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| GlaxoSmithKline's Ste-Foy, Quebec facility--Courtesy of GlaxoSmithKline |
New problems have developed at GlaxoSmithKline's ($GSK) vaccine plant in Canada, interrupting production and affecting supply. The bottom line for Canada is that it will shave 2 million doses of its FluLaval trivalent vaccine off what GSK can deliver for the upcoming flu season. The impact on the U.S.? That is still being evaluated.
A GSK spokesperson said the issues were unrelated to concerns the FDA wrote up in a warning letter issued to the Ste-Foy, Quebec, plant in June. Health Canada also went in for a look. Health Canada said earlier this month that GSK's plan of action for fixing problems and meeting its commitment looked good. But days later, on Aug. 14, GSK temporarily suspended production to investigate "irregular results within our quality control monitoring." That shutdown lasted till Aug. 26 and will delay delivery of vaccines to the Public Health Agency of Canada, she said.
But further complicating matters, the company also had an "invalid test result on one component of the trivalent vaccine" and so needed to retest. When results came back inconclusive, the company struck just under 2 million doses off the amount of product it would be able to deliver in Canada. According to the Canadian Press, that amounts to 30% of what GSK pledged and more than 15% of the total doses the country expected to receive from all producers to face the impending flu season.
GSK said the "challenges" at the plant in recent months have interfered with production and affected delivery dates and the total amount of influenza vaccine supply the company will be able to deliver in the U.S. and Canada. The problems will affect its ability to provide any additional doses for the U.S., the company said, but it still hopes to provide at least 28 million doses of four-strain and three-strain flu shots to the U.S. this year. Some of that comes from a plant in Germany. That compares to the 26 million doses it sent to the U.S. last year but is also at the minimum level of the 28 million to 33 million doses it had said it would be able to produce for the U.S.
The "challenges" include the FDA warning letter in which FDA inspectors questioned the quality of the new FluLaval vaccine and its intermediates. It said that of 20 lots that had been manufactured in 2014 to that point, 21% had to be rejected because of bacterial growth and problems with "endotoxin excursions." Health Canada also took a look and found 10 observations. But GSK's efforts to fix some of the issues did not resolve them, leading GSK to resort to what the agency said was a "former process which had been in place … and had been used to safely produce vaccine for several years."
- here's the Canadian Press story