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FDA: Plenty Of Flu Vaccine

October 18, 2005
As the 2005-2206 flu season gets underway, federal health officials are seeking to reassure consumers that, unlike last season, there will be plenty of flu vaccine for all who want it.

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The Food and Drug Administration says it doesn’t know how many doses will be distributed, but that it will be more than last year, when production problems at a pharmaceutical plant reduced the U.S. vaccine supply by half.

"A tremendous amount of work has brought us to the point that will allow Chiron to distribute influenza vaccine for this flu season," said Dr. Jesse Goodman, Director of FDA's Center for Biologics Evaluation and Research.

"However, as with all influenza vaccine manufacturers, Chiron's influenza vaccine must undergo safety testing and lot release evaluation before it can be released to the market."

FDA said it is committed to working with all of the influenza vaccine manufacturers to expedite product lot release and availability of vaccine. While occasional spot shortages may occur as manufacturers complete their final testing, officials say they expect these shortages to resolve as vaccine continues to be released to health care providers and others who administer the vaccine.

There are four manufacturers distributing influenza vaccine this year: Sanofi Pasteur, Inc., MedImmune Vaccines, Inc., GlaxoSmithKline Biologicals, and Chiron.

FDA said it has been actively working with them to ensure an adequate, safe, and effective supply of vaccine. As part of this overall effort, the agency said it has had close interactions with the Medicines and Healthcare Products Regulatory Agency, the U.K. regulatory authority and Chiron, as the company has worked to correct the problems that led to its license suspension by MHRA.

Influenza season may begin as early as October and run through May. The best time to get vaccinated is in October or November, but getting vaccinating in December or later, doctors say, still can be beneficial.

The yearly flu vaccination ritual is not related to the fears of a global bird flu pandemic.

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