Perhaps the "bolt out of the blue" defense can earn the Bush administration a passing grade on 9/11, but the flu vaccine fiasco -- which is bound to result in the deaths of far more Americans than bin Laden ever killed -- cannot be passed off so easily. From today's Wall Street Journal (sub. only):
Federal regulators said an inspection of Chiron Corp.'s flu-vaccine plant in England last year turned up manufacturing problems similar to those that led British authorities to shut down the facility last week.Still no account as to why the British saw the writing on the wall and lined up half a dozen suppliers for their flu season, while US officials felt confident in relying on simply two -- one of them with a pretty troubling track record.
U.S. Food and Drug Administration officials documented what they called "deviations" from good manufacturing standards at Chiron's Liverpool plant in June 2003. John Taylor, the FDA's associate commissioner for regulatory affairs, said "systemic quality-control issues" led inspectors to conclude that Chiron wouldn't necessarily be able to discover problems, identify the root cause and take steps to prevent similar issues from arising again.
The FDA's disclosure suggests that there were early-warning signs about the problems that later led to the Liverpool facility's shutdown and the resulting shortage of influenza vaccine in the U.S. just as flu season is set to start. . . .
. . . in August of this year, Chiron reported that it found batches of vaccine contaminated with serratia, a common bacteria that, when injected, can cause bloodstream infections. The FDA asked for a complete investigation and began at least weekly conference calls with the company. Chiron reported that the contamination was limited to eight lots of flu vaccine, after tracing the contamination back to two pools of unfinished product, Mr. Taylor said. The company ultimately tested all the lots and re-tested those that didn't show contamination. Chiron "was still saying they'd be able to supply the U.S. market," Mr. Taylor said.
In a statement yesterday, the FDA said its vaccine branch never heard from Chiron that U.K. regulators were on the verge of blocking vaccine shipments. The FDA said "there had been no communication" between its vaccine regulators and their counterparts in England until after Chiron's license was suspended.