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Flu vaccine delay has Health Canada scrambling to cover shortfall

Written by: Kate Schwass-Bueckert, QMI Agency
Sep. 4, 2014

(QMI Agency files)


Health Canada has turned to alternate flu vaccine suppliers after drug manufacturer GSK informed it there will be a delay in fulfilling Canada's order this year.

The problem with production was caused, in part, by "quality-control monitoring" issues, GSK said in a statement to QMI Agency.

But there is no shortage of vaccine for this upcoming flu season, the Public Health Agency of Canada (PHAC) said in a statement.

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"Provinces and territories are expected to have almost 12 million doses of vaccine available over the course of the season. This is more than was needed last year even with the current shortfall," the statement said.

Even so, the agency has submitted a supplemental order of 1.2 million doses through three additional manufacturers to bolster the "shortfall in additional supply," the agency said.

The first shipment of vaccine is expected the week of Sept. 15.

"A new delivery schedule for the flu vaccine from GSK is still being determined, but it is expected that deliveries will start in the second or third week of October, long before flu immunization demand reaches its peak," PHAC said.

The company, formerly GlaxoSmithKline, made headlines in recent months after inspectors with Health Canada and the U.S. Food and Drug Administration cited the company's Ste-Foy, Que., facility for failing to follow good manufacturing practices.

Canadian inspectors recorded 10 infractions in June, but said none were issues that would affect Canadians' health.

The same Health Canada report said that to ensure there is enough of the flu vaccine this fall for Canadians, the company reverted to a process used in 2012 that had been safely used to produce the vaccine for several years.

GSK said it identified quality-control monitoring issues at the Quebec facility on Aug. 14 and the production line was shut down until Aug. 26, which is part of the reason for the delay.

As well, the company had an "invalid" test result in a component of the trivalent vaccine — which protects against three different flu viruses — that, even with retesting, has come back with inconclusive results.

This will mean just under two million committed doses are no longer available, GSK communications manager Michelle Smolenaars Hunter said in an e-mail.

Shipments from GSK to the U.S. will also be affected, but she said they are not yet sure what the full impact will be south of the border.

The issues the company faced are unrelated to recent and planned inspections, Smolenaars Hunter said.

She said all vaccines that leave their facilities are safe.

"Vaccines manufacturing is a complex and rigorous process, involving quality-control monitoring at every step of production. Patient safety is GSK's first priority, and we are confident our quality-control standards ensure the safety of GSK influenza vaccines made available for patients," Smolenaars Hunter said.

"Every batch of GSK vaccine is subject to extensive review before it is released, and vaccines that do not pass this rigorous review are discarded."

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