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By Richard Cuthbertson
Canwest News Service, Vancouver Sun
04/14/2010
CALGARY — The Alberta government is recalling more than 650,000 unused doses of adjuvanted H1N1 flu vaccine and is also seeking a refund from the pharmaceutical giant that manufactured the product.
The moves come after Health Canada recently slashed the original provisional expiration date on the vaccines from 18 months to just six.
That’s left Alberta with hundreds of thousands of doses, for which it paid $2.2 million, that are now reaching a six month shelf life and must be yanked, according to Dr. James Talbot, senior medical officer of health with Alberta Health and Wellness.
“It’s sort of an unprecedented situation,” he said in an interview Wednesday.
Talbot noted there are no safety issues with the vaccine, nor are there any adverse reactions associated with it. The issue, he said, is expired vaccine may not properly protect people from H1N1.
“To make sure that any of the stuff that’s about to be beyond its shelf life isn’t accidentally given to people, we’re pulling it back,” Talbot said.
Talbot said there will be discussions with federal authorities, regulators and the vaccine manufacturer, GlaxoSmithKline, about “reimbursements.”
Health Canada says that in October 2009 the vaccine was given a “provisional expiry date” of 18 months. But data no longer supports that assessment and Health Canada requested GlaxoSmithKline revise the shelf life.
“We are assessing impacts of the revised expiry date including the impacts on the purchase contract,” Health Canada spokeswoman Christelle Legault said in a e-mail. “Discussions with (GlaxoSmithKline) will continue. It’s premature to speculate on the outcome of these discussions.”
A spokeswoman with GlaxoSmithKline suggested in an e-mail that, after further testing, the shelf life could be extended in the future.
“Much of the vaccine that may have expired in Canada was delivered early in the vaccination program and Health Canada is evaluating what still remains,” Michelle Smolenaars Hunter said.
“Discussions are ongoing with Health Canada and it would be premature to speculate what the outcome of these discussions could be.”
Even though roughly 650,000 adjuvanted doses are being pulled in Alberta, there are no worries about a shortage of vaccine. Currently, only a handful of people a day are getting immunized, largely for travel reasons, Talbot said.
The medical officer also noted the province has 120,000 doses of the non-adjuvanted vaccine.
“We have more than enough for any kind of reasonable demand over the next little while until this is resolved,” he said.