Bush wants more information about governor’s vaccine plan

The acting commissioner of the U.S. Food and Drug Administration said his agency will not approve Gov. Rod Blagojevich’s plan to buy the flu vaccine from Europe until it has more information about the source of the supplies.

In a letter sent Wednesday to Blagojevich, Lester Crawford also said regulators want to know more about the vaccine’s distribution and whether the state would provide liability protection for consumers.

“Your answers to these questions will help expedite resolving important safety questions regarding distribution of the vaccine you have obtained from foreign sources,” Crawford wrote.

Administration officials can easily address Crawford’s questions, Blagojevich spokeswoman Abby Ottenhoff said.

“It sounds like the FDA is eager to be helpful in finding vaccine for Illinois residents and the best way they can do that is to expedite this process.”

Blagojevich said his administration has a tentative deal with the British wholesaler Ecosse to buy about 262,000 doses of an Aventis vaccine made in France for use in Canada and Europe.

The governor sent a letter to the FDA on Monday asking for permission to import the doses and distribute them to Illinois nursing homes patients and hospitalized children.

The vaccine has not been clinically tested on U.S. flu patients, though Blagojevich has said a review of the literature showed its properties are identical to those of the vaccine used in the United States.

Federal officials, however, warn that the vaccine might not be safe or effective because it is made differently from the U.S. flu medication.

The vaccine shortage developed earlier this month when regulators closed a Chiron Corp. plant in Liverpool, England, because of bacterial contamination, cutting the expected U.S. supply by 48 million doses, almost half. Aventis Pasteur, the country’s other major supplier, cannot make up for the shortage because the vaccine can’t be mass produced quickly.

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Provided by ArmMed Media
Revision date: July 8, 2011
Last revised: by Andrew G. Epstein, M.D.