Health Canada signs off on GSK's plans to improve its flu vaccine plant
GlaxoSmithKline ($GSK) has submitted its plans to whip its troubled Quebec flu vaccine plant into shape to Health Canada, and the regulator says the action outline is up to snuff.
"The timelines proposed have been deemed acceptable by Health Canada," the department told The Canadian Press Monday.
The department also said it would keep an eye on GSK's progress in implementing the fixes, conducting regular testing on lots of vaccine prior to their release onto the market in its home country. Glaxo is contracted to produce 53% of the seasonal flu vaccines for Canada this year.
While Health Canada has not gone into detail on the nature of the problems at the Ste. Foy-based facility, it has said that during an earlier inspection, it ID'd 7 observations it classified as major. The British drugmaker also received an FDA warning letter earlier this year, which revealed that ongoing bacteria problems at the plant had already forced the company to chuck more than 20% of the lots it had produced there in 2014.
Glaxo is still working with the FDA to address that issue and the rest of the concerns noted in the warning letter, with the plant on tap to provide a good portion of the 28 million to 33 million doses of four-strain and three-strain seasonal flu shots the company will provide for the U.S. this season.
In particular, the pharma giant is counting on Quebec-produced Fluarix Quadrivalent to follow up with another big year after posting a 76% sales jump in last year's fourth quarter.
- here's the Canadian Press story
Fluviral, FluLaval Tetra production on hold at Glaxo's troubled Quebec plant
As Glaxo begins 2014-15 flu vaccine shipments, manufacturing questions linger
Canada gives GSK 30-day deadline for turnaround plans at FluLaval plant
FDA slaps Glaxo with warning letter for FluLaval plant
Quadrivalent flu vaccines drive surge in sales at AstraZeneca, GSK and Sanofi