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From: TSS (216-119-132-20.ipset12.wt.net)
Subject: Re: VACCINE CONTAMINATION AT LIVERPOOL PLANT ONCE HOME OF THE MAD COW POLIO VACCINE BLUNDER
Date: October 13, 2004 at 12:43 pm PST

In Reply to: VACCINE CONTAMINATION AT LIVERPOOL PLANT ONCE HOME OF THE MAD COW POLIO VACCINE BLUNDER posted by TSS on October 8, 2004 at 12:15 pm:

FOR IMMEDIATE RELEASE Media Inquiries: 301-827-6242
P04-96 Consumer Inquiries: 888-INFO-FDA
October 13, 2004


FDA and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)
Working Cooperatively to Address Flu Vaccine Quality at Chiron's U.K.
Facility

Today, the U.S. Food and Drug Administration (FDA) and the U.K. Medicines
and Healthcare Products Regulatory Agency (MHRA) announced their intent to
continue in a cooperative effort to address the manufacturing quality
concerns related to the production of Chiron's influenza vaccine, Fluvirin,
at the company's Liverpool facility.
Regarding the ongoing joint effort, FDA Acting Commissioner Lester M.
Crawford said, "The decision to work cooperatively to evaluate the scope of
contamination and evidence presented in Chiron's investigation report is a
significant positive step to understand fully what is at issue with
influenza vaccines from Chiron's 2004 production. In addition, this
effort will help to successfully address any significant issues before
production for 2005 begins."
MHRA officials have been accompanying the FDA inspectors as observers in
FDA's ongoing facility inspection of Chiron's plant. The inspection follows
MHRA's September 28-30 inspection of the facility and subsequent
announcement on October 5 to suspend Chiron's license.
MHRA Chief Executive Officer, Prof. Kent Woods, added "Contrary to some
reported statements, MHRA, as the responsible regulatory authority in the
United Kingdom, made the decision to suspend Chiron's license after an
internal meeting on October 4 and first informed the company and the FDA of
this decision on October 5. At the same time, we informed other drug
regulatory authorities via an intergovernmental rapid information alert."
Chiron officials confirmed that they were first informed of the license
suspension on October 5. A primary objective of the ongoing FDA
investigation that commenced on October 10 is to evaluate Chiron's own
internal investigation and findings concerning the contamination of some
lots and its manufacturing quality systems related to assuring sterility of
final vaccine product.

####

TSS



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