Fluvirin influenza vaccine manufacturer’s licence suspended

The Medicines and Healthcare products Regulatory Agency (MHRA) suspended Chiron Vaccines manufacturer’s licence for influenza vaccine on October 5, 2004 for a period of three months with immediate effect. A result of this action is that the company will not be able to release any batches of their influenza vaccine (Fluvirin) manufactured at their Speke site to any market. The suspension was imposed as a result of Chiron’s failure to comply with the requirements of Good Manufacturing Practice, leading to concerns of possible microbial contamination of product.

The suspension does not affect any other product manufactured at Speke (including yellow fever vaccine). Influenza vaccines manufactured at Chiron’s sites in Italy and Germany (Agippal and Begrivac) are also not affected by this suspension.

No vaccine manufactured at Chiron’s site in Speke for the present campaign has been released.


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