The approval of the action plan and the timelines proposed in it by Health Canada come as inspections at the Ste-Foy, Quebec plant, which is Canada’s only flu vaccine production plant, by the US FDA earlier this summer uncovered endotoxin contamination issues.
The site manufactures five different types of seasonal flu vaccine for the global market, and three of which have been approved in Canada.
“GSK’s proposed approach and the timelines proposed have been deemed acceptable by Health Canada,” Health Canada spokesman Eric Morrissette told us. “We will monitor the progress of the implementation of the corrective action plan and conduct regular testing on lots of vaccine prior to their release onto the Canadian market.”
Health Canada will also “continue to work closely with GSK to assure that the vaccines manufactured at this site are safe and of good quality,” he said.
The announcement comes as GSK spokesman Rob Perry told us that GSK began shipping flu vaccines in mid-July, which was about three weeks earlier than in 2013.
US Warning Letter
A warning letter from early June from the FDA said “endotoxic excursions” caused the UK drugmaker to discard 20 lots of vaccine made at the plant in 2014.
Endotoxins are proteins found in the cell walls of gram negative pathogens that can cause allergic reactions or other health issues.
Inspections conducted by Health Canada also identified problems similar to what the FDA uncovered, according to an inspection summary report posted by the regulator.
But Health Canada said its inspectors “were satisfied” with GSK’s responses to the US FDA, “with the exception of those related to a new manufacturing process, for which Health Canada has imposed a term and condition on ID Biomedical's establishment license so that Health Canada can assess whether the company has been able to put acceptable levels of controls in place.”
Health Canada also said it will continue to exchange information and results with the US FDA on the GMP practices at the Quebec site.
Discarded Vaccines
Perry said that GSK has "been working closely with the FDA to address its concern related to our Ste-Foy manufacturing facility, and batches of flu vaccine that did not meet quality standards were discarded early in the manufacturing process."
He also told us that between now and October the company will ship approximately 30m doses of flu vaccine to customers in the US, which is about 4m more than last year.
GSK had until Aug. 4 to respond to the Health Canada inspection report and responded on July 31, according to the Canadian Press. GSK bought the site from ID Biomedical in 2005, and now has contracts to produce 53% of Canada's seasonal flu vaccine, as well as between 28m and 33m doses for the US market.