Monday, October 20th13.6°C
23836
23671

Health Canada OKs GSK's plan to fix Quebec flu vaccine plant problems

TORONTO - Health Canada says it has approved a plan by GlaxoSmithKline to fix contamination problems it has been experiencing at its Ste. Foy, Que., flu vaccine production plant.

The department says GSK's action plan and the timelines proposed in it are satisfactory.

Inspections conducted this spring by the U.S. Food and Drug Administration and Health Canada identified problems at the facility largely related to bacterial contamination linked to the plant's water purification system.

While the precise nature of the problems has not been make public, the FDA issued GSK a warning letter, the last step before possible suspension of a licence to supply to the U.S. market.

And Health Canada's inspection report identified seven so-called major observations, things classified as signs that production is not consistently hitting required standards.

The company was given a month to respond to the Health Canada report and did so on July 31.

"We have completed the evaluation of GSK's action plan of its Ste. Foy facility, ID Biomedical. GSK's proposed approach and the timelines proposed have been deemed acceptable by Health Canada," the department said Monday via email.

"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."

GSK declined to comment about its remediation plan, saying it would be inappropriate to speak publicly about an ongoing process.

The FDA warning letter noted GSK has repeatedly been forced to discard batches of vaccine made at the facility because of bacterial counts that registered above specified limits. The letter, dated June 12, said 21 per cent of this year's product could not be released to the market.

The plant, which GSK bought from ID Biomedical in late 2005, has contracts to produce 53 per cent of Canada's seasonal flu vaccine for the coming season as well as 23 million doses for the U.S. market. It is the only flu vaccine production facility located in Canada and holds the country's long-term pandemic flu vaccine contract.

The FDA has already released for distribution two lots of vaccine from the Ste. Foy plant, GSK says. Flu vaccination programs typically begin in the United States in September, several weeks before the late October or early November launch in most Canadian provinces and territories.

GSK has said in the past that fixing its production problems would not affect its ability to deliver flu vaccine for the Canadian market this fall.

Follow @Helen Branswell on Twitter.

The Canadian Press


Read more Business News

23708


Recent Trending




Today's Market
S&P TSX14337.77+110.09
S&P CDNX811.351.22
DJIA16399.6719.26
Nasdaq4316.075+57.637
S&P 5001904.01+17.25
CDN Dollar0.88580.00
Gold1247.20+2.50
Oil81.27-0.35
Lumber330.70-0.20
Natural Gas3.665-0.101

 
Okanagan Companies
Pacific Safety0.10-0.01
Knighthawk0.01-0.005
QHR Technologies Inc1.12+0.01
Cantex0.055-0.025
Anavex Life Sciences0.191+0.001
Metalex Ventures0.050.00
Russel Metals32.28-0.07
Copper Mountain Mining1.99+0.05
Colorado Resources0.15+0.005
ReliaBrand Inc0.0111-0.0019
Sunrise Resources Ltd0.060.00
Mission Ready Services0.450.00

 



23041

FEATURED Property
20586872093 Horizon Drive
4 bedrooms 3 baths
$599,000
more details
image2image2image2
Click here to feature your property
Please wait... loading


Keep it rubber side down

This time of year, I always worry about which friends of mine will get caught going off the road in adverse weather conditions. With a little preparation most accidents can be avoided. Having won the...


Big bank predicts rate hike

Photo: Thinkstock.comThe end of record-low rates is nigh, according to one major bank, which has taken a stance and predicted when the Bank of Canada will raise its long-standing overnight rate. &ldq...


Experts share strategies in Kelowna

The third week in October is “Small Business Week”, a week dedicated to supporting local, small businesses. The week was designed to bring awareness to Canadians about the role small busin...

_



23545




Member of BC Press Council


22962