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Congress probing vaccine shortage

FDA's actions under scrutiny

WASHINGTON -- Congress yesterday began investigating whether the US Food and Drug Administration overlooked problems at a British plant that led to the withdrawal of half the US flu vaccine supply.

And the Securities and Exchange Commission joined federal prosecutors in looking at whether US-based Chiron Corp. tried to cover up problems at its vaccine plant in Liverpool, England.

Earlier this month, Britain's Medicines and Healthcare Products Regulatory Agency suspended Chiron's license to ship influenza vaccine from Liverpool, saying it had found bacterial contamination.

The House Government Reform Committee and the Senate Health, Education, Labor and Pensions Committee each sent a letter to the FDA, asking what the agency knew about the decision on Chiron, and when.

The British decision may mean the destruction of 48 million doses of vaccine, out of 100 million destined for the US market from Chiron and Aventis-Pasteur. Another 2 million doses will be available from MedImmune, which makes a nasal vaccine called FluMist.

The FDA has said it was caught by surprise by the British decision.

The FDA and MHRA made a joint declaration yesterday, denying reports officials knew about the extent of the problem earlier.

The congressional committees said they would ask the FDA about reports that the Centers for Disease Control and Prevention and FDA officials knew as early as Sept. 13 that the MHRA might refuse to license the vaccine.

A federal grand jury is investigating whether Chiron broke any securities laws.

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