The UK Medicines and Healthcare Products Regulatory Agency (MHRA) Wednesday reinstated Chiron's license to manufacture trivalent influenza vaccine (tradenamed Fluvirin) at its Evans Vaccines Plant (Speke, Liverpool, UK).
In an official statement, the agency said, "MHRA inspectors have concluded that satisfactory progress has been made in the manufacturing areas which had previously caused concern. Their findings were considered at the MHRA's Inspections Action Group (IAG) on 1st March 2005, and the IAG's recommendation to lift the suspension was accepted by the MHRA on the same day. The suspension has therefore been lifted with effect from 5pm on Wednesday 2nd March. The company has been informed, and is now free to recommence full manufacturing of the vaccine."
In its own statement, Chiron (Emeryville, CA) noted that, "The decision is conditioned on the understanding that Chiron's high level of commitment to the completion of its remediation plan and ongoing improvements will continue. Chiron will provide the MHRA with regular weekly updates to ensure that progress on its various projects proceeds satisfactorily, and the MHRA may conduct further inspections. Chiron now has clearance to initiate full production of FLUVIRIN vaccine."
The statment also quoted Chiron CEO Howard Pien as saying, "We are grateful for the guidance and effort from the regulatory agencies as we have navigated a path toward remediation. Our employees have worked tirelessly and we are extremely proud of this result. This is a significant accomplishment. In this new beginning we remain focused on continuing to remediate and improve so Chiron can successfully deliver on the results required to supply influenza vaccine for the 2005-2006 season."
The US Food and Drug Administration's Center for Biologics Evaluation and Research responded with a statement of its own. CBER director Jesse Goodman said Wednesday that, "FDA considers MHRA's action today an extremely important milestone in Chiron's efforts to supply influenza vaccine for the U.S. market for the coming flu season, but work remains. FDA and MHRA will continue to closely monitor Chirons progress as manufacturing proceeds. When all critical stages of manufacturing are in full swing, and needed corrective actions can be fully evaluated, FDA plans to conduct a comprehensive inspection of Chiron's Liverpool facility to assure that Chiron can produce a safe and effective vaccine."
Chiron had scheduled an investor conference call for 8:30 a.m. Pacific Standard Time today, to be followed by a press conference call and Webcast at 9:30 a.m. PST. Video of both events will be available live and through March 10 at www.chiron.com/webcast/.