Dec 8 2004
The Chiron Corporation, a vaccine manufacturer, were told today that the suspension of their licence for manufacturing influenza vaccine at the Speke factory in Liverpool, would continue for a further three months.
This action, taken by the Medicines and Healthcare products Regulatory Agency, (MHRA) follows on from an earlier immediate suspension of Chiron's manufacturers licence enforced on 5th October.
This new suspension does not result from any newly identified safety issues or findings at the Liverpool plant. It is routine regulatory action to give Chiron more time to carry out the extensive and detailed remedial plan which is now being put in place.
The MHRA and the US Food and Drug Administration (FDA) are in close liaison over these issues, and FDA investigators will accompany the MHRA inspectors to the site in the near future to look at the progress of Chiron's remediation plan.
The suspension can be lifted at any time if Chiron is able to satisfy the MHRA that it has rectified the site's problems.
This does not affect UK supplies of flu vaccine. We have already sourced all the extra vaccine we need for this year's flu programme.