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MHRA to Reinspect Chiron Flu Vaccine Plant
On 12 January, Howard Pien, CEO of Chiron (Emeryville, CA, www.chiron.com) told JPMorgan Healthcare Conference attendees that he expects the UK Medicinesand Healthcare products Regulatory Agency (MHRA), accompanied by USFood and Drug Administration inspectors as observers, to conducta new a series of inspections of Chiron's Evans Vaccines plant (Speke,Liverpool, UK). The inspections will presumably review the shortcomingsin the plant's trivalent influenza vaccine manufacturing process thatprompted MHRA to yank approval for the vaccine last October.
Although the inspections and remediation effort "may advance towardtherestoration of the facility's license, as successive phases ofmanufacturing pass inspection by the MHRA," (in the words of a statementChiron issued the day of the conference), according to the WallStreet Journal, "Pien said there is 'no basis yet to predictwhether orwhen' the company will be able to resume production of flu vaccines forthe US market."
Chiron has not responded to questions this week asking whetherinspections actually have been scheduled.