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VMD 'Has No Objection' To Merial Re-Starting FMD Vaccines

by 5m Editor
31 August 2007, at 12:14pm

UK - The Veterinary Medicines Directorate (VMD) has confirmed it has no objection to Merial re-starting manufacture of foot and mouth disease (FMD) vaccines from stored, inactivated antigens at our Pirbright Centre. These antigens are fully safety tested. Recommencement of finished vaccine production means that Merial are now able to serve our overseas customers on the same basis as we have already done for the UK.

Following the FMD outbreak in Surrey, Merial voluntarily suspended production on Saturday 4th August. Vaccine production was temporarily recommenced on 6th August in order to supply DEFRA’s order for 300,000 FMD vaccine doses. That batch was completed on Monday 8th August and since that time no further finished vaccine has been made.

There remains no production of FMD virus by Merial at Pirbright. Full production - involving FMD virus - will not recommence without full consultation with DEFRA and the VMD. Merial are constantly reviewing any such decision with DEFRA and the VMD.

Merial invited VMD to re-inspect the Centre during the week commencing 13th August and it is as a consequence of that rigorous inspection that Merial is now in a position to recommence vaccine production. VMD has the responsibility in the UK for inspecting Good Manufacturing Practice at veterinary facilities such as Merial’s. It thus assures that Merial conduct our operations to the required UK standards. Prior to this most recent VMD inspection, the Pirbright Centre was last issued with a full GMP certificate by the VMD in April 2007.

Merial have operated at Pirbright for 15 years and in all that time there has not been a breach of bio-security from our operations. After continuous examination of our systems we have found no evidence that the outbreak in Surrey can be traced to any failure in our bio-security procedures or equipment. We are eager to learn the findings of the investigations into the cause of the FMD outbreak and we continue to work with the investigators as required.

5m Editor