Chiron manufacturing ban extended

pharmafile | December 10, 2004 | News story | |   

Chiron is facing a further three-month ban on vaccine production at its Liverpool factory, after problems were first detected by inspectors in October.

The company's licence to produce vaccines at the site has been suspended since the MHRA inspectors raised doubts about sterility standards in manufacturing at the site, preventing it from distributing 50 million doses of Fluvirin for the 2004/5 flu season, mostly destined for the US.

The ban triggered a chronic shortage of vaccine in the US but has not affected UK, which was able to draw on other supplies.

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A spokesman for the MHRA said: "It is routine regulatory action to give Chiron more time to carry out the extension and detailed remedial plan which is now being put in place."

The extension is nevertheless a further blow to Chiron who need to restart production in the spring to be able to supply vaccine for the 2005 flu season.

The MHRA are working in close consultation with US regulators the FDA over the issue, with inspectors from both regulators to visit the site again shortly.

Chiron is likely to face stiff competition in the US influenza market next year as GlaxoSmtihKline has announced that it would supply four million Fluarix doses to the market this season, and at least 10 to 20 million doses the following year.

The US government has battled to make up the shortfall in supplies of the flu vaccine, asking Aventis Pasteur MSD to produce more of its Fluzone jab and using antiviral medicines rimantadine and Roche's Tamiflu.

 

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