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Chiron Cuts Supply of Flu Vaccines Made in Germany; Liverpool Plant Under Inspection
Chiron Corporation (Emeryville, CA) announced yesterday that quality problems at its Marlburg, Germany manufacturing plant will prevent the company from supplying its “Begrivac” influenza virus vaccine to non-US markets for the 2005–2006 flu season. The announcement came while a US Food and Drug Administration (Rockville, MD) reauthorization inspection was still underway at the company’s Evans Vaccines plant (Speke, Liverpool, UK). This plant manufactures the “Fluviron” influenza vaccine that was pulled from the shelf last year because of CGMP-related issues.
Chiron expected to supply 12 million doses of the Begrivac vaccine to primarily German and UK markets. The company had previously announced that it had uncovered a small number of Begrivac vaccine lots that did not meet product sterility specifications. In this announcement, Chiron predicted that the time required to conduct any further testing or finding any additional manufacturing or regulatory problems as a result of the investigation could force the company to stop its supply of the vaccine.
Chiron is still expecting to produce 18–26 million doses of the Fluviron vaccine (a vast majority of which are bound for the United States) for the 2005–2006 flu season, pending the FDA on-site inspection of its Liverpool facility. Once inspections are completed, Chiron expects to respond to any observations noted by FDA. The company must also receive supplemental approvals for changes to the product and its manufacturing process from the UK Medicines and Healthcare Products Regulatory Agency and from FDA, respectively.