Production at Chiron’s facility in Liverpool, UK had been halted in October 2004 after regulators raised contamination concerns about the plant’s manufacturing process. The vaccine maker may now proceed with its efforts to return Fluvirin to the US market for the 2005-2006 influenza season.
Chiron is currently the subject of a $4.5 billion takeover bid being launched by its partner Novartis. It is possible that the timing of this move may have been influenced by this positive report on the Liverpool plant.
Although the results of the FDA inspection into the factory is an important milestone, there are still a number of regulatory hurdles that Chiron must clear before Fluvirin is allowed to be re-launched into the US market.
Chiron must receive supplemental approvals from the FDA in response to filings of these facilities, equipment and process changes before the company can supply Fluvirin vaccine in the US.
In addition, Chiron’s ability to deliver Fluvirin vaccine to the US market will depend upon successful production and final testing of the vaccine, as well as release of the vaccine by the FDA. Chiron also expects that the UK Medicines and Healthcare products Regulatory Agency (MHRA) will again inspect Chiron’s Liverpool facility before the company commences shipment of the vaccine.
“The Fluvirin remediation plan called for unprecedented communication and cooperation between the FDA and the MHRA. Chiron has now achieved a key milestone in this remediation effort,” said Howard Pien, CEO of Chiron. “We remain focused on our objective of delivering Fluvirin vaccine to the US market in support of public health efforts to prepare for the upcoming influenza season.”