Bacterial contamination issues at GSK Canadian flu vaccine plant identified
Canada’s only flu vaccine production plant, owned by GSK, has received word from a Health Canada inspection that 10 issues need to be addressed to meet required standards, according to a Canadian Press article today. GSK has until Aug 4 to submit a plan to fix the problems.
Health Canada posted a summary of its inspection findings late yesterday. Some major findings related to two new vaccines being made at the plant that are licensed in Canada but not yet sold there. The regulatory agency said GSK has to give 90 days’ notice before resuming production of the vaccines to allow further inspections and action as necessary.
None of the issues raised pose a critical risk to public health, but 7 of the 10 fall into the major observation category, says the story.
The plant has contracts to produce 53% of Canada’s seasonal flu vaccine for next season and “also holds a 10-year contract to produce pandemic for vaccine for Canada when needed,” the story notes.
It is also scheduled to provide 23 million flu vaccine doses for the United States for 2014-15. The US Food and Drug Administration (FDA) issued a warning letter to the plant Jun 21 saying that 21% of the upcoming season’s product had unacceptable bacterial counts and could not be used.
Health Canada inspects the plant, which is in Ste. Foy, Quebec, every 2 years. The plant is reportedly cooperating with both Health Canada and the FDA on resolving the issues, the story said.