipated were necessary in the U.S. -- would not be available. The MHRA confirmed that Chiron would “not be able to release any batches of their influenza vaccine” produced at the company’s Liverpool production facility.

Why? Reports now appear to confirm that Chiron’s flu vaccine was contaminated by the Serratia bacterium, a highly infectious germ that can pose a potentially grave risk of infection if injected into the body.

Given that the U.S. Center for Disease Control and Prevention (‘CDC’) urged that vaccination priority be given to the elderly, infirm, people with chronic medical conditions, and young children -- many of whom are more prone to compromised immune systems -- the risk of infecting those already at greater risk for the flu was not a viable option.

The FDA relied upon the judgment of their U.K. colleagues regarding Chiron’s Fluvirin.® “[N]one of the influenza vaccine manufactured by the Chiron Corporation for the U.S. market is safe for use,” officials concluded

flu shot influenza vaccine, FDA Drug Approval, Chiron The announcement has sparked public alarm, and concern over America's ability to provide sufficient quantities of flu vaccine prior to the onslaught of what many health officials predict will be a deadly flu season.

What went wrong? How could the United States have relied upon Chiron, one of the only two injectable flu vaccine manufacturers licensed in the U.S., to deliver between 46 to 50 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 vaccine sales and production skyrocketed, with 2003 annual revenues totalling $1.75 billion?



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